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Melanoma Vaccine Trial Resumes Patient Enrollment
"This action by the FDA will allow CancerVax to move forward rapidly with our Phase 3 clinical trials of the CANVAXIN(TM) vaccine in the treatment of patients with advanced-stage melanoma," said David F. Hale, President and CEO of CancerVax. "Our interactions with the FDA have been very positive and productive. We will continue to work cooperatively with the FDA to make progress towards a license application for the CANVAXIN(TM) vaccine. We anticipate that this process will be expedited by the Fast Track designation recently granted by the FDA for the CANVAXIN(TM) vaccine."
The Fast Track designation allows CancerVax the opportunity for increased interactions with FDA staff, and the potential for priority review of a license application should the CANVAXIN(TM) vaccine prove to be safe and effective in clinical trials for the post-surgical treatment of metastatic melanoma. The CANVAXIN(TM) vaccine is being evaluated in two international, randomized, double-blind, placebo-controlled Phase 3 clinical trials.
The partial clinical hold on new patient enrollment was not the result of any clinical practice or safety concerns related to the CANVAXIN(TM) vaccine. Patients in the two Phase 3 clinical trials who were already receiving the CANVAXIN(TM) vaccine were permitted to continue to do so. The CANVAXIN(TM) vaccine has been supplied to these patients without interruption.
"We believe that resuming enrollment in these trials is welcome news for our clinical investigators and most importantly, for patients with melanoma and their families who have been anxiously waiting for these Phase 3 clinical trials to re-open," said Hale.
Melanoma is the deadliest form of skin cancer. New cases of melanoma in the U.S. have doubled over the past 30 years, and the American Cancer Society estimates that in 2003 there will be 54,200 new cases of melanoma and 7,600 deaths in the U.S. alone. While melanoma is curable in most patients when identified and treated in its earliest stages, patients with melanoma that has metastasized (spread to other parts of the body) have a poor prognosis for long-term survival. Even after surgery and current treatment, only 10-50% of patients with metastatic melanoma survive five years. According to the American Cancer Society, the lifetime risk of malignant melanoma in the U.S. has risen from 1/1,500 people in 1935 to 1/74 people in 2000, with a forecast of 1/50 people by 2005.
CancerVax's patented, core technology is based on the development of allogeneic, whole-cell cancer vaccines, which express multiple antigens that are associated with melanoma and other solid tumors. The experimental CANVAXIN(TM) therapeutic cancer vaccine is composed of three allogeneic tumor cell lines that together express over 30 tumor- or melanoma-associated antigens. Although the vaccine's mechanism of action has not been established, research indicates that the antigens expressed in the CANVAXIN(TM) vaccine stimulate the body's own immune system to produce cancer-fighting T cells and antibodies. The polyvalent (multiple antigen) nature of the CANVAXIN(TM) vaccine confers a high probability of an antigenic match with individual patients with melanoma and other solid tumors. The CANVAXIN(TM) vaccine has been administered to more than 2,600 cancer patients in clinical trials and appears to be well-tolerated. It has received both Orphan Drug and Fast Track designations from the FDA for the treatment of metastatic melanoma.