Therapure Innovations Receives FDA Approval To Proceed With A Phase 1 Clinical Trial Of Its Novel Anemia Therapeutic TBI 304H

On March 12, 2015 Therapure Innovations, a division of Therapure Biopharma Inc., reported that the U.S. Food and Drug Administration (FDA) has given the Company approval to proceed with a Phase 1 clinical trial of TBI 304H (a monoclonal antibody) for the treatment of chemotherapy-induced anemia (Press release, Therapure Biopharma, MAR 12, 2015, View Source [SID1234598115]). TBI 304H targets blood-forming stem cells that are involved in red blood cell production through a novel pathway.

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Anemia is a condition with potentially severe health effects; it results from low levels of red blood cells or hemoglobin, the body’s main oxygen-carrying components. Anemia is a common side effect of chemotherapy; about 5 in 10 patients who receive chemotherapy develop anemia, depending on the type of cancer.

"This product candidate presents a potential new means for treating anemia, and we believe that it offers great promise as a therapeutic for patients suffering from chemotherapy-induced anemia," says David Bell, vice president and chief scientific officer of Therapure. "This is our first proprietary product to move to the clinic, and we are delighted to be able to advance our development program."

"Proceeding with our Phase 1 clinical study is a major milestone for Therapure" says Nick Green, Therapure’s president and CEO. "It’s exciting to see our Innovations division begin to emerge with the first of its pipeline products, and we look forward to more positive developments in the future."

The Phase 1 clinical trial is a single-center, open-label, intrasubject escalating dose study, which will evaluate the safety, tolerability and pharmacokinetics of TBI 304H following administration to subjects experiencing chemotherapy-induced anemia. TBI 304H is manufactured by Therapure Biomanufacturing, the contract manufacturing and development division of Therapure Biopharma Inc., in its cGMP facility in Mississauga, Ontario.