CK Life Sciences Announces U.S. FDA’s Clearance to Commence Phase III Clinical Testing of Melanoma Vaccine
HONG KONG, March 6, 2012 /PRNewswire-Asia/ — CK Life Sciences Int’l., (Holdings) Inc. (“CK Life Sciences” or the “Company”) today announced that the FDA (U.S. Food and Drug Administration) has granted clearance for its subsidiary Polynoma LLC (“Polynoma”)’s Investigational new drug (IND) application, allowing it to proceed with Phase III clinical testing of its melanoma vaccine.
One of A Few Asian Companies Cleared by FDA for Phase III Clinical Trial
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.
Melanoma Treatment in Demand
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.
CK Life Sciences‘ Melanoma Vaccine Stimulates Immunity to Fight Cancer
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. An SPA is an agreement between the FDA and the applicant that a proposed protocol’s design and analysis plan are acceptable to the FDA as support for potential future approval of a drug, biologic or vaccine, if the results of the clinical trial are positive. It is a process that can support the future registration and launching of the product.
Drug research and development requires extensive testing, involving multiple stages of compound screening as well as pre-clinical and clinical development (Phase I, II, III clinical trials) prior to approval and registration by health authorities such as the FDA. Phase III clinical testing is generally the last step before a drug can be submitted for approval for registration and sale, and involves the generation of controlled clinical trial results that are statistically significant and clinically relevant.
For enquiries, please call Mrs. Wendy Tong Barnes or Ms. Carolina Cheung of CK Life Sciences at +852-2122-2150.
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.
About Polynoma LLC
Polynoma LLC is an oncology-focused biotechnology company based in the United States and is a subsidiary of CK Life Sciences. It is currently developing a therapeutic vaccine for the treatment of melanoma. In addition to melanoma, Polynoma is also planning to evaluate the effectiveness of the vaccine in other cancer indications. For additional information, please visit www.polynoma.com.
SOURCE CK Life Sciences Int’l., (Holdings) Inc.