MIGENIX to Add 600mg Daily Celgosivir Dose to Phase II Viral Kinetics Study



    VANCOUVER and SAN DIEGO, Jan. 31 /CNW/ - MIGENIX Inc. (TSX: MGI, OTC:
MGIFF), a clinical-stage developer of drugs for infectious diseases, will add
a 600mg celgosivir combination therapy arm to its currently enrolling Phase II
viral kinetics study in hepatitis C virus ("HCV") treatment-naive patients.
The protocol amendment to this study has received Health Canada and
Institutional Review Board (IRB) approvals. The purpose of this new treatment
arm is to assess 600mg celgosivir (an oral alpha glucosidase I inhibitor) for
tolerability, pharmacokinetics and viral kinetics when combined with the
standard of care drugs, pegylated interferon plus ribavirin, as compared to
the standard of care drugs alone and to 400mg celgosivir plus the standard of
care for up to 12 weeks of therapy.
    AnnKatrin Petersen, M.D., VP Clinical Development for MIGENIX commented,
"The favorable tolerability experienced to date with 400mg per day of
celgosivir in triple combination with pegylated interferon plus ribavirin,
along with the clinically significant benefit demonstrated in our previous
non-responder study, gives us confidence that increasing the dose to 600mg per
day in combination therapy is an important development step for the
optimization and advancement of celgosivir."
    The currently enrolling Phase II viral kinetics study is a 12-week
randomized, active-controlled study initially planned to enroll up to 20
patients in two treatment arms: (i) celgosivir (400mg once daily) plus
peginterferon alfa-2b plus ribavirin ("PRC"); and (ii) peginterferon alfa-2b
plus ribavirin ("PR"). Tolerability, pharmacokinetics and viral kinetics are
being evaluated in the trial. The approved protocol amendment allows for the
addition of a 600mg once daily dosing arm and the flexibility to increase the
total number of patients in the study up to 50. With 15 patients enrolled to
date, it is planned that approximately six additional patients will be
enrolled, all in the new 600 mg arm. Results from the study are expected to be
reported in the third calendar quarter 2008.
    Jim DeMesa, M.D., President and CEO of MIGENIX added, "With results from
this study expected in the third quarter 2008, we now have another near-term
clinical milestone. Additional key clinical milestones include Omigard
Phase III results for preventing catheter-related infections (CLIRS study)
expected by our partner, Cadence Pharmaceuticals, in the second half of 2008
(enrollment to be completed in the second quarter) and Cutanea Life Sciences,
our partner in the CLS001 rosecea product, planning to advance CLS001 to
Phase III."

    About Celgosivir (MX-3253)

    Celgosivir, an oral inhibitor of alpha-glucosidase I, is currently the
only anti-HCV drug in clinical development which acts on host-directed
glycosylation. In preclinical studies, celgosivir has shown in vitro synergy
with various interferons on the market or in development including Pegasys,
PEG-Intron, Infergen, Alferon and IFN-omega (with or without ribavirin) and
other drugs in development for the treatment of HCV (e.g. polymerase
inhibitors) and therefore could have the potential to be included as part of
many combination therapeutic approaches to improve efficacy in future anti-HCV
therapies.
    Results announced in April 2007 from a Phase II study demonstrated a
clinically significant benefit when celgosivir was added to the standard of
care in non-responder patients. Interim results from the first 10 patients in
the current viral kinetics study who had completed 4-weeks of therapy were
reported in December 2007. Detailed analysis of data from these two studies,
and an extension protocol designed to provide expanded access to the
non-responder patients, provided the rationale for increasing the dose of
celgosivir from 400mg per day to 600mg per day in combination therapy as the
next step for the optimization and advancement of celgosivir.

    About HCV

    HCV, the most common chronic blood-borne infection in the United States,
causes inflammation of the liver and may progress to more serious
complications such as cirrhosis of the liver, liver cancer and death.
Approximately 2.7 million people in the United States are chronically infected
with HCV, and the Centers for Disease Control and Prevention (CDC) estimates
that by the year 2010, the number of deaths attributed annually to HCV could
surpass that due to HIV/AIDS in the US. Worldwide, the World Health
Organization estimates that 170 million individuals have chronic HCV
infection, with 3 to 4 million new infections each year.
    Therapy for HCV currently employs a drug combination approach, which is
anticipated to continue in the future. The current standard of care for
treatment-naive chronic hepatitis C is pegylated interferon combined with
ribavirin (PR), which fails to provide a satisfactory outcome for
approximately 50% of patients infected with HCV genotype 1 (the most prevalent
genotype in North America).

    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: increasing the celgosivir dose to 600mg being an
important development step for the optimization and advancement of celgosivir;
our plans to add approximately six patients at 600mg dose in the celgosivir
Phase II viral kinetics study and having results from the study in the third
quarter 2008; Cadence Pharmaceuticals completing enrollment in the CLIRS trial
in the second quarter of 2008, with results available in the second half of
2008; and Cutanea Life Sciences' plans to advance omiganan for the treatment
of rosacea to Phase III clinical development.
    With respect to the forward-looking statements contained in this news
release, we have made numerous assumptions regarding, among other things: our
ability to enroll approximately six patients at the 600mg dose in the
celgosivir Phase II viral kinetics study and having results from the study in
the third quarter of 2008; Cadence's ability to enroll sufficient patients to
complete the Omigard CLIRS trial; the adequacy of the CLIRS trial design to
generate data that are deemed sufficient by regulatory authorities to support
potential regulatory filings, including an NDA, for Omigard; 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; our ability to manage licensing
opportunities; and our ability to initiate, fund and complete non-clinical
studies, clinical studies, manufacturing and all ancillary activities within
our expected timelines.
    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; potential delays; 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;
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
Ext. 233, aayres@migenix.com; Dian Griesel, Ph.D., Investor Relations Group,
Tel: (212) 825-3210, Theproteam@aol.com

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MIGENIX INC.

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