Hollis-Eden Pharmaceuticals Commences Phase I/II Clinical Trial with APOPTONE(TM) (HE3235) in Late-Stage Prostate Cancer Patient
30 Luglio 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 clinical trial with its oral drug candidate
APOPTONE� (HE3235) in late-stage prostate cancer patients who have
failed hormone therapy and at least one round of chemotherapy
treatment. The Phase I/II open-label dose ranging study, being
conducted with the Prostate Cancer Clinical Trial Consortium
(PCCTC), will evaluate the safety, tolerance, pharmacokinetics and
potential activity of APOPTONE when administered twice daily for 28
days in up to 44 late-stage prostate cancer patients. 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). In
addition, in conjunction with Memorial Sloan-Kettering Cancer
Center, the clinical trial will evaluate circulating tumor cell
(CTC) enumeration as a marker for effectiveness for tumor
treatment. Previous studies have shown that metastatic prostate
cancer patients with less than 5 CTCs per 7.5 ml of blood have
statistically better survival than patients with greater than 5
CTCs. APOPTONE has been tested in a number of preclinical cancer
models and has been shown to date to be active in controlling the
incidence, growth and development of new tumors. Hollis-Eden
believes that APOPTONE may be directly inducing apoptosis, or cell
death, in tumor cells, as opposed to traditional hormone blockade
therapies directed at simply interrupting either the synthesis or
the signaling of the tumor cell growth through the androgen or
estrogen receptor. While hormone blockade therapy can effectively
control prostate cancer for a period of time, it will eventually
fail and the cancer can continue to grow and spread. Analysis of
gene expression from tumor�cells in preclinical studies conducted
to date indicate APOPTONE appears to act as an apoptotic agent,
down-regulating genes that protect tumor cells from apoptosis, such
as Bcl-2, while increasing the expression of pro-apoptotic genes
such as caspases. �The preclinical data generated to date suggest
that APOPTONE may offer a unique therapeutic approach to late-stage
prostate cancer where traditional therapies have failed,� said
Howard Scher, M.D., Chief of the Genitourinary Oncology Service at
Memorial Sloan-Kettering Cancer Center. �Advancing APOPTONE into a
Phase I/II clinical trial for late-stage prostate cancer is another
significant achievement for Hollis-Eden,� stated Richard B. Hollis,
Chairman and Chief Executive Officer. �The patients entering our
initial clinical trial will be in the later stages of prostate
cancer having failed at least one round of chemotherapy. Based on
our previously reported positive data from testing APOPTONE in
preclinical models of late stage prostate cancer, we are excited to
study the compound�s unique therapeutic approach in a patient
population with limited treatment options. We will be assessing the
activity of APOPTONE therapy by measuring PSA levels before and
over the course of treatment, as well as the standard markers of
progression-free survival. In addition, we will be evaluating the
ability of APOPTONE treatment to impact circulating tumor cells.
This new marker is used as a prediction of PFS and overall survival
(OS) in patients treated with therapies for metastatic breast,
prostate and colorectal cancer. We are also pleased to be
conducting this study in collaboration with the Prostate Cancer
Clinical Trial consortium, made up of some of the finest prostate
cancer clinics in the world.� Hollis added, �This should be an
exciting second half of the year for Hollis-Eden as we generate
clinical data in prostate cancer with APOPTONE and with our novel
anti-inflammatory drug candidate TRIOLEX in patients with type 2
diabetes, ulcerative colitis and rheumatoid arthritis. In addition
to these major market opportunities, our goal is also to establish
ourselves as a world leader in treating or preventing diseases
related to aging based on our hormonal signaling technology
expertise.� Preclinical Trial Results To Date In preclinical models
of mice implanted with the human prostate cancer cell line LNCaP,
treatment with APOPTONE at the time of tumor cell challenge reduced
the incidence of LNCaP tumors in a dose dependent fashion. In the
high-dose group, APOPTONE completely prevented tumor growth,
compared with 92% tumor incidence in placebo-treated animals. In a
separate model, mice with established LNCaP prostate tumors were
randomized to receive treatment with either APOPTONE or placebo,
and tumors were then tracked for three weeks. At the end of the
study, tumor volume in the animals receiving placebo was on average
more than seven times larger than in animals treated with APOPTONE
(p ? 0.05). Two out of the nine treated animals became completely
tumor�free. In a preclinical model of late-stage prostate cancer
using the human xenograft LuCaP 35V, a tumor cell type that is
known to grow independently of any hormone stimulation, treatment
with APOPTONE showed marked suppression of tumor growth from day 21
until the end of the 28-day study vs. control (p ? 0.05). This
LuCaP 35V data is noteworthy because it extends the activity of
APOPTONE beyond the previously described activity in models of
hormone-dependent tumors to hormone-independent tumors, also known
as castration-resistant tumors, which are associated with
late-stage prostate cancer. APOPTONE also was tested in a novel
model of prostate cancer bone disease developed by the Company�s
collaborators at the University of Washington. The study was
designed to see if APOPTONE could kill castrate-resistant prostate
tumor cells transplanted directly to the bone of experimental
animals. In this model of metastatic prostate cancer, C42B
castrate-resistant human prostate cancer cells were implanted into
the tibia bone of castrated mice and allowed to grow. Once animals
expressed prostate-specific antigen (PSA) in their serum,
indicating that the prostate cancer cells were growing in the bone,
the animals were randomized to daily treatment with either APOPTONE
or placebo. At the end of the four-week treatment period there was
a statistically significant lowering of PSA levels in
APOPTONE-treated animals of greater than 50% (p ? 0.05) relative to
the placebo-treated animals. More importantly, the weight of the
tumored tibia from APOPTONE-treated animals was significantly lower
when compared with the placebo-treated animals (p ? 0.05),
indicating that tumor growth in the bone was inhibited by APOPTONE
treatment. 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.
Prostate Cancer Clinical Trial Consortium (PCCTC) The membership of
the PCCTC presently includes: Dana Farber Cancer Institute; Johns
Hopkins University: Memorial Sloan-Kettering Cancer Center:
University of California San Francisco; The Regents of the
University of Michigan; Oregon Health & Sciences; The
University of Texas, M.D. Anderson Cancer Center; University of
Wisconsin; Duke University and University of Washington. 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 a clinical trial in 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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