NEW YORK, Aug. 17, 2011 /PRNewswire/ -- Hadasit Bio-Holdings, Ltd. - (OTCBB: HADSY), a publicly traded portfolio of biotech companies, all based on intellectual property developed by the Hadassah University Hospital, Israel's foremost medical research center, announced that its portfolio company Enlivex Therapeutics (92% owned by Hadasit Bio) has completed the recruitment of three out of four groups in its Phase I / II clinical trial using its treatment for the reduction of graft versus host disease (GVHD) in patients undergoing bone marrow transplantation.
Based on the current rate of enrollment and high level of safety observed so far, the trial's enrollment is expected to be completed during the next quarter with a total of 12 patients. The trial is being performed in three of Israel's leading hematology medical centers: Hadassah, Tel - Hashomer and Rambam.
The trial is being performed on bone marrow transplant patients, but the results are also relevant to a number of other autoimmune diseases - in which the individual's immune system targets its own organs - as well as inflammatory diseases - such as Multiple Sclerosis and Inflammatory Bowel Disease.
An external safety committee meets at the end of each dose group to examine the safety of the treatment and has thus far been impressed by initial results showing this to be a promising treatment method and has consistently approved advancement to the next group, while raising the dose.
The Company previously announced the preliminary results from the earlier stages of this trial. The treatment continued to show promise after analysis of intermediate results. In terms of efficacy, the Company estimates that, if the results received at the end of the trial are consistent with the data received so far, it will have evidence of a significant improvement in patients' health following the use of its treatment in comparison with the current standard treatments administered. There is currently no effective FDA-approved treatment for GVHD.
Since this is a life-threatening condition, and assuming the safety and efficacy will be robust, the Company intends to apply to the FDA for approval of an advanced clinical trial that would be regarded as a pivotal trial equivalent to a Phase II/III. In addition, the Company expects to receive approval for an Orphan Drug status and Fast Track designation, which will significantly reduce the costs and shorten the development timeline towards commercialization of the product while providing additional protection from competition.
Ophir Shahaf, CEO of Hadasit Bio Holdings, said, "We are excited about the progress in Enlivex, which is one of Hadasit Bio-Holdings' most advanced portfolio companies. In addition to Enlivex's progress, we have also noticed a general trend in favor of cell therapy technologies and stem cell therapy. This area was an unfulfilled promise up until a few years ago, but has recently received recognition by major players in the field pharmaceutical companies, regulators and investors as a breakthrough technology with the potential to bring about real change in pharmaceutical innovation, where there has been a significant decrease in quantity and quality of effective treatments in recent years."
Alon Moran, CEO of Enlivex, added, "We are encouraged by the results observed to date, both in terms of safety and efficacy. Although the results are partial and not yet final, we will have a significant asset if the remaining results are consistent with what we have seen so far. We expect to complete the trial in the near future and are preparing for the next, larger, multi-national study. In a year's time, we may be in the midst of an advanced, substantial trial and close to agreements with strategic partners."
About Enlivex Therapeutics:
The company's first product is designed to treat Graft versus Host Disease (GVHD), which is a fatal disease affecting about 30% -50% of patients who undergo bone marrow transplantation. GVHD currently has no effective treatment and the size of this market opportunity is estimated at $300 million annually. The company's success in GVHD is expected to open additional markets in autoimmune and inflammatory diseases, a field which is the third sector in scope in the pharmaceutical world (after cancer and heart disease) and is estimated at billions of dollars.
The company is developing a drug treatment based on inducing immune tolerance by injecting the patient's autologous cells (or donor cells in the case of GVHD) in the early stages of programmed death. The technology is based on years of research by Prof. Dror Mevorach from the Hadassah Medical Center - a world renowned expert in the field of programmed cell death.
About Hadasit Bio-Holdings
Hadasit Bio-Holdings Ltd., established in 2006, is the publicly traded subsidiary of Hadasit Ltd. - the technology transfer company of the Hadassah University Hospital, Israel's foremost medical research center. The Company was established for the purpose of promoting and commercializing the intellectual property and R&D capabilities generated by Hadassah.
HADSY is the domestically traded ADR of Hadasit Bio-Holdings, a public investment vehicle representing a portfolio of biotech companies, all based on inventions developed at Hadassah.
Hadasit Bio-Holdings focuses on advancing companies that are past successful preclinical trials and close to completion of Phase I/II clinical trials. The portfolio companies develop drugs with blockbuster potential (markets that are worth over a billion dollars) and operate in the fields of cancer, inflammatory diseases and tissue regeneration using stem cells - areas in which the Hadassah Hospital has extensive knowledge and recognition as a global leader.
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