Hollis-Eden Pharmaceuticals Commences Phase I/II Clinical Trial with TRIOLEX(TM) (HE3286) in Rheumatoid Arthritis Patients
05 Août 2008 - 1:00PM
Business Wire
Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH), the world leader
in the development of a new class of small molecule compounds based
on endogenous adrenal steroid hormones, announced that it has
commenced a Phase I/II open label dose ranging clinical trial with
its investigational oral drug candidate TRIOLEX� (HE3286) in
patients diagnosed with rheumatoid arthritis (RA) and receiving a
stable dose of methotrexate, the current standard of care in RA.
The purpose of the Phase I/II clinical trial is to evaluate the
safety and tolerance of TRIOLEX when administered orally for 28
days at three different dose levels. The study will also evaluate
the pharmacokinetics (PK) and metabolism profiles of methotrexate
and TRIOLEX when used in combination, and assess any potential
anti-inflammatory activity of TRIOLEX. �The commencement of this
clinical trial caps six years of international collaborations with
world renowned experts working on the development of a new
treatment for RA,� commented Dr. Dominick L. Auci, Director of
Allergy, Autoimmunity and Inflammation at Hollis-Eden
Pharmaceuticals. �This body of work, presented over the years at
numerous international meetings and published in peer reviewed
journals, clearly documents the remarkable activity of TRIOLEX
across several animal models of RA, each emphasizing different
aspects of the pathophysiology thought to drive the human disease.
We are particularly excited to begin this trial because TRIOLEX,
without being immune suppressive, has consistently performed as
well or better than the biologics in these models and works where
methotrexate fails.� Preclinical Data in Models of Rheumatoid
Arthritis Hollis-Eden has conducted extensive preclinical study
with TRIOLEX in models of rheumatoid arthritis with striking
results. The Company previously reported positive results from
preclinical studies with TRIOLEX in models of collagen induced
arthritis (CIA) and collagen antibody induced arthritis (CAIA).
These models represent both the cell-mediated and antibody-mediated
aspects of human rheumatoid arthritis. In a model of CIA, mice were
immunized to induce disease and were then treated orally with
TRIOLEX or placebo beginning one week after disease onset. While
the severity of arthritis worsened steadily in the placebo-treated
group, it nearly resolved or remained at a minimum in the
TRIOLEX-treated group (p < 0.001). Treatment resulted in a
difference in arthritis severity that was on average 45% lower in
the TRIOLEX-treated group than in the placebo-treated group. The
DBA mouse model of CIA is a model widely used in industry and
academia to test new agents as potential treatments for RA. In the
murine model of CAIA, TRIOLEX significantly reduced disease in a
dose dependent fashion, with the highest dose completely
eliminating disease. In the CAIA model, disease is induced by
injecting animals with atherogenic antibodies, a method that
largely bypasses the animals� own cellular immune systems. Severe
joint inflammation occurs within hours after the injection of
antibodies. TRIOLEX was highly effective in this model whether
treatment began one day or five days after injection with
antibodies. Benefit at the peak of disease was associated with a
significant reduction of interleukin-6 (IL-6) and matrix
metalloproteinase-3 (MMP-3) messenger RNA from the joints of
TRIOLEX-treated animals when compared to placebo-treated controls.
IL-6 and MMP-3 are thought to be among the most important drivers
of disease and tissue destruction in human RA. Methotrexate is far
less effective in the CAIA model than in models of CIA, where
disease is driven by the animal�s own cellular immune system.
Hollis-Eden believes that the benefit of TRIOLEX in animals was
associated with expansion of regulatory T cells, an important
subset of immune cells thought to be critical in controlling
autoimmunity. The Company also believes that TRIOLEX may induce
resolution in pro-inflammatory pathways, such as those governed by
NF-kappaB. NF-kappaB is a transcription factor that controls many
of the genes involved in the inflammatory signaling pathway,
including TNF-alpha, IL-1beta and IL-6. These cytokines are thought
to be key inflammatory mediators that play an important underlying
role in RA and other autoimmune and inflammatory diseases. Unlike
currently prescribed corticosteroids that can cause immune
suppression and bone loss, animal studies to date show that TRIOLEX
does not interact with the glucocorticoid receptor and only
partially inhibits the NF-kappaB pathway without causing immune
suppression or bone loss. These observations suggest that rather
than blocking the inductive phase of the inflammatory response,
which historically leads to profound immune suppression, TRIOLEX
may drive the active resolution of unproductive inflammation.
�Advancing TRIOLEX into rheumatoid arthritis patients represents
years of preclinical studies that produced consistently impressive
results,� stated Richard Hollis, Chairman and CEO of Hollis-Eden
Pharmaceuticals. �We believe a big breakthrough in medicine would
be to deliver a pharmaceutical that has the ability to regulate
unproductive inflammation without the side effects of currently
approved anti-inflammatories. Given its biochemical structure and
signaling pathways, TRIOLEX potentially represents such a
breakthrough product. TRIOLEX is a stabilized, synthetic analog of
a naturally occurring molecule metabolized by the body from
dehydroepiandrosterone (DHEA) and whose role in nature we believe
is to regulate stress-inflammatory responses to maintain
homeostasis. Translating our preclinical data into human clinical
trials would be a major triumph in our efforts to develop a novel
therapy for patients suffering from RA. We look forward to a
possible renaissance in the use of smarter, safer steroid hormones
to treat diseases of inflammation and autoimmunity as well as other
conditions associated with aging.� About Rheumatoid Arthritis
Rheumatoid arthritis affects more than 1.3 million people in the
United States and is driven by both a cellular and antibody
mediated autoimmune response and, as a result, combinations of
highly immune suppressive drugs are commonly used to treat both
aspects of active disease. Annual sales in the United States of
drugs to treat RA are expected to reach $14 billion by 2009, driven
by the increase in the aging population and the use of new
expensive biological treatments. For example, Celebrex�, a commonly
used anti-inflammatory drug for RA that inhibits the cox-2 enzyme
currently has annual sales in excess of $2 billion. About
Hollis-Eden Pharmaceuticals, Inc. Hollis-Eden Pharmaceuticals, Inc.
is a world leader in the development of a proprietary class of
adrenal steroid hormones as novel pharmaceuticals for human health.
Through its Hormonal Signaling Technology Platform, Hollis-Eden is
developing a new series of small molecule compounds that are
metabolites or synthetic analogs of endogenous hormones derived by
the adrenal glands from the body�s most abundant circulating
adrenal steroid. These steroid hormones, designed to restore the
biological activity of cellular signaling pathways disrupted by
disease and aging, have been demonstrated in humans to possess
several properties with potential therapeutic benefit -- they
regulate innate and adaptive immunity, reduce nonproductive
inflammation and stimulate cell proliferation. The Company�s
clinical drug development candidates include TRIOLEX� (HE3286), a
next-generation compound currently in clinical trials for the
treatment of type 2 diabetes ulcerative colitis and rheumatoid
arthritis, and APOPTONE� (HE3235), a next-generation compound in a
clinical trial for late-stage prostate cancer. In addition to these
clinical development candidates, Hollis-Eden has an active research
program that is generating additional new clinical leads that are
being further evaluated in preclinical models of a number of
different diseases. For more information on Hollis-Eden, visit the
Company�s website at www.holliseden.com. This press release
contains forward-looking statements within the meaning of the
federal securities laws concerning, among other things, the
potential and prospects of the Company�s drug discovery program and
its drug candidates. Any statement included in this press release
that are not a description of historical facts are forward-looking
statements that involve risks, uncertainties, assumptions and other
factors which, if they do not materialize or prove correct, could
cause the Company�s actual results to differ materially from
historical results or those expressed or implied by such
forward-looking statements. Such statements are subject to certain
risks and uncertainties inherent in the Company�s business,
including, but not limited to: the ability to complete preclinical
and clinical trials successfully and within specified timelines, if
at all; the ability to obtain regulatory approval for TRIOLEX
(HE3286), APOPTONE (HE3235) or any other investigational drug
candidate; the Company�s future capital needs; the Company�s
ability to obtain additional funding; the ability of the Company to
protect its intellectual property rights and to not infringe the
intellectual property rights of others; 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. Existing and prospective investors are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this press release.
Except as required by law, the Company undertakes no obligation to
update or revise the information contained in this press release as
a result of new information, future events or circumstances arising
after the date of this press release.
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