Date: 2012-06-04
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Polynoma (USA - CA)
Product: POL 103A - sevipromut-L
Action
mechanism: immunotherapy product. Polynoma’s melanoma vaccine, POL 103A, is designed to stimulate the body’s immune system to fight cancer using a combination of shed antigens produced by three proprietary melanoma cell lines. In this novel approach, antigens are rapidly released from the cancer cells, then purified and processed prior to administration to patients. Multiple antigens provide more targets for immune recognition and can be used allogeneically to treat broad patient populations without requiring individualized preparation.
Disease: melanoma
Therapeutic area: Cancer - Oncology
Country: Canada, USA
Trial
details: The purpose of this study is to determine how safe and how well POL-103A works in preventing the relapse of melanoma after patients who have undergone surgery. Polynoma’s Phase III program consists of two stages, the first being a lead-in stage that is currently enrolling 99 patients and is designed to assess vaccine safety and bioactivity, as well as select the vaccine dose to be used in the second and final stage of the study. The ensuing second stage is designed to assess the efficacy of POL 103A, with the goal of enrolling 960 melanoma patients randomized to POL 103A or a placebo vaccine comparator on a 2:1 basis. The study will be conducted in fourteen countries across the U.S. and Europe. (NCT01546571)
Latest
news: * On June 4, 2012, Polynoma announced the start of a Phase III clinical trial program for POL 103A, the Company’s novel melanoma vaccine. Polynoma’s global, multi-center, double-blind, placebo-controlled Melanoma Antigen Vaccine Immunotherapy Study (MAVIS) is designed to enroll a total of 1059 patients with resected Stage IIb, IIc or III melanoma. The trial is being conducted under a Special Protocol Assessment (SPA) agreed upon with the FDA. The current Phase III study of POL 103A has been initiated based on the results of two randomized, placebo-controlled Phase II trials that demonstrated strong efficacy in terms of significantly improved recurrence-free survival (RFS) and overall survival (OS). Additionally, POL 103A has exhibited an excellent safety profile. “The goal is to reach the RFS 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,” stated John Chiplin, PhD, President and Chief Executive Officer of Polynoma.
