Link to Hebrew immediate report
HBL - Hadasit Bio-Holdings Ltd. (TASE:HDST, OTC:HADSY) is pleased to announce that Thrombotech Ltd. ("Thrombotech"), a portfolio company (24%), has begun with patient enrollment in a Phase IIa clinical trial that will be conducted in 7 medical centers in Europe, India and Israel, in patients suffering from ischemic stroke using Thrombotech’s leading product, THR-18 (the "trial" and the "drug”, respectively).
The purpose of this trial, to be held in the form of a multi-center, randomized, double-blind trial is to test safety and efficacy of the drug in said indication. Thrombotech expects the experiment to include approximately 25 patients divided into 3 groups. One group will receive the medication now approved for treating ischemic stroke, tPA, and the other two groups will be treated with the drug (two different doses) in combination with tPA. According to Thrombotech patient enrollment is expected to be completed within a year.
Thrombotech’s expectations regarding the purpose and effectiveness of the drug, the number of patients, the number of medical centers and the termination of recruitment are forward-looking statements, as defined in the 1968 Securities Act, based on the information available to Thrombotech at the date of this report, including Thrombotech’s assessment of its development, experience from prior experiments, as well as preliminary documents and information received from relevant professionals in relation to the above experiment.
These expectations may not be realized, in whole or in part, or may materialize in an unanticipated manner. The main factors that can influence this are product development failure, changing the characteristics of the patients, the inability to recruit patients suitable for the trial which may be due to low frequency of patients or inadequacy of the patients to the criteria of the trial, failure to meet the goals of this trial or the timeline listed above, delaying or non-receipt of requisite approvals, changing the work program, and / or realization of any risk factors associated with the experiment and its results.
HBL- Hadasit Bio-Holdings