SAN DIEGO, Oct. 5, 2011 /PRNewswire/ -- OncoSec Medical Incorporated (OTCBB: ONCS), which is developing its advanced-stage OMS ElectroOncology™ therapies to treat solid tumor cancers, announced today that the OncoSec Medical System (OMS) devices have been qualified and released and are now ready for shipment to clinical sites in time for the upcoming OMS ElectroImmunotherapy™ clinical trials.
In March 2011 OncoSec acquired the rights to an electroporation delivery technology platform that can be used to efficiently deliver a chemotherapeutic or DNA-based cytokine agent for the treatment of solid tumors, which OncoSec has branded as the OncoSec Medical System (OMS). Since then, projects were initiated to establish engineering and manufacturing capabilities, as well as, transfer and update regulatory, design and manufacturing documentation, including implementing a new quality assurance system. Over the course of five months a manufacturing plan was executed to ensure that the devices acquired by OncoSec were safe and ready for use in clinical trials. The company now has inventory of OMS investigational devices adequate to support known and anticipated clinical study requirements well into 2013. OncoSec's current infrastructure and facility is designed to support manufacturing, assembly, testing, technical and regulatory support for multiple clinical trials in compliance with FDA and quality systems regulations. The extent of OncoSec manufacturing operations allow the company to build and maintain the current device supply to support on-going and future clinical trials, scale up production as needed as well as design and develop a next generation OMS electroporation system. The company utilizes contract manufacturers for key operations, such as clean room assembly and sterilization, which are not presently economically conducted in-house.
"Since acquiring the technology our team has worked diligently to test, and re-test, the OMS device to ensure that it is safe and ready for in-human use, as well as, manufacture new applicators and applicator handles for the OMS ElectroImmunotherapy™ clinical trials. I am delighted to report that they are now ready for shipment to the clinical sites," said Dr. Michael Cross, OncoSec's Chief Business Officer, "This milestone also highlights the fact that OncoSec now has the in-house capabilities to build, maintain and develop our own devices, while still having the flexibility to outsource specific manufacturing activities, where required, thereby allowing OncoSec to hold strict control over manufacturing costs."
OncoSec intends to initiate three Phase II clinical trials using the OMS ElectroImmunotherapy™ treatment approach for melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma by the end of October 2011. "The release of these devices is an integral step in our development plan. With the achievement of this milestone, we continue to meet the goals set out by our corporate strategy, and expect to move toward validating the data seen in the Phase I study in our upcoming clinical trials," said Punit Dhillon, President and CEO.
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 for OMS ElectroImmunotherapy™. More information is available at www.oncosec.com. Additional information may also be found at OncoSec's Facebook, Twitter, and LinkedIn sites.
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.
|SOURCE OncoSec Medical Incorporated|
Copyright©2010 PR Newswire.
All rights reserved