HBL - Hadasit Bio-Holdings Ltd.
September 10, 2015
Israel Securities Authority Tel Aviv Stock Exchange Ltd.
Re: Report of D Pharm Ltd. - Approval of THR-18 Trial Protocol
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 announced through an immediate report that on September 9, 2015, the regulatory authorities in Moldova approved the protocol of 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).
D Pharm stated that the trial is exploratory, and as such, no primary target or secondary target was defined for the trial, rather, it examines a number of indices without preference to any of them. The trial’s targets are to assess the safety of the Drug, monitor clinical changes to the state of patients and examine the working mechanism of the Drug through brain imaging of patients, performed by computed tomography (CT).
The trial will be double-blind, random and controlled, and is expected to include 40 patients, each of which will randomly receive the Drug or a placebo, together with the tPA. The ratio between the recipients of the Drug and placebo will be
1:1. The Drug will be provided to patients in one dose (of 0.54 mg per kg), which is the maximum dose in the previous trial by D Pharm, as published by D Pharm on June 1, 2014 (reference no.: 2014-01-081372).
After treatment with the Drug or placebo, monitoring will take place for 30 days. The trial will be performed in one medical center in Moldova. D Pharm estimates that recruiting patients will begin in the fourth quarter of 2015.
D Pharm stated that its estimations regarding the methods of the clinical trial, the number of patients that will participate and the date for the commencement of recruiting patients for 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 regulatory authorities in Moldova 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. D Pharm further stated that 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 September 9, 2015 (reference no.: 2015-01-118152).
HBL - Hadasit Bio-Holdings Ltd.
By: Ms. Tamar Kfir, CEO