Hadasit Bio-Holdings

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Helsinki Approval for Stage I/IIa Clinical Trials of KAHR Medical Ltd.

Dec. 1, 2015

 HBL - Hadasit Bio-Holdings Ltd.

(the “Company”)                                                                                           December 1, 2015

 

To:                                           To:

Israel Securities Authority      Tel Aviv Stock Exchange Ltd. 

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

 

 

Re: Immediate Report - Helsinki Approval for Stage I/IIa Clinical Trials of KAHR Medical Ltd.

 

Further to the immediate report published by the Company on June 29, 2015 (reference number 2015-01-058740), regarding filing a request to approve a Stage I/IIa clinical trail of the KAHR-102 product by Kahr, intended to treat lymphoma and autoimmune disorders, through a chimeric protein that contains two areas of action in the same molecule (hereinafter: the “Drug” and the “Clinical Trial,” respectively), to the Committee for Human Experimentation (the “Helsinki Committee”) at the Sheva Medical Center of Tel HaShomer, and regarding Kahr’s intent to submit similar requests to Helsinki Committees of Sourasky Medical Center Ichilov in Tel Aviv (hereinafter: “Ichilov”) and the Hadassah Ein Karem Medical Center in Jerusalem (hereinafter: “Hadassah”), the Company is pleased to announce as follows:

On November 30, 2015, Kahr received approval of the Ichilov Helsinki Committee for Clinical Trials, after approval from the Ministry of Health on September 7, 2015 (hereinafter: the “Approval”).

In accordance with the protocol of the clinical trial approved by Ichilov, the primary objective of the clinical trial is to prove the safety and determine the maximum dosage of the drug and the secondary purpose is to examine the drug efficacy and pharmacokinetics of the drug.  

The clinical trial will take place in patients with lymphoma and will comprise of two phases. In the first stage, the patients will receive different doses of treatment, in order to determine the safety of the drug, the pharmacokinetics, and 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 the efficacy of the drug against the growth (hereinafter: the “Additional Data").

In the second phase, patients will be given the maximum dose, as determined in the first phase, in accordance with the protocol of the clinical trial, and the Additional Data, the pharmacokinetics and efficacy 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.[1]

The clinical trial is expected to begin in the second quarter of 2016 and end during the third quarter of 2017. The financial cost expected for the performance of the trial is a total of USD 700 thousand (without the cost of production of the drug and preliminary preparations for the trial).

Within the term for performance of the clinical trial, interim results are expected to be received. 

Kahr intends to submit the updated protocol for the clinical trial, approved by Ichilov, to the Sheba Medical Center in Tel Hashomer and to Hadassah as well.

The information presented above, regarding the amount of patients who will take part in the Clinical Trials, the term of the trial and the expected financial cost, as stated above, is forward-looking information, as defined in the Securities Law, 5728-1968, that is contingent on, inter alia, regulatory approval, the financial state of Kahr and the patient recruitment rate, and there is no certainty that it will materialize.

 

 

Sincerely,

                                                                                               

HBL - Hadasit Bio-Holdings Ltd.

       By: Ms. Tamar Kfir, CEO



[1]               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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