Clinical Trials, Data, and Staging

Clinical Trials, Data, and Staging

The biotech and medical industries have come a long way. While many marvels have been created – such as vaccines, treatments and prosthetics – some of the research could pose dangers to the public, if it is not used correctly or if the initial findings from early experimentation are wrong. It is for these reasons that the FDA requires proper clinical testing (or clinical trials) to be performed, before they are eligible for public use. We would like to explore what exactly a clinical trial is, the data they collect and how a clinical trial moves on to the next phase:

SAN DIEGO, CA, October 20, 2011 — OncoSec Medical Incorporated (OTCBB: ONCS), which is developing its advanced-stage OMS ElectroOncology therapies for the treatment of solid tumor cancers, announced today the submission of its Device Master File (DMF) to the U.S. Food and Drug Administration (FDA) for its patented OncoSec Medical System (OMS) which consists of a generator and hand-held applicator. The Company has been developing the OncoSec Medical System as its lead medical device for delivering DNA based cytokines and chemotherapeutic agents for the treatment of solid tumor cancers. In numerous Phase I through Phase IV clinical trials, the OncoSec Medical System has been shown to be both safe and effective for optimizing the cellular uptake of DNA based cytokines or chemotherapeutic agents resulting in improved therapeutic benefits for the patient.

The DMF, which includes technical, manufacturing, clinical and non-clinical information about the OncoSec Medical System, marks an important milestone for the Company. This regulatory filing facilitates FDA review of the complete system when any investigational clinical study application references its use.

“This DMF submission brings the OncoSec Medical System another step closer to becoming the treatment of choice for different types of solid tumor cancers,” stated Punit Dhillon, President and Chief Executive Officer of OncoSec. “In a very short period of time, OncoSec has moved aggressively with its clinical and regulatory strategy, with the DMF being one important piece of that strategy. Moving forward, we will continue to demonstrate the value of our treatment approaches as our clinical studies begin.”

OncoSec plans to initiate three Phase II clinical trials under physician sponsored INDs using the OncoSec Medical System to deliver DNA IL-12: OMS-I100 for the treatment of melanoma; OMS-I120 for the treatment of Merkel cell carcinoma; and OMS-I130 for the treatment of cutaneous T-cell lymphoma.

About OncoSec Medical Inc.

OncoSec Medical Incorporated (OTCBB: ONCS) develops novel OMS ElectroOncology therapies that combine its proprietary electroporation delivery technology with a chemotherapeutic or novel DNA-based immunotherapeutics. Targeted local delivery of these agents is designed to achieve selective destruction of cancerous tumors while sparing healthy normal tissue, resulting in improved functional, cosmetic and quality of life outcomes. These therapies have achieved validating safety and efficacy data in early and late stage clinical studies of over 400 cancer patients. OncoSec’s clinical programs include three Phase II clinical trials. More information is available at 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’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.

OncoSec submits the Device Master File (DMF) for its patented OncoSec Medical System (OMS) to the U.S. Food and Drug Administration (FDA).

The device consists of a generator and hand-held applicator designed to deliver DNA-based cytokines and chemotherapeutic agents for the treatment of solid tumor cancers. Numerous Phase I through Phase IV clinical trials have demonstrated the safe effective use of the device in optimizing cellular uptake of DNA based cytokines or chemotherapeutic agents resulting in improved therapeutic benefits for the patient.


Real Time Web Analytics