Enrollment for Phase II Study is Now 50 Percent Complete
SAN DIEGO, CA — June 26, 2012 — OncoSec Medical Inc. (OTCBB:ONCS), a company developing the OncoSec Medical System (OMS) ElectroOncology therapies to treat advanced-stage solid tumors, announced that Dr. Adil Daud, principal investigator, presented preliminaryenrollment and safety data at the Second European Post-Chicago Melanoma Meeting in Munich, Germany for the company’s on-going Phase II metastatic melanoma clinical trial, OMS-I100.
To date, OMS-I100, a Phase II open-label, multi-center clinical trial investigating the safety and efficacy of plasmid interleukin-12 (DNA IL-12) with electroporation, has completed approximately 50 percent of enrollment. Based on currently available safety data, no grade three or higher adverse events related to the treatment have been reported, and most reported adverse events were treatable and transient.
Dr. Adil Daud said, “Interest in this study has been encouraging, and we expect to complete enrollment before the end of this year. We look forward to continuing follow-up of the patients that have been treated in order to measure any indication of a systemic immune response using DNA IL-12 and electroporation.”
Punit Dhillon, President and CEO of OncoSec said, “Although preliminary, these results may validate the safety and tolerability of DNA IL-12 and electroporation that was demonstrated in the Phase I study.” Mr. Dhillon added, “Following the design and implementation of our clinical development plan in 2011, we are pleased with the rapid enrollment for this study since initiation in February 2012, and believe it supports the adoption of the technology through our collaboration with leading academic institutions. We look forward to presenting an interim analysis of the clinical and immune response for this study later this year.”
A total of up to 25 patients with Stage III or IV cutaneous and in-transit metastatic melanoma will be enrolled in this Phase II, single-arm, open-label, and multi-center study. The trial is designed to assess local and distant objective responsefollowing treatment of cutaneous melanoma lesions with DNA IL-12 and electroporation with a primary endpoint of 24 weeks. One treatment cycle will consist of three treatments applied to up to four lesions on days one, five and eight with a maximum dose of 1.5 mg DNA IL-12 per treatment cycle. At 12 months, patients will be moved to the follow-up phase of the study and will be followed for up to five years for safety.
The incidence of many common cancers is falling, but the incidence of melanoma continues to rise at a rate faster than that of any of the seven most common cancers. Between 1992 and 2004, melanoma incidence increased 45 percent, or 3.1 percent annually. An estimated 68,000 new cases of melanoma were diagnosed in the U.S. in 2010 — with nearly 8,700 resulting in death. Approximately 75 percent of skin cancer deaths are from melanoma. In 2004, the most recent figures available, the total direct medical cost associated with the treatment of skin cancer in the U.S. was $1.5 billion. Currently there are few treatmentoptions for metastatic melanoma because of the aggressive nature of the disease. Current treatment approaches are associated with high morbidity and only marginal improvements in overall survival.
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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 ourresults 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’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 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.