SAN DIEGO--(EON: Enhanced Online News)--OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, today announced its melanoma development strategy. The company plans to continue forward in its development path to seek FDA approval for its ImmunoPulse therapy and outlines key activities in the melanoma program that the company expects to share more details about within the next 12 months.
Phase II Study Expansion
The company plans to move forward with an expansion study of its Phase II trial for metastatic melanoma. The effectiveness of an accelerated treatment cycle will be evaluated, where an additional 10 patients will be enrolled and will receive a second cycle of treatment after three weeks. OncoSec may amend the protocol depending on the study outcomes.
OncoSec’s Phase II melanoma study completed enrollment on June 18, 2013. Positive immune response data, confirming the systemic effects of DNA IL-12 administered locally with electroporation, was announced at the 8th World Congress of Melanoma meeting in July. Top-line interim clinical data detailing available objective response rates (complete and partial response rates at Day 180) is expected in the upcoming months.
OncoSec is conducting a research study with Old Dominion University to evaluate the effects of ImmunoPulse in combination with Anti-CTLA-4, Anti-PD-1 and Anti-PDL-1 in a melanoma mouse model. The research study supports the company’s strategy to investigate methods that can potentially improve response rates of front-line therapy. Moreover, a positive outcome from these preclinical studies may result in the ability to expand ImmunoPulse’s reach into a larger melanoma patient population, including those with unresectable metastatic melanoma. Data from this study is expected in early 2014.
Initiation of Phase IIb Study
While OncoSec’s current Phase II studies in metastatic melanoma and Merkel cell carcinoma are coming to a conclusion, the company is preparing for its next phase of development and is setting up for the initiation of a Phase IIb trial. The Phase IIb study will be a randomized, controlled study, providing the company with information for a key inflection point in the development of this program.
Punit Dhillon, President and CEO of OncoSec Medical, said, “With the completion of our last financing, OncoSec expects to be well funded to focus on an aggressive clinical development strategy. In addition to our clinical program, we are focusing resources on a research pipeline that supports the expansion of clinical candidates and explores novel DNA plasmid constructs and cytokines for other cancer indications. We hope to continue strengthening our position in the melanoma landscape and are excited to share our research findings and data this year.”
About OncoSec Medical Inc.
OncoSec Medical Inc. is a biopharmaceutical company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers. ImmunoPulse and NeoPulse therapies address an unmet medical need and represent a potential solution, for less invasive and less expensive therapies that are able to minimize detrimental effects resulting from currently available cancer treatments such as surgery, systemic chemotherapy or immunotherapy and other treatment alternatives. OncoSec Medical's core technology is based upon its proprietary use of an electroporation platform to dramatically enhance the delivery and uptake of a locally delivered DNA-based immunocytokine (ImmunoPulse) or chemotherapeutic agent (NeoPulse). In early and late stage clinical trials, treatment of various solid cancers using these powerful and targeted anti-cancer agents has demonstrated selective destruction of cancerous cells while sparing healthy normal tissue. OncoSec's clinical programs include three Phase II clinical trials for ImmunoPulse targeting lethal skin cancers. More information is available at http://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.