SAN DIEGO--(BUSINESS WIRE)--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.
About OncoSec Medical Inc.
OncoSec Medical Inc. is a biopharmaceutical company developing its ImmunoPulse immunotherapy to treat solid tumors. OncoSec Medical's core technology leverages a proprietary electroporation platform to enhance the local delivery and uptake of IL-12 and other DNA-based immune-modulating agents. Clinical studies of ImmunoPulse have demonstrated an acceptable safety profile and preliminary evidence of anti-tumor activity in the treatment of various skin cancers, as well as the potential to initiate a systemic immune response without the systemic toxicities associated with other treatments. OncoSec's clinical programs currently include three Phase 2 trials targeting metastatic melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma (http://clinicaltrials.gov/ct2/results?term=oncosec&Search=Search). As the company continues to evaluate ImmunoPulse in these indications, it is also investigating additional indications and combination therapeutic approaches. For more information, please visit www.oncosec.com.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management’s current preliminary expectations and are subject to risks and uncertainties, which may cause our results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to raise additional funding, our ability to acquire, develop or commercialize new products, uncertainties inherent in pre-clinical studies and clinical trials, unexpected new data, safety and technical issues, competition, and market conditions. These and additional risks and uncertainties are more fully described in OncoSec Medical’s filings with the Securities and Exchange Commission. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. OncoSec Medical disclaims any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.