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

19 Jul 2006

FREDERICK, MD, USA | Jul 19, 2006 | Intracel, a biotechnology company developing and commercializing active and passive

cancer immunotherapies, has been granted a special protocol assessment (SPA) by the U.S. Food and Drug Administration (FDA) for the execution of a confirmatory, Phase III clinical trial of OncoVAX, a patient-specific active immunotherapy, 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 that is intended to form the primary basis for regulatory approval.

“Intracel now has a clear path to drug approval,” stated Dr. Mitchell H. Finer, Ph.D., Intracel’s CEO. “OncoVAX has the potential to become the first adjuvant therapy for stage II colon carcinoma, where the current standard of care worldwide is surgery alone. This is the only immunotherapy product in development for the treatment of minimal residual disease, where immunotherapy products have the greatest chance for clinical success.”

If successfully completed, the pivotal Phase III trial could form the basis of a biologics licensing application for OncoVAX in the United States. The randomized multi-center study will be conducted in the US and Europe with 560 patients enrolled over two years. An interim analysis will be performed one year following randomization of the last patient, with primary analysis conducted three years after all 560 patients have been randomized to the study. Intracel’s previous randomized study, published in The Lancet and Vaccine, demonstrated a statistically significant 33% increased overall survival and 40% reduction in deaths or recurrences in treated Stage II colon cancer patients, compared to controls at a five–year median follow-up.

Renowned Researchers to Lead Trials
The company announced the two co-principal Investigators for this clinical trial will be Herbert C. Hoover, Jr., MD, in the United States, and Cornelis Punt, MD, PhD, in Europe.

Dr. Hoover is the Director and Chief of Surgical Oncology for the Lewis Cancer & Research Pavilion at St. Joseph’s/Candler Hospital in Savannah, GA. A graduate of the University of Kansas School of Medicine, he has held positions at Johns Hopkins School of Medicine, the State University of New York at Stony Brook, Harvard University Medical School and was Surgery Department Chair at Lehigh Valley Hospital, Allentown, PA. Dr. Hoover participated in the first clinical study of OncoVAX in 1981, and has collaborated with Intracel over the past 25 years to bring OncoVAX to its current state of clinical development.

A pioneer in the translation of immunotherapy approaches from the laboratory to the clinic, Professor Cornelis J. A. Punt is Vice Chairman of the Department of Medical Oncology at the University Medical Center, St. Radboud, Nijmegen, The Netherlands. He is Chairman of the Dutch Colorectal Cancer Group, known for its studies on neoadjuvant radiotherapy and TME surgery in rectal cancer, and is the principal investigator for the ongoing CAIRO studies in advanced colorectal cancer. He was Chairman of the 2006 European Multidisciplinary Colorectal Cancer Congress, held in Berlin, Germany, and has served as associate editor of Annals of Oncology.

No current adjuvant therapies for Stage II Colon Cancer
Colon cancer is the fourth most prevalent malignancy, according to the American Cancer Society, with approximately 210,000 new cases diagnosed each year in the U.S. and Western Europe. The disease is classified in four stages, depending on the depth of invasion of the cancer into the bowel wall and the spread into the regional lymph nodes or other tissues. Surgical resection is the only curative treatment, but micrometastases may spread to cause disease recurrence. Various therapeutic agents have been approved for the adjuvant treatment of Stage III and Stage IV colon cancer; however, none have demonstrated significant benefit in Stage II colon cancer.

According to the Surveillance Epidemiology and End Results (SEER) of the National Cancer Institute and the tumor registries of Great Britain, The Netherlands, Switzerland and Germany, roughly 40% of colon cancer patients are currently diagnosed as Stage II cases. By the time OncoVAX® is commercialized in 2010, the number of Stage II colon cancers diagnosed will likely represent almost 70% of all colon cancers.

About OncoVAX®
OncoVAX immunotherapy is based on a long-standing attempt by scientists to manipulate the body’s immune response and its long-term memory to prevent the return of disease months or years after surgery. Such an approach has already been successful in preventing a number of infectious diseases. Immune stimulation should be able to create 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.

Intracel’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 to five weeks after surgery. A booster vaccination is administered six months later.

The OncoVAX vaccine is a somatic cell (whole cell) therapy considered an active immunotherapy, because once injected it triggers the body’s immune system to attack and destroy cancer cells. Active immunotherapy vaccines cause the immune system to produce cytotoxic T-cells. OncoVAX is tumor-specific, meaning it does not provoke a generalized immune response. In a pharmacoeconomic study, OncoVAX treatment showed impressive health economic benefits.

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

SOURCE: Intracel

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