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MIGENIX Completes First Clinical Study of Celgosivir in Chronic Hepatitis C Patients
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MBI-3253 (CELGOSIVIR) - TREATMENT OF HEPATITIS C VIRUS (HCV) CHRONIC INFECTIONS
MBI-3253 (celgosivir) is an oral prodrug of castanospermine, a natural product derived from the Australian Black Bean chestnut tree, Castanospermum australe. Celgosivir is a potent inhibitor of alpha-glucosidase, an enzyme found in mammalian cells, which affects the early stages of glycoprotein processing. HCV and other enveloped viruses require proper glycosylation of structural proteins for one or more of the following: stability, maturation, assembly and secretion of infective particles. One potential advantage of celgosivir is that it inhibits a mammalian enzyme rather than a viral target. As a result, it is less likely to lead to drug-resistant viral mutants, as is seen with conventional antiviral drugs, and has the potential to be used in combination with current HCV therapies. Micrologix intends to initiate Phase II clinical development with celgosivir in calendar 2004.
Press announcement from Migenix
VANCOUVER and SAN DIEGO, Sept. 27 /CNW/ - MIGENIX Inc. (TSX: MGI;OTC: MGIFF), a clinical-stage developer of drugs for infectious and degenerative diseases, has completed a Phase IIa monotherapy clinical study of celgosivir (MX-3253), an orally administered, first-in-class, a-glucosidase I inhibitor, in development for the treatment of chronic hepatitis C virus (HCV) infections. The study met its objectives by confirming the drug was well-tolerated with some evidence of antiviral activity in patients with chronic HCV infection.
Eric Yoshida, M.D., Associate Professor of Gastroenterology at the
University of British Columbia and an investigator in the monotherapy study
stated, "The recent celgosivir monotherapy trial in hepatitis C patients
indicates that this agent is safe and there appears to be a modest anti-HCV
effect. It should be noted that ribavirin monotherapy did not demonstrate a
significant anti-HCV effect alone, but in combination with peg-interferon had
a dramatic effect with regards to antiviral efficacy. Celgosivir may have a
similar or better effect and we are awaiting a combination trial with great
interest."
Jim DeMesa, M.D., President and CEO of MIGENIX added, "This Phase IIa
study in HCV patients with celgosivir as monotherapy, along with the safety
and nonclinical synergy data generated to date, supports our combination
therapy development strategy. A Phase IIb combination therapy study is
expected to begin enrollment shortly and is intended to demonstrate that
celgosivir can improve the current combination therapy for chronic HCV
patients. It is encouraging that most investigators from the monotherapy trial
are also participating in the combination trial."
This Phase IIa monotherapy trial was designed to test the safety and
tolerability of celgosivir in patients chronically infected with HCV and to
evaluate viral load changes as monotherapy at different doses. The trial was
conducted at six clinical centers in Canada and enrolled 43 patients
randomized to receive celgosivir orally at either 200 mg once daily, 200 mg
twice daily or 400 mg once daily for twelve weeks. The patients participating
in the study were HCV genotype 1 (a difficult-to-treat strain of hepatitis C)
who were treatment naive or intolerant to interferon/ribavirin therapy.
The results of the study demonstrate that celgosivir was well-tolerated
with generally mild to moderate, reversible side effects, no serious adverse
events, and some indication of antiviral activity. In two patients, a 1.0
log(10) or greater reduction in viral load was observed, with one patient
achieving a peak reduction in HCV RNA of 2.6 log(10) (99.8% clearing of the
virus). As expected based on the mechanism of action and pharmacokinetics of
celgosivir, other viral load changes in this monotherapy study were not
clinically significant. A phase IIb combination therapy trial is expected to
begin shortly, with support from Schering-Plough and is intended to
demonstrate the clinical effectiveness of Celgosivir in combination with the
current standard of care.
About Hepatitis C
Hepatitis C virus, 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 carry 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
chronic hepatitis C is pegylated interferon combined with ribavirin, which
fails to provide a satisfactory outcome for the majority of patients infected
with HCV genotype 1. It is estimated that successful therapy is achieved in
less than 50% of patients. In addition, these drugs can cause significant side
effects that limit tolerance to therapy, or a frequent lack of sustained
treatment response.
About MIGENIX
MIGENIX is committed to advancing therapy, improving health, and
enriching life by developing and commercializing drugs in the areas of
infectious and degenerative diseases. The Company's clinical programs include
drug candidates for the treatment of chronic hepatitis C infections (Phase
II), the prevention of catheter-related infections (Phase III), the treatment
of neurodegenerative diseases (Phase I) and the treatment of acne (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"
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James M. DeMesa, M.D.
President & CEO
Certain statements in this news release contain forward-looking
statements within the meaning of the United States Private Securities
Litigation Reform Act of 1995. All statements other than statements of
historical fact may be deemed to be forward-looking statements. Forward-
looking statements frequently, but not always, use the words "intends",
"plans", "believes", "anticipates" or "expects" or similar words; that events
"will", "may", "could" or "should" occur; and/or include statements concerning
our strategies, goals, plans and expectations. Forward-looking statements in
this news release include, but are not limited to statements concerning:
commencing enrollment in the MX-3253 Phase IIb combination therapy study
shortly. We may not actually achieve the plans, intentions or expectations
disclosed in our forward-looking statements and you should not place undue
reliance on our forward-looking statements. Factors that could cause actual
events or results expressed or implied by such forward looking statements to
differ materially from any future results expressed or implied by such
statements include, but are not limited to: uncertainties related to early
stage of technology and product development; 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 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.
For further information: Jonathan Burke, MIGENIX Inc.,
Tel: (604) 221-9666, Extension 241, jburke@migenix.com; Dian Griesel,
Ph.D., Investor Relations Group, Tel: (212) 825-3210, Theproteam@aol.com;
To request a free copy of this organization's annual report, please go to
http://www.newswire.ca and click on reports@cnw.
http://www.newswire.ca/en/releases/archive/September2005/27/c4225.html
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