Omiganan Phase II Rosacea Study Demonstrates Promising Results



    Partner Plans to Advance to Phase III

    VANCOUVER and SAN DIEGO, Oct. 17 /CNW/ - MIGENIX Inc. (TSX: MGI; OTC:
MGIFF), a clinical-stage developer of drugs for infectious diseases, has been
notified by its partner for the dermatologic applications of omiganan, Cutanea
Life Sciences, that a recently completed Phase II rosacea study has
demonstrated:

    
     -  superior lesion count reductions and Treatment Success (as defined by
        Investigator Global Assessment scores), with once-daily (QD) omiganan
        2.5% gel compared to 1% omiganan QD and vehicle at nine weeks of
        treatment;

     -  a dose-dependent response in both lesion reductions and Treatment
        Success among the once-daily treatment arms; and

     -  omiganan was well-tolerated at all doses tested.
    

    Based on the results from this study, Cutanea has selected a once-daily
dose of omiganan 2.5% for further development for the treatment of
papulopustular rosacea.
    In Cutanea's press release, Dr. Guy Webster, Founding and Current
President of the American Acne & Rosacea Society and Clinical Professor of
Dermatology at Jefferson Medical College stated, "Topical omiganan is a novel
approach, actually the first in a new class of dermatologic drugs, for the
treatment of rosacea. Initial results are promising and I look forward to a
more precise estimation of the effectiveness of the drug in the larger Phase
III program."
    Jim DeMesa, M.D., President & CEO of MIGENIX added, "These positive
results are a further indication of omiganan's potential in the treatment and
prevention of infection and inflammation. With this topical formulation for
the treatment of rosacea now planned to enter Phase III, and with Omigard(TM)
(omiganan for the prevention of catheter-related infections) expected to
complete Phase III next year with our partner, Cadence Pharmaceuticals, we
will have two Phase III clinical opportunities with omiganan with the
potential to provide us relatively near-term and ongoing revenue."

    About the Phase II Rosacea Study

    The trial compared omiganan 2.5% and 1% topical gel to vehicle in
subjects with papulopustular rosacea. The objective of this exploratory Phase
II study was to find the optimal dose and regimen of omiganan for further
study as a treatment for rosacea. The trial enrolled 240 patients with
papulopustular rosacea and Investigator Global Assessment (IGA) scores of
grade 3 or 4 (moderate to severe disease). Patients were randomized into one
of five treatment groups in a 2:2:2:1:1 ratio: omiganan 1% QD, omiganan 2.5%
QD, omiganan 2.5% twice-daily (BID), Vehicle QD, or Vehicle BID. During the
total nine-week treatment period, safety and efficacy assessments were
performed at weeks one, three, six, and nine.
    Study results demonstrated that the formulation was well-tolerated at all
doses tested. Among the once-daily treatment arms, a dose-dependent response
was observed in both lesion reductions and Treatment Success, as defined by
Investigator Global Assessment (IGA) scores. After nine weeks of treatment,
once-daily (QD) omiganan 2.5% gel showed superior lesion count reductions and
Treatment Success, compared to 1% omiganan QD and vehicle. Omiganan provided
greater improvements compared to vehicle among patients with a more severe
condition at Baseline (more numerous inflammatory lesions). Lesion counts
continued to drop at all evaluations over the duration of the study,
indicating that further improvements may be expected with a duration of
treatment exceeding nine weeks. Twice daily (BID) application of 2.5% omiganan
did not demonstrate substantial improvement in lesion reduction or the number
of patients reaching Treatment Success compared to once daily application.
    The primary efficacy endpoint was mean percent reduction in the number of
inflammatory lesions from Baseline to Week 9. Patients receiving once-daily
omiganan 2.5% showed a mean 31% reduction in the number of inflammatory facial
lesions compared to a 14% reduction in patients receiving once-daily vehicle.
And, among rosacea patients with 18 or more lesions at Baseline, the mean
reduction for once-daily omiganan 2.5% was 40%, compared to an 11% lesion
increase in the once-daily vehicle group.
    Secondary endpoints included the absolute change from Baseline in the
number of inflammatory lesions at Week nine and at each interim visit, the
percent change in number of inflammatory lesions at interim visits, the
absolute change from Baseline in IGA score and other signs and symptoms of
rosacea at Week nine and each interim visit, and Treatment Success at Week
nine and each interim visit.
    Although a statistically significant difference between active and
vehicle was not achieved for the primary endpoint (using a percent change in
lesions), this study demonstrated that in both the intent-to-treat and the per
protocol populations, omiganan 2.5% QD was statistically significantly better
than vehicle QD at Week nine in the absolute change of inflammatory lesions
(p=0.041 for the intent-to-treat population and p=0.012 for the per protocol
population). While in this exploratory study this endpoint was identified as a
secondary endpoint, the FDA currently requires the absolute change (rather
than the percent change) in the number of inflammatory lesions as one of the
co-primary endpoints, along with Treatment Success, for demonstrating efficacy
in a Phase III trial in rosacea.

    About Omiganan for Dermatologic Uses

    Omiganan pentahydrochloride is a novel, cationic, antimicrobial peptide,
in development as a topical treatment for papulopustular rosacea and may
prevent the inflammatory cascade that is theorized to lead to the signs and
symptoms of rosacea. Omiganan topical gel has been evaluated in early stage
clinical trials at concentrations of 0.5% to 3.0%, and late stage trials at
1.0%. At each of these concentrations and in all trials conducted, omiganan
was found to be well tolerated and non-irritating with no evidence of systemic
absorption. While cationic antimicrobial peptides, such as omiganan, are well
known for their antimicrobial properties, recent research has shown that they
also may play a role in the inflammatory response. Omiganan, in in vitro
assays, demonstrated a rapid bactericidal activity against microorganisms that
colonize the skin and that may play a role in the pathogenesis of inflammatory
lesions.

    About Rosacea

    Rosacea is a chronic dermatologic disorder with no current cure and a
poorly understood etiology that afflicts an estimated 14 million Americans.
Symptoms primarily manifest on the facial skin and include facial flushing,
central facial inflammatory lesions, and facial erythema. According to surveys
conducted by the National Rosacea Society, nearly 70% of rosacea patients said
the disorder had lowered their self-confidence and self-esteem; 41% reported
it had caused them to avoid public contact or cancel social engagements; and
nearly 30% claimed to have missed work due to rosacea. Of these rosacea
patients that sought medical treatment, over 70 percent reported an
improvement in their emotional and social well-being.
    Typical onset of rosacea occurs between 30 and 50 years of age and is
more prevalent in women than men. Clearing up the initial outbreak is only the
beginning, as rosacea is characterized by periods of relapses and remissions.
Relapse episodes can be spurred by sun exposure, stress, hot or cold weather,
alcohol, spicy foods, exercise, and certain skin care products and
medications.
    Absent a cure for rosacea, treatment is aimed at alleviating the
disorder's symptoms. Topical or oral medications are generally prescribed for
mild to moderate papulopustular Rosacea, while oral medications are prescribed
for severe disease. Current oral antibiotic therapies may alleviate symptoms
of rosacea, but may present an issue with undesirable side effects. While
there are other topical products currently available on the market, there is
an opportunity to improve the existing irritation profile for these
treatments.

    About Cutanea Life Sciences

    Cutanea Life Sciences is an emerging specialty pharmaceutical company
focused on improving human health and appearance through the development and
commercialization of treatments for diseased and aging skin conditions. The
Company strives to maximize value through flawless execution of strategically
designed programs. Its core strategy is to in-license novel, patented,
mid-stage treatment candidates for aggressive development as potential
market-leading dermatologic treatments for commercialization or out-license.
The Company focuses on leveraging each of its products to address a variety of
indications that serve the collective interest of patients and medical
professionals. Cutanea Life Sciences is a member of the family of
bio/pharmaceutical companies founded in conjunction with Paramount
BioSciences, LLC.

    About MIGENIX

    MIGENIX is committed to advancing therapy, improving health, and
enriching life by developing and commercializing drugs primarily in the area
of infectious diseases. The Company's clinical programs include drug
candidates for the treatment of chronic hepatitis C infections (Phase II and
preclinical), the prevention of catheter-related infections (Phase III) and
the treatment of dermatological diseases (Phase II). MIGENIX is headquartered
in Vancouver, British Columbia, Canada with US operations in San Diego,
California. Additional information can be found at www.migenix.com.

    "Jim DeMesa"
    ------------
    James M. DeMesa, M.D.
    President & CEO

    FORWARD-LOOKING STATEMENTS

    This news release contains forward-looking statements within the meaning
of the United States Private Securities Litigation Reform Act of 1995, and
forward-looking information within the meaning of applicable securities laws
in Canada, (collectively referred to as "forward-looking statements").
Statements, other than statements of historical fact, are forward-looking
statements and include, without limitation, statements regarding our strategy,
future operations, timing and completion of clinical trials, prospects, plans
and objectives of management. The words "anticipates", "believes", "budgets",
"could", "estimates", "expects", "forecasts", "intends", "may", "might",
"plans", "projects", "schedule", "should", "will", "would" and similar
expressions are often intended to identify forward-looking statements, which
include underlying assumptions, although not all forward-looking statements
contain these identifying words. By their nature, forward-looking statements
involve numerous assumptions, known and unknown risks and uncertainties, both
general and specific, that contribute to the possibility that the predictions,
forecasts, projections and other things contemplated by the forward-looking
statements will not occur.
    Although our management believes that the expectations represented by
such forward-looking statements are reasonable, there is significant risk that
the forward-looking statements may not be achieved, and the underlying
assumptions thereto will not prove to be accurate. Forward-looking statements
in this news release include, but are not limited to, statements concerning
our expectations for: Cutanea Life Sciences' plans to advance omiganan for the
treatment of rosacea into Phase III clinical development, MIGENIX having two
Phase III clinical opportunities with omiganan with the potential to provide
relatively near-term and ongoing revenue, Cadence completing the Omigard(TM)
Phase III clinical trial next year and the results of the Cutanea Phase II
rosacea study indicating that further improvements may be expected with a
duration of treatment exceeding nine weeks.
    With respect to the forward-looking statements contained in this news
release, we have made numerous assumptions regarding, among other things:
Cutanea's ability to manage, fund and advance omiganan for dermatological
applications into Phase III, the adequacy of Cutanea's Phase II results for
regulatory authorities to support advancing to Phase III and Cadence's ability
to complete the Phase III Omigard(TM) trial.
    Actual results or events could differ materially from the plans,
intentions and expectations expressed or implied in any forward-looking
statements, including the underlying assumptions thereto, as a result of
numerous risks, uncertainties and other factors including: dependence on
corporate collaborations; uncertainties related to early stage of technology
and product development; uncertainties as to the requirement that a drug be
found to be safe and effective after extensive clinical trials and the
possibility that the results of such trials, if completed, will not establish
the safety or efficacy of our products; potential delays; uncertainties as to
future expense levels and the possibility of unanticipated costs or expenses
or cost overruns; the possibility that opportunities will arise that require
more cash than presently anticipated and other uncertainties related to
predictions of future cash requirements; and other risks and uncertainties
which may not be described herein. Certain of these factors and other factors
are described in detail in the Company's Annual Information Form and Annual
Report on Form 20-F for and other filings with the Canadian securities
regulatory authorities and the U.S. Securities & Exchange Commission.
    Forward-looking statements are based on our current expectations and
MIGENIX assumes no obligations to update such information to reflect later
events or developments.

    The Toronto Stock Exchange has not reviewed and does not accept
    responsibility for the adequacy or accuracy of this release.





For further information:

For further information: Art Ayres, MIGENIX Inc., Tel: (604) 221-9666,
Extension 233, aayres@migenix.com; Dian Griesel, Ph.D., Investor Relations
Group, Tel: (212) 825-3210, Theproteam@aol.com

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