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.