Data Safety Monitoring Board approves continuation of Adventrx phase 2b CoFactor trial in cancer

By Lisa Kerner

Charlotte, N.C., June 26 - Adventrx Pharmaceuticals, Inc. said the independent Data Safety Monitoring Board completed a planned interim analysis of safety and efficacy data from 150 patients in the company's phase 2b clinical trial of CoFactor in colorectal cancer.

The board has recommended that the multi-center, randomized study continue without any modifications. Currently 250 of the total planned 300 patients have been enrolled.

"We are enthusiastic about comparing CoFactor against leucovorin as a 5-FU biomodulator in first line treatment of metastatic colorectal cancer," chief medical adviser James A. Merritt said in a company news release.

"The trial is progressing as planned and has recruited over 80% of the total patient number expected."

CoFactor is designed to enhance the activity and reduce toxicity of the cancer chemotherapeutic agent 5-fluorouracil (5-FU).

The Food and Drug Administration has cleared CoFactor for a phase 3 pivotal clinical trial for metastatic colorectal cancer slated to begin in the second quarter of this year.

Adventrx is a biopharmaceutical research and development company located in San Diego.

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