JERUSALEM, Jan. 23, 2012 /PRNewswire/ -- 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.
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 of six portfolio biotech companies all
based on inventions developed by Hadassah. Hadasit
Bio-Holdings focuses on advancing companies that have already shown
proof of concept and successful preclinical trials to completion of
Phase I/II.
The portfolio companies develop drugs with blockbuster potential
(targeting markets that are worth over a billion dollars) operating
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. The company is managed by Ophir
Shahaf.
For more information please visit: www.hbl.co.il
Contact:
Josh Dver or Rob Fink
KCSA Strategic Communications
212-896-1239
jdver@kcsa.com
SOURCE Hadasit Bio-Holdings