FMI HOLDINGS LTD. 6-K 2005
Report of Foreign Private Issuer
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For the month of December, 2005
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A Life Sciences Company
Forbes Medi-Tech Initiates Dosing Phase in Clinical Trial for Cholesterol-Lowering Drug, FM-VP4
Vancouver, Canada Forbes Medi-Tech Inc. (TSX:FMI and NASDAQ:FMTI) today announced that it has started dosing subjects in a US Phase II trial for its cholesterol-lowering drug, FM-VP4. The primary efficacy objective of this trial is to determine the effect of two doses of FM-VP4, 450mg and 900mg, given for 12 weeks, compared to placebo, on low density lipoprotein-cholesterol (LDL-C). The goal of this trial is to demonstrate a minimum of 15% reduction from baseline in LDL-C at Week 12. The trial is expected to be completed in the third quarter of 2006.
Dosing is a major step forward in the clinical process, said Charles Butt, President and CEO of Forbes Medi-Tech Inc.
The multicenter Phase II trial with 150 male and female mild to moderate hypercholesterolemic subjects is randomized, double-blind and placebo-controlled. Subjects will be eligible if they have a LDL-C of 130-210 mg/dL and a triglyceride (TG) of <300 mg/dL. After the run-in period, patients fulfilling the inclusion criteria will be randomized for the double-blind period. Randomization will be equal across three groups with approximately 50 subjects in each group.
In addition to the effects on LDL-C, the effects of FM-VP4 on total cholesterol (TC), high density lipoprotein-cholesterol (HDL-C), HDL:LDL ratio, triglycerides (TG), and C-reactive protein (CRP) will be evaluated in this trial. The safety and tolerability of FM-VP4 will be assessed by physical examinations, laboratory measurements and the evaluation of any adverse events.
FM-VP4 is a cholesterol absorption inhibitor, a new class in cholesterol-lowering drug. FM-VP4 may have an application as a monotherapy, an adjunct therapy or, perhaps even more importantly, as a combination therapy with statins. Combination therapies are significant, as they allow for a lower statin dose, which may reduce the risk of side effects. According to Datamonitor (Dec. 03) the statin combination market is expected to grow at a compound annual rate of 44%, reaching US$4.7 billion by 2011. The cardiovascular market represents a significant opportunity as industry-wide sales of cardiovascular pharmaceuticals are estimated to grow to over US$40 billion by 2011. (Datamonitor, 2004)
About Forbes Medi-Tech Inc.
Forbes Medi-Tech Inc. is a life sciences company dedicated to the research, development and commercialization of innovative products for the prevention and treatment of cardiovascular disease. Our vision is to develop and market products along a treatment continuum that cardiovascular disease consumers, healthcare professionals and specialized cardiovascular disease research and healthcare institutions will identify, recommend and seek. Our business strategy is to develop and commercialize proprietary compounds to address the unmet needs of patients within the cardiovascular disease market.
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For more information, please contact:
Manager, Investor Relations
Telephone: (604) 681-8976
NASDAQ and the Toronto Stock Exchange have not reviewed and do not accept responsibility for the adequacy or accuracy of the content of this News Release. This News Release contains forward-looking statements regarding the future development of the Companys drug candidate, FM-VP4, including planned outcomes and timing of the U.S.Phase II clinical trial, the future growth of the cardiovascular pharmaceutical market and the Companys strategy and vision, which statements can be identified by the use of forward-looking terminology such as objective, goal, toward, outcome, 2006, will, expected, estimated, 2011, vision, to develop, strategy or comparable terminology referring to future events or results or terminology referring to future dates. The Companys actual results could differ materially from those anticipated in these forward-looking statements as a result of numerous factors, including uncertainty whether the FM-VP4 Phase II clinical trial will be completed as planned or will be successful; the need for additional clinical trials, the occurrence and success of which is not assured; the need for further regulatory approvals, which are not assured and which may be denied or withdrawn; uncertainty whether FM-VP4 will be commercialized; uncertainty whether the Company will realize is strategies and vision; intellectual property risks; manufacturing risks and the need to manufacture to regulatory standards; product liability and insurance risks; the risk of unknown side effects; the effect of competition; and the Companys need for future funding; any of which could cause actual results to vary materially from current results or the Companys anticipated future results. See the Companys reports filed with the Canadian and U.S. securities regulatory authorities from time to time for cautionary statements identifying important factors with respect to such forward-looking statements, including certain risks and uncertainties, that could cause actual results to differ materially from results referred to in forward-looking statements. The Company assumes no obligation to update the information contained in this News Release.