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Celgosivir Cleared for Phase IIb Combination Study in HCV Non-responders
Aug 11, 2005 - 11:19:00 PM, Reviewed by: Dr.
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Celgosivir is currently being evaluated in a Phase IIa monotherapy study in treatment-naive and interferon-intolerant genotype I HCV patients.
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By MIGENIX Inc. ,
MIGENIX Inc. , a clinical-stage developer of drugs for infectious and degenerative diseases, has received a Notice of Authorization from Health Canada for a clinical trial application (CTA) to begin a Phase IIb combination study of MX-3253 (celgosivir), a compound in development for the treatment of chronic hepatitis C virus (HCV) infections. Enrollment in the study is expected to commence in the next few weeks with results expected around mid- year calendar 2006.
"This is an important step in the development of celgosivir", stated Jim DeMesa, MD, President and CEO of MIGENIX. "Our recent agreement with Schering- Plough, the strong preclinical synergy of celgosivir with interferon-alpha plus ribavirin, and the participation of many of the same investigators from our Phase IIa trial - combined with this regulatory approval - give us great encouragement for success in this Phase IIb trial".
About MX-3253 and the Phase IIb Combination Study
MX-3253 (celgosivir) is an alpha-glucosidase I inhibitor and is currently the only oral anti-HCV drug in development that acts through host-directed glycosylation. In preclinical studies, celgosivir has demonstrated strong synergy with interferon-alpha plus ribavirin and has the potential to be included as part of a combination therapeutic approach to improve efficacy. Celgosivir is currently being evaluated in a Phase IIa monotherapy study in treatment-naive and interferon-intolerant genotype I HCV patients with results of the study expected before the end of the third quarter of calendar 2005.
The Phase IIb combination study of MX-3253 is a randomized, multi-center, active-controlled, 12 week evaluation of MX-3253 in three treatment arms of up to 20 chronic HCV patients each: celgosivir plus peginterferon alfa-2b plus ribavirin (3-way combination); celgosivir plus peginterferon alfa-2b (2-way combination); and placebo plus peginterferon alfa-2b plus ribavirin (control). An agreement was completed in July with Schering-Plough for (a) the supply of PEGETRON(TM) (peginterferon alfa-2b powder for solution plus ribavirin 200 mg capsules) and (b) certain technical and laboratory support and other services for the study.
Patients for the Phase IIb study will be selected based on having genotype 1 chronic HCV and having failed to respond to pegylated alpha interferon plus ribavirin therapy (non-responders). Today, there are very limited treatment options for the 40% to 50% of hepatitis C patients who have failed treatment with the current standard of care, pegylated interferon plus ribavirin. Among this patient population, approximately 10% respond to retreatment with pegylated interferon plus ribavirin. Patients who respond to therapy during the Phase IIb trial will have the option to continue on treatment for up to 48 weeks. The study will measure viral load at various time points, as well as a number of safety parameters. 
- MIGENIX
www.MIGENIX.com
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 HCV 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
CONTACTS
Jonathan Burke
MIGENIX Inc.
Tel: (604) 221-9666
Extension 241
Gino de Jesus or
Dian Griesel,Ph.D.
Investor Relations Group
Tel: (212) 825- 3210
Forward-looking Statements
[email protected] [email protected]
Certain statements in this new release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements in this release include, but are not limited to statements concerning: expecting results of the MX-3253 Phase IIa monotherapy study before the end of the third quarter of calendar 2005 and having results from the MX-3253 Phase IIb combination study around mid-year calendar 2006. These statements are only predictions and actual events or results may differ materially from those reflected in the 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; government regulation; dependence on corporate collaborations; management of growth; dependence on key personnel; dependence on proprietary technology and uncertainty of patent protection; intense competition; and manufacturing and market uncertainties. Certain of these factors and other factors are described in detail in the Company's Final Prospectus, Annual Information Form and Annual Report on Form 20-F, news releases 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.
CONTACT: Jonathan Burke, MIGENIX Inc., Tel: (604) 221-9666, Extension 241,; Gino de Jesus or Dian Griesel, Ph.D., InvestorRelations Group, Tel: (212) 825-3210, ; To request a freecopy of this organization's annual report, please go tohttp://www.newswire.ca and click on reports@cnw [email protected] [email protected]
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