Hadasit Bio-Holdings

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Enlivex has completed patient enrollment in its Phase I/II clinical trial

Jan. 15, 2012

Link to Hebrew immediate report

Hadasit Bio-Holdings Ltd. (TASE:HDST, OTC:HADSY) has announced the following regarding its portfolio company, Enlivex Ltd. ("Enlivex")

Enlivex (92% owned) has notified the company that it has completed the recruitment of 12 patients in a total of four dosage groups in its Phase I/II clinical trial. Enlivex is developing an innovative drug treatment for autoimmune diseases - diseases in which the immune system attacks a patient's own organs, and inflammatory diseases. The trial was conducted on bone marrow transplant patients who often acquire Graft vs. Host Disease (GVHD). Results however, are relevant also to other diseases involving the immune system. The experiment was performed in 3 of Israel's leading medical centers: Hadassah, Tel - Hashomer and Rambam.

An external safety committee has been meeting following each dosage group to assess the treatment’s safety. After having been impressed by the treatment’s results they repeatedly approved advancement to the next treatment group while increasing the dose.

Thus far the data from the study has shown that the treatment was well tolerated by the patients and no safety issues observed. The data obtained thus far has shown that the treatment is effective and may reduced the GVHD grade severity to levels that do not normally endanger the patient but rather allow for the transplant to destroy the cancer in the patient's body. This is most significant since GVHD is often a fatal and incurable disease.

In addition, the study’s data suggests that the treatment may have a significant effect on liver protection, one of the target organs where the GVHD is often most severe.

The company expects most of the study’s data to be collected within the first half of 2012 and for the final follow-ups and data collection to be completed in early July 2012.

The Company wishes to clarify that there is no assurance that this experiment will be completed successfully or that the experiments interim results will indeed be corroborate by a Phase III clinical trial allowing for an application for marketing approvals. In addition, completion of the experiment involves raising considerable financial resources and regulatory approvals to continue the experiment, which are not under the company’s control.


Hadasit Bio - Holdings Ltd.


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