Hollis-Eden Pharmaceuticals Reports on Progress in Drug Development Programs; Announces Second Quarter 2008 Financial Results
07 Agosto 2008 - 6:00AM
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 steroid hormones, today reported on the Company�s
progress in its drug development programs in the areas of metabolic
disorders, inflammatory conditions and cancer, and announced
financial results for the second quarter of 2008. Recent Progress
in Drug Development Programs During the second quarter of 2008,
Hollis-Eden continued to advance its clinical development programs,
with clinical trials now underway in four indications with its lead
drug candidates � TRIOLEX� (HE3286), in a Phase II clinical trial
for type 2 diabetes and in Phase I/II clinical trials for
ulcerative colitis and rheumatoid arthritis, and APOPTONE�
(HE3235), in a Phase I/II clinical trial for prostate cancer.
Hollis-Eden believes TRIOLEX is a potential first-in-class insulin
sensitizer and anti-inflammatory without immune suppression or bone
loss, and that APOPTONE is a potential first-in-class apoptosis
drug for cancer. Metabolic Disorders: Type 2 Diabetes In June 2008,
Hollis-Eden reported positive interim data from its ongoing Phase
I/II clinical trial with its investigational oral drug candidate
TRIOLEX (HE3286) in obese insulin resistant subjects, supporting
the potential benefit of an anti-inflammatory approach to improving
insulin sensitivity in patients with type 2 diabetes. Leading
academic researchers have linked inflammation and type 2 diabetes,
and the role of inflammation in promoting insulin resistance and
type 2 diabetes is well described in the scientific literature. The
data, presented at a corporate symposium held in conjunction with
the 68th Scientific Sessions of the American Diabetes Association,
demonstrated that TRIOLEX is safe and well tolerated to date, and
that it significantly improved insulin sensitivity and
significantly lowered fasting blood glucose, insulin and
triglyceride levels in obese insulin resistant subjects treated
orally with the compound for 28 days when compared to
placebo-treated subjects. These effects were accompanied by
significant decreases in circulating and cellular inflammatory
mediators. The Company initiated a Phase II clinical trial with
TRIOLEX in type 2 diabetes patients in mid-July. This Phase II,
double-blinded placebo controlled 12-week dosing trial will enroll
patients who are stable on metformin treatment only, the current
first-line therapy for type 2 diabetes, with a hemoglobin A1c
(HbA1c) level in excess of 7.5 percent. The primary endpoints for
the trial will be safety and a reduction in HbA1c. Hollis-Eden
plans to release preliminary data from this clinical trial in the
fourth quarter of 2008, and plans to complete enrollment in the
trial by the end of the year. Hollis-Eden believes that the
mechanism of action for TRIOLEX involves regulation of inflammation
and reduced activation of 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. TRIOLEX
also appears to act independently of the PPAR-gamma nuclear
receptor and thereby may avoid the side effects associated with the
current glitazone class of insulin sensitizing agents, such as
Avandia� and Actos�, which work through the PPAR-gamma pathway.
Side effects reported to date with the glitazone class of drugs
include weight gain, edema and increased cardiovascular events.
Inflammatory Diseases: Ulcerative Colitis and Rheumatoid Arthritis
Hollis-Eden is currently enrolling patients in a Phase I/II
clinical trial with TRIOLEX in ulcerative colitis (UC). This Phase
I/II oral dose ranging study will evaluate the safety, tolerance,
pharmacokinetics and activity of TRIOLEX when administered orally
for 28 days in patients with active, mild-to-moderate UC.
Hollis-Eden also has initiated a Phase I/II clinical trial with
TRIOLEX for the treatment of rheumatoid arthritis (RA). The 28-day
oral dose ranging study, which opened for enrollment this week,
will assess safety and pharmacokinetics in stable RA patients on
methotrexate, a commonly used RA treatment. The Company believes
that certain aspects of the pathology driving UC and RA are
similar. Therefore, data obtained in this UC study could
potentially help support the design of the Company�s clinical
development program for RA, and could help accelerate the
development of TRIOLEX for potential use in patients with acute
inflammatory conditions. Hollis-Eden previously reported that oral
treatment with TRIOLEX provided benefit in several preclinical
models of autoimmune diseases, including rheumatoid arthritis,
multiple sclerosis and systemic lupus erythematosus and that
benefit was associated with an expansion of regulatory T cells.
Ongoing pre-clinical studies are aimed at new indications and at
elucidating the role of regulatory T cells in TRIOLEX�s mechanism
of action. Hollis-Eden plans to present data from its ongoing
clinical and preclinical studies at the 6th International Congress
on Autoimmunity, to be held at Porto, Portugal September 10th to
the 14th, where the Company has been invited to present in an oral
session. Inflammatory Diseases: Cystic Fibrosis Cystic Fibrosis
Foundation Therapeutics (CFFT), the non-profit drug discovery and
development arm of the Cystic Fibrosis Foundation, selected TRIOLEX
in late 2007 as a drug candidate for lung inflammation associated
with cystic fibrosis. Hollis-Eden is currently in discussions with
CFFT about the design of a possible Phase II study with TRIOLEX in
cystic fibrosis. If Hollis-Eden and CFFT agree on the economics,
clinical plan and an initial protocol, the Company will submit a
separate investigational new drug application (IND) for TRIOLEX
with the U.S. Food and Drug Administration (FDA) to gain clearance
to initiate a clinical trial in CF. The Company believes that
successfully developing a compound for cystic fibrosis could lead
to opportunities relative to other pulmonary indications, such as
COPD and asthma, with TRIOLEX. Oncology: Prostate Cancer
Hollis-Eden 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 in late-stage prostate cancer patients.
Based on safety findings after the initial 28-day cycle, patients
will be eligible for additional cycles of treatment. 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 in these models.
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. �At mid-year 2008,
Hollis-Eden has made significant progress in advancing our clinical
development programs in four indications with our lead compounds,
TRIOLEX and APOPTONE, and we believe we are well-positioned to
potentially further demonstrate in multiple clinical trials their
safety and activity in major market indications,� stated Richard B.
Hollis, Chairman and CEO of Hollis-Eden. �This progress represents
a significant milestone in our quest to translate the therapeutic
potential of our Hormonal Signaling Technology Platform into
beneficial pharmaceuticals for the treatment of metabolic and
autoimmune disorders, cancer, and other diseases associated with
the process of aging. The opportunity to potentially deliver a new
class of compounds that could restore fundamental biochemical
signals lost to disease and aging is rare in our industry, and we
are passionately focused today on converting our technology into
commercial products. �By year-end, our goal is to report
preliminary clinical data from our Phase II trial in type 2
diabetes and from our Phase I/II trials in ulcerative colitis,
rheumatoid arthritis and prostate cancer. Establishing clinical
'proof of concept' with our compounds in one of these indications
could present the opportunity to leverage our technology platform
for multiple additional clinical applications with large market
opportunities. Given their safety profile and the positive data
generated in clinical and preclinical trials to date, we believe
our proprietary class of compounds hold the potential of yielding
'first-in-class' pharmaceuticals that could offer potential
advantages over currently marketed therapies, and play a
significant role in major disease markets in the United States and
globally. So today we believe we are strategically positioned to
potentially convert our technology into substantial shareholder
value and to establish ourselves as a major factor in our
industry.� Second Quarter 2008 Financial Results For the quarter
ended June 30, 2008, the Company reported a net loss of $6.0
million (or $0.21 per share), compared to a net loss of $5.8
million (or $0.20 per share) in the second quarter of 2007. For the
six months ended June 30, 2008, Hollis-Eden reported a net loss of
$11.7 million (or $0.40 per share), compared to a net loss of $12.3
million (or $0.42 per share) in the first six months of 2007.
Included in the net loss for the second quarter and first half of
2008 was $0.7 million and $1.2 million, respectively, of
stock-based compensation expense related to the adoption of SFAS
No. 123R, compared to $0.6 million and $1.6 million in the same
periods last year. Research and development expenses were $4.4
million and $8.8 million for the quarter and six-month periods
ended June 30, 2008, respectively, compared to $4.6 million and
$9.2 million for the same periods in 2007. Research and development
expenses decreased in 2008 compared to 2007 mainly due to the
discontinuation of the Company�s NEUMUNE� (HE2100) research and
development program and a decrease in stock option compensation
expenses. General and administrative expenses were $1.8 million and
$3.6 million for the three-month and six-month periods ended June
30, 2008, respectively, compared to $1.9 million and $4.5 million
for the same periods in 2007. General and administrative expenses
decreased primarily as a result of reduced costs related to
salaries, consulting, audit fees and stock option compensation
expense. Other income and expenses were $0.3 million and $0.7
million for the three-month and six-month periods ended June 30,
2008, respectively, compared to $0.7 million and $1.5 million for
the same periods in 2007. The decrease in interest income was due
to lower cash balances and interest rates. As of June 30, 2008, the
Company reported $34.1 million in cash and cash equivalents. Cash
used in operations for the second quarter of 2008 totaled $4.8
million versus $6.3 million for the second quarter of 2007. Year to
date in 2008, cash used in operations totaled $9.0 million,
compared to $14.8 million in the first half of 2007. More detailed
information is available in the Company�s Form 10-Q filed today
with the Securities and Exchange Commission
(http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0000899
394). (Due to its length, this URL may need to be copied/pasted
into your Internet browser's address field. Remove the extra space
if one exists.) Conference Call: Hollis-Eden will conduct a
conference call and live webcast on August 7, 2008 at 2:00 p.m.
Eastern (11:00 a.m. Pacific) to discuss second quarter 2008
financial results. The conference call can be accessed by dialing
800-237-9752 (domestic) or 617-847-8706 (international) and
requesting the Hollis-Eden conference call. A live webcast of the
conference call will be available under �Event Calendar� on the
Investors section of Hollis-Eden�s website at www.holliseden.com.
The webcast will be archived at the Company�s website for 30 days,
and a replay of the call will be available by phone for 24 hours
beginning approximately one hour after the call is completed, and
can be accessed at 888-286-8010 (domestic) or 617-801-6888
(international), passcode 30718006. 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 and the
benefits to be derived therefrom including the potential advantages
of TRIOLEX and APOPTONE compared to other treatment approaches, how
these drug candidates are believed to work and their respective
potential for use in the targeted indications. 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, clinical trials, and drug development
and commercialization including, but not limited to: the outcome of
final analysis of data from the Company's phase I/II clinical trial
of TRIOLEX once it is completed may vary from the Company's initial
analysis, and the FDA may not agree with the Company's
interpretation of such results; the ability to complete preclinical
and clinical trials successfully and within specified timelines, if
at all; the ability to obtain regulatory approval for TRIOLEX,
APOPTONE 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; the market potential for the indications 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. 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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