- Pre-IND meeting with FDA scheduled for January for lead antibody
TORONTO, Dec. 5 /CNW/ - 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 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 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 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.
The TSX has not reviewed and does not accept responsibility for the
adequacy or accuracy of this statement.
For further information:
For further information: Warren Whitehead, C.M.A., Chief Financial
Officer, ARIUS Research Inc., (416) 862-2323 ext. 214,
firstname.lastname@example.org, email@example.com; James Smith, Investor
Relations, (416) 815-0700 ext. 229, firstname.lastname@example.org