HBL – Hadasit Bio Holdings Ltd.
February 3, 2016
Israel Securities Authority Tel Aviv Stock Exchange Ltd.
Re: Immediate Report – Receipt of Helsinki Approval for Phase I/IIa Clinical Trial at Tel Hashomer by KAHR Medical Ltd. (“KAHR”)
Further to the Company’s immediate report dated December 1, 2015 (hereinafter: the “Previous Report”) regarding KAHR’s receipt of approval by the Tel Aviv Sourasky Medical Center Committee for Medical Experiments in Human Subjects (hereinafter respectively: “Ichilov” and the “Helsinki Committee”) for a Phase I/IIa trial of KAHR’s KAHR-102 product, which is intended for treatment of lymphoma and autoimmune diseases (hereinafter: the “Clinical Trial”), the Company is hereby honored to report that it received approval from the Helsinki Committee at the Tel Hashomer Medical Center (hereinafter: “Tel Hashomer”).
As noted by the Company in the Previous Report, pursuant to the protocol of the Clinical Trial approved by Ichilov and now by Tel Hashomer, the primary objective of the Clinical Trial is to prove the safety and maximum dosage of the medicine, while the secondary objective is to test pharmacokinetics and efficacy.
The Clinical Trial will be performed with lymphoma patients and will have two stages. In the first stage, the patients will receive different doses of the medicine in order to determine safety, pharmacokinetics and the maximum dosage that may be administered during treatment. In addition, as part of stage one, data will be collected regarding the medicine’s efficacy in combatting the tumor (hereinafter: the “Additional Data”).
In the second stage, the patients will receive the maximum dosage determined in the first stage, in accordance with the Clinical Trial protocol, and data regarding safety, pharmacokinetics and efficacy will be collected again.
Further to information provided it by KAHR, the Company estimates that the trial will include between 25 and 40 patients. The Clinical Trial is scheduled to commence during Q3 of 2016 (and not, as reported by the Company in the Previous Report, during Q2 of 2016, because of a delay in receiving the medicine to be used in the Clinical Trial from the manufacturer) and to be completed during Q4 of 2017 (and not, as reported by the Company in the Previous Report, during Q3 of 2017, for the reason set forth above). The estimated financial cost of the Clinical Trial is $700,000 (not including the manufacturing costs of the medicine and pre-trial preparations).
Intermediate results are expected to be received during the Clinical Trial period.
The Clinical Trial protocol that was approved by Ichilov and Tel Hashomer was also submitted to the Hadassah-Ein Kerem Medical Center in Jerusalem (hereinafter: “Hadassah”) and the Company anticipates that Hadassah will approve the protocol during the next two weeks. The Company will provide an update regarding the status of the approval by Hadassah in the Company’s upcoming periodic report.
The information provided above regarding the estimated date of approval by Hadassah, the number of patients that will participate in the Clinical Trial, the trial period and the estimated financial cost, constitutes forward looking information, as defined in the Securities Law, 5728-1968, and depends, inter alia, on regulatory approvals, KAHR’s financial situation and the rate of patient recruitment, and there can be no guarantee that it will come to fruition.
HBL – Hadasit Bio Holdings Ltd.
By: Tamar Kfir, CEO
Assuming the necessary approval is received from the Hadassah-Ein Kerem Medical Center in Jerusalem, in addition to the approvals received from Ichilov and Tel Hashomer, the Clinical Trial will be performed in all three of the aforementioned medical centers.