Intracel And FDA Agree On Pivotal Phase III Clinical Protocol For Colon Cancer Vaccine
"We have developed a cancer vaccine that has the potential to meet a long-standing, unmet medical need in patients with Stage II colon cancer, an earlier stage than most approved treatments address," said Michael G. Hanna, Jr., Ph.D., chief scientific officer of Intracel and discoverer of the OncoVAX platform. "Intracel has overcome many technological hurdles and is now able to produce this complex biologic product to meet the potency, identity and safety qualifications required. We are excited to be starting this pivotal Phase III clinical trial."
Colon cancer is one of the most prevalent malignancies, with approximately 240,000 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 (i.e., removal of the tumor) 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, but none are available for adjuvant treatment of Stage II of the disease.
"Achievement of a successful Phase III clinical trial for colon cancer will be only the tip of the iceberg," said Mitchell Finer, Ph.D., chief executive officer of Intracel. "Intracel's clinical investigators have completed Phase I/II studies in melanoma, renal and ovarian cancer, and the current clinical study paves the way for further advanced clinical development of the OncoVAX vaccine for these other types of cancer, as well."
Some Background on Colon Cancer and the Phase III Trial
Intracel's proposed Phase III trial of the OncoVAX vaccine for Stage II colon cancer is based on an earlier published study that showed delays in the recurrence of tumors following surgery in those patients with Stage II disease. The Phase III trial will be conducted in patients with Stage II disease, and the primary endpoint will be disease-free survival. Secondary endpoints will include recurrence-free interval and five-year overall survival.
Stage II colon cancer involves limited penetration of the tumor through the bowel wall and no involvement of the regional lymph nodes. The proportion of patients first presenting with Stage II disease has been increasing over the last decade, due in large part to greater use of diagnostic tests such as sigmoidoscopy and colonoscopy. Intracel's proposed Phase III clinical protocol is designed for patients with Stage II disease, for which there is an unmet medical need.
The randomized, multi-center Intracel study will be conducted in the United States and Europe, with 560 patients enrolled. Enrollment is expected to take two years. An interim analysis will be performed one year following randomization of the last patient. The primary analysis will be conducted three years after all 560 patients have been randomized to the study.
OncoVAX Immunotherapy
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. Theoretically, 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.
The approach used by Intracel's scientists involves the preparation of 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 injections given a week apart, starting four to five weeks after surgery. A booster vaccination is administered six months later. Cells in the first two vaccines are mixed with Bacillus Calmette-Guerin (BCG), which acts as an immune stimulant. BCG is a strain of Mycobacterium already approved for treatment of urinary bladder carcinoma.
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. OncoVAX vaccine is patient-specific, meaning it does not provoke a generalized immune response. Instead, active immunotherapy vaccines cause the immune system to produce cytotoxic T-cells. 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 intended to treat different forms of cancer, infectious diseases, as well as autoimmune disorders. Intracel has pioneered bringing fully human antibodies from clinical use to market and has a portfolio of fully human monoclonal antibodies in various stages of 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. For more information, please visit www.intracel.com.
Contact: Intracel Peter Nardin, 301-668-8400 ext. 1003 Peter.Nardin@intracel.com
Source: Intracel