Pharmaceutical Exec for maker of $150,000 per year Cancer Drug blasted

“I think, we’re very responsible in our drug pricing. And we tend to support the price of our drugs with strong economic data,” Caruso said. “So rather than pledge to a particular number, I think it’s important that we continue to develop robust data that provides a solid foundation for the value that our products provide the health care system.”
Those comments sparked immediate frustrations due to the fact that Johnson & Johnson has gained notoriety for its high drug costs. Currently, the pharmaceutical company is producing and marketing a cancer drug called Imbruvica, which costs roughly $9,550 for one bottle of 90 pills.
Imbruvica’s dosage calls for four capsules per day, meaning one bottle lasts about a 22 days. In total, a year-long supply of the drug would cost approximately $154,922. Another drug Johnson & Johnson markets, used to treat Hepatitis C, sells for a little more than $22,000 for a month’s supply, equaling $264,000 for a one-year supply.
“Johnson & Johnson’s justification for their prescription drug prices are outrageous,” Vijay Das, a health care advocate at Public Citizen, stated in response to Carusos’ conference call comments. “Sick patients and taxpayers are held hostage in order for the drug maker to extract extreme profits.”

New Breast Cancer drug effective against other types of Cancer

Palbociclib (Ibrance, Pfizer), a new oral drug whose efficacy in combating breast cancer has been demonstrated alone and in combination with endocrine therapy, also has the potential to combat other types of cancer, according to research conducted at the Abramson Cancer Center of the University of Pennsylvania. The findings were published in JAMA Oncology.
Palbociclib targets the rapid division of tumor cells by inhibiting the activity of the enzymes CDK4 and CDK6, which propel cell division in most cancers. It is the first CDK4/6 inhibitor to be approved for the treatment of breast cancer.
“This drug has minor effects on normal cells other than neutrophils,” said senior author Peter J. O'Dwyer, MD. “In tumors, it can cause shrinkage, or more commonly, arrest of growth. As we discover new functions for the CDK4/6 target of this medicine, we are likely to use it in combinations to make other anticancer agents work better.”
In addition to inhibiting the cell cycle, palbociclib has been shown, for example, to alter several recently described non–cell-cycle functions of CDK4/6, a finding expected to expand its therapeutic role, O’Dwyer added.

Cancer drug company, KaloBios, files for bankruptcy

KaloBios, the troubled drugmaker taken over by Martin Shkreli last month, is seeking bankruptcy protection less than two weeks after his arrest for securities fraud.
It is the second pharmaceutical with ties to the former hedge fund manager now in turmoil following his indictment on charges unrelated to his involvement with them, though the drugmakers are not lacking for problems of their own.
The other, Turing Pharmaceuticals Inc., is cutting jobs and seeking a new CEO after Shkreli resigned the position because of his arrest.Turing, under Shkreli, acquired the rights to a treatment for a rare parasitic infection that mainly strikes pregnant women and raised the price from $13.50 to $750 per pill.
A report published in May by the pharmacy-benefits company Express Scripts found that 576,000 Americans spent at least $50,000 on prescription drugs in 2014, a sum roughly equivalent to the U.S. median household income.
An investigation by the Senate Special Committee on Aging is now focused on Turing and three other pharmaceutical companies.
So when it was revealed that Shkreli had acquired a controlling stake in publicly traded KaloBios, a failing drug developer doing research on cancer treatments, its shares soared 20 percent in a day.

Most effective way to treat Lung Cancer

A new study conducted by the Jonsson Comprehensive Cancer Center at UCLA, which enrolled over 1,000 people who had PD-L1-expressing non-small cell lung cancer (NSCLC), the most common type of lung cancer, appears to show that cancer immunotherapies are far superior to chemotherapy when it comes to treating lung cancer. In UCLA's study about two-thirds of the patients enrolled tested positive for PDL1-expressing tumors. All patients, regardless of PD-L1 expression, were randomly assigned into three groups: two who received differing doses of Merck's Keytruda, and one who got chemotherapy. As a whole, the results showed that patients receiving Keytruda were considerably more likely to have their tumors shrink significantly compared to the chemotherapy group. Additionally, patients receiving Keytruda also lived significantly longer than those who received chemotherapy. Patients on Keytruda also had less incidence of treatment toxicity than the chemotherapy cohort. Cancer immunotherapies have demonstrated remarkable responses in a number of different cancer types, lending hope that new treatments may be on the way.

Tiny drones to target Cancer

Dr. Wilfred Ngwa, a medical physicist in radiation oncology at Brigham and Women’s Hospital, is working to apply drone technology to cancer treatment.

Ngwa and his colleagues have developed tiny drones designed to target and kill cancer cells that have spread in the body. The drones are implanted into the tumors carrying immunotherapy medicine and microscopic nanoparticles that can amplify the effect of radiation therapy on cancer cells locally.

“Once they are implanted, as is currently done in the clinic,” Ngwa said. “They can be programmed to release these microscopic nanoparticles and the immunotherapy medicine so that they can work together with the radiation to train your white blood cells to fight cancer more effectively.”

After the cancer cells begin to die, he said the immunotherapy medicine acts as a “homing beacon,” calling in the patient’s white blood cells, which are then trained to kill the cancer cells and able to patrol the rest of the body, fighting cancer cells that have spread. The “drones” are made of FDA-approved, biodegradable polymers. The medicine is loaded onto them, and they are programmed to trigger the release of the treatment on the desired schedule. Once they’ve been implanted into a patient and have released the therapy, they biodegrade.

Preventing Cancer is not the priority in Drug Development

The way the patent system interacts with the Food and Drug Administration’s drug approval process skews what kinds of cancer clinical trials are run. There’s more money to be made investing in drugs that will extend cancer patients’ lives by a few months than in drugs that would prevent cancer in the first place.

That’s one of the findings from the work of Heidi Williams, an M.I.T. economics professor and recent MacArthur Foundation “genius” grant winner, who studied the problem along with Eric Budish, a University of Chicago economics professor, and Ben Roin, assistant professor of technological innovation, entrepreneurship and strategic management at M.I.T. To secure F.D.A. approval, after patenting a drug, drug companies race the clock to show that their product is safe and effective. The more quickly they can complete those studies, the longer they have until the patent runs out, which is the period of time during which profit margins are highest. Developing drugs to treat late-stage disease is usually much faster than developing drugs to treat early-stage disease or prevention, because late-stage disease is aggressive and progresses rapidly. This allows companies to see results in clinical trials more quickly, even if those results are only small improvements in survival.

Many more cancer trials focused on treatments for patients with late-stage cancers than for early-stage cancers, according to the study. Between 1973 and 2011, there were about 12,000 trials for relatively later-stage patients with a 90 percent chance of dying in five years. But there were only about 6,000 focused on earlier-stage patients with a 30 percent chance of dying. There were over 17,000 trials of patients with the lowest chance of survival (those with recurrent cancers) but only 500 for cancer prevention.

Melanoma treatment could benefit from nanotech drug

Current treatments are hampered because producing drug levels in the lymph node high enough to eliminate tumors creates problems with toxicity. Another drawback is the cancer often also becomes resistant to treatment.
The researchers say the new approach, which they have tested on laboratory animals, can also decrease drug resistance and the toxic effects that this type of chemotherapy often brings.
The nanotech drug-delivery system could also be a step forward in the treatment of any cancer that tends to spread through the lymphatic system, says lead author Adam Alani, an assistant professor in Oregon State University's College of Pharmacy.
In addition to melanoma, cancers of the breast, prostate, pancreas, gastric system, lung, and head and neck also tend to spread via the lymphatic system.
The main disadvantage of current treatments is that the levels of drugs required to have a therapeutic effect in the lymphatic system are too toxic. Also, giving the drugs one at a time tends to breed resistance to them.
Nanoparticles are tiny particles ranging between 1-100 nanometers in size, or about the same size as biomolecules such as proteins and antibodies. By controlling their chemistry, size and surface charge, scientists can engineer them to carry drugs to precise targets in the body.

Keytruda helps in fight to treat Lung Cancer

Pembrolizumab is shown to be effective against various types of cancer, including melanoma and lung cancer, where it has shown durable anti-tumor activity and acceptable toxicity in previously treated and untreated patients with advanced NSCLC.
The trial, which took place from August 2013-August 2015, enrolled 1,034 patients from 24 countries from Europe, the USA and Asia (including Japan, South Korea and Taiwan). Patients with tumors that expressed the highest amounts of PD-L1 responded better and lived, on average, twice as long as patients treated with docetaxel alone (14.9 months versus 8.2 months), said senior author Roy S. Herbst, M.D., the Ensign Professor of Medicine and chief of medical oncology at Yale Cancer Center and Smilow Cancer Hospital at Yale-New Haven.
The immunotherapy was also definitively found for the first time to be effective in patients with low levels of PD-L1 in their tumors. In this study supporting the first-line approval, patients given KEYTRUDA 10 mg/kg every two weeks demonstrated a 37 percent reduction in the risk of death and those given KEYTRUDA 10 mg/kg every three weeks demonstrated a 31 percent reduction in the risk of death.

Study finds mechanism that causes normal cells to become Cancer

Researchers studying brain tumors said they have discovered a new biological mechanism that causes normal cells to become cancer cells, a finding that both challenges current treatment strategies and could lead to new approaches against the disease.
In a study published online Wednesday in the journal Nature, the researchers reported that a mutation in what are called IDH genes causes changes in how DNA is folded into the nucleus of cells. This in turn enables abnormal interactions between other genes, turning on a process that promotes the development of tumors.
“This shows us there is a whole other side of how cancer can form and progress,” said Jeremy Rich, chairman of stem cell biology and regenerative medicine at the Cleveland Clinic.While the study focused on the brain tumor called glioma, researchers said mutant IDH genes are present in many other cancers, including leukemia, and colon and bladder cancers.The process appears to operate independently of the so-called driver mutations that fuel cancer. The finding may help explain why treating tumors with drugs targeted at such mutations. a strategy known as precision medicine, is having limited success. While such targeted treatment often dramatically shrinks tumors initially, in most cases, patients eventually relapse.
“This puts a further dent in our ability to think that silver bullets are ready-in-the making for many cancer types,” Dr. Rich said.

Developing more precise Lung Cancer imaging

Researchers at The University of Texas at Arlington and the University of Washington are working on a solution and have developed a new, personalized respiratory-motion system that uses mathematical modeling to capture images of a patient's lung when it is depressed, offering a clearer, more precise image of the tumor to be destroyed.
The work is supported by a three-year, $250,000 National Science Foundation grant and promises to lead to improved, more precise radiation therapy. Shouyi Wang, an assistant professor in UTA's Industrial, Manufacturing and Systems Engineering Department and a data analytics expert, is the principal investigator on the grant.
Wang's approach monitors respiratory gating, or a patient's motion breath-by-breath, and uses the data collected to focus a radiology beam on the targeted area when the chest cavity is relaxed -- the stage that provides the best picture of a cancerous site.
"We will develop a powerful new mathematical model that considers different factors and takes into account all of the major variables, and predicts performance and the best method for a particular patient," Wang said. "Respiratory gating is a readily available technology, but it has been very slow to gain acceptance in managing respiratory motion in radiation therapy.
"We are going to build evidence that it works, that it can be better utilized, easily implemented and that it can be cost-effective."

Non-invasive early Cancer detection

AWSensors, is coordinating the European project LIQBIOPSENS to develop liquid biopsy technologies for the early detection of colorectal cancer. The new system will allow quick and easy cancer detection and monitoring at a third of the cost of existing, typically invasive, procedures.
The Spanish company AWSensors has developed technology for a high-sensitivity molecular detection system for use in cancer screening. It is based on a technique known as liquid biopsy: the analysis of small fluid samples, like blood or saliva, making it completely non-invasive. It is also fast, giving results within the hour. When combined with genomic analysis, it will be possible to obtain reliable early diagnoses and devise precision medicine approaches to cancer treatment.The new system will be tested on the blood samples of colorectal cancer patients over the next three years. This cancer is the second cause of death in Europe and one of the most common, alongside breast, lung and prostate cancers.
The current go-to method for reliable cancer diagnosis is tumor tissue biopsy, but this method is invasive, painful and expensive. It also only provides information of a single point in the evolution of the disease. The new system also has the advantage of being up to three times cheaper than other real-time methods, such as quantitative PCR, and can be carried out by non-specialists.
LiqBiopSens will therefore enable simple, inexpensive, non-invasive screening for early detection and periodic monitoring of tumors.

Gene therapy platform for Macular Degeneration

Physics researchers at The University of Texas at Arlington have developed a new platform that uses ultrafast near-infrared lasers to deliver gene therapy to damaged areas of the retina to enable vision restoration in patients with photo-degenerative diseases.
"Most therapies focus on slowing down or halting degeneration but cannot target already-damaged areas of the retina," said Samarenda Mohanty, assistant professor of physics and head of UTA's Biophysics and Physiology Group, who led the research. "Our capacity to specifically target these damaged areas cell by cell opens up a new world of possibilities for vision restoration."
The laser-based method creates a transient sub-mircometer hole that allows the gene for light-sensitive proteins, or opsins, to permeate into the damaged retinal cell. The genes are then activated to produce the opsins, which attach to the cell membrane and convert external light into the photocurrent signals that are basis of sight.

Groundbreaking Breast Cancer laser treatment

A promising new treatment for early stage breast cancer recently wrapped up its first round of clinical trials.
The treatment "Novilase Breast Therapy"- or laser ablation, replaces traditional surgery.
"So instead of excising the cancer, like we have traditionally done with lumpectomies we can insert a laser fiber into the center of the cancer and heat it thereby killing the cancer cells with heat as opposed to surgically excising it," said Dr. Barbara Schwartzberg who led the clinical trial at Rose Medical Center.
The trial participants came from 11 institutions, including Rose. Most of the locations were across the U.S. And that first clinical trial had a 91% success rate among the patients.
Schwartzberg says instead of patients going to the operating room, receiving anesthesia and a large scar after it's done; this method is done as an outpatient procedure with local anesthesia and excellent cosmetic outcome.
"Once they're done, they're up, band-aid, wrap, hug and they are on their way," says Schwartzberg.

Brain Cancer patients beat odds with experimental treatment

The tumor-treating fields, as the therapy is called, disrupts the division of cancer cells by delivering low-intensity, intermediate-frequency alternating electric fields. It is delivered through “transducer arrays” attached to the shaved scalp. The randomized control trial of the device would determine whether the therapy improved survival rates of patients with glio-blastoma multiform.
In 2014, the clinical trial was terminated because the results were so positive. There were 210 patients using the electric field device as well as receiving chemotherapy and 105 receiving chemo alone. After 38 months, the median overall survival rate for those using the device plus the chemotherapy drug temozolomide was 20.5 months. The median overall survival rate for those using temozolomide alone was 15.6 months. Put another way, 43 per cent of people who received the experimental therapy as well as the standard therapy were alive after two years, compared to 29 per cent who just received the standard therapy. The study was funded by Novocure Ltd., the company that manufactures the device.

X4 to begin trials of Cancer Drugs

Cambridge-based X4 Pharmaceuticals is run by one of Termeer’s former employees at Genzyme, Paula Ragan, who worked in various business development roles there from 2007 to 2012. While the Series A investment the company is announcing today (a round led by Cormorant Asset Management) has been known for a few months now, Ragan said in an interview that the company is about to become more high-profile

“This is really our coming out party,” she said. “We’ve been around, building momentum for the past year-plus.”

By the end of March, Ragan plans to begin an initial trial of a drug that inhibits production of a certain protein called CXCR4. Ragan explains that the protein acts as a beacon to attract cells to surround a tumor, effectively hiring the tumor from the body’s T cells that would otherwise destroy them. By blocking CXCR4, the drug can eliminates one way that solid cancers try and evade detection.

Laser treatment shows promise for early Breast Cancer

Using a laser to heat and destroy tumors, called laser ablation, may be an effective way to treat small breast cancers, potentially saving some women from a lumpectomy, new research suggests.
The laser ablation technique used in this study is called Novilase Breast Therapy. It involves placing small probes in the center of the cancer and then using heat from the laser to destroy the tumors.
“It works,” said Dr. Barbara Schwartzberg, a breast cancer surgeon at the Sarah Cannon Research Institute at Rose Medical Center in Denver. Schwartzberg is also the chief medical officer for Novian Health, the company behind Novilase Breast Therapy, and the sponsor of the study.
The researchers behind the new study evaluated 60 women with early stage, small breast cancers that measured up to 2 centimeters in diameter, or about three-quarters of an inch. The women were treated at various sites in the United States and the United Kingdom.
After laser ablation treatment, the tissue that was heated slowly shrinks and forms a scar, according to the Society for Interventional Radiology. The women in the study also had radiation therapy.
Four weeks after the ablation treatment, the treated tissue was removed through surgery. The researchers then examined this tissue to look for remaining cancer cells. The women also had MRIs.
The researchers found that 91 percent of the patients had complete destruction of the cancer when the laser procedure was performed according to technical guidelines. Overall, there was an 84 percent complete tumor destruction rate with the laser treatment, the study found.

Lung Cancer Treatment granted accelerated approval

U.S. health regulators on Friday said they have granted accelerated approval to Roche Holding's drug for advanced lung cancer in patients with a specific genetic mutation.                                                The drug, alectinib, to be sold under the brand name Alecensa, was approved to treat patients with advanced ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate, treatment with Pfizer's Xalkori.
"Today's approval provides a new therapy for a group of patients who would have few treatment options once their disease no longer responds to treatment with Xalkori," Richard Pazdur, head of the Food and Drug Administration's Hematology and Oncology Products division, said in a statement.

Aspirin doesn't help Breast Cancer outcomes

Researchers found no link between taking aspirin and improved breast cancer outcomes, however the drug's effect on breast density may help with earlier diagnosis, according to two new studies presented at a conference on breast cancer.
Several studies have shown aspirin to cut the risk of colorectal, breast and other cancers.
Researchers from the University of Pennsylvania presented the new studies at the San Antonio Breast Cancer Symposium. "Past studies have found that aspirin may hold anti-cancer benefits. However, many of them were preliminary, preclinical, and didn't support a clear mortality benefit. They also didn't look at prior use of aspirin," said Dr. Julia Tchou, an associate professor of surgery at the University of Pennsylvania. "Our data did not support the notion that this century-old pill has protective qualities and down-the-road benefits for breast cancer patients. However, larger patient cohort studies are needed to confirm our results."

FDA grants Orphan Drug Designation for treatment of Ovarian Cancer

TapImmune, Inc. (TPIV), a clinical-stage immunology-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer & metastatic disease, announced today that it has received Orphan Drug Designation from the U.S. Food & Drug Administration's Office of Orphan Products Development (OOPD) for its cancer vaccine TPIV 200 in the treatment of ovarian cancer. The TPIV 200 ovarian cancer clinical program will now receive benefits including tax credits on clinical research and 7-year market exclusivity upon receiving marketing approval.

TPIV 200 is a multi-epitope peptide vaccine that targets Folate Receptor Alpha which is overexpressed in multiple cancers including over 90% of ovarian cancer cells.  In Phase I clinical studies conducted at the Mayo Clinic in patients with breast and ovarian cancer this vaccine was shown to be safe and well tolerated and to give robust cellular immune responses in 20 out of 21 evaluable patients.  Further, the data showed that 16 out of 16 patients in the observation stage still showed immune responses.

Therapy for Prostate Cancer may increase Alzheimer's risk

Men taking androgen deprivation therapy (ADT) for prostate cancer were almost twice as likely to be diagnosed with Alzheimer’s disease in the years that followed than those who didn’t undergo the therapy, an analysis of medical records from two large hospital systems by Penn Medicine and Stanford University researchers has shown. Men with the longest durations of ADT were even more likely to be diagnosed with Alzheimer’s disease. The findings do not prove that ADT increases the risk of Alzheimer’s disease. But the authors say they clearly point to that possibility, and are consistent with other evidence that low levels of testosterone may weaken the aging brain’s resistance to Alzheimer’s. “We wanted to contribute to the discussion regarding the relative risks and benefits of ADT, and no one had yet looked at the association between ADT and Alzheimer’s disease,” “Based on the results of our study, an increased risk of Alzheimer’s disease is a potential adverse effect of ADT, but further research is needed before considering changes to clinical practice.”

Drug-laden “popping bubbles” treatment for Liver Cancer

In an interdisciplinary collaboration between prominent academic and industry investigators, researchers have discovered a novel method for repositioning an FDA-approved anti-cancer compound so it can specifically target liver cancer tumors. A “triple attack” technique combining chemotherapy, thermal ablation, and hyperthermia provided a highly targeted, yet minimally invasive approach.“In this study, we re-purposed the topical agent bexarotene (Targretin), currently in limited use for cutaneous manifestations of T-cell lymphomas, and re-engineered it for use in solid tumor applications by forming self-assembling nanobubbles,” explained Dipanjan Pan, assistant professor of bioengineering at the University of Illinois at Urbana-Champaign, who led the study. “These tiny bubbles filled with Targretin in ‘prodrug’ form can be ‘popped’ to release the drug inside liver cancer cells, activating the prodrug during cellular internalization process. The probability of its undesired systemic release is minimal due to this highly selective activation mechanism, which helps to spare the healthy cells.”

Using a deadly virus to kill Cancer

The virus, called Lassa, is the cause of a particularly nasty hemorrhagic fever endemic to West Africa. The research sounds terrifying, but a team from Yale and Harvard universities is using part of Lassa’s genetic code to make another virus safe enough to inject into the human brain, where it will hunt down and kill cancer cells. Lassa’s partner in this search-and-destroy mission is vesicular stomatitis virus, or VSV. Most people who contract it never get sick, and those who do usually have only flulike symptoms. But if it infects the brain, VSV becomes deadly. Ironically, it’s the more fearsome Lassa that makes the usually innocuous VSV safe for use in that delicate organ.
The Lassa-VSV virus is a chimera, an organism that’s created by combining the genomes of two different organisms to make something new. It kills brain tumors without damaging healthy neurons, apparently because it can bind with normal cells but doesn’t actually infect them.When researchers implanted two tumors into mouse brains, one in each hemisphere, and then injected the mice with Lassa-VSV, the virus infected and killed one tumor, then diffused through the brain to attack the second one without infecting brain cells along the way.

Coffee chemicals may ward off type 2 diabetes

The prevalence of coffee and diabetes in modern media makes a great deal of sense: almost 1 in 10 Americans are diabetic, and more than half of American adults drink coffee daily.

The US spends roughly $40 billion on coffee per year, and in 2012, the total estimated cost of diagnosed diabetes in America was $245 billion. There are more than 1,000 distinct chemical compounds in coffee. This includes quinic acid, 3,5-dicaffeoylquinic acid, acetylmethylcarbinol, dimethyl disulfide, putrescine, niacin, trigonelline, theophylline and of course, caffeine. 

Recent research conducted by Søren Gregersen and colleagues at the Department of Endocrinology and Internal Medicine at Aarhus University Hospital in Denmark may have narrowed the search to as what effects occur.  The present study found that cafestol and caffeic acid increased insulin production in the presence of glucose. Cafestol was also found to increase glucose uptake into muscle cells at a similar rate to current diabetes drugs. "This newly demonstrated dual action of cafestol suggests that cafestol may contribute to the preventive effects on type 2 diabetes in coffee drinkers."

This

study will add another welcome avenue of research into potential treatments for diabetes. 

Depressed head and neck Cancer patients have higher recurrence risk

Depression is a significant predictor of five-year survival and recurrence in head and neck cancer patients, according to a new study from The University of Texas MD Anderson Cancer Center. The research team focused their analysis on a single cancer type. By limiting the sample set and adjusting for factors known to affect outcome, such as age, tumor size and previous chemotherapy, they were able to uncover a more profound effect of depression.
The researchers followed 130 MD Anderson patients newly diagnosed with oropharyngeal squamous cell carcinoma (OSCC), a type of head and neck cancer in which the tumor originates at the back of the throat and base of the tongue.
At the beginning of their radiation therapy, patients completed a validated questionnaire to identify those with symptoms of clinical depression. Researchers monitored the participants, all of whom completed treatment, until their last clinic visit or death, a median period of five years.
Depression was the only factor shown to have a significant impact on survival.
Patients scoring as depressed on the questionnaire were three-and-one-half times less likely to have survived to the five-year interval, compared to those who were not depressed on this scale. The degree of depression was also found to be significant, as every unit increase on this scale resulted in a 10 percent higher risk for reduced survival.
The results were replicated with a different psychological health survey and were not influenced by how soon following diagnosis the depression assessment was done.

New leads in the struggle against Leukemia

The research initiative generating these leads, Beat AML, is led by the Knight Cancer Institute at Oregon Health & Science University and The Leukemia & Lymphoma Society (LLS). Beat AML brings together academic health centers and biopharmaceutical companies to accelerate discoveries that will improve outcomes for patients with acute myeloid leukemia (AML), a blood cancer lacking effective treatments. Less than 25 percent of newly diagnosed patients survive beyond five years.
A total of nine pharmaceutical and biotech companies have joined the collaboration, providing 27 potential treatments for analysis on the research platform. Recent additions are: argenx; AstraZeneca; Genentech; Janssen Research & Development, LLC; Seattle Genetics; and Takeda Pharmaceuticals International Co. Among the participants that joined early on are Aptose Biosciences and Constellation Pharmaceuticals.
"Acute myeloid leukemia is now the most frequently diagnosed leukemia in adults, while the current standard of care is based on 40-year-old chemotherapy agents with a very poor cure rate," said Louis J. DeGennaro, Ph.D., LLS's president and CEO. "LLS, together with its partners in the Beat AML collaboration, has gone on the offense against this deadly disease to lead the way to new treatment options desperately needed by patients."

Cancer Treatment Centers of America® earns Top Hospital Award

For the first time, The Leapfrog Group has named Cancer Treatment Centers of America (CTCA) at Midwestern Regional Medical Center (Midwestern) to its annual list of Top Hospitals. This recognition showcases the hospital's commitment to providing safe, efficient and high quality patient care.  Out of the 1,600 hospitals that reported information to The Leapfrog Group, CTCA at Midwestern was one of only 98 to receive the honor of being named a Top Hospital. On November 27, 2015 CTCA at Midwestern opened a 168,078 square-foot, six-story inpatient tower to better serve patients from around the country and internationally. The new tower offers 72 innovative, single-occupancy inpatient oncology rooms, and common space designed to bring comfort and convenience to patients and their loved ones. When designing the tower, the same elements that made CTCA at Midwestern a Top Hospital were considered of utmost importance, including superior patient care, safety and efficiency. Only six percent of hospitals eligible receive the Top Hospital award, which is given to urban, rural and children's hospitals that publicly report their performance through the annual Leapfrog Hospital Survey and meet the high standards defined in each year's Top Hospitals Methodology. The selection is based on the results of the survey, which measures hospitals' performance on patient safety and quality, focusing on three critical areas of hospital care: how patients fare, resource use and management structures established to prevent errors. Performance across many areas of hospital care is considered in establishing the qualifications for the award, including survival rates for high-risk procedures and a hospital's ability to prevent medication errors.

CTCA serves patients from around the world at its hospitals in Atlanta, Suburban Chicago, Philadelphia, Phoenix and Tulsa. For more information, visit cancercenter.com, Facebook.com/cancercenter and Twitter.com/cancercenter.

Singapore finding leads to new Cervical Cancer treatments

The team from the NUS Cancer Science Institute of Singapore (CSI Singapore) found new molecular interactions involved in the development of tumors in cervical cancer.
They found that the human papilloma virus (HPV), which causes cervical cancer, interacts with a protein called EDD1 to destabilize a tumor suppressor protein, which stops the formation of tumors.
The three-year study also showed that an increase in a tumor suppressor protein called TIP60, found in the human body, could prevent the growth of cancer cells.
The protein acts as a "guardian of the cell" against cancerous growth, said Assistant Professor Sudhakar Jha, principal investigator at CSI Singapore, who was involved in the study.

The discovery is an exciting one, he says, as understanding the interactions is a critical first step towards coming up with treatments to target HPV-induced cancers.
Current treatment methods such as surgery and chemotherapy come with their limitations, he noted. "The problem with chemotherapy is that it kills not just the cancer cells but also other normal cells," said Prof Jha.
The roles of EDD1 and TIP60 had not been well explored in previous studies and this is the first to show how the protein EDD1 interacts with TIP60.
While still in its early stages, the finding could help develop treatments to either restore the tumour suppressor protein to normal levels or target the EDD1 protein. In patients with cervical cancer, the levels of TIP60 are 80 per cent lower than normal levels.

Lung Cancer patients gain access to new treatment

Another approval by the U.S. Food and Drug Administration (FDA) that helps in the fight against lung cancer, the fourth in two months. The FDA approved necitumumab (Portrazza) in combination with standard chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for their advanced disease.

Necitumumab binds to the epidermal growth factor receptor (EGFR), a protein commonly found on squamous NSCLC tumors, and blocks EGFR from binding its ligands, thus preventing tumor growth. Necitumumab is the first monoclonal antibody type of EGFR inhibitor to be approved in lung cancer, whereas there are a number of tyrosine kinase type of EGFR inhibitors (TKI) already FDA approved and used in clinical practice. These TKIs include gefitinib, erlotinib, afatinib, and osimertinib.
"This marks the fourth approval by the FDA in less than two months for a therapeutic designed to treat lung cancer. This is remarkable. It demonstrates the amount of progress being made in the field and the new hope that exists for lung cancer patients, especially those with squamous histology," said Fred R. Hirsch, MD, PhD, Professor of Medicine and Pathology at the University of Colorado Cancer Center.

Australian researchers create new Brain Cancer treatment

A new three-pronged therapy to treat some of the most aggressive malignant brain tumors is twice as effective than current treatments, researchers from UOW have found.
The therapy, developed by scientists at UOW's Centre for Medical Radiation Physics (CMRP) and recently published in journal Physics in Medicine and Biology, combines radiation, chemotherapy and a radio-sensitising drug in vitro. It has been shown to more than double tumour cell death compared to a radiation-only control in high-grade glioma brain tumours.
On average, approximately 1600 brain cancers are diagnosed each year in Australia; that is roughly one person diagnosed every five hours. "In Australia, the five-year survival rates for brain cancer are low compared to other cancers. Radiotherapy, chemotherapy and surgery act only as palliative treatment options for these patients and we haven't seen any improvements in treatment in the past 30 years."
Dr Oktaria said her team combined two types of drugs prior to applying radiation, a radiosensitiser (BrUdR), which makes the tumour more sensitive to the radiation, and a chemo drug (MTX), which helps to block the growth of tumor cells after the radiation has been delivered.
"The combination of drugs and radiation enables more radiation dose to reach the target. This means that a much lower dose, 2.3 times less, can be used to kill 90 per cent of the tumour cells."
"This is expected to improve local tumour control while reducing adverse effects caused by the exposure of healthy brain tissue to radiation, which can impair brain function and cause problems with memory and speech."
The research, conducted at the Illawarra Health and Medical Research Institute at UOW and the Prince of Wales Hospital in Sydney, also proved promising as it uses a conventional x-ray machine, meaning hospitals do not need to be provided with new equipment to utilize the treatment.

Please Give to Sydney 12-year-old with Hodgkin's Lymphoma Cancer Fund

The family of a 12 year old Sydney boy who are fundraising so he can access an expensive cancer drug have said they are "incredibly embarrassed" to have to rely on the goodness of Australians to complete their son's treatment for Hodgkin's Lymphoma. Following two months of intensive chemotherapy, Angus successfully beat the Hodgkin Lymphoma in his neck into remission.

February, the family's fears came to fruition when the cancer returned in Angus' neck and abdomen.

The treatment was more intense, chemotherapy then radiotherapy, followed by a stem cell transplant.

The drug brentuximab can reduce the chances of another relapse by 40 to 50 percent.
However, the cost of the drug is $11,000 per dose and Angus will need 16 treatments, the total cost coming to $186,000. Unfortunately, for Angus, the drug is not listed on the Pharmaceutical Benefit Scheme as an appropriate treatment for Hodgkin's Lymphoma, due to insufficient data in Australia!

Founded is the charity Rare Cancers Australia after identifying a gap in support for patients who suffer from less common cancers, have set up a special fundraising website called "Sick or Treat" on Toby's behalf, where fully tax deductible donations can be made.

Rare Cancers Australia and the pharmaceutical company behind brentuximab have been able to subsidise the cost of the drug to $100,000, with $32,000 already raised on Angus' behalf.

Donations to help Angus gain access to brentuximab can be made via the Rare Cancers Australia Sick or Treat website.

IntelliSpace Portal 8.0 platform for the treatment of Cancer

Royal Philips' IntelliSpace Portal 8.0 helps address the changing demands in radiology that result from an increasing prevalence of cancer and its economic toll. It delivers new applications, like fast 3-D quantitative renderings of tumors, in a fully integrated oncology suite to improve diagnostic confidence and patient care. A key but challenging clinical need for today's radiologists is determining how tumors are reacting to new local image guided treatment approaches, such as tumor ablation and chemoembolization. Currently, this is done by evaluating 1-D or 2-D MRI-images taken after the procedure, which give only limited insight and no quantified information. With the growing interest in finding new 3-D quantification options, IntelliSpace Portal 8.0 now includes, as an option for qualified researchers, a quantitative technology (qEASL), which can be used in conjunction with its Multi-Modality Tumor Tracking (MMTT) application. With this technology, researchers can make a specialized analysis of 3-D imaging scans (e.g. CT and MRI) with the aim to enhance measurement of living and dying tumor tissue by giving them a visual indication of how cells respond to therapy.

Scientists create a multifunctional endoscope to detect Cancer

A scientific team from the Center for Nanoparticle Research within the Institute for Basic Science (IBS) has developed a multifunctional endoscope that integrates transparent bioelectronics such as lasers with theranostic nanoparticles (NPs), therapy to test new medication and tailor a unique treatment plan for a patient. Conventional endoscopes lack the spatial resolution necessary to detect and treat small cancers and other abnormalities.
The team, led by the director of the Centre for Nanopaticle Research Professor Taeghwan Hyeon, demonstrated a multifunctional surgical endoscope system to diagnose and treat intestinal diseases, such as colon cancers. This 'smart' endoscope system contains transparent bioelectronics, which provides pH-based sensing combined with radio frequency ablation (RFA); a medical procedure in which part of the electrical conduction of a tumor is ablated using heat generated from a medium frequency alternating current.
The system's additional sensors for monitoring mechanical contacts and mapping temperatures provide accurate physiological sensing capabilities during cancer detection and ablation. The transparency enables optimal integration of a number of multifunctional sensing and therapeutic components on the endoscope tip without blocking the line of sight of the camera or light. By loading transparent bioelectronics on the camera of the endoscope, the tissue observed through the camera in fluorescence mapping and phototherapies can be exactly matched with the characterized ablated tissues by transparent devices. The system also has custom-designed biocompatible NPs with phototherapeutic and chemotherapeutic agents, which can be delivered locally and activated with light. According to the team's paper, this multifunctional endoscopic system could be useful for the detection of flat or depressed abnormal growths.

Cancer cells can poison normal cells

Now a team of researchers from the University of Delaware, Nemours/A.I. duPont Hospital for Children, St. Joseph's Hospital and Medical Center in Phoenix and Therapy Architects LLC in Wilmington, Delaware, has reported that cancer cells can actually cause neighboring normal cells to become cancerous. They found that cancer cells produce an enzyme, a protease, which splits a cell-cell adhesion molecule called E-cadherin from normal cells. The action of the protease liberates the segment of E-cadherin that projects outside the cells. This segment, designated soluble E-cadherin, or sE-cad, then associates with a signaling molecule called epidermal growth factor receptor on normal cells and converts them to cancerous cells.
"The serum of adult cancer patients contains high levels of sE-cad," says Pratima Patil, who received her doctorate in biological sciences from the University of Delaware earlier this year. "Our finding documents that tumor cells modify normal epithelial cells, disrupting their cellular architecture, and use them as accomplices to generate sE-cad, which is known to facilitate tumor progression."
This finding opens up new cancer research areas, including determining how cancer cells interact with neighboring normal cells and promote cancer development. 

Pigeons used to diagnosis Cancer

Brazilian folk tradition holds that if your asthma is acting up, you might consider sharing dinner with a bird. Feeding leftovers to a white-naped jay in particular is thought by some healers to transfer the illness to unsuspecting avians. If that doesn’t work, the roasted, powdered liver of the black vulture also apparently helps open restricted airways.
Birds and certain bird bits, their beaks, their feathers, their livers, are involved in traditional remedies throughout the world, practices that trace back to Mesopotamia, Ancient Egypt and early China. It turns out birds may play a helpful role in modern western medicine too. A new study suggests that the common pigeon can reliably distinguish between benign versus malignant tumors and, in doing so, could help researchers develop better cancer screening technologies.
In the study, 16 pigeons were trained to detect cancer by putting them in a roomy chamber where magnified biopsies of possible breast cancers were displayed. Correctly identifying a growth as benign or malignant by pecking one of two answer buttons on a touchscreen earned them a tasty 45 milligram pigeon pellet. Once trained, the pigeons’ average diagnostic accuracy reached an impressive 85 percent. But when a “flock sourcing” approach was taken, in which the most common answer among all subjects was used, group accuracy climbed to a staggering 99 percent, or what would be expected from a pathologist. The pigeons were also able to apply their knowledge to novel images, showing the findings weren’t simply a result of rote memorization.

Experimental Brain Cancer treatment

A new clinical trial in which cancer patients are given a chemotherapy drug delivered directly into their tumors is giving hope to people with a highly aggressive type of brain cancer. An experimental drug treatment program at Lenox Hill Hospital in New York City directed by Dr. John Boockvar.
"So this clinical trial is novel because we're giving a high dose of the medication that we normally give by mouth directly into the tumor," Boockvar said.
A catheter is placed in the patient's groin and threaded to the brain, so that a higher amount of the drug goes directly to the tumor. "And thereby limiting exposure to the rest of your body of that drug," Boockvar explained.
The second phase is about to roll out and will determine the effectiveness of the treatment.

Montreal doctor at forefront of promising Cancer Drug study

One such promising advance, is that a new drug cocktail therapy used experimentally sent the first few patients, about 40 in total located in Quebec, United States, England and British Columbia, who tried it into “complete remission,” Saad says. “So we’re very excited about this response.”
Lead investigator Saad and his team at the Centre hospitalier de l’Université de Montréal Research Centre (CRCHUM) are now testing this drug in several centres worldwide. The drug is not yet approved for patient use, and goes by its developmental code name ARN-509 and JNJ-56021927.
The drug blocks genes that affect prostate cancer cell growth. It’s combined with anti-androgen drug Zytiga (abiraterone acetate), which stops the production of the hormone testosterone that feeds prostate cancer cells. Zytiga was approved three years ago, and is usually prescribed alone — the go-to treatment for aggressive prostate cancer. But when that fails, patients with advanced cancer die within 18 months on average.
“This is one of the first combination treatments of two drugs rather than one, and it attacks the cancer in a complementary fashion,” said Saad, who last year recruited several patients locally to participate in the initial clinical trial for safety.

New Liver Cancer treatment introduced in Bangladesh

The procedure, transarterial chemoembolization (TACE), is regarded as the best option for those whose cancerous tumour in the liver cannot be removed surgically.
A team led by Associate Professor of Hepatology of the Bangabandhu Sheikh Mujib Medical University Mamun-Al-Mahtab Shwapnil carried out the procedure at a private hospital on Friday.
 This procedure had been implemented in Bangladesh for the first time.
“This marks a new era in the arena of interventional hepatology in Bangladesh,” he said.
Surgery is not possible for many liver cancer patients due to the size and location of the tumor, particularly when it grows into the blood vessels.
Globally doctors use other methods of treatment as well as TACE.
This is a minimally invasive image-guided treatment in which chemotherapy is delivered directly to the tumor through blood vessels.“Our (Bangladeshi) patients will now have access to this unique and advanced management of liver cancer at less than half the price of TACE in India,” Shwapnil said.
He expects that this procedure will shortly be available in government hospitals as well, since the doctors in the team work in different government hospitals.
Dr Sheikh Mohammad Noor-E-Alam, Dr Md Ashraful Islam, Dr Syed Abul Foez, Dr Jahangir Sarkar, Dr Ahmed Lutful Moben, Dr Md Abdur Rahim and Dr Foez Ahmed Khandaker were the other members of the team.
Most of them received training on this procedure from the Institute of Liver and Biliary Sciences (ILBS) in New Delhi and from Global Health City in Chennai.
Liver cancer ranks third among all cancer deaths in Bangladesh.

FDA giving this Cancer Drug approval for new uses

The FDA approved Opdivo to treat a type of kidney cancer. The next day, the agency gave the nod for the same drug to be used to treat an advanced skin cancer. That's the sixth approval this year for Opdivo, an injection that helps the immune system fight cancer cells. This particular immuno-oncology drug is a programmed death receptor-1 (PD-1) blocking antibody. Immunotherapies works to attack cancer cells using the body's own immune system, unlike chemotherapy and radiation that kills both cancerous and healthy cells.
The drug was originally approved in December to treat metastatic melanoma in patients that had already had treatment.
The drug is also approved to treat lung cancer and patients with advance melanoma that have received treatment. Sales of Opdivo had reached $467 million in the first nine months of the year, with most of that coming in the three months through Sept. 30.
Bristol-Myers Squibb is still in clinical trials to see if there are more tumor types that Opdivo can treat.

Test improves diagnosis and treatment of Pancreactic Cancers

Primary tumors shed cancerous cells, known as circulating tumor cells (CTCs), into the blood. These have been widely studied as prognostic biomarkers for various cancers. Because these cells are often larger, irregularly shaped and tend to cluster together, they get trapped in smaller vessels.
The authors hypothesized that most cells released from a gastrointestinal tumor would flow into the portal vein and then get sequestered by the narrow vessels in the liver. These cells would not reach the peripheral venous system. CTCs from gastrointestinal tumors are rarely identified in the peripheral blood until the cancer is widely metastatic.
The portal vein samples contained far more tumor cells in all stages evaluated, including locally advanced as well as metastatic tumors. Blood collected from the portal vein had a mean of more than 100 CTCs per 7.5 milliliters. Patients with less advanced disease, who could potentially benefit from surgery to remove the tumor, had fewer CTCs. Those patients averaged about 80 CTCs per 7.5 milliliters.
In contrast, when the researchers used peripheral blood to test the same patients, they found few, if any, circulating tumor cells. Those samples contained, on average, less than one CTC in 7.5 milliliters of blood, the equivalent of one cell in a billion.
"Access to circulating tumor cells may help us define the diagnosis and guide treatment," Waxman said. "Having the ability to count them and to probe their molecular profiles can make a substantial difference in how we treat each patient's tumor."

UK breakthrough leads to better Prostate Cancer treatment

Cancer researchers from the University of Glasgow and Royal Philips Cancer researchers have identified a gene which could help doctors to predict the aggressiveness of prostate cancer in patients. Prostate cancer is the fourth most common cause of cancer death in the UK, claiming the lives of approximately 11,000 men each year1. It is also the most common cancer in men in the UK, accounting for a quarter of all new cases of cancer in males, around 42,000 each year in total.
They examined 1,475 patient samples to learn more about the expression of a particular gene, known as PDE4D7. They found that the gene provided a valuable insight into the aggressiveness of prostate cancer, and the likely recurrence of the disease after treatment.
Professor George Baillie, of the University of Glasgow, said: "Prostate cancer, like any other cancer, is a genetic disease which is driven by the activation of cancer-causing oncogenes and at the same time by inactivation of tumor-suppressor genes.
The gene we examined acts as a more effective biomarker to predict the aggressiveness of patients' prostate cancer than any others which have been used before.

Study shows children with Cancer have Genetic Predisposition

The most detailed analysis yet of the role germline mutations in genes associated with cancer predisposition play in the development of childhood cancer suggests that comprehensive genomic screening may be warranted on all pediatric cancer patients, not just those with a family history of cancer. The study from the St. Jude Children's Research Hospital. Researchers anticipate that systematic monitoring of patients and family members who have germline mutations in cancer predisposition genes will allow the detection of cancers at their earliest and most curable stage, thereby improving the outcomes for these children and family members.
Researchers conducted next-generation DNA sequencing of both the tumor and normal tissues from 1,120 pediatric cancer patients and found that 8.5 percent of patients had pathogenic or likely pathogenic mutations of genes within their normal tissue that increase their risk of developing cancer. Prior to this study, the presence of such germline mutations in pediatric cancer patients was thought to be extremely rare and restricted to children in families with strong histories of cancer. This study revealed that more than half of the children with germline mutations lacked any family history of cancer. 

Blocking body's Endocannabinoids effective Liver Cancer

A new study reveals that the liver's Cannabinoid receptors could be targeted to fight liver cancer in some patients; and it offers a way to predict what treatments have the best chance of working.
The study reveals the metabolic processes by which the most common form of liver cancer, Hepatocellular carcinoma (HCC), is able to grow in oxygen-deprived, or hypoxic, conditions. In doing so, the researchers show how metabolic processes can be modeled to predict which patients will respond to drugs that block CB1 receptors, says Adil Mardinoglu, a systems biologist at Stockholm's KTH Royal Institute of Technology.
"This opens up the possibility for a precision-medicine approach to predict if a patient will respond to a specific drug therapy," Mardinoglu says.
"Our study explains why some cancer drugs are not effective in all patients, and what should be done before the treatment of a cancer," Mardinoglu says. "Even though it is the same cance, in this case, liver cancer, it is vital to characterize the tumor before its treatment. Only 30 percent of patients respond to most clinically-used cancer drug available for the treatment of HCC due in part to a lack of patient stratification." The research team found that these oxygen-deprived HCC cells thrive instead on carbon produced by mitochondria, a double-membrane sub-unit of most cells, which is where cellular respiration and energy production takes place. The mitochondria break down short chain fatty acid (acetate) molecules to generate acetyl-CoA, which then provides the carbon source for HCC cells to produce lipids. The protein, mitochondrial acetyl-CoA synthetase (ACSS1), was found to be a key enzyme in this process of tumor growth.

Cancer trial to watch for Glioblastoma

Shares of Immuno Cellular Therapeutics Ltd (NYSEMKT:IMUC), declined -17.15% to $0.430, during its last trading session.
Immuno Cellular Therapeutics, declared the presentation recently of recently updated overall survival (OS) results and immune response data from the phase 2 trial of ICT-107 in patients with newly diagnosed glioblastoma. ICT-107 is a dendritic cell-based immunotherapy targeting multiple tumor-associated antigens on glioblastoma stem cells. The data are being presented at the 20th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology, being held in San Antonio, TX. The data from the phase 2 trial continue to indicate a survival advantage in the ICT-107 treated group contrast to the control group. The data also show a noteworthy association between immune response and survival, especially in HLA-A2 positive (HLA-A2+) patients, which is the target patient population for the phase 3 registration trial.

• In HLA-A2+ patients, immune response was shown to be associated with survival. 60% of ICT-107 treated patients demonstrated a statistically noteworthy immune response contrast to only 36% of control patients. In a KM comparison of OS for immune responders as compared to non-responders, the responder curve showed a statistically noteworthy survival benefit with a log-rank p-value of 0.0084. For ICT-107 treated patients, the KM comparison of OS for responders as compared to non-responders showed a statistically noteworthy survival benefit with a log-rank p-value of 0.0147. The Company believes that the relationship between immune response and OS supports the phase 3 design improvement of adding more ICT-107 doses for patients in the first year of the protocol.
• Immune response did not differ statistically for MGMT methylated contrast to unmethylated patients. This result supports counting both MGMT types of patients in phase 3 testing.
• Of particular interest was the unpredictable finding that there was an raised immune response in some control patients post-treatment. One potential explanation is that the phase 2 control (activated dendritic cells without peptide loading) was immunologically active. The phase 3 design employs a different control comprising the patients’ own monocytes, which are less immunologically active than dendritic cells. This control could assist clarify a potential survival difference between ICT-107 and control treated patients.

Clinical shows Pacritinib and EGFR Inhibitor in targeting Brain Tumor

CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) today announced findings from an investigator-sponsored preclinical study showing the potential synergistic effect of combining pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R, with an epidermal growth factor receptor (EGFR) inhibitor in decreasing brain tumor initiating cells (BTIC) viability. BTICs have cancer stem cell characteristics and are believed to be responsible for disease initiation and recurrence. Additionally, high rates of mutations in BTICs may lead to the rapid emergence of resistance in GBM, the most common and aggressive primary brain cancer. "The tolerability profile of pacritinib observed in the clinic to date, along with the ability to achieve meaningful intracerebral levels in preclinical models, makes it a candidate to be explored for use in combination therapy for GBM," said Jack W. Singer, M.D., Chief Scientific Officer and Global Head of Translational Medicine at CTI BioPharma.

Generon collaborating with Mayo Clinic to initiate a Phase IIa Study

Generon Corporation, a leading biotech company in China, announced today that the US FDA has cleared a phase IIa IND entitled "An open-label, cohort dose escalating study to assess the safety and efficacy of F-652 in patients with alcoholic hepatitis". The clinical study is a multi-center trial led by Dr. Vijay Shah, Chair, Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN. Generon had reached an agreement with Mayo Clinic to conduct the phase IIa clinical study earlier this year.
The current phase IIa clinical program is a collaboration between Generon and an alcoholic hepatitis consortium funded by the US National Institute on Alcohol Abuse and Alcoholism (NIAAA) of the National Institutes of Health (NIH). The alcoholic hepatitis consortium, "Translational Research and Evolving Alcoholic Hepatitis Treatment (TREAT)" is a joint effort of three institutions: Mayo Clinic, Rochester, MN; Indiana University Health, Indianapolis, IN; and Virginia Commonwealth University Medical Center, Richmond, VA.
The Phase IIa study is a single arm, open-label study to investigate the safety, tolerability, and PK and PD of F-652 in combination with systemic corticosteroids. F-652 will initially be administered once per week for a two-week period, which may then be extended to four weeks. Dr. Vijay Shah commented: "Alcoholic hepatitis is a highly morbid condition with poor pharmacological treatment options currently. We are excited to collaborate with Generon to test the possible role of F-652 through the NIAAA funded alcoholic hepatitis consortium that we participate in."

Mutations in Cancer protein suggest new treatments

Scientists have struggled to find a way to block a protein known to play an important role in many cancers. The protein, STAT3, acts as a transcription factor, it performs the crucial task of helping convert DNA into the RNA instructions used to make new proteins. When overly active, STAT3 performs this task too well, fueling the growth and division of abnormal cells, and contributing to cancer. Scientists have taken various approaches to selectively blocking STAT3 in cancer, but none have produced successful treatments. Researchers led by Rockefeller University's James E. Darnell, head of the Laboratory of Molecular Cell Biology, have suggested a new way to target STAT3. They report successfully disrupting STAT3's ability to act as a transcription factor, suggesting a basis for new, targeted approaches to fighting cancer. "We have described some interesting mutations in the STAT3 protein that, if we could mimic with a drug, could become very valuable tools in our fight against cancer," says Darnell, Vincent Astor Professor Emeritus at Rockefeller. "Three of the mutations, for instance, enable the STAT3 dimer to bind to DNA, but prevent the transcription of that DNA into RNA instructions for protein synthesis, a crucial step for cancer cells," says Darnell.
"What's the good of knowing the intricacies of how proteins work if we can't use that information to stop cancer in a targeted way?" 

A new synthetic material that's strong enough to fill gaps in bone while stimulating new bone growth could advance the grafting treatments needed by people suffering from bone cancer and other bone defects, says a biomedical engineer at Texas A&M University who is developing the technology.

Read more at: http://phys.org/news/2015-11-material-advance-bone-grafting-treatments-cancer.html#jCp

A new synthetic material that's strong enough to fill gaps in bone while stimulating new bone growth could advance the grafting treatments needed by people suffering from bone cancer and other bone defects, says a biomedical engineer at Texas A&M University who is developing the technology.

Read more at: http://phys.org/news/2015-11-material-advance-bone-grafting-treatments-cancer.html#jCp

New Prostate Cancer treatment,use of electricity

"The electricity is so powerful they have to be paralysed while we're doing it or they would just jump off the table."
This was St Vincent's Private Hospital urologist Phillip Stricker, speaking of an emerging treatment for prostate cancer that involves zapping the tumour with more electricity than a bolt of lightning.
"You can't underestimate the potential of this technology," Professor Stricker said.
"It's going to save a lot of people from having unnecessary surgery."
The technology is known as the "nanoknife".
Traditional methods of treating prostate cancer, which attack the whole prostate with radiation or surgery, often come at the cost of the patient's continence or erectile function. The nanoknife targets only the site of the cancer, destroying the cells of the cancer without the structures surrounding it, including the erectile and urethral nerves. Urologists in three countries are trialling the technology on patients who have a single site of localised prostate cancer that needs more treatment than active surveillance. About 15 to 20 per cent of prostate cancer patients are suitable for the treatment.
Demonstrating that in a study of 25 patients, in 76 per cent of cases the cancer had not returned after eight months.
None of them developed incontinence or impotence.

Glioblastoma multiforme, a cancer of the brain also known as "octopus tumors" because of the manner in which the cancer cells extend their tendrils into surrounding tissue, is virtually inoperable, resistant to therapies, and always fatal, usually within 15 months of onset.

Read more at: http://phys.org/news/2015-11-nanocarriers-brain-cancer-therapy.html#jCp

Glioblastoma multiforme, a cancer of the brain also known as "octopus tumors" because of the manner in which the cancer cells extend their tendrils into surrounding tissue, is virtually inoperable, resistant to therapies, and always fatal, usually within 15 months of onset.

Read more at: http://phys.org/news/2015-11-nanocarriers-brain-cancer-therapy.html#jCp

Pancreatic Cancer research dream team selected

The Stand Up To Cancer-Cancer Research UK-Lustgarten Foundation Dream Team of top cancer researchers from the United States and the United Kingdom was named to launch a fresh attack on pancreatic cancer, one of the deadliest forms of cancer on both sides of the Atlantic.
Daniel D. Von Hoff, MD, physician-in-chief and distinguished professor at the Translational Genomics Research Institute (TGen) in Phoenix, chief scientific officer at HonorHealth, and professor of medicine at the Mayo Clinic, will lead the team, with Ronald M. Evans, PhD, professor and director of the Gene Expression Laboratory at the Salk Institute for Biological Studies in La Jolla, California, and Gerard I. Evan, PhD, professor and chair of the Department of Biochemistry at the University of Cambridge in the United Kingdom, as the co-leaders.
Stand Up To Cancer (SU2C), Cancer Research UK, and The Lustgarten Foundation selected the team and are providing $12 million in funding over three years.
Serving as principal investigators on the team are Christopher Heeschen, MD, PhD, lead, Center for Stem Cells in Cancer and Aging at the Barts Cancer Institute, Queen Mary University of London; David Propper, MD, a consultant medical oncologist at Barts Cancer Institute and the London NHS Trust; and Joshua D. Rabinowitz, MD, PhD, professor of chemistry and integrative genomics at Princeton University in Princeton, New Jersey.
The team also includes more than two dozen other researchers based in the United States and the United Kingdom, and two advocates, Suzanne Berenger of England and Howard Young of the United States, both of whom are pancreatic cancer survivors.

Vigilant Biosciences' first test to aid in diagnosis of Oral Cancer

Vigilant Biosciences, Inc., a leading innovator and developer of solutions that aid in the early detection and intervention of cancer, announced today that it has CE Marked its OncAlert Oral Cancer CD44/Total Protein LAB Test. CE Marking allows Vigilant Biosciences to market the product in the 28 countries of the European Union (EU) as well as Norway, Iceland, Liechtenstein and Switzerland.

Vigilant Biosciences' OncAlert LAB Assay is a noninvasive, accurate and cost-effective, quantitative tool for clinicians involved in the diagnosis and treatment of oral cancer. It is the first and only test to detect a tumor-initiating stem cell biomarker for head and neck cancer. The test measures soluble CD44 and total protein levels – specific protein markers known to indicate early stage cancers – in an oral rinse, to serve as an aid in diagnosis of oral cancer, along with other clinical factors.

As previously announced, Vigilant Biosciences has multiple distribution agreements secured across the EU and expects to begin shipping the product during the first quarter of 2016.

Janssen's new drug submission for review by Health Canada

Janssen Inc. announced today that Health Canada has accepted for review the New Drug Submission (NDS) for daratumumab as a treatment for patients with multiple myeloma. Health Canada will review the submission with advance consideration under the Ministry's Notice of Compliance with Conditions Policy (NOC/c) based on data from the Phase 2 MMY2002 (SIRIUS) monotherapy study.
Daratumumab is a new class of therapy, a human anti-CD38 monoclonal antibody.  It received Breakthrough Therapy Designation and the Biologics License Application (BLA) was granted priority review and accelerated approval by the U.S. Food and Drug Administration (FDA) on November 16, 2015. The submission for daratumumab is primarily supported by data from the Phase 2 SIRIUS study. The study enrolled patients with multiple myeloma who had received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or were double refractory to a PI and an IMiD.³  The data presented showed daratumumab demonstrated a 29 per cent overall response rate and a tolerable safety profile in these heavily pre-treated patients.⁴ The submission also is supported with data from other studies, including the multi-centre, two-part open-label Phase 1/2 GEN501 monotherapy study. This study enrolled patients with multiple myeloma who had a relapse after, or had disease that was refractory to, two or more different prior therapies, including IMiDs, PIs, chemotherapy, and autologous stem-cell transplantation. The study showed daratumumab demonstrated a tolerable safety profile and a 36 per cent overall response rate in patients treated with a 16 mg/kg dose.

Stem-cell scientists redefine how blood is made

Stem-cell scientists led by Dr. John Dick have discovered a completely new view of how human blood is made, upending conventional dogma from the 1960s. "Instead, through a series of experiments we have been able to finally resolve how different kinds of blood cells form quickly from the stem cell, the most potent blood cell in the system, and not further downstream as has been traditionally thought," says Dr. Dick. The research also topples the textbook view that the blood development system is stable once formed. Not so, says Dr. Dick. "Our findings show that the blood system is two-tiered and changes between early human development and adulthood."
For people with blood disorders and diseases, the potential clinical utility of the findings is significant, unlocking a distinct route to personalizing therapy.
There are also promising implications for advancing the global quest in regenerative medicine to manufacture mature cell types such as platelets or red blood cells by engineering cells (a process known as inducing pluripotent stem cells), says Dr. Dick.

Phase 3 study in Chronic Lymphocytic Leukemia

Infinity Pharmaceuticals, Inc., today announced that it has reached target enrollment of 300 patients in DUO, a randomized Phase 3 monotherapy study evaluating the safety and efficacy of Duvelisib compared to Ofatumumab (an anti-CD20 antibody) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The primary endpoint of this study is progression free survival (PFS). Duvelisib is an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma. Infinity is jointly developing duvelisib with AbbVie, its strategic development and commercialization partner for duvelisib in oncology.

FDA speedy review for Opdivo in Kidney Cancer

US regulators are undertaking a priority review of Bristol-Myers Squibb’s immunotherapy Opdivo for the treatment of patients with advanced renal cell carcinoma, the most common form of kidney cancer which kills more than 100,000 people every year.

The company is seeking to expand the drug’s scope, adding to its skin and lung cancer indications, to include RCC patients who have received prior anti-angiogenic therapy. The FDA is expected to make a decision by March 16.

Opdivo (nivolumab) already carries a Breakthrough Therapy Designation for RCC indication, which BMS says underscores the “critical need” for new treatment options for this patient group. 

The drug’s supplemental filing is centered on findings from the Checkmate-025 trial, which assessed Opdivo versus Novartis’ Afinitor (everolimus), the current standard of care, in previously treated advanced or metastatic clear-cell renal cell carcinoma.

The trial was stopped early in July after an analysis showed that Opdivo significantly improved overall survival compared to Afinitor, marking the first time an immunotherapy was shown to offer a survival advantage for this group of patients, whose treatment options remain limited.

Vitamin C halts aggressive Colorectal Cancer

High levels of vitamin C kill certain kinds of colorectal cancers in cell cultures and mice, according to a new study from Weill Cornell Medicine investigators. The findings suggest that scientists could one day harness vitamin C to develop targeted treatments. A team of researchers from Weill Cornell Medicine, Cold Spring Harbor Laboratory, Tufts Medical Center, Harvard Medical School and The Johns Hopkins Kimmel Cancer Center found that high doses of vitamin C, roughly equivalent to the levels found in 300 oranges, impaired the growth of KRAS mutant and BRAF mutant colorectal tumors in cultured cells and mice. The findings could lead to the development of new treatments and provide critical insights into who would most benefit from them.

FDA wants to close the Cancer test loophole

The US government is finally examining a regulatory loophole that has allowed companies like Theranos to market diagnostic tests to patients without going through the US Federal Drug Administration first. FDA officials pointed out today in a hearing that these tests endanger patient safety — and that bad tests can require costly clean-up.
The Energy and Commerce's Subcommittee on Health held a hearing in Washington today to discuss a controversial category of diagnostic tests called "lab developed tests" or LDTs. It gives companies that develop and conduct a diagnostic test in a single lab the ability to avoid submitting their tests to the FDA before using them on patients. The LDT category exists because research hospitals often need to modify commercial tests to suit patient needs. So, today's hearing was designed to hear arguments for and against a change proposed by the FDA last year that would require that developers of certain LDTs obtain approval before they start to market their tests to patients. Developers would also have to monitor customer complaints after they put out their tests. The FDA wants to make sure that these tests "are accurate, reliable and that they do, in fact, identify a disease," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, during the hearing. Right now, this form of verification isn't conducted by FDA or federal lab inspectors. And that's a problem, Shuren told the subcommittee. If diagnostic tests return inaccurate results, "physicians can make the wrong decisions and patients can get hurt."
The FDA yesterday released a report that discusses 20 LDTs that caused harm to patients, Shuren said. Among them was a genetic breast cancer test that gave out inaccurate results in 20 percent of cases.

Breast Cancer metastasis study suggests new therapy

Breast cancer cells do not undergo a commonly accepted transformation to spread to distant organs such as the lungs, Weill Cornell Medicine investigators have found in a new study. This discovery may settle a longstanding debate about how cancers spread, the investigators say, and may change the way many forms of the disease are treated. For more than a decade, many researchers have believed that a biological process that transforms the shape of cells that line cavities, organs and blood vessels in the body was necessary for metastasis. Epithelial to mesenchymal transition, or EMT, strips away the cells’ ability to hold on tightly to their neighbors, allowing them to migrate throughout the body.
“There is a substantial effort underway to develop drugs aimed at reversing the EMT process in order to halt metastasis, but our findings suggest that this approach may not work,” he added. “Instead, we suggest combining chemotherapy with a drug that blocks EMT as the first treatment given to breast cancer patients, and likely others with cancer as well.”

Newly FDA approved Prostate Cancer treatment

A minimally invasive prostate cancer therapy, approved by the FDA just a few weeks ago, uses ultrasound energy to destroy cancerous tissue.
The therapy, called HIFU (High Intensity Focal Ultrasound) has been widely available for 15 years in more than 40 countries in Europe, Asia, and Latin America. Louisville urologist Dr. John Jurige has performed the procedure outside the United States for years, now he will perform the first HIFU treatment in the US in Louisville on Tuesday.
"I think it is a game changer because traditionally we've had surgery and radiation therapy as the primary options for patients and in certain patients who are found to have prostate cancer at an early stage, who are particularly motivated to preserve these quality of life issues particularly the sexual functioning and the bladder control we now have another weapon that we can now use for these patients," Dr. Jurige said.
Dr. Jurige has performed the procedure roughly 400 times over the last 8 years, in the Bahamas and Cancun, Mexico. This treatment is mainly for patients with early stages of prostate cancer. Dr. Jurige says FDA approval will likely lead to the procedure being more widely covered by insurance.

Drug could help Cancer patients avoid heart damage

Cancer patients are referred to cardiologists after certain cancer drugs or radiation treatments have already weakened their hearts. Special clinics are springing up in hospitals to take care of the growing number of cancer survivors with this problem.
"If you wait until the disease has occurred, it may be too late" to do much good, said Dr. Javid Moslehi, who heads one such specialty clinic at Vanderbilt University. "We in the cardiology community have to do a better job of preventing cardiac disease rather than jumping in" after damage has occurred.
He had no role in the new study, which was done in Norway.
Radiation treatments can harm arteries, making them prone to harden and clog and cause a heart attack. It also can cause valve or rhythm troubles. Certain cancer drugs, such as Herceptin and doxorubicin, sold as Adriamycin and other brands, can hurt the heart's ability to pump, and lead to heart failure.The new study aimed to prevent cardiac side effects. Led by Dr. Geeta Gulati of Akershus University Hospital in Lorenskog, Norway, it involved 120 women with early-stage breast cancer and tested two drugs long used to treat high blood pressure and heart failure - candesartan and metoprolol. The drugs are available as generics and cost less than a dollar a day.
The University of South Florida has a federally funded study underway, testing drugs to prevent heart failure for women on Herceptin, that may help answer some questions.

New type of Cancer treatment

A new therapeutic approach that targets an aggressive form of lymphoma may greatly increase the efficacy of treatment and result in better outcomes for patients, according to new research by scientists at Weill Cornell Medicine.
Diffuse large B-cell lymphoma (DLBCL) is an aggressive cancer of the B-cells, a type of white blood cell. It is the most common form of non-Hodgkin lymphoma, affecting approximately 20,000 Americans each year. Current therapies are ineffective for at least 40 percent of patients with DLBCL and come with severe side effects ranging from fever and nausea to heart and nerve damage.
Scientists from Weill Cornell Medicine, Memorial Sloan Kettering Cancer Center and the University of Michigan Medical School found that a combination therapy that targets proteins in cancer cells was more effective than either of the drugs alone. The researchers used an experimental drug developed at Memorial Sloan Kettering called PU-H71, which binds to Hsp90 to trap it in a complex with the other proteins it stabilizes, known as client proteins. With this method, they identified client proteins that are critical to lymphoma survival and can be targeted therapeutically. They then treated lymphoma cells in petri dishes, mice and human tumor samples with PU-H71 and ibrutinib, a drug that is used to treat lymphoma that targets one of the major lymphoma survival pathways identified. Every time, the drug combination proved to be more effective at killing lymphoma cells than ibrutinib or PU-H71 alone.
“PU-H71 acts like a stone thrown at a window,” Goldstein said. “It hits the window – the cancer cell – and makes all these cracks. It weakens it. And then ibrutinib comes in and just taps it, and it falls apart.”
The investigators expect this new combination therapy to soon move into a phase II clinical trial. If successful there, cancer treatment could move in a whole new direction.

GA state agency stalls move by Cancer Treatment Centers

Cancer Treatment Centers of America’s bid to attract more Georgia patients was stalled by the state Thursday.
Department of Community Health Commissioner Clyde Reese told the DCH board that his agency received overwhelming opposition to the company’s bid to gain access to more insured patients in Georgia.
The powerful state hospital lobby had worked hard against the change, arguing that CTCA cherry-picks patients with the highest-paying insurance coverage while leaving other hospitals to shoulder the burden of care of Medicaid and other indigent cancer patients.

The proposed rule would have given the hospital a pathway to become a general hospital that isn’t required to have an emergency room. With the new designation, it would no longer have to get most of its patients from out of state. It would also be able to apply, like other hospitals, to expand beyond 50 beds.
The company says the current cap unfairly prevents Georgia patients from getting help at its facility.

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FDA approves Lung Cancer drug

A new lung cancer pill from AstraZeneca has been approved by US regulators, in a major boost for the British drugmaker.
AZD9291, which will be sold as Tagrisso, is for advanced non-small-cell lung cancer, the most common form of lung cancer. Tagrisso targets a genetic mutation, known as T790M, that helps tumours evade current lung cancer pills. The drug will be made available to patients in the US as soon as possible and its price will be “comparable to other oral cancer therapies,” a spokeswoman said. AstraZeneca will reveal the price early next week.
Its approval means AstraZeneca has taken another step forward in its ambition to bring six new cancer treatments to patients by 2020, following the recent launch of Lynparza for ovarian cancer in the US.
The approval comes just two-and-a-half years since Tagrisso was first tested on humans. It had received breakthrough status in the US and has also received accelerated assessment in the EU following its filing in the summer, as well as priority review in Japan.

Canadian Doctor first in world to Break Blood-Brain Barrier

The blood-brain barrier has been broken for the first time in history. Doctor Todd Mainprize, of the Sunnybrook Health Sciences Centre in Toronto, and in contact with other neuroscientists, has successfully broken the blood-brain barrier, opening the way for revolutionary new treatments for brain cancer, Alzheimer’s, depression, stroke, Parkinson’s, and more.

The procedure, which took place earlier in the week was used to successfully treat a brain tumor by non-invasively delivering medication deep into the brain using microbubbles and focused ultrasound to force cancer medication through the blood-brain barrier.

The treatment involves first dosing the patient with medication. Afterward, harmless microbubbles are injected into the bloodstream, and a high-intensity ultrasound beam is directed at the tumor, causing the microbubbles to vibrate. This gently tears the proteins around the capillary walls, allowing the medication to painlessly and harmlessly enter the brain tissue, something that has been impossible to achieve up to this point.

Proton therapy center opens in Irving, Texas

Texas Center for Proton Therapy in Irving delivered proton beam radiation treatment to its first patients on Tuesday, opening three months ahead of its original schedule.

It’s the first cancer treatment center of its type in North Texas. Before it opened, Dallas-Fort Worth was the largest metropolitan area without a proton beam cancer treatment center, with the nearest at M.D. Anderson Cancer Center in Houston and the ProCure Proton Therapy Center in Oklahoma City.

Texas Center for Proton Therapy is the only center in the state that offers the latest generation proton therapy technology, including image-guided pencil-beam scanning in multiple treatment rooms, which delivers treatment to tumors with more precision than traditional radiation.The accuracy of proton therapy minimizes damage to healthy tissue surrounding tumors and reduces side effects.

It’s especially important for pediatric patients whose bodies are still growing and developing, and in adult patients with cancers in highly sensitive areas such as the brain, spine, chest, prostate, head and neck.