- Pre-IND meeting with FDA scheduled for January for lead antibody program
TORONTO, Dec. 5 /PRNewswire-FirstCall/ - ARIUS Research Inc. (TSX: ARI), a biotechnology company discovering and developing the next wave of antibody therapeutics, today 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."
"This new manufacturing agreement is the result of the solid working relationship we have developed with the ARIUS team," said F. David King, Vice President, Business Development of Avid. "Our goal is to form strategic partnerships with innovative life sciences companies like ARIUS, serving as a premier service provider by seamlessly integrating our experience and capabilities with our clients' needs."
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.
About Avid Bioservices, Inc.
Avid Bioservices provides a comprehensive range of cGMP manufacturing services for the biotechnology and biopharmaceutical industries. Avid manufactures cGMP commercial product, as well as clinical supplies for all phases of clinical trials. The company's comprehensive range of cGMP services includes cell banking, stability testing, clinical product manufacturing and purification, bulk packaging, final product filling and regulatory support. Avid also provides a variety of process development activities, including cell line optimization, analytical method development and product characterization. Avid has over 10 years of antibody manufacturing experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes. Avid Bioservices is a wholly owned subsidiary of Peregrine Pharmaceuticals Inc. For more information about Avid, visit http://www.avidbio.com.
ARIUS is a biotechnology company discovering and developing the next wave of antibody therapeutics. Established in 1999, ARIUS has built a proprietary technology platform, FunctionFIRST(TM), that rapidly identifies and selects antibodies based on their functional ability to affect disease. This antibody generation engine has enabled ARIUS to assemble a portfolio of more than 500 antibody candidates. In addition to the antibodies it is developing in-house, ARIUS has ongoing partnerships with key biotechnology and drug development companies. ARIUS is listed on the TSX under the symbol "ARI". For further information, visit http://www.ariusmabs.com.
Certain statements in this news release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements in this release include, but are not limited to, ARIUS successfully advancing its new product programs as well as licensing opportunities. These statements are only predictions and actual events or results may differ materially. Factors that could cause such actual events or results expressed or implied by such forward-looking statements to differ materially from any future results expressed or implied by such statements include, but are not limited to: early stage of development; technology and product development; dependence on and management of current and future corporate collaborations; future capital needs; uncertainty of additional funding; no assurance of market acceptance; dependence on proprietary technology and uncertainty of patent protection; intense competition; manufacturing and market uncertainties; and government regulation. These and other factors are described in detail in ARIUS' Annual Report, forthcoming news releases and other filings with Canadian securities regulatory authorities available at http://www.sedar.com. Forward-looking statements are based on our current expectations and ARIUS is not obligated to update such information to reflect later events or developments.
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|SOURCE ARIUS Research Inc.|
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