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Phase 2 Study of MBI-3253 (Celgosivir) in Hepatitis C Patients Initiated
VANCOUVER, BC, and SAN DIEGO, CA, Sept. 7 /PRNewswire-FirstCall/ -- Micrologix Biotech Inc. (TSX: MBI; OTC: MGIXF) has received a Letter of Authorization for its clinical trial application (CTA) from Health Canada to begin a Phase IIa human clinical study with MBI-3253 (celgosivir), an oral first-in-class therapy in development for the treatment of chronic Hepatitis C Virus (HCV) infections. Study site selection has been completed, with the study expected to begin enrolling patients within the next few weeks and results expected in the second quarter of calendar 2005.
Lorne Tyrrell, MD, Ph.D., an internationally recognized hepatitis expert and Chair of the Micrologix Hepatitis C Clinical Advisory Board, stated, "Preclinical results to date indicate that MBI-3253 could be effective as monotherapy and in improving combination therapy with existing treatments for HCV infections. HCV-infected patients currently have few treatment options, and those options have limited effectiveness in treating the most common strain of HCV infection in North America (genotype I). If MBI-3253 can achieve evidence of viral load reduction as monotherapy and/or in combination therapy, it could be an important new product candidate to improve treatment outcomes for HCV patients."
MBI-3253, an a-glucosidase I inhibitor, has already demonstrated efficacy in a surrogate model of HCV infection and has been well tolerated in over 500 human subjects to date. Recent peer-reviewed publications have shown that (a) a-glucosidase is important for HCV replication, (b) the hepatitis C virus is hypersensitive to a-glucosidase inhibition, and (3) MBI-3253 is additive and/or synergistic with the currently approved HCV therapies (ribavirin and interferon).
Nancy Coulson, Senior VP of Product Development at Micrologix commented, "This approval represents a great step forward for MBI-3253 since a recognized regulatory agency has reviewed the clinical, preclinical, and manufacturing data available for the product. This confirms our assessment that the work done to date has been well done, and along with the information we have thus far, further increases our confidence in achieving clinical success".
Jim DeMesa, MD, President & CEO of Micrologix added, "Our team has once again executed rapidly to get this potential blockbuster product opportunity advancing through development in just a few months after its acquisition. This is important since starting this study as planned allows us to get clinical efficacy data in the near-term. Overall, clinical activity within our company is expected to be significant over the next 12 months as we initiate Phase II studies for MBI-3253 (HCV) and MITO-4509 (Alzheimer's disease) and continue Phase III trials with MBI-226 (catheter-related infections)."
About the Clinical Study
Approximately 60 treatment-naive or interferon-intolerant HCV patients will be treated for 12 weeks at 5 sites in Canada, divided into three dosing groups. The objective of this initial study is to evaluate HCV viral loads at various time points during the study and at 12 weeks. The study will also assess the safety of MBI-3253 in HCV patients. Since MBI-3253 has shown additive and/or synergistic effects with currently marketed products in preclinical models, combination studies are being planned to further evaluate efficacy.
About MBI-3253 and HCV
MBI-3253 (celgosivir) is an orally-administered, unique antiviral agent exerting its effects through the inhibition of the mammalian cell enzyme, a-glucosidase I. Alpha-glucosidase I inhibitors can inhibit the replication of a broad range of enveloped viruses (including HCV) by preventing the correct folding of their envelope glycoproteins.
Chronic hepatitis C virus (HCV) infection is a serious public health concern affecting approximately 4.5 million people in the United States. Worldwide, the disease affects as many as 185 million people. HCV causes inflammation of the liver, which may lead to fibrosis and cirrhosis, liver cancer, and ultimately, liver failure. Cirrhosis of the liver resulting from chronic HCV infection is the leading indication for liver transplantation in the U.S. Each year, 8,000 to 10,000 people in the U.S. die from complications of HCV. Current therapies for HCV infection have only limited effectiveness, especially against genotype I, the most common strain of HCV in North America. It is predicted that deaths from HCV will surpass those of AIDS in the United States by 2010, at which time the global HCV market is forecasted to be approximately $6 billion.
Source: Micrologix Biotech Inc.