Hollis-Eden Pharmaceuticals Presents Additional Positive Findings for APOPTONE(TM) (HE3235) in Preclinical Models of Castration-
29 Septembre 2008 - 1:00PM
Business Wire
Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH) today presented new
findings that suggest APOPTONE� (HE3235) is inhibiting in
preclinical models of castration-resistant prostate cancer, the
ability of tumors to synthesize the hormones necessary for their
survival, as well as significantly down regulating the androgen
receptor. Recent reports from the scientific literature indicate
that androgen receptor signaling is active in all stages of
prostate cancer, including late stage castration-resistant prostate
cancer, and that castration-resistant prostate cancer may be driven
by the intratumoral production of androgens. The Company�s new
findings were reported this week at the 13th International Congress
on Hormonal Steroids and Hormones & Cancer being held in Quebec
City, Canada, September 27th � 30th. Dr. Richard Trauger, Director
of Infectious Disease and Cancer at Hollis-Eden Pharmaceuticals,
presented the data, from work performed by Dr. Eva Corey, Research
Associate Professor, Department of Urology, at the University of
Washington. Preclinical Data Presented Using the
castration-resistant LuCaP 35V xenograft model (human prostate
tumors implanted in immunodeficient mice), Dr. Trauger reported
that APOPTONE treatment significantly reduced tumor volume (p <
0.05), and delayed tumor-doubling time relative to that in
vehicle-treated animals. An analysis of tumor samples from these
mice also demonstrated that APOPTONE lowered levels of androgen
receptor protein and significantly reduced gene expression relative
to the vehicle controls (p < 0.05). In addition, tumors in mice
treated with APOPTONE had reduced levels of testosterone and
dihydrotestosterone (DHT) relative to the vehicle-treated animals,
suggesting that APOPTONE suppressed hormone synthesis directly
within the tumors. These preclinical results demonstrate that
APOPTONE significantly inhibits tumor growth in this model of
castration-resistant prostate cancer, apparently by suppressing
critical hormones and receptors necessary for tumor cell survival.
Data were also presented from a separate model of prostate mediated
bone disease, where C4-2B castration-resistant tumor cells were
implanted directly into the tibia of castrated SCID mice. APOPTONE
treatment significantly lowered the tumor bearing tibia weight and
reduced PSA levels relative to the vehicle-treated animals (p <
0.05). �We are excited to be collaborating with Hollis-Eden to test
in a Phase I/II clinical trial whether APOPTONE treatment can help
patients in the later stages of prostate cancer where there are
very few treatment options,� stated Bruce Montgomery, M.D.,
Associate Professor, Division of Oncology, University of
Washington. �APOPTONE appears in preclinical studies to suppress
the androgen receptor while also inhibiting the ability of
castration-resistant tumor cells to synthesize their own androgens.
The potential that APOPTONE acts to cut off the tumors� fuel supply
and cause programmed cell death is completely different from the
effect of classical hormonal blockade therapy.� Ongoing Phase I/II
Clinical Trial The Phase I/II clinical trial, now currently
enrolling patients, is a dose escalation trial currently scheduled
to evaluate up to four different dosing groups to determine the
maximum tolerated dose. Primary objectives of the study are to
determine the safety, tolerance, pharmacokinetics and potential
activity of the compound over 28 day dosing cycles in up to 44
patients with advanced prostate cancer who have failed hormone
therapy and at least one round of taxane-based chemotherapy.
Potential activity of the compound will be measured by standard
prostate-specific antigen (PSA) tests and effect on
well-established markers of progression-free survival (PFS) such as
CT scan, MRI and circulating tumor cells. If any signs of activity
are observed in a particular dosing regimen the Company plans to
expand the number of patients in order to confirm the findings and
initiate a Phase II clinical study at the safest and most effective
dose or dosing regimens. �Hormone sensitive cancers, such as
prostate and breast cancer, are among the most commonly diagnosed
cancers in men and women, respectively,� stated Richard Hollis,
Chairman and CEO, Hollis-Eden Pharmaceuticals. �Our expertise in
steroid chemistry and our experience in working with steroid
hormone chemical structures for over a decade have allowed us to
synthesize and screen hundreds of chemical structures for activity
in hormone sensitive cancers. APOPTONE represents years of work to
identify an active steroidal chemical structure that to date has
performed remarkably well in preclinical models of both prostate
and breast cancer. Data presented today by Dr. Trauger in prostate
cancer are especially encouraging as we bring APOPTONE into human
clinical trials. The fact that APOPTONE has inhibited the growth of
human tumors in animal models of prostate cancer, and now has been
shown in an animal model to apparently suppress hormone synthesis
directly within the tumor, should bode well for potential human
translation in our current trial in prostate cancer patients.�
�Over the last several weeks,� added Hollis, �our scientists have
presented data at the International Autoimmune Conference in Porto,
Portugal, at the World Congress on Insulin Resistance in Los
Angeles, California, and today at the International Congress on
Hormonal Steroids & Hormones and Cancer meeting in Quebec City,
Canada. Presenting our data at scientific conferences around the
world allows us the opportunity to establish our data with
luminaries and thought leaders in various fields of medicine as
well as to provide updated information about our development
programs to investors. We will continue to have our scientists
present our scientific findings at conferences to build the
validation for our science and will submit those findings for
future publication in scientific journals, which typically lag the
actual issuance of data by several months or longer. We remain
focused on generating data from our currently enrolling clinical
trials in prostate cancer, type-2 diabetes, ulcerative colitis and
rheumatoid arthritis and expect that positive data from these
trials would be our value drivers in the near-term.� Prostate
Cancer Market Approximately 234,000 patients are diagnosed with
prostate cancer each year in the United States. The pharmaceutical
market for treating prostate cancer is approximately $7 billion per
year. Current treatments for prostate cancer focus on blocking
testosterone and other hormones associated with disease progression
and range in annual sales from $500 million to $1.8 billion. With
approximately 30,000 men in the United States dying from prostate
cancer each year, there remains a tremendous unmet medical need
where novel treatments are needed. 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 and ulcerative
colitis and being prepared for clinical trials in rheumatoid
arthritis, and APOPTONE� (HE3235), a next-generation compound
selected for clinical development for 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 and the benefits to be derived therefrom
including the potential advantages of APOPTONE compared to other
treatment approaches, how APOPTONE is believed to work and its
potential for use in the treatment of prostate cancer or other
cancers. The inclusion of forward-looking statements should not be
regarded as a representation by the Company that any of its plans
will be achieved. Any statements 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 risks and uncertainties inherent in clinical trials,
and drug development and commercialization, including the
uncertainty of whether results in preclinical and clinical testing
of APOPTONE to date will be predictive of results in later stages
of development; 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
obtain and protect its intellectual property rights and to not
infringe the intellectual property rights of others; the
development of competitive products by other companies, the market
potential for prostate cancer and the other markets the Company is
targeting, and the Company�s ability to compete; 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. This caution is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
All forward-looking statements are qualified in their entirety by
this cautionary statement. 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. None of the Company's drug candidates has been approved
for sale, significant additional animal and human testing is
required in order to seek marketing approval for any of its drug
candidates, and the Company cannot assure you that marketing
approval can be obtained for any of its drug candidates or that,
even if such marketing approval were received, such drug candidates
would ultimately achieve commercial success. Furthermore, as is
typically the case at this stage of the regulatory review process,
the FDA has not yet performed an in-depth review of the Company's
preclinical and clinical data, so its views remain subject to
change.
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