VANCOUVER and SAN DIEGO, June 27 /CNW/ - MIGENIX Inc. (TSX: MGI,
OTC: MGIFF), a clinical-stage developer of drugs for infectious diseases, has
received notice that Schering-Plough Corporation ("Schering") will not enter
into a second period of exclusivity to negotiate terms of a license agreement
for MIGENIX's Hepatitis C Virus ("HCV") product, celgosivir. MIGENIX is,
therefore now free to advance discussions with other interested parties.
Schering has expressed a willingness to consider providing MIGENIX with
guidance on study design and drug supplies in support of celgosivir's further
clinical development. The exclusivity with Schering arose in connection with
the terms of a Material Transfer and License Option Agreement between MIGENIX
and Schering related to a recently completed Phase II non-responder study of
Jim DeMesa, M.D., President and CEO of MIGENIX stated, "The results from
the recent non-responder study demonstrated clinically significant benefits
when celgosivir was added to the standard of care (pegylated interferon plus
ribavirin). Those results have increased the interest of both the clinical
community and of several pharma and biotech companies active in HCV product
development. Because celgosivir offers a unique mechanism of action,
once-daily oral dosing, a good safety profile, and has demonstrated synergy
with other HCV treatments, we are optimistic about the potential of celgosivir
to contribute to the treatment of HCV patients."
About Celgosivir (MX-3253)
Celgosivir, an oral inhibitor of alpha-glucosidase I, 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 in
many combination therapy approaches to improve efficacy in anti-HCV treatment.
The Phase II non-responder combination study reported April 11, 2007 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 ribavirin. The following is a summary of the non-responder
- a 42% Early Virologic Response ("EVR") with the triple combination
compared to a 10% EVR in the control treatment arm.
(*) EVR = 2 log10 or greater HCV viral load reduction at
- a mean HCV viral load reduction ("VLR") of 1.63 log10 (triple
combination) compared to a 0.92 log10 reduction (control).
- 90% viral load reduction (1 log10) reduction, or greater, at 12 weeks
in 66% (8/12) of the triple combination patients, compared to only
40% (4/10) in patients in the control treatment.
- EVR in 57% of null responders (4/7) in the triple therapy arm (null
responders = patients who have not achieved greater than a
0.4 log10 viral load reduction on prior treatment with optimized
peg-interferon plus ribavirin).
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. Fifty of 57 patients entering the study
completed all 12 weeks of treatment.
Material Transfer and License Option Agreement with Schering-Plough
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.
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
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.
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 for advancing discussions with parties interested in
celgosivir; and celgosivir having the potential to be included as part of many
combination therapy 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 advance discussions with parties interested in
celgosivir, our ability to manage licensing opportunities; 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, Email: email@example.com; Dian Griesel, Ph.D., Investor Relations
Group, Tel: (212) 825-3210, Email: Theproteam@aol.com