Enrollment commences in ConjuChem's CJC-1134-PC Phase 2 trial for Type 2 diabetes

Sep 15 2011

ConjuChem, LLC, a biotechnology company dedicated to the discovery of novel therapeutics, today announced it has initiated patient enrollment for its Phase 2 clinical trial of its proprietary GLP-1 receptor agonist drug, CJC-1134-PC, in patients with Type 2 diabetes mellitus who are receiving metformin monotherapy. Metformin therapy is a currently used therapeutic option for Type 2 diabetes mellitus in overweight or obese patients.

The randomized, double-blind, placebo-controlled trial will be conducted at approximately 45 study sites throughout the United States and Canada. The dose-ranging study will include up to 225 patients and will seek to evaluate the safety and efficacy of weekly injections of CJC-1134-PC for 17 weeks. The pharmacokinetic and pharmacodynamic relationship of CJC-1134-PC and glycosylated hemoglobin (HbA_1c) and/or fasting plasma glucose (FPG) will be evaluated. Results of the Phase 2 study will be used to establish the optimal dose for future planned Phase 3 studies.

"We are very excited about the possibilities for CJC-1134-PC as a treatment option for Type 2 diabetes," said ConjuChem CEO Patrick Soon-Shiong, M.D. "Positive results from this study will be a vital step in the fight against diabetes, a disease that afflicts more than 366 million people worldwide and causes 4.6 million deaths every year, according to the International Diabetes Federation (IDF)."

The latest IDF figures, unveiled Tuesday at the European Association for the Study of Diabetes (EASD) congress in Lisbon, estimated that health systems spend $465 billion annually fighting the disease, which includes both Type 1 and Type 2 diabetes.

Two previous Phase 2 randomized, double-blind, multiple dose clinical trials conducted in 2008 with CJC-1134-PC revealed positive results for glycemic control and weight loss in Type 2 diabetes patients. "The data from previous studies have been very promising, demonstrating the positive tolerability profile and initial efficacy, as assessed by the reduction of hemoglobin following a once per week dosing," said Soon-Shiong. "The entire ConjuChem team and those associated with the project are encouraged about the potential for CJC-1134-PC to improve the lives of those suffering with Type 2 diabetes."

Formerly ConjuChem Biotechnologies Inc. of Montreal, Canada, the privately held ConjuChem, LLC is now based in Los Angeles. Along with CJC-1134-PC currently in clinical development, ConjuChem's additional product candidates include a long-lasting insulin derivative and a fusion inhibitor compound for the treatment of HIV.