New Clinical Study Results Indicate Higher Early Virologic Response with Celgosivir Combination Therapy in HCV Non-Responders

    Data to be Presented April 15th at EASL Conference in Barcelona, Spain

OTC: MGIFF), a clinical-stage developer of drugs for infectious diseases, has
received new top-line results confirming the previously announced clinical
results (November 6, 2006) indicating evidence of clinical benefit, safety and
tolerability in a Phase II study using the oral alpha-glucosidase inhibitor,
celgosivir (MX-3253), in combination with pegylated interferon and ribavirin.
    In addition to confirming the overall conclusions of the original study
analysis, retesting resulted in a larger percentage of patients achieving an
Early Virologic Response(*) ("EVR") rate with celgosivir plus peginterferon
alfa-2b and ribavirin (the "triple combination") as compared to treatment with
peginterferon alfa-2b and ribavirin alone (the "control treatment") in
patients with chronic hepatitis C virus genotype 1 infections who were
characterized as non-responders to prior therapy with optimized pegylated
interferon plus ribavirin, achieving:

    -   42% (5/12) EVR with the celgosivir triple combination arm compared to
        10% (1/10) EVR in the control treatment arm. This compares with 33%
        (4/12) EVR (triple combination) vs 10% (1/10) (control treatment) in
        the original study results. (*) EVR = 2 log(10) or greater
        HCV viral load reduction at 12 weeks.

    -   1.63 log(10) (triple combination) mean HCV viral load reduction
        ("VLR") compared to a 0.92 log(10) VLR (control treatment). This
        compares with a 1.2 log(10) VLR (triple combination) vs a 0.4 log(10)
        VLR (control treatment) in the original study results.

    -   a more rapid onset of treatment effect as measured by VLR within the
        first 2 weeks of therapy in the triple combination as compared to the
        control treatment.

    These new top-line results complete the retesting announced February 6,
2007 as a result of Schering-Plough Corporation ("Schering") having informed
MIGENIX that approximately 50% of the original viral load samples from the
study, which Schering tested under a Material Transfer and License Option
Agreement between the companies, required retesting.
    AnnKatrin Petersen, M.D., Vice President, Clinical Development of MIGENIX
stated, "the increase in EVR to 42% after retesting (33% previously) for the
celgosivir triple combination group in these very difficult to treat patients,
along with the clear evidence of rapid reduction in viral load give us
increased confidence in the potential of celgosivir to contribute in the
treatment of HCV patients."
    Jim DeMesa, M.D., President and CEO of MIGENIX added, "This confirmation
of our previously announced results allows us to now focus on providing a data
package to Schering-Plough over the next few weeks for their limited period of
exclusive review under our License Option Agreement. The better EVR results
seen upon retesting, especially in these very difficult-to-treat non-responder
patients, reinforces our optimism in celgosivir's potential to improve
treatment outcomes for these HCV patients with few therapeutic options."

    EASL Presentation

    The results from this study will be presented on April 15, 2007 at the
42nd Annual Meeting of the European Association for the Study of the Liver
(EASL) being held in Barcelona, Spain April 11-15, 2007. The presentation
entitled: "Phase II Proof of Concept Study of Celgosivir in Combination with
Peginterferon Alfa-2b and Ribavirin in Chronic Hepatitis C Genotype-1
Non-responder Patients" will be made in the General Session 4 on Sunday, April
15th from 1:00pm-1:15pm in Hall F of the CCIB Conference Center. Dr. Kelly
Kaita, the Director of the Viral Hepatitis Investigative Unit (VHIU) at the
Health Sciences Centre, University of Manitoba and a lead investigator in the
MIGENIX Phase II study will make the presentation on behalf of MIGENIX.

    Additional Information About the Clinical Study

    The Phase II non-responder combination study was designed to determine,
over 12 weeks of treatment, the efficacy, safety, and tolerability of
celgosivir in combination with peginterferon alfa-2b, with or without
ribavirin, in HCV-positive (genotype 1) patients who were non-responders or
partial responders to prior therapy with optimized pegylated interferon and
    A total of 57 patients were enrolled into this Phase II study (36 were
non-responders and 21 were partial responders). Patients were randomized into
three treatment arms: (i) celgosivir (400mg once daily) plus peginterferon
alfa-2b plus ribavirin ("triple combination"); (ii) celgosivir (400mg once
daily) plus peginterferon alfa-2b ("double combination"); and (iii) celgosivir
placebo plus peginterferon alfa-2b plus ribavirin ("control treatment"). Of
the 36 non-responders, 30 patients completed the 12-weeks of treatment: 12 in
the triple combination arm, 8 in the double combination arm, and 10 in the
control treatment arm. Beyond the triple combination and control treatment
results reported above the following results were also consistent with the
originally reported results: (a) the double combination did not show a
meaningful difference in mean viral load reduction and EVR when compared to
the control treatment in non-responder patients; and (b) in the partial
responder patient population, there were insufficient patients (n=3) in the
triple combination arm for any conclusions to be drawn and the double
combination showed less effect than the control treatment.
    Celgosivir combination therapy was well tolerated and resulted in no
significant adverse events. As expected from previous experience, the most
frequent side effects related to celgosivir were gastrointestinal in nature
and were generally mild. Other frequently observed side effects were fatigue
and flu-like symptoms - which are side effects usually associated with
pegylated interferon and ribavirin. Only 7 of the 57 patients entering the
study dropped out prior to week 12.

    Material Transfer and License Option Agreement

    Under the terms of the Agreement, Schering supplied PEGETRON(TM)
(peginterferon alfa-2b powder for solution plus ribavirin 200 mg capsules) as
well as certain technical and laboratory support and other services for
MIGENIX's celgosivir Phase II combination study in chronic HCV patients and a
related extension protocol. In addition, the Agreement granted Schering
limited periods of exclusivity for data review of clinical trial results and
for the negotiation of a license agreement. With the new top-line results, we
will be working to provide a data package to Schering over the next few weeks,
after which Schering's limited period of exclusivity for data review under the
Agreement will commence. No license terms have been negotiated with Schering
to date.

    About Celgosivir (MX-3253)

    Celgosivir is an alpha-glucosidase I inhibitor and is currently the only
anti-HCV drug in clinical development that acts on host-directed
glycosylation. In preclinical studies, celgosivir has shown excellent in vitro
synergy with various interferons in the clinic 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 has the potential to be included as part
of many combination therapeutic approaches to improve efficacy in anti-HCV

    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, which fails to provide a satisfactory outcome for approximately 50%
of patients infected with HCV genotype 1 (the most prevalent genotype in North
America). In addition, these drugs can cause significant side effects that
limit tolerance to therapy, or a frequent lack of sustained treatment

    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

    James M. DeMesa, M.D.
    President & CEO


    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 regarding the time required to complete and provide a data
package of the celgosivir Phase II study results to Schering; our expectations
for the celgosivir Phase II study results being presented on April 15, 2007 at
the EASL conference; and celgosivir having the potential to be included as
part of many combination therapeutic approaches to improve efficacy in
anti-HCV therapy.
    With respect to the forward-looking statements contained in this news
release, we have made numerous assumptions regarding, among other things, our
ability to successfully complete the celgosivir Phase II data package for
Schering within our expected timelines, EASL accepting the new celgosivir
Phase II results, the competitiveness of the celgosivir study results to date
and future results supporting its potential in the treatment of HCV.
    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: 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;
dependence on corporate collaborations; 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 Final Prospectus dated November 29, 2006, Annual
Information Form and Annual Report on Form 20-F for the year ended April 30,
2006 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,; Dian Griesel, Ph.D., Investor Relations Group,
Tel: (212) 825-3210,

Organization Profile


More on this organization

Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890