AsianScientist (Mar. 8, 2012) – Hong Kong-based CK Life Sciences Int’l., (Holdings) Inc. announced this week that the U.S. Food and Drug Administration (FDA) has granted clearance for its subsidiary Polynoma LLC’s Investigational new drug (IND) application, allowing it to proceed with Phase III clinical testing of its melanoma vaccine.
This makes CK Life Sciences one of a few Asian companies to obtain clearance from the FDA to commence Phase III clinical testing of a new drug.
“We are very delighted that the FDA has granted clearance for the Phase III clinical testing of our melanoma vaccine. We look forward to the positive results of the clinical trial, and the prospect of offering a new medicine for melanoma patients,” said Mr. HL Kam, President and Chief Executive Officer of CK Life Sciences.
Malignant melanoma is the most serious form of skin cancer. An estimated 132,000 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 United States and Europe being the major 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 United States 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.
Using a combination of antigens from three proprietary melanoma cell lines, Polynoma’s melanoma vaccine is intended to stimulate the body’s immune system to fight the cancer.
Preparation for the Phase III clinical trial is already underway, and it is expected that patient enrollment will commence within several months. This latest development follows the approval Polynoma obtained from the FDA of a clinical trial protocol under a Special Protocol Assessment (SPA) agreement.
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Source: CK Life Sciences International (Holdings) Inc.
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