TORONTO, Jan. 28 /PRNewswire-FirstCall/ - ARIUS Research Inc., (TSX: ARI), a biotechnology company discovering and developing the next wave of antibody therapeutics, today announced it has completed its Pre-IND (Investigational New Drug) meeting with the FDA to discuss the upcoming IND submission for ARH460-16-2, its lead CD44 Cancer Stem Cell Program. ARH460-16-2 is an anti-cancer antibody targeting a novel epitope of CD44 found in hematological and solid cancers, including breast, colon and prostate. The Pre-IND meeting focused on development plans for the drug, including manufacturing details, preclinical pharmacology and toxicology data, and the proposed plans for the Phase I clinical program.
"The completion of our pre-IND meeting with the FDA is an important milestone for the Company and demonstrates the significant progress we have made with our lead CD44 Cancer Stem Cell Program and our ability to advance drug candidates towards human clinical trials," said Dr. David Young, President and Chief Executive Officer. "We are pleased with the outcome of this meeting and will continue to prepare for our IND submission with the intention of initiating human clinical trials this year."
Concurrently, ARIUS announced the promotion of Susan Hahn, PhD, formerly Director of Development, to the position of Vice President of Development. "Dr. Hahn has been instrumental in leading the development of our antibody programs that we are taking to the clinic," said Dr. Young. "In her new role, Dr. Hahn will continue to focus on meeting ARIUS' development milestones as we move each of our lead drug candidates towards human clinical trials."
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. 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 Company will now complete manufacturing and advanced toxicology studies toward filing the IND later this year.
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.
|SOURCE ARIUS Research Inc.|
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