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Arius completes Pre-IND Meeting with FDA for Lead CD44 Cancer Stem Cell Program
TORONTO, Jan. 28 /CNW/ - ARIUS Research Inc., (TSX: ARI), a biotechnology company discovering and...
About this update from Affinity Metals Corp
[{"type":"text","content":"\n\n\n\nTORONTO, Jan. 28 /CNW/ - ARIUS Research Inc., (TSX: ARI), a biotechnology\ncompany discovering and developing the next wave of antibody therapeutics,\ntoday announced it has completed its Pre-IND (Investigational New Drug)\nmeeting with the FDA to discuss the upcoming IND submission for ARH460-16-2,\nits lead CD44 Cancer Stem Cell Program. ARH460-16-2 is an anti-cancer antibody\ntargeting a novel epitope of CD44 found in hematological and solid cancers,\nincluding breast, colon and prostate. The Pre-IND meeting focused on\ndevelopment plans for the drug, including manufacturing details, preclinical\npharmacology and toxicology data, and the proposed plans for the Phase I\nclinical program.\n\n\n"The completion of our pre-IND meeting with the FDA is an important\nmilestone for the Company and demonstrates the significant progress we have\nmade with our lead CD44 Cancer Stem Cell Program and our ability to advance\ndrug candidates towards human clinical trials," said Dr. David Young,\nPresident and Chief Executive Officer. "We are pleased with the outcome of\nthis meeting and will continue to prepare for our IND submission with the\nintention of initiating human clinical trials this year."\n\n\nConcurrently, ARIUS announced the promotion of Susan Hahn, PhD, formerly\nDirector of Development, to the position of Vice President of Development.\n"Dr. Hahn has been instrumental in leading the development of our antibody\nprograms that we are taking to the clinic," said Dr. Young. "In her new role,\nDr. Hahn will continue to focus on meeting ARIUS' development milestones as we\nmove each of our lead drug candidates towards human clinical trials."\n\n\nThe CD44 Cancer Stem Cell program was generated using ARIUS' proprietary\nFunctionFIRST(TM) technology, which selects antibodies based on their ability\nto kill cancer cells. Pre-clinical data from a dose-ranging pilot toxicology\nstudy in non-human primate models demonstrated no dose-limiting toxic effects\nat doses up to 95 mg/kg and significant tumor growth inhibitory activity in in\nvivo animal models of breast, prostate, liver and AML cancers. The Company\nwill now complete manufacturing and advanced toxicology studies toward filing\nthe IND later this year.\n\n\nAbout ARIUS\n\n\nARIUS is a biotechnology company discovering and developin...