MIGENIX Completes First Clinical Study of Celgosivir in Chronic Hepatitis C Pati

[Guest guest]

MIGENIX Completes First Clinical Study of Celgosivir in Chronic

Hepatitis C Patients

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.

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 "

------------

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: Burke, MIGENIX Inc.,

Tel: , Extension 241, jburke@...; Dian Griesel,

Ph.D., Investor Relations Group, Tel: ,

Theproteam@...;

To request a free copy of this organization's annual report, please

go to

http://www.newswire.ca and click on reportscnw (DOT)

http://www.newswire.ca/en/releases/archive/September2005/27/c4225.html