Adventrx delays dosing in phase 3 CoFactor trial to await FDA response to request for protocol changes

By E. Janene Geiss

Philadelphia, March 17 - Adventrx Pharmaceuticals, Inc. said Friday that is has delayed the start of its phase 3 clinical trial using CoFactor as the first line of treatment for metastatic colorectal cancer in order to wait for a response from the Food and Drug Administration about protocol adjustments.

The company previously planned to begin patient dosing for the trial in the first quarter of this year, but after extensive consultations with oncologists, Adventrx requested certain adjustments to the special protocol assessment to optimize the trial, including increasing the trial size to 1,200 patients, according to a company news release.

The company said it anticipates patient dosing to begin in the second quarter.

Adventrx is a San Diego biopharmaceutical research and development company focused on introducing new technologies for anticancer and antiviral treatments that address problems such as drug metabolism, toxicity, bioavailability and resistance.

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