MISSISSAUGA, Canada I March 11, 2015 I Therapure 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 304H (a monoclonal antibody) for the treatment of chemotherapy-induced anemia. TBI 304H targets blood-forming stem cells that are involved in red blood cell production through a novel pathway.
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.
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 (Europe) and MHRA (UK) standards, and a new 43,000 sq. ft. facility housing 30,000 sq. ft. of cGMP warehouse.
SOURCE: Therapure Biopharma
Post Views: 87
MISSISSAUGA, Canada I March 11, 2015 I Therapure 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 304H (a monoclonal antibody) for the treatment of chemotherapy-induced anemia. TBI 304H targets blood-forming stem cells that are involved in red blood cell production through a novel pathway.
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.
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 (Europe) and MHRA (UK) standards, and a new 43,000 sq. ft. facility housing 30,000 sq. ft. of cGMP warehouse.
SOURCE: Therapure Biopharma
Post Views: 87
