OncoSec Medical Inc. (OTCQB: ONCS), a company developing its ImmunoPulse DNA-based immunotherapy to treat solid tumors, will re-launch its Phase II cutaneous T-cell lymphoma (CTCL) trial under a protocol amendment.
In July 2012, a Phase II trial using OncoSec's ImmunoPulse DNA IL-12 was initiated at the University of California San Francisco (UCSF) under an FDA-approved investigator-sponsored Investigational New Drug application (IND) with Weiyun Ai, M.D. as principal investigator. In November 2012, this IND was transferred to OncoSec. Following review of the protocol under OncoSec's own accord, the company determined that an amendment to the protocol should be considered in order to broaden the inclusion and exclusion criteria, implement a more patient-friendly treatment design, and expand the exploratory endpoints for the trial. In consultation with Key Opinion Leaders (KOLs), OncoSec has amended the protocol, and Institutional Review Board approval is pending.
OncoSec will expand enrollment to Stanford University, a renowned center of excellence. Stanford is regarded as having a large CTCL patient population and is experienced in investigating novel therapies in this disease.
Yuon Kim, M.D. will serve as principal investigator for the Stanford University study. Dr. Kim is an internationally renowned expert in cutaneous lymphomas and director of the multidisciplinary cutaneous lymphoma program at Stanford University Medical Center. Her team of top physicians and clinical/research staff are dedicated to providing excellence in patient care and advancing the development of new and innovative therapies that improve patient survival and quality of life.
Punit Dhillon, President and CEO of OncoSec, said, "Currently available therapies for CTCL largely manage symptoms, and since there are few effective treatments for this disease, it remains an unmet medical need. The safety and preliminary efficacy of ImmunoPulse is being evaluated in this study to assess the therapeutic potential in this disease."
"We are extremely excited to be bringing Stanford University on board," said Robert Pierce, M.D., OncoSec's Chief Medical Officer. "Plasmid IL-12 delivered without electroporation in this patient population has provided evidence of preliminary efficacy, but has shown to be severely toxic. We believe the safety profile observed thus far with using electroporation to deliver plasmid IL-12, along with the preliminary evidence of local and systemic anti-tumor activity observed in our Phase II melanoma study, suggest that this treatment might offer similar evidence of safety and activity in patients with CTCL."
In the revised protocol, all subjects will be eligible to receive up to six treatment cycles consisting of treatment days (Days 1 and 8) in a 28-day cycle. A total of up to 34 patients will be enrolled in this study. Subjects will be followed for safety and clinical evaluation every four weeks. Quality of Life will be assessed using the Skindex29, Functional Assessment of Cancer Therapy - General (FACT-G) and Visual Analog Scale for Pruritus (VAS-P) instruments. Survival follow-up will occur at three-month intervals over two years following the end of the study.
Researchers discover mechanism affecting splicing process in retinal cells