Patient enrollment complete in Enlivex Phase I/II clinical trial for autoimmune diseases

Jan 23 2012

Hadasit Bio-Holdings (TASE: HDST, OTC: HADSY) a publicly traded portfolio of biotech companies, all based on intellectual property developed and owned by Hadassah University Hospital, Israel's foremost medical research center, today announced that the recruitment of 13 patients for the Enlivex Phase I/II clinical trial has been completed.

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), however results are also relevant to other diseases involving the immune system.

Alon Moran, CEO of Enlivex, stated, "The initial results are looking very encouraging. The key goal of the trial is to show safety, and based on initial results we believe this was achieved. Moreover, in terms of efficacy, we see a clear tendency to reduce the chance of patients developing more severe grades of GVHD which are more difficult and dangerous to control than the lower and less severe disease levels, as well as early engraftment and early discharge from the hospital, all of which are important findings."

Mr. Moran continued, "This is great news as it is commonly believed that complete elimination of GVHD may reduce the effectiveness of the stem cell transplant in eradicating the patient's cancer, which makes our end goal the diversion of GVHD to the lower grades. We will be very optimistic once these results are confirmed in larger experiments.  For now, we continue to monitor patients' responses, and in parallel, proceed with the company's development plans – preparations for another significant trial, obtaining special regulatory approvals (orphan drug and fast track approvals), manufacturing, expansion of intellectual property, and further product development. We believe that following an additional fundamental experiment, we can join forces with a strategic partner in order to bring the drug to the market."

The experiment was performed in three of Israel's leading medical centers: Hadassah, Tel - Hashomer and Rambam.

An external safety committee has been meeting following each dosage group -four altogether - 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 were observed. Patient monitoring will be completed in June 2012, however, the data so far has shown that the treatment is effective and may reduce 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 extremely 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 (reduction of liver GVHD), one of the target organs where the GVHD hits hardest.

Commenting on the results, Ophir Shahaf, CEO of Hadasit Bio-Holdings, stated, "We are excited about the completion of the study and its preliminary results. The external safety committee's repeated approvals allows for the study's advancement with increasing doses of the drug. Observation of the treated patients shows that the drug provides a level of relief and supports their treatment. Continued positive results, which are expected this year, and regulatory approvals for a fast track will lead us through further development of the drug on an aggressive time-line. "

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