Hollis-Eden Pharmaceuticals Announces HE2500 Significantly Reduces Ongoing Paralysis and Accelerates Recovery in Preclinical Model of Multiple SclerosisSAN DIEGO, Apr 23, 2002 (BW HealthWire) --
Data with HE2500 Presented at Experimental Biology Meeting Hollis-Eden Pharmaceuticals, Inc.
(NASDAQ:HEPH) today announced data from a preclinical study demonstrating that
HE2500, an investigational immune regulating hormone, significantly reduces
ongoing paralysis and accelerates recovery from experimental autoimmune
encephalomyelitis (EAE), a preclinical model that mimics multiple sclerosis (MS)
Dr. Halina Offner, Professor of Neurology at Oregon Health & Science University,
conducted the study and is presenting the data at the Federation of American
Societies for Experimental Biology this week in New Orleans, Louisiana.
6 The EAE animal model, caused by inflammatory T-cells directed against myelin
in the brain and spinal cord, shares many characteristics with MS, and has been
widely used to study efficacy in a preclinical model for potential treatments
for MS. The experiment was designed to test the effects of HE2500 on the
severity of the disease. Treatment of EAE diseased animals with HE2500
injections daily significantly delayed disease onset, reduced the signs of
disease, and prevented or attenuated relapses compared to placebo. Also, HE2500
treated animals had a significantly reduced production of inflammatory mediators
in the brain. These results suggest that the compound's ability to reduce the
severity of the disease was due to its anti-inflammatory action in the brain.
6 "I am very excited about these initial data, because they demonstrate that
this new class of immune regulating hormones is very effective for treating
ongoing paralytic disease," says Dr. Offner. "HE2500 acts by limiting the entry
of inflammatory cells into the brain and thereby reducing the production of
inflammatory mediators in the brain. This compound ultimately could be used to
treat both men and women with MS and may also be useful to treat other
autoimmune diseases. Dose-finding studies are currently being planned for MS."
Preclinical data to support the use of this class of compounds in collagen
induced arthritis (CIA), an animal model for rheumatoid arthritis, will also be
presented by Dr. Offner in May at the 6th International Symposium on the
Immunotherapy of Rheumatic Diseases in Limassol, Cyprus.
"The results garnered in this experiment continue to scientifically support the
important role immune regulating hormones may play in autoimmune diseases," said
Richard Hollis, Chairman and CEO, Hollis-Eden Pharmaceuticals. "We are very
pleased to be working with Dr. Offner who is a leading researcher in multiple
sclerosis and other autoimmune conditions. This result demonstrating the
anti-inflammatory properties of HE2500 in this model of MS substantiates the
favorable results obtained with HE2500 in an animal model of psoriasis, as well
as results demonstrating anti-inflammatory and histological benefits of HE2200
in a model of inflammatory bowel disease. The previously published clinical
results with HE2000 in HIV demonstrated multiple inflammatory chemokines being
normalized after therapy. We believe the potential ability to restore and
regulate a dysregulated immune system in autoimmune diseases with our drug
candidates represents an opportunity to serve a number of important markets.
There are significant potential commercial benefits for companies that address
these markets with drugs that do not cause immunosuppressive side effects, and
can be offered with pharmacoeconomic advantages."
Hollis-Eden Pharmaceuticals, Inc. is a development-stage pharmaceutical company
based in San Diego, California, engaged in the development of products for the
treatment of infectious diseases and immune systems disorders. The Company's
vision is to become the world leader in immune regulating hormones and their
application to numerous diseases. HE2000 is the Company's lead investigational
drug and is currently being studied in clinical trials for HIV/AIDS in South
Africa. Hollis-Eden is also conducting a Phase I/II clinical trial with HE2000
in the United States in HIV infected patients failing at least their second
antiviral drug regimen. Phase II studies in Thailand are also being conducted
with HE2000 in the treatment of malaria, and in Singapore for the treatment of
hepatitis B. In addition, Hollis-Eden recently entered into a Cooperative
Research and Development Agreement (CRADA) with the United States Department of
Defense to develop HE2100 as a radioprotectant (a drug that may potentially be
used to protect a person from radiation injury due to a nuclear accident or
event). Hollis-Eden recently announced the initiation of a Phase I/II clinical
trial with HE2200 for vaccine potentiation in elderly patients receiving a
hepatitis B vaccine. The Company also has access to HE2500 through its
relationship with Aeson Therapeutics. HE2500 is currently being studied in Phase
II clinical trials in cardiovascular disease. For more information on
Hollis-Eden, contact the Company's website at www.holliseden.com.
Statements made in this press release may constitute forward-looking statements
and are subject to numerous risks and uncertainties, including the failure to
successfully complete clinical trials, the Company's future capital needs, the
Company's ability to obtain additional funding and required regulatory
approvals, the development of competitive products by other companies, and other
risks detailed from time to time in the Company's filings with the Securities
and Exchange Commission. The actual results may differ materially from those
contained in this press release.
CONTACT: Hollis-Eden Pharmaceuticals, Inc.
Dan Burgess, 858/587-9333, ext. 409