Polynoma Commences Phase III Melanoma Vaccine Clinical Trial
- First Patient Dosed in Global Study -
June 04, 2012
SAN DIEGO--(BUSINESS WIRE)--Polynoma LLC, a U.S. oncology-focused biopharmaceutical company within Hong Kong-based CK Life Sciences Int'l., (Holdings) Inc., today 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 U.S. Food and Drug Administration (FDA).
"Initiation of our multinational Phase III clinical program is a major milestone for Polynoma, and is a strong demonstration of our commitment to rapidly advancing new treatments with broad potential impact in oncology," stated John Chiplin, PhD, President and Chief Executive Officer of Polynoma.
Polynoma's melanoma vaccine has an extensive clinical history, having been safely administered to over 650 patients. 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.
Dr. Chiplin commented, "POL 103A's strong safety profile and tolerability have a significant advantage over Interferon, which has limited efficacy and poor tolerability despite its being the current standard of care for resected Stage IIb – III melanoma patients, for whom there are currently no other alternatives."
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.
Dr. Chiplin continued, "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."
About POL 103A Melanoma Vaccine
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 (shed) 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.
Malignant melanoma is the most serious form of skin cancer. An estimated 200,000 new cases of melanoma are diagnosed annually around the world, with about 76,000 in the United States alone. The melanoma market is estimated to be in excess of US$1 billion, with the U.S. and Europe being the primary markets.
Melanoma is treated with a combination of surgery, radiation therapy, immunotherapy or chemotherapy, depending on the stage of the disease. 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 patients at high risk of recurrence, but its limited efficacy and significant toxicity have restricted its use.
Polynoma LLC is a U.S. oncology-focused biopharmaceutical company headquartered in San Diego; and is a subsidiary of CK Life Sciences. Polynoma's lead product candidate is the therapeutic vaccine POL 103A for the treatment of melanoma. The vaccine has an extensive clinical history, having been safely administered to over 650 patients. The current Phase III trial of POL 103A was initiated based on the results of two randomized controlled Phase II trials that demonstrated strong efficacy and safety data. In addition to melanoma, Polynoma is also planning to evaluate the effectiveness of the vaccine in other cancer indications.
About CK Life Sciences
CK Life Sciences Int'l., (Holdings) Inc. is a listed company on The Stock Exchange of Hong Kong Limited (stock code: 0775). Bearing the mission of improving the quality of life, the Company is engaged in the business of research and development, commercialisation, marketing and sale of health and agriculture related products. CK Life Sciences is a member of the Cheung Kong Group. For additional information, please visit www.ck-lifesciences.com.
For additional information, please visit www.polynoma.com
Dr. John Chiplin, 858-361-6288