Link to Hebrew immediate report
Hadasit Bio-Holdings Ltd. (TASE:HDST, OTC:HADSY) has announced the following regarding its portfolio company, Thrombotech Ltd.
Thrombotech Ltd. ("Thrombotech"), a portfolio company in which Hadasit Bio-Holdings Ltd. has a 24% position, has notified the company that it has received an IND approval from the Food and Drug Administration (FDA) enabling the initiation of a Phase IIa clinical trial in the U.S.
Thrombotech’s lead product – THR-18 will be used to dissolve blood clots in stroke patients.
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.
The primary outcome of the Phase IIa clinical trial will be to establish THR-18’s safety in treating stroke victims. Thrombotech has already begun its Phase IIa clinical trial in a number of sites in Israel (Hadassah, Ichilov and Wolfson) and is awaiting regulatory approvals in Europ and India.
According to the information provided to the company, "Global Data", a company researching the global stroke market, found that in 2008 the global market for stroke drugs was approximately $2.8 Billion and is expected to grow at an annual rate of approximately 3.4% till 2015
The Company wishes to clarify that the IND approval provides no guarantee for the completion of product development by Thrombotech, or that the experiments will be completed successfully and that its product will become commercial. Among other things, the success depends on the experiments outcome; that a suitable market exists for Thrombotech’s products, insurance coverage for Thrombotech’s products and that Thrombotech will have the required funds for completion of its trials and product marketing (as the experiments are completed successfully and the necessary regulatory approvals are received).
Hadasit Bio - Holdings Ltd.