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
migenix.
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.
MIGENIX Inc.
migenix
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