Dr. Herbert Hoover

FDA Grants “Fast Track ” Designation for the Development of OncoVAX®

OncoVAX® Vaccine Designed to Prevent Recurrence in Stage II Colon Cancer Patients Following Surgical Tumor Resection

Frederick, MD. - July 2006 - Intracel continues to announce significant regulatory and clinical milestones in the development of its autologous colon tumor cell vaccine both in Europe and in the United States. The company’s novel, innovative and proprietary investigational vaccine, OncoVAX®, is being developed to prevent disease recurrence in Stage II Colon Cancer patients following surgical tumor resection. Intracel has now been granted “Fast Track” designation from the US Food and Drug Administration (FDA) for this development program.

Under the FDA Modernization Act of 1997, Fast Track regulations facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. This designation allows for a rolling submission of a potential Biologics License Application (BLA) to the FDA for OncoVAX® and ordinarily provides for a 6 month priority review cycle as opposed to 10 months for a standard review. 

In July of this year, Intracel announced that the US FDA had granted a Special Protocol Assessment (SPA) for the upcoming confirmatory, pivotal Phase III study of OncoVAX® in Stage II Colon Carcinoma. An SPA provides a mechanism for the FDA and sponsors to reach agreement on the design, size, execution and analysis of a clinical trial intended to form the primary basis for regulatory approval. The Phase III trial is expected to begin in the fourth quarter of this year. The combination of the two designations (Fast Track and SPA) demonstrates Intracel’s continued efforts to utilize regulatory mechanisms that decrease the product development risks and increase the speed at which OncoVAX® can be brought to market. 

Mitchell H. Finer, Ph.D., Intracel’s Chief Executive Officer stated, “We have promised significant regulatory milestones to our investors over the past year and we have continued to deliver. We are committed to bringing this vaccine to the market to address the unmet medical need in Stage II colon cancer by developing a drug that prevents or significantly decreases disease recurrence following tumor resection. Intracel believes OncoVAX® has significant potential to bring new hope to the patients with this disease.”

Michael G. Hanna Jr, Ph.D., Intracel’s Chairman (Emeritus) and Chief Scientific Officer stated, “I am pleased with the advancements made in the past several months. The FDA has acknowledged the potential that OncoVAX® carries by granting the SPA and Fast Track designations. We have received national regulatory approval and ethics committee approvals to move forward in the Netherlands and the United Kingdom. With the FDA and other regulatory approvals we have twelve prominent clinical centers committed to our study. Working together with a world-renowned contract research organization, we are looking forward to starting the trial before year-end.” 

About OncoVAX®

OncoVAX® immunotherapy is based on a decades-long attempt by scientists to transform the body’s immune response and its long-term memory to prevent the return of the disease. Such an approach has already been successful in preventing a number of infectious diseases. In most cases immune stimulation creates a population of white blood cells that can kill tumor cells wherever they arise in the body, years after surgical removal of the original tumor.

Vaccinogen’s scientists prepare a vaccine from the patient’s own tumor. The cells are dissociated, irradiated to make them non-tumorigenic and administered to the patient by three weekly injections, starting four weeks after surgery. A booster vaccination is administered six months later.

About Vaccinogen

Vaccinogen is a biopharmaceutical company developing and commercializing cancer vaccines and other immunotherapeutic products. Based in Frederick, MD, the company has a portfolio of product candidates for the treatment of cancer, infectious disease, autoimmune and anti-inflammatory diseases and fully human monoclonal antibodies in various stages of clinical development. The company maintains a European subsidiary in Emmen, The Netherlands that operates a fully functioning cGMP manufacturing center for the production of OncoVAX® vaccine.

 

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