Thrombotech Ltd. Receives Regulatory Approval for Phase IIa Trials in the U.S.
Mar 05, 2012, 09:27 ET
JERUSALEM, March 5, 2012 /PRNewswire/ -- Hadasit Bio-Holdings (TASE: HDST, OTC: HADSY) a publicly traded portfolio of biotech companies, all based on intellectual property developed and owned by Hadassah University Hospital, Israel's foremost medical research center, today announced Thrombotech Ltd. ("Thrombotech"), a portfolio company which Hadasit holds a 24% stake in, received an IND approval from the Food and Drug Administration (FDA) enabling the initiation of a Phase IIa clinical trial in the U.S. An IND approval is a prerequisite for clinical trials in patients in any U.S. Medical Center that is supervised and controlled by the FDA.
Thrombotech's lead product, THR-18 is designed to improve the safety and efficacy of the currently available treatment for ischemic stroke patients, tPA, by significantly decreasing the life-threatening side effects. The Phase IIa clinical trial will be used to establish THR-18's safety in treating these stroke victims. Thrombotech has already begun its Phase IIa clinical trial in a number of sites in Israel (Hadassah, Ichilov and Wolfson hospitals) and is awaiting regulatory approvals in Europe and India.
According to Global Data, a company researching the global stroke market, the global market for stroke drugs in 2008 was approximately $2.8 billion and is expected to grow at an annual rate of approximately 3.4% through 2015.
"This important regulatory approval serves as external validation for our development program and the quality of the science and management behind the company. It will enable us to recruit more patients in some of the leading medical centers specializing in stroke in the US and move towards commercialization of the therapy for this serious medical condition," said Thrombotech CEO, Dr. Ruth Ben Yakar.
Commenting on the approval, Ophir Shahaf, CEO of Hadasit Bio-Holdings stated, "We are proud to expand the clinical trial to medical centers in the US, a world leader in CNS therapeutics and stroke treatment in particular. The company's goal is to prove that its lead drug enables safe and effective treatment over a wider therapeutic window, so that more patients will benefit from stroke therapy with less detrimental side effects."
Thrombotech Ltd. is an Israel-based biotechnological company that is based on years of cutting-edge thrombotic research at the Hadassah Medical Center in Jerusalem. Thrombotech developed a peptide, THR-18, which allows the existing thrombolytic stroke medication to easily dissolve blood clots, extending its short therapeutic time window and diminishing life-threatening side effects.
The Company is based on the extensive research conducted by Professor Abd el-Raouf Hijazi of the Hadassah Ein - Karem Hospital. Hadasit Bio, Clal Biotechnology Industries and Ofer Hi-Tech are the major shareholders in the company. Dr. Ruth Ben Yakar is the CEO.
About Hadasit Bio-Holdings
Hadasit Bio-Holdings, Ltd., established in 2006, is the publicly traded subsidiary of Hadasit Ltd. - the technology transfer company of the Hadassah University Hospital, Israel's foremost medical research center. The Company was established for the purpose of promoting and commercializing the intellectual property and R&D capabilities generated by Hadassah.
HADSY is the domestically traded ADR of Hadasit Bio-Holdings, a public investment vehicle of six portfolio biotech companies all based on inventions developed by Hadassah. Hadasit Bio-Holdings focuses on advancing companies that have already shown proof of concept and successful preclinical trials to completion of Phase I/II.
The portfolio companies develop drugs with blockbuster potential (targeting markets that are worth over a billion dollars) operating in the fields of cancer, inflammatory diseases and tissue regeneration using stem cells - areas in which the Hadassah Hospital has extensive knowledge and recognition as a global leader. The company is managed by Ophir Shahaf.
For more information please visit: www.hbl.co.il
KCSA Strategic Communications
Rob Fink / Josh Dver
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SOURCE Hadasit Bio-Holdings
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