HBL - Hadasit Bio-Holdings Ltd.
November 11, 2015
Israel Securities Authority Tel Aviv Stock Exchange Ltd.
Re: Recruiting the First Patient for the THR-18 Clinical Trial
The Company is pleased to announce that D Pharm Ltd., a company traded on the Tel Aviv Stock Exchange, held about 5.57% by the Company (hereinafter: “D Pharm”), today, November 11, 2015, announced through an immediate report that on November 10, 2015, treatment of the first patient has begun through the Phase IIa clinical trials in patients with ischemic stroke and treated with tPA combined with the trial product of D Pharm, THR-18 (hereinafter: the “Drug” and the “Trial,” respectively).
The trial is exploratory and as such does not defined a primary or secondary target for the trial, but rather examines a number of measures without giving priority to any of them. The objectives are to assess the drug safety, monitor the clinical changes to the state of the patients and examine the mode of the drug’s operation through brain imaging of the patients, performed through computer tomography (CT scans).
The trial is a double blind, random and controlled trial, and is expected to include 40 patients, each of whom will randomly receive the drug or placebo together with tPA. The ratio between recipients of the drug and placebo is 1:1. After the treatment with the drug or placebo, the patient will be monitored for 30 days. The drug will be provided to patients in one dosage (of 0.54 mg per kg), which is the maximum dosage from the previous trial. The trial is run in a single medical center in Moldova. For additional details regarding the trial, see D Pharm’s immediate report regarding receipt of approval of the protocol of the THR-18 trial dated September 10, 2015 (reference no.: 2015-01-118152).
D Pharm’s estimations regarding the methods of the clinical trial, the number of patients that will participate and the date for the conclusion of the trial is forward-looking information as defined in the Securities Law, 5728-1968, based on the work plan of D Pharm, the documents and information received by D Pharm from the relevant professional entities and familiarity with the procedures and processes of the global regulatory authorities regarding clinical trials. These estimations may not be realized, in whole or in part, or may be realized in a manner that is materially different from that which is anticipated. The factors that may impact the same are a change to the development plan of D Pharm, a change to the policy of the regulatory authorities, lack of sufficient financing resources, failure of any of the trial’s stages, development of competing products, difficulty in recruiting patients for the trial or realization of any of the risk factors related to the process of the trial and its results.
It should be noted that before the completion of the development stage of the Drug has not yet been completed and there is no certainty that the Drug will achieve the objectives of the trial as required and/or reach marketing on a commercial basis.
For details regarding D Pharm’s report on the matter, see D Pharm’s immediate report dated November 11, 2015 (reference no.: 2015-01-152910).
HBL - Hadasit Bio-Holdings Ltd.
By: Ms. Tamar Kfir, CEO