PONIARD TO BEGIN TRIAL OF ORAL PLATINUM THERAPY

Poniard Pharmaceuticals has filed an investigational new drug application with the FDA for an oral formulation of picoplatin. Following FDA review, the company intends to initiate a Phase I clinical trial of oral picoplatin.

Picoplatin is a new-generation platinum therapy with an improved safety profile, according to the company. It is designed to overcome and prevent platinum resistance associated with chemotherapy in solid tumors.

In preclinical studies, picoplatin has been shown to have up to 40 percent oral bioavailability and a higher therapeutic index and better efficacy against platinum-sensitive and resistant tumor variants than currently marketed platinum-based therapeutics.

"We believe that oral picoplatin has significant potential for use in combination with other oral chemotherapies and targeted therapies, including in a refractory setting following relapse from first-line therapies, due to its convenience and potential to overcome platinum resistance," Jerry McMahon, chairman, president and CEO of Poniard, said.

Poniard is currently evaluating intravenous picoplatin in an ongoing Phase II clinical trial in small-cell lung cancer and in Phase I/II clinical trials in colorectal and hormone-refractory prostate cancers.

The company also plans to initiate the pivotal Phase III SPEAR trial of intravenous picoplatin for small-cell lung cancer in the first half of 2007. Poniard received FDA orphan drug designation for picoplatin for the treatment of small-cell lung cancer and entered into a special protocol assessment agreement with the FDA for the SPEAR trial.