Access Pharmaceuticals begins phase 2 study of AP5346 for head, neck cancer

By Angela McDaniels

Seattle, Feb. 23 - Access Pharmaceuticals Inc. said it has begun a phase 2 clinical study of AP5346, its DACH platinum polymer therapeutic, for the treatment of head and neck cancer.

According to a company news release, the aim of the study is to demonstrate the ability of the tumor-targeting polymer system to deliver more platinum to tumors than can be attained with oxaliplatin, the currently approved DACH platinum compound.

"The effectiveness of platinum drugs is believed to increase as more platinum is delivered to the DNA of tumor cells," senior vice president of research and development David P. Nowotnik said in the release.

"In preclinical studies, we have demonstrated that AP5346 delivers greater than 10-fold more platinum to the tumor DNA than is achieved by oxaliplatin."

The clinical study is being conducted at the Moores Cancer Center of the University of California, San Diego.

A phase 1 study in Europe demonstrated that AP5346 is well-tolerated, and of 16 patients that could be evaluated, two experienced partial responses and one had stable disease, the company said.

The safety and effectiveness of the drug will also be evaluated in an upcoming phase 2 trial in patients with recurrent, platinum-sensitive ovarian cancer.

Access is a Dallas-based emerging pharmaceutical company that develops polymer-linked cytotoxics for use in the treatment of cancer.

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