Hadasit Bio-Holdings

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DPharm Ltd. – Receipt of Final Report for Clinical Trial Phase II

Jul. 30, 2015

HBL – Hadasit Bio-Holdings Ltd.

(“The Company”)

July 30, 2015

To:                                         To:

Israel Securities Authority            Tel Aviv Stock Exchange Ltd.

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

 

Re: Report of DPharm Ltd. – Receipt of Final Report for Clinical Trial Phase II of DP-b99

The company is honored to announce that DPharm Ltd, a company traded on the Tel Aviv Stock Exchange (hereinafter: “DPharm”), held by the company at approximately 5.57%, published today via immediate report that pursuant to the report from DPharm on May 31, 2015 (reference number: 2015-01-035550) on July 30, 2015, DPharm received a final trial report from the Clinical Trial Phase II of DPharm’s product DP-b99 for the treatment of acute pancreatitis (the “Trial”), (the “Drug”).

The trial was double blind, random and controlled and was meant to include 30 patients, some treated with DP-b99 and some with a placebo pill. In practice, there were 10 patients in the Trial, 5 whom were administered the drug and 5 as a control group with the placebo. The Trial was halted after including these patients, due to the low recruitment rate (for additional details regarding the circumstances of halting the Trial, see the quarterly report of DPharm from July 28, 2015, reference number: 2015-01-083085).

The primary objectives of the trial were to test the safety of the drug on patients suffering from acute pancreatitis and to examine its affectivity in preventing the development of pancreatitis into acute pancreatitis, a situation involving life-threatening complications. Tracking of the development of the pancreatitis is performed via biological signs (various lab tests, CT imaging of the abdomen and clinical trials). All of the patients were supposed to receive the drug or the placebo twice a day for two days and to remain under surveillance for an additional 12 days.

The information from the Trial was analyzed to assess the safety of the drug. The results of this assessment showed that the medication is safe for usage for these patients, and no side effects which could be attributed to the Medication were exhibited. A later analysis of signs of CRP and MMP9 upon inflammation found that on average, their values were lower in the drug group in comparison with the placebo group. Due to the small number of patients, the conclusions from this finding are limited.

DPharm announced that it will continue to update regarding the rest of the development proceedings for this drug.

Sincerely,

HBL – Hadasit Bio-Holdings Ltd.

By: Ms. Tamar Kfir, CEO

 
 

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