Melanoma Vaccine FDA-Cleared for Phase 3 Clinical Testing
(ChemotherapyAdvisor) – Melanoma patients may have received a shot of life today with news that a vaccine for the deadly cancer has received FDA clearance for Phase 3 clinical testing. Hong Kong-based CK Life Sciences made the exciting announcement today and its subsidiary Polynoma LLC, which developed the vaccine, will now be permitted to recruit patients for the trials. The news puts CK Life Sciences into a rare group of Asian pharmaceutical companies that have received clearance for the commencement of Phase 3 clinical testing of an investigational new drug.
Annually, new melanoma cases have reached upward of 132,000, worldwide, with 76,000 in the United States alone. With such a large number of new cases per year, and with limited treatment options currently available, the melanoma vaccine would be a welcome addition to the oncologists' treatment arsenal.
Polynoma's melanoma vaccine is polyvalent, HLA-unrestricted, and derived from partially purified tumor antigens extracted from three different proprietary melanoma cell lines. The vaccine is administered intravenously, along with the adjuvant, aluminum hydroxide.
Results from a double-blind, randomized, placebo-controlled, Phase 2 clinical trial demonstrated that the vaccine was efficacious in prolonging time to disease progression and overall survival in melanoma patients. The vaccine was also safe, with no grade 3 or grade 4 toxicity reported.