Thrombotech receives FDA IND approval for THR-18 Phase IIa clinical trial in stroke victims

Mar 5 2012

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."