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ARIUS announces manufacturing agreement with Avid Bioservices for CD44 Cancer Stem Cell antibody

07 Dec 2007 - ARIUS Research Inc. announced that it has entered into a manufacturing supply and technology transfer agreement for its CD44 Cancer Stem Cell antibody with Avid Bioservices, a company providing cGMP manufacturing services for the biotechnology and biopharmaceutical industries. Avid has begun manufacturing a supply of the drug for human clinical trials which ARIUS plans to initiate in 2008. ARIUS also announced it has scheduled a pre-IND meeting with the FDA that will take place in January.
 
"The initiation of manufacturing and the scheduling of our pre-IND meeting with the FDA in January reflect the significant progress we have made with our CD44 Cancer Stem Cell program," said Dr. David Young, President and Chief Executive Officer of ARIUS. "Avid has proven expertise in the scale-up and manufacture of clinical and commercial grade antibodies and will provide us with a supply of our CD44 targeting drug to initiate human clinical trials in 2008, subject to the clearance of our IND by the FDA."
 
ARIUS is advancing the formal pre-clinical toxicology program for its lead CD44 Cancer Stem Cell program, an anti-cancer antibody targeting a novel epitope of CD44 found in breast, colon, and prostate cancers. Pre-clinical data from a dose-ranging pilot toxicology study in non-human primate models demonstrated no dose-limiting toxic effects at doses up to 95 mg/kg and significant tumor growth inhibitory activity in in vivo animal models of breast, prostate, liver, and AML cancers. The CD44 Cancer Stem Cell program was generated using ARIUS' proprietary FunctionFIRST(TM) technology, which selects antibodies based on their ability to kill cancer cells.