PC-DAC(TM)：Exendin-4 药物进行临床I/II 期多剂量测试

生物谷

ConjuChem Biotechnologies Inc. (蒙特娄，Montreal)宣布PC-DAC(TM):Exendin-4 药物进行糖尿病第二型的临床第 I/II 期多剂量测试中，公司已取得正面的初步成果，证明药物耐受性高，而且当以每周一次使用频率时﹔测试中每一种测试剂量均可以降低血糖。

测量平均空腹血糖(fasting plasma glucose，FPG)时，各用药组为期五周的平均空腹血糖浓度下降数据（开始用药后第一天和第七天），无论是和血中基本浓度相较，或是和使用安慰剂组相较，都可以看到具有明显的统计学意义。

在1 mg, 2 mg和 3 mg三种用药剂量中，得到的数字分别如下，-9% (baseline 154 mg/dL)， -11% (baseline 172 mg/dL)以及 -7% (baseline 170 mg/dL)，而使用安慰剂的这一组数据为-1% (baseline 158 mg/dL)。

平均空腹血糖浓度下降的数据具有明显的统计学意义，各用药组的p值均已小于0.005。和使用安慰剂组相较时的统计学意义上，在1 mg, 2 mg两种用药剂量中＞p值均已小于0.005，不过3 mg组的p值小于0.03。http://www.conjuchem.com

英文原文：

Life Sciences News Brief
Vol.7 no.5 Apr. 5，2007

PC-DAC(TM):Exendin-4 Phase I/II Multiple-Dose Study

ConjuChem Biotechnologies Inc. (Montreal) 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. 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). http://www.conjuchem.com