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.

ADVERTISINGThe company says the current cap unfairly prevents Georgia patients from getting help at its facility.

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.

Leukemia Treatment Breakthrough

After several rounds of chemotherapy and a bone marrow transplant, doctors at the Great Ormond Street Hospital (GOSH) explained that there were no treatment options left for Layla, and offered palliative care.“We didn’t want to accept palliative care,” said Lisa, in a press release. “So we asked the doctors to try anything for our daughter, even if it hadn’t been tried before.”
Recent developments had been made in the lab regarding a treatment where immune cells (T-cells) are programmed through gene therapy to identify and kill cancerous cells. Oftentimes, though, leukemia patients do not have enough health T-cells to collect in the first place, meaning doctors must use modified T-cells from donors. A team at GOSH and the UCL ICH, along with scientists at the University College London and biotech company Cellectis, had been developing a bank of donor T-cells (called UCART19 cells) to be used in the final stage of testing before clinical trials could begin. When Qasim heard of Layla’s case, it was these cells that came to mind.
“The approach was looking incredibly successful in laboratory studies, and so when I heard there were no options left for treating this child’s disease, I thought, ‘Why don’t we use the new UCART19 cells?’” Qasim explained. “The treatment was highly experimental and we had to get special permissions, but she appeared ideally suited for this type of approach.”
After some time, doctors were confident the leukemia cells were gone. They gave Layla a bone marrow transplant to replace her entire blood and immune system, which had been wiped out from the treatments. She is now recovering at home, though she’ll return to GOSH for regular checkups on her bone marrow cells and blood count.
Though Layla’s case was a huge success, doctors warn about making assumptions about the treatment.

Antiangiogenesis increases effectiveness of Radiation

Treatment with antiangiogenesis drugs may improve the effectiveness of radiation treatment of nervous system tumors that interfere with the hearing of patients with the genetic disorder neurofibromatosis 2 (NF2). The use of an antiangiogenesis drug reduced the radiation dose required to shrink tumors in animal models of the NF2-associated tumors called vestibular schwannomas. They also discovered several mechanisms behind this effect and determined the time window during which radiation therapy produces the best results in the tested model. "We found that treatment with an antibody blocking the angiogenic factor VEGF improves neurologic function in our mouse model by alleviating tissue edema, which may further improve neurologic function by decreasing muscle atrophy and increasing nerve regeneration, both of which we observed."
"NF2 is a disease that needs new solutions, and we demonstrated that combining anti-VEGF with radiation therapy can achieve better tumor control, allowing a reduction in radiation dose that can minimize neurological toxicity," says Xu, who is an assistant professor of Radiation Oncology at Harvard Medical School. "Our study provides compelling rationale and paves the way for further testing of combined therapy in human patients, and we are currently planning a clinical trial."

Osteoporosis drug effective against Pancreatic Cancer

Bazedoxifene, a therapeutic approved by the U.S. Food and Drug Administration for the prevention of osteoporosis, suppressed the growth of pancreatic tumors by inhibiting the IL-6/STAT3 signaling pathway that the cancer cells use to survive and multiply, according to preclinical data.
IL-6 is a cytokine, a type of small protein, which plays an important role in cancer development, and high serum IL-6 levels are a poor prognostic factor for overall survival in pancreatic cancer; therefore, IL-6 is considered a viable target for pancreatic cancer therapy. Bazedoxifene is a third-generation selective estrogen receptor modulator, which received FDA approval in 2013 as part of a combination drug for the prevention of postmenopausal osteoporosis in women.
The researchers noted that some of the limitations of the study include that bazedoxifene may need to be modified chemically to be more efficacious as single agent, and/or it may need to be combined with other drugs such as nab-paclitaxel. 

App creates 'smartphone supercomputer' to help find Cure for Cancer

An app that allows users to help find a cure for cancer by pooling their smartphones' computing power has been launched today by Vodafone Foundation and The Garvan Institute of Medical Research.

DreamLab automatically downloads and solves research problems while the user sleeps, sending the results back to the Institute and speeding up research into breast, ovarian, prostate and pancreatic cancer.
The app only works when the phone is fully charged, and will not access personal information. Users will still be able to use their phone at the same time.
DreamLab aims to create the nation's first "smartphone supercomputer", and if 100,000 users pooled their phones' processing capabilities researchers would be able to crunch data approximately 3,000 times faster than the current rate, the Institute said.
The app is currently only available for Android users.

UK's Cancer drugs fund update

The Cancer Drugs Fund will continue to pay for the breast cancer treatment Kadcyla, after the company Roche cut its price, the NHS in England has said.

The fund, which pays for drugs not routinely available on the NHS, has been cutting the number it offers, in order to balance the books.
Many, including breast cancer treatment Avastin, remain off the fund's list, as treatments for certain tumours.
Charities say the fund is worryingly unstable and causes patients anxiety.
16 medicines have been taken off the list because NHS experts said they did not provide enough benefit for the amount of cost. Kadcyla (also known as trastuzumab emtansine) was expected to be axed. Initial costs were set at £90,000 per patient.
Evidence suggests it can add six months of life on average to women dying with an aggressive form of breast cancer.
The current fund will remain in place until 1 April 2016.
NHS England and NICE will be discussing proposals for a new system in the coming weeks .

Lee Memorial focuses on Cancer, Heart Disease

Most of us know heart disease is the No. 1 killer of Americans, followed closely by cancer. It is a lesser known fact that cancer therapy can cause adverse effects on the heart. Lee Memorial Health System is meeting the challenge with a new collaborative effort between cardiovascular medicine and oncologic services.Nationally, cardiologists are seeing increasing numbers of oncology patients presenting with cardiovascular problems. With 13.7 million current cancer survivors in the U.S. and projected increases to 18 million in 2023, that trend is expected to continue.
The Division of Cardio-Oncology is a collaborative effort focusing on three distinct areas:
• Patients with existing heart disease who develop cancer to ensure their heart can withstand the stress of treatment. Including an initial cardiac evaluation, allows for real-time monitoring.
• Those currently undergoing chemotherapy with cardio toxic agents, to monitor for subtle changes in cardiac function that may signal an early decrease in cardiac function.
• Cancer survivors having undergone either radiation therapy with portals that have included the heart, or received cardio toxic regimens, need to be followed by cardiology periodically, as part of their disease surveillance program.
Working with other cardio-oncology programs nationally as well as partnering with the American College of Cardiology has created a new facet to advance the science of cardio-oncology. This is a truly a unique challenge.  Through these collaborative efforts it’s expected that in the future we can define best treatments, surveillance modes and risk factors for developing cardiac toxicities and work in a more proactive fashion for these patients.

Trials underway using HIV virus as cure for Cancer-stricken patients

Now, a genetically altered HIV virus is being used to eradicate cancer.

Researchers at the University of Pennsylvania Medical Center's Abramson Cancer Unit have been using the breakthrough treatment with great success in clinical trials that began in 2010. 

The virus has been engineered so that it can't cause the disease anymore but it still retains a program so that it will now attack cancer cells. Each call can kill more than 1,000 cancer cells. 

A 70-year-old retired corrections officer, was at the end of the line when he volunteered to be the first person to sign up for the experimental therapy.  He hadn't responded to 10 years of chemotherapy or other treatments. The altered HIV penetrated his ailing body and he has been cancer-free for five years. 

The patient, who was suffering chronic lymphocytic cancer, was among 14 patients in the initial phase of clinical trials to respond favorably, with others like him in remission more than five years.  More extraordinary, 90 percent of the some 40 children involved in the breakthrough therapy are also showing positive results. 

Researchers are hopeful that someday this remarkable therapy will win FDA approval that would allow wide-scale use. Medical researchers are now beginning clinical trials with the altered HIV on patients with other forms of cancer, including pancreatic, ovarian, brain and forms of blood cancer.

New startup to make Bacteria-Based Cancer Treatments

A company called Evelo Therapeutics, launched Wednesday, with a plan to create a variety of cancer treatments based on bacteria found in the microbiome. The microbiome is an environment consisting of trillions of micro-organisms living in the body that contributes to overall health.  Evelo, located in Cambridge, Massachusetts, received $35 million in funding from the venture capital firm Flagship Ventures to study oncobiotic therapeutics.  The startup will explore what role these microbial agents play in the formation of cancer.
One avenue would be to test how specific kinds of bacteria inhibit tumor metabolism by competing for nutrients. Another approach would use bacterial infusions to transform a tumor’s immediate surroundings into a less hospitable environment for growth.
A third tactic being considered by Evelo would gauge how bacteria triggers the immune system to attack tumor cells.

Prostate Cancer treatment varies widely in Canada

Low-risk prostate cancer patients in Canada may be opting for treatment with major life-changing side-effects without fully understanding other options, including the choice to forego treatment unless the disease progresses, a new report reveals.

While the report's data suggested that three-quarters of men with low-risk prostate cancer in Manitoba and Prince Edward Island had opted for active surveillance, more than half of low-risk prostate cancer patients in British Columbia, Alberta, Saskatchewan and Nova Scotia were treated with surgery, radiation, or a combination. Inconsistencies in the number of men placed on active surveillance suggest inconsistencies in its presentation to patients as a favorable option.

"One in eight Canadian men will face a diagnosis of prostate cancer in their lifetime," said Dr. Stuart Edmonds, Vice President, Research, Health Promotion and Survivorship at Prostate Cancer Canada. "The data contained in this report have the potential to provide important evidence to improve practice and lead to better outcomes for men." 

British doctors develop revolutionary new Cancer Therapy

British doctors are developing a revolutionary new therapy for cancer and associated conditions based on the use of high-powered beams of ultrasound.The researchers, working at the Institute of Cancer Research (ICR), at the Royal Marsden hospital in Sutton, outside London, have already used the technology to kill harmful tissue deep inside the bodies of patients suffering from metastatic bone lesions, without recourse to any form of surgery. And in future, doctors believe they will also use ultrasound to zap prostate, breast and other tumors. “This technology has immense potential,” said Professor Gail ter Haar, who is based at the institute. High-intensity focused ultrasound (Hifu) could also be used to release specially designed capsules of cancer drugs inside a tumor, say researchers.
Ultrasound involves using sound waves with frequencies above the audible limit for humans. At low power, ultrasound can be used to generate images of internal organs or fetuses growing in the womb. However, at very high energies, it can destroy tissue. Such beams, which are typically 10,000 more powerful than those used in pregnancy scans, cause cells to heat up and die. “When we pick a target tissue to kill off, we need to heat it up to about 55C for at least a second. That is enough to kill it off,” said Ter Haar. “Crucially, we can do that with ultrasound. More importantly we can do it at places that are deep inside an organ, while leaving tissue on the surface unaffected.”

Obama administration plans forum on high Cancer drug prices

Trying to turn up the political heat on the pharmaceutical industry, the Obama administration announced on Tuesday that it would hold a forum this month on the high prices of some prescription drugs.

The move came amid reports of price manipulation and opinion polls that identify drug prices as a top concern for many consumers and voters. Hillary Rodham Clinton and other Democrats have called for efforts to stop what they call price gouging by drug makers. Senior House Democrats are forming a panel to explore possible legislation on drug pricing.

Sylvia Mathews Burwell, the secretary of health and human services, said Tuesday that she would hold a daylong conference on Nov. 20 to consider ways of speeding up the discovery of innovative drug treatments while making them more affordable.

New type of Cancer Treatment targets proteins in Cancer Cells

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.
Drs. Goldstein and Melnick and their team focused on proteins that exist in all cells. In particular, they looked at one protein called Hsp90, which acts like a scaffolding for other proteins in the cells. Cancer cells hijack this scaffolding function to stabilize the mutant proteins they require for survival.
"If we could identify the proteins that Hsp90 is stabilizing in these cells," Dr. Goldstein said, "then we might be able to therapeutically target them in combination with Hsp90 inhibition."
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.

Approval of Cancer-hunting virus signals new treatment era

A new cancer treatment strategy is on the horizon that experts say could be a game-changer and spare patients the extreme side effects of existing options such as chemotherapy. The Food and Drug Administration (FDA) for the first time approved a single treatment that can intelligently target cancer cells while leaving healthy ones alone, and simultaneously stimulate the immune system to fight the cancer itself.
The treatment, which is called T-VEC (for talimogene laherparepvec) but will be sold under the brand name Imlygic, uses a modified virus to hunt cancer cells in what experts said was an important and significant step in the battle against the deadly disease.
It works by introducing a specially modified form of the herpes virus by injection directly into a tumor, specifically skin cancer, the indication for which the drug has been cleared for use.

New therapy for Triple-negative Breast Cancer shows promise

Recent laboratory findings provide novel insight into potential new therapeutic approaches for triple-negative breast cancer, a particularly difficult to treat and aggressive form of the disease.
Scientists from Van Andel Research Institute (VARI) and Wayne State University demonstrated in preclinical experiments that the drug cabozantinib inhibits growth of several triple-negative breast cancer subtypes. In preclinical experiments, the team demonstrated that cabozantinib impedes triple-negative breast cancer progression and spread by inhibiting the MET protein. Graveel and Sloane's laboratories used unique cancer models that include both breast cancer cells and the connective tissue cells that often support cancer growth. Their findings not only provide evidence for cabozantinib's therapeutic potential for triple-negative breast cancer, but also imply that MET plays a crucial role in growth and invasion by triple-negative cancer cells.

Heart drug stops the progression of Cancer

A common heart drug may stop the progression of angiosarcoma, a cancer of the inner lining of blood vessels, according to a study by researchers at Texas Tech University Health Sciences Center (TTUHSC) El Paso.

Angiosarcomas are highly lethal tumors that can occur in any part of the body. The tumor typically appears as a growth or lesion on the skin; the larger the growth, the greater the risk of mortality.

Previous research in Bryan's lab suggested that propranolol, a drug that's typically used for high blood pressure, might be effective against angiosarcomas, so Chow and Bryan proceeded to use the medication for treatment.
After one week of the propranolol treatment, the tumor ceased its rapid expansion and showed no evidence of clinical enlargement or extension. Within six months of use of propranolol, and eventually, added chemotherapy and radiation,the tumor was undetectable. The results are published in the journal JAMA Dermatology.
The finding is not only promising against cancer, but for patient finances. Current prescription drug therapies for sarcomas can cost patients more than $10,000 a month. Propranolol, however, costs about $4 a month.
 

Canadian provinces vary widely on coverage of Breast Cancer treatments

New research from the Canadian Breast Cancer Network (CBCN) shows the country’s current drug review process is extending patients’ lives in some provinces while leaving others to die in another.
According to the report, Ontario approved the therapies in the shortest length of time while Quebec, Nova Scotia and PEI lagged behind with some of the longest delays in the country.
Perjeta, a patented injectable drug manufactured by Roche Holding AG, is a treatment for HER2+ metastatic breast cancer. In clinical trials, the drug kept the cancer from worsening for six extra months, compared to the current standard of care.

Ontario agreed to cover and pay for Perjeta in November 2013. Quebec took almost two years to follow suit, waiting until July of this year to agree to cover the treatment.

The lack of a firm deadline for provinces to decide which therapy the taxpayer should pay for, and for whom, takes up time that metastatic breast cancer patients don’t have.