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Sumagen Initiates Clinical Testing of Omnia Biologics Manufactured HIV Vaccine
ROCKVILLE, Md., Jan. 10, 2012 /PRNewswire/ -- Biologics drug development and manufacturing services provider Omnia Biologics, Inc. (Omnia) (Rockville, MD) today announced that its customer Sumagen, Co., Ltd., (Seoul, S. Korea and London, ON) will begin clinical trials of their revolutionary HIV vaccine design. The Food and Drug Administration approved Phase I clinical trial will begin in January.
The design and testing of the vaccine was spearheaded by Dr. Chil-Yong Kang, a professor at University of Western Ontario's (UWO) medical school. Dr. Dale VanderPutten of Omnia Biologics commented on the development, "To date experimental HIV vaccines have been largely either subunit vaccines or used non-HIV vaccine vectors and have universally failed in the clinic. Dr. Kang and his team took a page from the successes of polio, flu, rabies and other highly effective vaccines focusing instead on a viral vaccine that is genetically attenuated, irradiated and chemically inactivated."
Omnia participated in the international effort to propel this important advance into the clinic by providing process and assay development services and manufacturing the vaccine under GMP for South Korean biotech company Sumagen Co. Ltd and their academic partner Dr. Kang and UWO. Preclinical testing has shown the vaccine to be safe and produce strong immune responses.
Steve Hubert, Vice-President of Operations at Omnia commented on his team's success, "It is especially heartening for our team at Omnia to be able to translate this important technology into the clinic as other well established contract manufacturers failed in their attempts to produce the vaccine at clinical scale."
About Omnia Biologics: (www.omniabiologics.com)
Omnia offers translational medicine services in the areas of process development, assay development, GMP manufacture, and fill-finish for preclinical and clinical programs for novel therapeutics platforms. These include vaccines, autologous therapeutics, new gene therapy platforms, and stem cell technologies. The company seeks and has established relationships with both biopharmaceutical companies and academic investigators throughout the world.
SOURCE Omnia Biologics, Inc.
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