GPC Biotech has announced that it has submitted the next section of a New Drug Application (NDA) for satraplatin in combination with prednisone as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer.

It has handed the non-clinical section of the rolling submission to the US Food and Drug Administration (FDA).

The company has already submitted the chemistry, manufacturing and controls section of the NDA in December and anticipates completing the submission by the end of the year.

"The non-clinical section is the second of three parts necessary to complete the NDA submission," said Bernd Seizinger, chief executive of the firm.

He added that he was "very pleased" in the platinum-based drug's journey to the market.

The FDA granted "fast track" designation to satraplatin as a second-line chemotherapy treatment for patients with HRPC in September 2003.

That status is granted to drugs that fill an unmet medical need or new treatments in order to bring them to patients sooner.

Satraplatin is a member of the platinum family of compounds.

Over the past two decades, platinum-based drugs have become a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers.

Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally-taken treatment, meaning patients can take it at home.

Ÿ Adfero Ltd