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
|SOURCE Hadasit Bio-Holdings, Ltd.|
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