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Therapure Innovations Receives FDA Approval to Proceed with a Phase 1 Clinical Trial of the Targeted Liver Cancer Therapeutic TBI 302Therapure Innovations, a division of Therapure Biopharma Inc., today announces that the U.S. Food and Drug Administration (FDA) has given the company approval to proceed with a Phase 1 clinical trial of TBI 302, a targeted therapeutic for the treatment of liver cancer. TBI 302 is the first drug to emerge from Therapure's targeted drug delivery platform, which takes advantage of the natural clearance pathway of hemoglobin predominantly through the liver. TBI 302 consists of the chemotherapy drug floxuridine attached to hemoglobin, which serves as the drug carrier and targeting agent. The targeted drug delivery approach of TBI 302 is intended to deliver drugs to the liver while sparing other tissues from the toxicity of chemotherapy drug exposure. "This technology addresses an area of unmet medical need that may provide a means to specifically deliver an active therapeutic to the site of the cancer and potentially provide a direct benefit to patients," says Dr. David Bell, Vice President and Chief Scientific Officer of Therapure. "Our company has extensive experience working with blood proteins and hemoglobin in particular, so we're excited to see this innovative product moving into the clinic." "We're proud of this major milestone achieved by our Therapure Innovations division," says Nick Green, Therapure's President and Chief Executive Officer. "Receiving the FDA's okay to initiate this trial speaks to the great team of skilled researchers, developmet specialists and manufacturing experts who continue to advance our proprietary pipeline products. In a short period of time, this is our second product to advance into clinical trials in a second therapeutic area." The Phase 1 clinical trial is an open-label, multicenter study of TBI 302, which will evaluate the safety, tolerability and pharmacokinetics of TBI 302 following administration to patients with advanced liver cancer. Liver cancer is the fifth most common cancer and the third leading cause of cancer-related deaths globally. When surgical removal of tumors is not an option, a range of chemotherapy drugs are used to manage the disease, but these can cause side effects in other tissues. Better methods are needed to target chemotherapy drugs to cancer cells while leaving healthy tissues unharmed. ABOUT THERAPURE INNOVATIONS Therapure Innovations (a division of Therapure Biopharma Inc.) is focused on drug discovery, research and development. Its scientists are developing innovative protein therapeutics in anemia, liver cancer and infectious disease using proprietary platform technologies. Its platform technologies also have the potential to improve the pharmacology of existing drugs and therapeutics in other clinical areas. Its international scientific advisory board consists of expert physicians, clinicians and investigators from a wide range of specialties. Visit www.therapurebio.com/innovations for more information. ABOUT THERAPURE BIOPHARMA INC. Therapure Biopharma Inc. is an integrated biopharmaceutical company focused on complex biological therapeutics and technologies that can provide new options for patient care. Therapure Biopharma Inc. has two divisions: Therapure Innovations and Therapure Biomanufacturing, its award-winning CDMO division. Therapure Biopharma Inc. operates out of two facilities located in Mississauga: a 130,000 sq. ft. cGMP facility that includes biomanufacturing, research and quality control laboratories and is built to meet FDA (US), HPFB (Canada), EMA (News - Alert) (Europe) and MHRA (UK) standards, and a new 43,000 sq. ft. facility housing 30,000 sq. ft. of cGMP warehouse. Visit www.therapurebio.com for more information.
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