|
Forbes Medi-Tech Announces Additional European Phase II Trial Data for FM-VP4 Monday April 19, 8:01 am ET Results Demonstrate Dose Response and Continued LDL Lowering Through Trial Duration VANCOUVER, British Columbia--(BUSINESS WIRE)--April 19, 2004-- Forbes Medi-Tech Inc. (NASDAQ:FMTI - News; TSX:FMI - News) today announced, further to the Company`s April 5th news release and conference call, details from the additional data recently received from the European Phase II clinical trial of its cholesterol-lowering compound, FM-VP4. During the study and as previously indicated, FM-VP4 demonstrated a dose-response that was statistically significant, as shown in Table 1. The data suggests that 400 mg/day may be the optimal dose, although further studies are required to confirm a plateau. -0- Table 1: Dose-Response of FM-VP4, Preliminary Phase II Clinical Trial Results -------------------------------------------------------------------- Dose, mg/day Normalized Response(a) p-value -------------------------------------------------------------------- -------------------------------------------------------------------- 800 93% less than 0.011 -------------------------------------------------------------------- 400 100% less than 0.007 -------------------------------------------------------------------- 200 76% less than 0.043 -------------------------------------------------------------------- 100 26% less than 0.47 -------------------------------------------------------------------- (a)Average response for each dose as a percentage of the response at 400 mg. (400mg equals 100%) -------------------------------------------------------------------- Additionally, the time-response to FM-VP4 indicated that LDL cholesterol levels may continue to decrease when given to patients for longer than 4 weeks, the duration of the completed trial, and that optimal efficacy may not have been achieved, as illustrated in Table 2. Table 2: Time-Response of FM-VP4, Preliminary Phase II Clinical Trial Results --------------------------------------------------------------------- Time Normalized Response(b) --------------------------------------------------------------------- --------------------------------------------------------------------- Week 4 100% --------------------------------------------------------------------- Week 3 85% --------------------------------------------------------------------- Week 2 81% --------------------------------------------------------------------- Week 1 52% --------------------------------------------------------------------- (b)Average response for doses 200 to 800mg/day as a percentage of the total response at 4 weeks. --------------------------------------------------------------------- An evaluation of preclinical animal data in comparison to these Phase II results has also indicated the need to examine the effects of timing of FM-VP4 with respect to food intake on the drug`s efficacy. "This additional data further supports our decision to move forward as planned with our US Phase II trial," said Charles Butt, President & CEO of Forbes Medi-Tech Inc. "These results provide guidance towards designing our US Phase II trial parameters in parallel with filing an IND." In addition to identifying trial duration and food-effects as areas for optimization, it has been noted that a patient population with lower triglyceride levels may be more appropriate for measuring the full potential efficacy of a cholesterol absorption inhibitor, a consideration that will be incorporated into the future clinical plan of FM-VP4. Note that all data presented in this news release is preliminary data and subject to change. The complete European Phase II trial report is anticipated in June 2004. Das mag ja statistisch signifikant sein, das Hauptproblem ist bis jetzt aber die geringe Reduktion des LDLs verglichen mit Statinen, von denen es einige bereits schon als Generika gibt. |
|
| aus der Diskussion: | -53% -->> da konnte ich nicht wiederstehen.... |
| Autor (Datum des Eintrages): | puhvogel (19.04.04 15:38:23) |
| Beitrag: | 16 von 16 (ID:12790352) |
| Alle Angaben ohne Gewähr © wallstreetONLINE | |