( - One Month Study in Seventy Type 2 Dia...)PC-DAC:Exendin-4 Phase I/II Multiple-Dose Study Preliminary Results,,,Demonstrate Safety and Efficacy at Once-Weekly Dosing,Health

MONTREAL, March 26 /CNW/ - ConjuChem Biotechnologies Inc. (TSX:CJB) today announced positive preliminary results from its Phase I/II multiple-dose clinical study for the treatment of Type 2 diabetes using the Company's proprietary PC-DAC(TM):Exendin-4. Results from the study demonstrated that PC-DAC(TM):Exendin-4 was generally well tolerated and, when administered once-weekly at each of the dosing levels tested, lowered blood glucose.

The Phase I/II trial, a randomized, double-blind, multiple-dose study, evaluated safety and tolerability of PC-DAC(TM):Exendin-4 in patients with stable Type 2 diabetes. Pharmacokinetic and pharmacodynamic parameters were also evaluated. All patients were on stable doses of metformin with HbA1c levels between 7.0% and 10.6%. The trial enrolled 70 patients at 7 centers in the U.S. and Canada with patients randomized to one of four parallel treatment groups: 1 mg (n=18), 2 mg (n=17), 3 mg (n=17) or placebo (n=18). Sixty-nine patients received 5 doses over a one month period. The product is a highly soluble liquid formulation injected with a 30 gauge needle.

Reductions in mean fasting plasma glucose (FPG) were statistically significant in all treatment groups versus baseline and placebo over the five-week treatment period (FPG was measured Days 1 and 7 post-dosing). The average reductions from baseline values for the 1 mg, 2 mg, and 3 mg treatment arms were -9% (baseline 154 mg/dL), -11% (baseline 172 mg/dL), and -7% (baseline 170 mg/dL), respectively, versus -1% (baseline 158 mg/dL) in the placebo group. The reductions were statistically significant versus baseline (p(less than)0.005 for all cohorts) and versus placebo (p(less than)0.005 for 1mg and 2 mg cohorts, p(less than)0.03 for the 3 mg cohort).

HbA1c improved in all three treatment groups wi
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