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ARIUS announces manufacturing agreement with Avid Bioservices for CD44 Cancer Stem Cell antibody
- Pre-IND meeting with FDA scheduled for January for lead antibody program - TORONTO, Dec. 5 /CNW...
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[{"type":"text","content":"\n\n\n\n- Pre-IND meeting with FDA scheduled for January for lead antibody\n\n\nprogram -\n\n\nTORONTO, Dec. 5 /CNW/ - ARIUS Research Inc. (TSX: ARI), a biotechnology\ncompany discovering and developing the next wave of antibody therapeutics,\ntoday announced that it has entered into a manufacturing supply and technology\ntransfer agreement for its CD44 Cancer Stem Cell antibody with Avid\nBioservices, a company providing cGMP manufacturing services for the\nbiotechnology and biopharmaceutical industries. Avid has begun manufacturing a\nsupply of the drug for human clinical trials which ARIUS plans to initiate in\n2008. ARIUS also announced it has scheduled a pre-IND meeting with the FDA\nthat will take place in January.\n\n\n"The initiation of manufacturing and the scheduling of our pre-IND\nmeeting with the FDA in January reflect the significant progress we have made\nwith our CD44 Cancer Stem Cell program," said Dr. David Young, President and\nChief Executive Officer of ARIUS. "Avid has proven expertise in the scale-up\nand manufacture of clinical and commercial grade antibodies and will provide\nus with a supply of our CD44 targeting drug to initiate human clinical trials\nin 2008, subject to the clearance of our IND by the FDA."\n\n\n"This new manufacturing agreement is the result of the solid working\nrelationship we have developed with the ARIUS team," said F. David King, Vice\nPresident, Business Development of Avid. "Our goal is to form strategic\npartnerships with innovative life sciences companies like ARIUS, serving as a\npremier service provider by seamlessly integrating our experience and\ncapabilities with our clients' needs."\n\n\nARIUS is advancing the formal pre-clinical toxicology program for its\nlead CD44 Cancer Stem Cell program, an anti-cancer antibody targeting a novel\nepitope of CD44 found in breast, colon, and prostate cancers. Pre-clinical\ndata from a dose-ranging pilot toxicology study in non-human primate models\ndemonstrated no dose-limiting toxic effects at doses up to 95 mg/kg and\nsignificant tumor growth inhibitory activity in in vivo animal models of\nbreast, prostate, liver, and AML cancers. The CD44 Cancer Stem Cell program\nwas generated using ARIUS' proprietary FunctionFIRST(TM) technology, which\nselects antibodies based on their ability to kill ca...