( th median HbA1cdecreasing 0.5% 0.8%...)PC-DAC:Exendin-4 Phase I/II Multiple-Dose Study Preliminary Results,,,Demonstrate Safety and Efficacy at Once-Weekly Dosing,Health

th median HbA1c decreasing 0.5%, 0.8%, and 0.6% in the 1 mg, 2 mg, and 3 mg groups at the end of the five-week period, decreasing 0.7%, 0.6%, and 0.7% at day 49, and decreasing 0.7%, 0.8%, and 0.9% at the end of the study period (day 63) versus baseline. The placebo group declined 0.35% at five weeks, 0.3% at day 49, and 0.2% at the end of the study period. The reduction for the pooled treatment groups was statistically significant versus placebo at day 49 and at the end of the study period (p(less than)0.03, ANCOVA).

There was no statistically significant effect on weight in the treatment cohorts versus baseline or placebo at the end of the 35-day treatment period.

The drug was generally well tolerated. The most common side effects during treatment included headache occurring in 3 out of 18 placebo patients (17%) and 15 out of 52 treated patients (29%) and nausea which was reported in 3 out of 18 placebo patients (17%) and 11 out of 52 treated patients (21%). There were no cases of drug-related vomiting in either the 1 mg or 2 mg cohorts; vomiting occurred in 5 patients in the 3 mg cohort, none of which led to patient drop-out. There were no skin reactions in the 2 mg and 3mg treatment groups; skin reactions were reported in 4 placebo patients and 1 patient in the 1mg cohort. Generally low-level antibodies were detected in 11 out of 52 treated patients (21%). There were no drug-related serious adverse events during the study. Commenting on these preliminary results, Thomas Ulich, M.D., ConjuChem's Executive Vice President of Research and Development, stated: "These encouraging results provide evidence that long-term once-weekly administration of PC-DAC(TM):Exendin-4 can be therapeutically useful for control of glycemia in patients with Type 2 diabetes. In particular, the study demonstrated that treatment with 2 mg of PC-DAC(TM):Exendin-4 was very well tolerated and effective in lowering blo
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