HBL-Hadasit Bio Holdings Ltd.
4 November 2014
Israel Securities Authority The Tel Aviv Stock Exchange Ltd
Re: Initial results for clinical trial Phase IIa in THR-18 for D Pharm Ltd.
The company is pleased to announce that D-Pharm Ltd., a company traded on the Tel Aviv Stock Exchange (herein: "D-Pharm"), of which approx. 13% is owned by the company, published today by immediate reporting (Ref no.: 2014-01-187455), as follows:
The recruitment of patients that have suffered from ischemic stroke and treated with tPA in combination with D Pharm’s experimental product THR-18 (“the drug”), for clinical trial Phase IIa (“the trial”) has been completed. The main clinical objective is to test the safety of the drug in combination with tPA, in patients suffering from ischemic stroke, and establishing the maximum dosage for the drug. In addition the trial tests, amongst other things, the affects of the drug on various indicators of brain injury after ischemic stroke.
The trial has achieved its objectives in terms of establishing the maximum dosage and in terms of the impact of the drug on cerebral edema and intracranial hemorrhage (ICH), effects sometimes caused after the use of tPA.
The trial is double-blind, randomized and controlled, including 30 patients, whom are divided into three subsequent groups, with dosage increases between the first group and the other two groups, as well as a control group. 18 patients were treated with the drug (6 with the first dosage and 12 with the second dosage) in conjunction with tPA, and 12 patients in the control group were treated with tPA and a placebo. Based on CT imaging conducted on the day following the treatment of all the trial participants, it was found that the drug notably reduced with statistical significance, both the number of brain edema cases and the cerebral hemorrhaging incidence amongst patients who received the drug, as compared to patients in the control group.
The drug safety profile as well as neurological and functional data indicators will be published following the monitoring period, with the highlights of the final report expected to be received by end of year.
The company’s assessments, regarding receival of the final trial report as reported by D Pharm, are forward looking information as defined by the Securities Act of 1968, and is based on D Pharm’s plan of operation, on documents and information received by D Pharm from relevant professional bodies, and on familiarity with the procedures and regulations of regulatory authorities worldwide regarding clinical trials. These assessments may not materialize, in whole or in part, or may materialize in a manner significantly different from expectations. The factors that may influence this are changes in D-Pharm’s development plan, policy changes by regulatory authorities, lack of sufficient funding, failure in any stage of the trial, the development of competing products, or the actualization of any risk factors associated with the trial and its results.
It should be noted that the development phase has not been completed as yet, and that there is no certainty that the drug will achieve the goals of the trial as required and / or reach the market on a commercial basis.
HBL-Hadasit Bio Holdings Ltd
By: Ms. Tamar Kfir, CEO