Hadasit Bio-Holdings

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Submitting an Application To Ethical Committees for Approval of Stage I/IIa Clinical Trials of KAHR Medical Ltd.

Jun. 29, 2015

HBL - Hadasit Bio-Holdings Ltd.

(the “Company”

June 29, 2015

 

To:                                                       To:

Israel Securities Authority                  Tel Aviv Stock Exchange Ltd. 

www.isa.gov.il                                    www.tase.co.il

 

 

Re: Immediate Report - Submitting an Application To Ethical Committees for Approval of Stage I/IIa Clinical Trials of KAHR Medical Ltd.

 

 

Further to the disclosure provided by the Company under Section 29.1.6.1 of the Company's Periodic Report 2014 (reference number: 2015-01-058795), in relation to KAHR Medical (2005) Ltd. (hereinafter: "KAHR"), a subsidiary owned 49% (on an undiluted basis) by the Company, regarding the implementation of a series of experimental toxicology experiments in mice and monkeys of the KAHR-102 product developed by KAHR (hereinafter: the “Preclinical Studies"), the Company is pleased to announce that, in view of obtaining positive results in a series of Preclinical Studies on June 28, 2015, KAHR filed to the human experimentation committee (hereinafter: the “Helsinki Committee") at Sheba Medical Center in Tel Hashomer, an application for approval of Phase I / IIa trials with the KAHR-102 product for the treatment of cancer and autoimmune diseases, lymphoma, using a chimeric protein containing two action areas in the same molecule.[1] Additionally, during the third quarter of 2015, KAHR is expected to submit similar requests to the Helsinki Committees of Ichilov Sourasky Medical Center in Tel Aviv (hereinafter: "Ichilov") and the Hadassah Medical Center Ein Karem (hereinafter: "Hadassah").

About the Phase I / IIa Trials of the KAHR-102 product by KAHR (hereinafter: the Treatment" and “Clinical Trial", respectively)

The purpose of the clinical trial is to prove the safety and efficacy of the drug.

The clinical trial will take place in patients with lymphoma who did not respond to the existing drugs on the market today and will comprise of two phases. In the first stage, the patients will receive different doses of treatment, in order to set the maximum dosage of treatment that can be obtained as part of the treatment. In addition, in the first phase, data will be collected about chemical and biological reactions of patients to the treatment as well as about the ability of the treatment to reduce tumors in patients with lymphoma (hereinafter: the “Additional Data").

In the second phase of the Clinical Trial, patients will be given the maximum dose, as determined in the first phase, in accordance with the trial protocol, and the Additional Data will be collected again.

The Company estimates that, as it was informed by KAHR, the trial is expected to include a total of between 25 and 40 patients.[2]

The information presented above, regarding the Company’s assessment in relation to the date of submission of applications to the Helsinki Committee and Hadassah, Ichilov and regarding the amount of patients who will take part in the Clinical Trials, as stated above, is forward-looking information, as defined in the Securities Law, 5728-1968, that is contingent on, inter alia, approval of regulators and patient recruitment rate, and there is no certainty that it will materialize. 

 

 

Sincerely,

                                                                                               

HBL - Hadasit Bio-Holdings Ltd.

       By: Ms. Tamar Kfir, CEO



[1]  In relation to pre-clinical experiments on monkeys, the final report is expected to be received at KAHR during the third quarter of 2015.

[2]  Assuming receipt of the required approvals of the three medical centers as stated above and following the clinical trial in the aforementioned three medical centers.

 
 

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