AnorMED Inc announced that it's licensee, North American Scientific Inc subsidiary, Theseus Imaging has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration requesting permission to initiate U.S. clinical studies of its Tc-99m Hynic-Annexin V technology, for the early determination of response to cancer treatment. Hynic Annexin V is based on the Apomate technology platform that uses the HYNIC linker licensed from AnorMED Inc.
AnorMED's HYNIC linker technology provides for efficient linking of technetium, the most commonly used imaging isotope, to an agent that targets the affected tissue. Medical imaging is used for the diagnosis and prognosis of a variety of diseases including cardiovascular disease, inflammation and cancer, among others. "We are encouraged by NASI's plan to move aggressively to initiate the studies described in the IND, which we believe will clearly establish the clinical value of Hynic-Annexin V in the early evaluation of patient response to chemotherapy." said Mike Abrams, President and CEO of AnorMED Inc.
Protocols included in the IND submission are designed to give early assessment of the effectiveness of anti-cancer therapy on a per patient basis in individuals with non-small cell lung cancer and small cell lung cancer. The planned studies will provide information about product safety, pattern of distribution in bodily tissues, imaging technique and optimal timing of imaging after initiation of chemotherapy. Hynic-Annexin V is intended to, within hours of initiation of therapy, provide objective evidence of tumor cell death in patients who respond to treatment. More importantly, such an agent would objectively demonstrate the ineffectiveness of such anti-cancer treatment within hours of initial exposure to chemotherapy. Early identification of ineffective treatment allows patients to avoid unnecessary side effects, discomfort and cost and provides physicians the opportunity to consider the early institution of more effective alternatives.