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CK Life Sciences Announces U.S. FDA's Clearance to Commence Phase III Clinical Testing of Melanoma Vaccine
Date:3/6/2012

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
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SOURCE CK Life Sciences Int'l., (Holdings) Inc.
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