FMTI
This news release is a few weeks old, but I came upon it and it struck me as a truckload of BS. Unless they're using an abacus, it doesn't take that long to determine whether participants achieved a 15% reduction in LDL-C. I suspect they're stalling for time to data mine. If the results were positive, they'd be trumpeting them right now.
I also saw that FMTI released another BS press release today about how FM-VP4 was selected as a top 10 unpartnered CV product by some unknown organization. Given that they certainly know the results right now, are they trying to pump up the price before announcing the failure?
Watch this one closely, if for no other reason than for entertainment value. Leaks are inevitable.
Forbes Medi-Tech Announces the Completion of the US Phase II Trial for Cholesterol-Lowering Drug, FM-VP4
Monday October 2, 8:00 am ET
VANCOUVER, BRITISH COLUMBIA--(MARKET WIRE)--Oct 2, 2006 -- Forbes Medi-Tech Inc. (TSX:FMI.TO - News)(NASDAQ:FMTI - News) today announced the completion of its 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 results are anticipated to be released in mid-to-late fourth quarter 2006.
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"The completion of the US Phase II trial marks the achievement of a major milestone in the Company's history," said Charles Butt, President and CEO, Forbes Medi-Tech. "We have applied our experience and knowledge from previous clinical activities and with the input of both the Company's pharmaceutical development team and our Medical & Scientific Advisory Board, we believe we have optimized the trial design and look forward to receiving the results."
The multicenter Phase II trial with over 150 male and female mild to moderate hypercholesterolemic subjects was randomized, double-blind and placebo-controlled. Subjects were eligible if they had a LDL-C of 130-210 mg/dL and a triglyceride (TG) level of less than 300 mg/dL. Randomization was equal across three groups with approximately 50 subjects in each group (450mg group, 900mg group and placebo 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 - Cholesterol Absorption Inhibitor
The global anti-dyslipidemic market was an estimated US$27 Billion in 2005 (Datamonitor 2006). The category within the anti-dyslipidemic market experiencing significant growth is the cholesterol absorption inhibitors (CAIs). CAIs are less potent than statins, but can provide enhanced safety as well as a synergistic efficacy in combination therapy. These products demonstrated 115.8% growth between 2003 and 2004, which was due primarily to the launch of Merck/Schering Plough's compound - Zetia®(i). Zetia®, like FM-VP4, inhibits dietary cholesterol absorption. Global sales for Zetia® in 2005 were $1.4 Billion.
The significant and continuous growth of the cholesterol absorption inhibitors confirms the strength of the alternative therapy market for cholesterol lowering. FM-VP4 is one of few other inhibitors in development and, as such, has the potential to achieve a significant market share.
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 (CVD). Our vision is to develop and market products along a treatment continuum that CVD savvy consumers, healthcare professionals and specialized CVD 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.
(i) Zetia® is a registered trademark of MSP Singapore Company, LLC.
