- Phase II PC-DAC(TM):Exendin-4 Data in December -
- PC-Insulin Preclinical Study Results -
MONTREAL, Nov. 5 /PRNewswire-FirstCall/ - ConjuChem Biotechnologies Inc. (TSX:CJB) announced today that dosing is complete for its Phase II clinical trial of PC-DAC(TM):Exendin-4. This Phase II trial was a randomized, double-blind, placebo-controlled, multiple dose study that evaluated the efficacy and safety of three months of weekly injections of PC-DAC(TM):Exendin-4 in patients with Type 2 diabetes not adequately controlled by metformin monotherapy. The trial enrolled approximately 120 evaluable patients randomized to one of three parallel treatment groups: a 1.5mg fixed-dose weekly cohort; a 1.5mg weekly dose titrating to 2mg at the 5th week cohort; and a placebo group. Top line data from the trial will be announced in December, 2008.
The Company also announced the results of a preclinical study evaluating the pharmacodynamics of its PC-Insulin versus Lantus(R) (insulin glargine (rDNA) injection) after repeated daily subcutaneous administration in streptozotocin-induced diabetic rats. A similar reduction in blood glucose was observed with both compounds at 2, 6, and 8 hours after each dose but glucose levels at 24 hours were only normalized in animals treated with PC-Insulin. In addition to a superior control of blood glucose, PC-Insulin was more effective in normalizing physiologic parameters such as water intake in the diabetic rats.
Commenting on the progress of the PC-Insulin program, Dr. Thomas Ulich, Executive Vice president, stated, "We are very encouraged with the emerging profile of PC-Insulin and believe it can achieve our objective of a more peakless basal insulin with a longer duration of activity." Results of this study will be submitted for the 2009 American Diabetes Association meeting. The Company plans to submit an IND in mid-2009.
Exendin-4, like Glucagon-like peptide-1 (G
|SOURCE ConjuChem Biotechnologies Inc.|
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