Coley Pharmaceutical Group Begins Phase I/II Trial of CpG 7909 in Combination with Herceptin (R) to Treat Breast Cancer
-- First clinical study to evaluate ability of CpG immunomodulators to enhance monoclonal antibody treatments for cancer --
WELLESLEY, Mass., and LANGENFELD, Germany, Oct. 30 /PRNewswire/ -- Coley Pharmaceutical Group, Inc., today announced that it has initiated a Phase I/II clinical trial of its lead product, CpG 7909, in multi-drug therapy with Herceptin (R), Genentech's approved monoclonal antibody product. The Phase I study will determine the safety and tolerability of the multi-drug therapy in patients with refractory metastatic breast cancer. Enrollment will be limited to patients whose disease has progressed despite previous treatment with Herceptin and chemotherapy.
The objective of the trial is to determine a safe dose of CpG 7909 that may be administered with standard doses of Herceptin. Once this is established, the study will proceed with a Phase II trial for a preliminary evaluation of clinical activity of the multi-drug therapy.
``Most physicians today employ a number of different cancer therapies to achieve optimal disease treatment for their patients,'' stated Harold Burstein, M.D., Ph.D., of the Dana-Farber Cancer Institute and Principal Investigator of the study. ``Preclinical studies have demonstrated that CpG 7909 works synergistically with monoclonal antibodies to mediate antibody dependent tumor destruction, providing early evidence to support the promise of this novel approach. I look forward to this opportunity to evaluate a potential new multi-drug therapy regimen, CpG 7909 together with Herceptin, to fight breast cancer in patients who have not responded to existing treatments.''
The Phase I study will evaluate the safety and tolerability of CpG 7909 administered once weekly, 30 minutes post Herceptin infusion (per dosing instructions), in 12 to 24 patients. Patients will be distributed among up to four groups receiving CpG 7909 in a dose escalation plan to assess the maximum tolerated dose (MTD). The MTD group will be expanded to 15 patients during the Phase II study to evaluate preliminary clinical effects. If investigators observe one or more positive clinical responses, 25 additional patients will be enrolled for a total of 40, in the Phase II part of the study.
Dr. Burstein serves as the Principle Investigator for the Phase I/II study being conducted at seven clinical research centers in the U.S., including the Dana-Farber Cancer Institute. Charles Vogel, P.A.C.P., P.A., a Clinical Professor at the University of Miami School of Medicine and Hyman Muss, M.D., of Fletcher Allen Health Care in Burlington, Vermont, have also agreed to participate in the study.
``This study will be the first evaluation in patients of CpG 7909 as part of a multi-drug therapy with monoclonal antibodies,'' stated Robert L. Bratzler, Ph.D., President and Chief Executive Officer of Coley Pharmaceutical Group. ``This initiation of our fifth clinical trial in cancer underscores our commitment to advancing our internal oncology therapeutic pipeline.''
Coley's CpG immunomodulators consist of proprietary synthetic oligonucleotide sequences that induce different immune response profiles, providing the potential to target specific diseases. CpG 7909, Coley's lead product, has previously been studied in animal models as part of a multi-drug regimen with anti-cancer monoclonal antibodies. These preclinical studies showed that the addition of CpG 7909 significantly enhanced efficacy in comparison to treatment with monoclonal antibody alone. The addition of CpG 7909 is thought to improve the therapeutic effect of monoclonal antibodies by:
Upregulating the expression of surface antigens on tumor cells to make tumors more ``visible'' to the immune system
Activating the body's natural killer cells' receptors to increase their ability to target the tumor
Increasing the recruitment of antibodies and natural killer cells to facilitate tumor destruction
Coley is also conducting clinical trials of CpG 7909 as a monotherapy for non-Hodgkin's lymphoma, basal cell carcinoma and melanoma. |
