Maxim Announces Results From Phase 2 Clinical Study of Ceplene in the Treatment of Advanced Kidney Cancer.
Business Editors and Health/Medical Writers
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SAN DIEGO--(BW HealthWire)--May 22, 2002
Ceplene Study Results Presented at American Society
of Clinical Oncology Meeting
Maxim Pharmaceuticals Inc. (Nasdaq\NM:MAXM)(SSE:MAXM) announced at the 38th meeting of the American Society of Clinical Oncology (ASCO) results from a controlled Phase 2 trial of its lead drug candidate Ceplene(TM) in combination with interleukin-2 (IL-2) for the treatment of metastatic renal cell carcinoma, a deadly cancer of the kidneys.
In the 41-patient Phase 2 study, advanced metastatic renal cell carcinoma patients were treated with a combination of Ceplene and IL-2, while patients in the control group were treated with the same dose of IL-2 alone. For the group of patients treated with the Ceplene/IL-2 combination, 42 percent achieved a partial response or disease stabilization compared to 26 percent for the group treated with IL-2 alone. Patients treated with the Ceplene/IL-2 combination achieved a median response duration of 11.7 months compared to 7.3 months for the patients treated with IL-2 alone.
The study was led by Dr. Mark R. Middleton, Christie Hospital NHS Trust, Manchester, England. In addition to the response results, the researchers also reported that Ceplene did not significantly affect the toxicity profile of IL-2 in this study. There are approximately 30,800 new cases annually of renal cell carcinoma in the United States. Metastatic renal cell carcinoma often is resistant to radiation therapy and chemotherapy, and the disease results in more than 12,100 deaths each year.
A second study of Ceplene in renal cell carcinoma was the subject of a presentation at the ASCO conference. Dr. Frede Donskov, Department of Oncology, Aarhus University Hospital and Institute of Medical Microbiology and Immunology, University of Aarhus, Aarhus, Denmark presented research entitled "Association of Intratumoral and Peripheral Blood Lymphocyte Subsets to Objective Response and Survival in Patients with Metastatic Renal Cell Carcinoma (mRCC) Undergoing Interleukin-2 based Immunotherapy." This study provides novel in vivo evidence of the possible contribution of lymphocyte subsets, specifically Natural Killer (NK) and cytotoxic T cells, to tumor reduction seen in responding patients during immunotherapy with the Ceplene/IL-2 combination. The two renal cell studies were among the five studies of Ceplene presented by researchers this week or accepted as abstracts at the ASCO meeting in Orlando, Florida.
