Polynoma has started a Phase III trial of its therapeutic melanoma vaccine, POL-103A, following approval from the FDA in January 2012. The trial, known as the Melanoma Antigen Vaccine Immunotherapy Study (MAVIS), will involve 1,059 patients in 14 countries across the U.S. and Europe who have Stage IIb, IIc or III melanoma and who have had surgery.
The trial will initially treat 99 patients to check its safety and bioavailability, and to work out the best possible dose. In the final stage, two-thirds of the people in the study will be given the vaccine and one-third will get a placebo.
Polynoma's vaccine is based on a mixture of known and unknown antigens that are shed by three cultured melanoma cell lines, and is designed to be given 11 times over 24 months. This is an "off-the-shelf" generic vaccine--it includes a broad range of antigens and does not need to be prepared fresh for each patient. In previous studies, the vaccine improved survival and reduced recurrences of the cancer.
John Chiplin, Ph.D., President and Chief Executive Officer of Polynoma, commented, "[t]he goal is to reach the RFS [recurrence-free survival] endpoint by mid-2016, another key milestone for the clinical program. Given the fact that other key oncology therapies have received approvals based on positive RFS findings, our plan is to file an early BLA submission to the FDA according to our SPA [Special Protocol Assessment--this allows the company to submit an uncompleted Phase III trial]."
This vaccine moves into a potentially huge market--estimated to be $1 billion--with a large area of unmet need. Interferon alfa-2b is the only currently approved treatment in the U.S. and Europe to reduce the likelihood of recurrence after resection in melanoma, but its efficacy and tolerability is limited.
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