Adventrx says patient recruitment past halfway point in trial of CoFactor for cancer

By Lisa Kerner

Erie, Pa., Feb. 14 - Adventrx Pharmaceuticals, Inc. said patient recruitment has surpassed the halfway point in the CoFactor multi-national phase 2b clinical trial for metastatic colorectal cancer, which began in May 2005.

Adventrx made the announcement at the BIO CEO conference in New York. The company also announced plans for its proposed phase 3 clinical studies for CoFactor (ANX-510), a folate-based biomodulator being developed to enhance the activity and to reduce the toxicity of the chemotherapy drug, 5-fluorouracil (5-FU).

The phase 2b study will evaluate CoFactor in the first-line treatment of 300 patients with metastatic colorectal cancer, according to company news release. Patients are being randomized to one of two arms containing either CoFactor or leucovorin, each in combination with 5-FU. The company will assess tumors every eight weeks, as well as the secondary endpoints of response rate, time to tumor progression and survival. The study, conducted at sites in Europe and India, is led by professor James Cassidy at the University of Glasgow in Glasgow, Scotland.

The first phase 3 clinical trial in patients treated first line for metastatic colorectal cancer is planned to be a 1,200-patient, randomized parallel group trial, Adventrx said. The study is designed to detect an improvement of 28 days in progression-free survival with secondary endpoints including response rate, duration of response, overall survival and incidence and severity of adverse events. The study, with dosing scheduled to being in the first quarter of this year, is being led by M. Wasif Saif, MD, of the Yale University School of Medicine.

The proposed second phase 3 clinical trial would be a randomized parallel group trial in 450 patients with advanced breast cancer who have completed taxane and doxorubicin treatment. Primary endpoints would be progression-free survival and overall survival with secondary endpoints of response rate and severity of adverse events. This trial is pending clearance regarding the clinical design from the Food and Drug Administration.

"CoFactor appears to offer a less toxic alternative to leucovorin with improved pharmacodynamics and antitumor activity in combination with 5-FU. The planned studies are designed to definitively establish these attributes in multiple clinical settings," James A. Merritt, MD, chief medical adviser for Adventrx, said in the release.

Adventrx is a San Diego-based biopharmaceutical research and development company focused on introducing new technologies for anticancer and antiviral treatments.

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