HedgePath Pharmaceuticals, Inc., a clinical stage
biopharmaceutical company that discovers, develops and plans to
commercialize innovative therapeutics for patients with cancer,
announced today enrollment has commenced in its Phase II(b) SCORING
(SUBA-Cap Objective Response in Gorlin's) clinical trial. HPPI will
study the efficacy and safety of twice-daily dosing of SUBA-Itraconazole
Oral Capsules as a potential therapy for basal cell carcinoma (BCC) in
patients with basal cell carcinoma nevus syndrome (BCCNS), also known as
Gorlin's Syndrome.
Nicholas J. Virca,
HPPI's President and Chief Executive Officer, commented, "We are
extremely pleased and enthused to launch our first clinical trial as a
single arm, Phase II(b), multi-center, open-label,
non-placebo-controlled study for which we plan to recruit up to 40
patients across three clinical trial sites in the US. Based on our
enrollment objectives and the first phase of our study plan, we expect
to be able to assess interim results in over half of these patients
during the first quarter next year."
Based on an Investigational
New Drug Application previously cleared by the Food and Drug
Administration, the primary endpoint of HPPI's study is the objective
response rate of BCC lesions to SUBA-Itraconazole in subjects with
BCCNS, under which a meaningful response will be defined as a 30% or
greater reduction in the cumulative size of target tumors, with an
appropriate sample size to be 33 of the 40 patients in order to maintain
a 90% power. A detailed description of the trial design and patient
eligibility criteria can be found at ClinicalTrials.gov under the study identifier NCT02354261.
No comments:
Post a Comment