Hollis-Eden to Present Interim Data From Its Phase I/II Clinical Studies of Apoptone(R) (HE3235) at Molecular Targets and Cancer
November 12 2009 - 3:37PM
PR Newswire (US)
- Company Provides Update on Progress of Lead Compounds - SAN
DIEGO, Nov. 12 /PRNewswire-FirstCall/ -- Hollis-Eden
Pharmaceuticals, Inc. (NASDAQ:HEPH), will present results of its
ongoing human clinical Phase I/II open-label dose-ranging trial
with Apoptone® (HE3235) for hormone-resistant prostate cancer (also
called castrate-resistant prostate cancer or CRPC) on November 16
at the American Association for Cancer Research - Molecular Targets
and Cancer Therapeutics Conference in Boston. Apoptone, a novel
steroid that is an analog of part of the dihydrotestosterone
metabolic pathway, stimulates ERK1 signal transduction that
counter-regulates PI3K, and thereby initiating tumor cell
apoptosis. Apoptone has demonstrated activity in animal models of
CRPC, the results of which were recently published in the British
Journal of Cancer and the journal Neoplasia. Concurrently with its
lead program Apoptone, Hollis-Eden Pharmaceuticals is pursuing
clinical development of a second oral small-molecule candidate,
Triolex®, from its synthetic steroid library. Triolex decreases
macrophage infiltration into fatty tissues and pro-inflammatory
processes. The lead indication for Triolex is Type 2 diabetes. A
Phase II trial (HE3286-0401) in obese, insulin-resistant diabetic
patients is fully enrolled and should be completed in the first
quarter of 2010. A Phase I trial (HE3286-0102) to assess safety and
early activity in obese insulin-resistant, pre-diabetic subjects is
complete, with final analysis in progress. Additional trials were
initiated during 2008 in rheumatoid arthritis (RA) and ulcerative
colitis (UC). James Frincke, Ph.D., Chief Executive Officer of
Hollis-Eden Pharmaceuticals commented: "We have reduced our burn
rate to enable operations focused on our lead programs to continue
into the latter half of 2010. We intend to use data from our
ongoing trials to engage with potential corporate partners for the
design and funding of late-stage development programs in diseases
with high unmet medical need." Triolex Clinical Program Update
Diabetes Pre-diabetes Phase I safety tolerance and early activity
trial HE3286-0102 This study has completed the planned enrollment
of 48 patients and data analysis has been initiated. Preliminary
results indicated that Triolex was safe and well-tolerated, and
there were no side effects observed such as those seen with
testosterone, estrogen, progesterone or glucocorticoids. Diabetes
Phase II two-stage exploratory and confirmatory trial HE3286-0401
This ongoing study in type 2 diabetic patients was undertaken based
on promising Triolex activity in insulin-resistant, prediabetic
subjects. The original study began in the second half of 2008. The
initial exploratory phase included 84 days of treatment with
Triolex or placebo along with metformin in patients with
uncontrolled HbA1c levels. Activity was found in a subset of
diabetics defined with biomarkers as obese, inflamed and
insulin-resistant. A confirmatory, placebo-controlled trial was
initiated in the second quarter of 2009 in patients dosed only with
Triolex or placebo in order to avoid potential confounding effects
of metformin on anti-inflammatory activity. The confirmatory stage
of the trial is fully enrolled; the last patient is expected to
complete the trial in the first quarter of 2010. Other Inflammatory
Diseases Two exploratory Phase I/II studies were initiated with
Triolex in other diseases with an auto-immune inflammatory
etiology. The results of these studies, combined with our completed
non-clinical long-term toxicology data, will permit
proof-of-concept trials in these indications as resources become
available. Ulcerative colitis Phase I/II safety, tolerance and
early activity trial HE3286-0301 This Phase I/II trial explored the
safety, tolerability and early signs of activity in chronic UC
patients who were experiencing an acute flare in their disease.
Patients were dosed for 28 days at 3 dose levels: 5 mg, 10 mg (5
bid) and 20 mg (10 bid) and Triolex was found to be safe and
tolerable. Adverse events were mild to moderate and equally divided
between Triolex and placebo-treated groups. The study was not
powered to show statistically significant activity differences
between placebo and drug-treated patients based on disease score
changes. There was no clear separation between the placebo and
active study arms over a one-month treatment period. Rheumatoid
arthritis Phase I safety, tolerance and drug compatibility study
HE3286-0201 This Phase I safety and tolerance study was conducted
in RA patients with stable disease that were concurrently taking
methotrexate as maintenance therapy. A secondary objective of the
study was to learn whether Triolex interfered with the action of
methotrexate, which is required for concomitant dosing trials in
patients with active disease. Three dose levels of Triolex were
given daily to 14 subjects for 28 days along with weekly
methotrexate. Three patients were dosed at 10 mg (5 mg bid), three
at 20 mg (10 mg bid) and eight at 40 mg (2 mg bid) on an
intent-to-treat basis. Triolex was found to be safe and well
tolerated. No disease flares or increased methotrexate toxicity
were observed. Most adverse events were mild to moderate. Subject
drug exposure remained dose proportional through the higher dose,
and no change in methotrexate or Triolex pharmacokinetics was
observed. About Hollis-Eden Pharmaceuticals Hollis-Eden
Pharmaceuticals is a development-stage company with two product
candidates in human clinical trials: Apoptone (HE3235), in the
dose-escalation portion of a Phase I/II trial of patients with
late-stage prostate cancer, and Triolex, in a Phase IIa trial in
obese Type 2 diabetes patients. Apoptone and Triolex represent the
lead candidates from Hollis-Eden's small molecule platform based on
metabolites or synthetic analogs of endogenous steroid hormones.
For more information on Hollis-Eden please visit
http://www.holliseden.com/. This press release contains
forward-looking statements within the meaning of the federal
securities laws concerning, among other things, the presentation of
the results of Hollis-Eden Pharmaceuticals, Inc. ongoing human
clinical Phase I/II open-label dose-ranging trial with Apoptone
(HE3235) for hormone-resistant prostate cancer (also called
castrate-resistant prostate cancer or CRPC) on November 16; the
completion of Hollis-Eden's Phase II trial (HE3286-0401) in obese,
insulin-resistant diabetic patients in the first quarter of 2010;
the continuation of Hollis-Eden's operations focused on its lead
programs into the latter half of 2010; Hollis-Eden's use of data
from its ongoing trials to engage with potential corporate partners
for the design and funding of late-stage development programs; and
Hollis-Eden's ability to conduct proof-of-concept trials in other
diseases with an auto-immune inflammatory etiology as resources
become available. 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 Hollis-Eden'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, Hollis-Eden 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. DATASOURCE: Hollis-Eden
Pharmaceuticals, Inc. CONTACT: Robert Weber, Chief Financial
Officer of Hollis-Eden Pharmaceuticals, 1-858-587-9333, Web Site:
http://www.holliseden.com/
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