GPC Biotech submits non-clinical section of rolling NDA for prostate cancer drug satraplatin

By E. Janene Geiss

Philadelphia, July 12 - GPC Biotech AG said Wednesday that the company has submitted the non-clinical section of the rolling submission of a New Drug Application to the Food and Drug Administration for satraplatin in combination with prednisone as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer.

The company submitted the chemistry, manufacturing and controls - or CMC - section of the NDA in December 2005 and anticipates completing the NDA submission by the end of 2006, according to a company news release.

The non-clinical section is the second of three parts necessary to complete the NDA submission, officials said.

GPC said it expects to have the final data on progression-free survival from its Sparc registrational trial in the fall and complete the filing by the end of this year.

The FDA granted fast-track designation to satraplatin as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer in September 2003.

The FDA's fast-track programs are intended to expedite the review of drugs to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

The rolling submission process enables companies that have been granted fast-track designation to submit sections of the application to the agency as they become available, allowing the review process to begin before the complete dossier has been submitted.

Satraplatin, an investigational drug, is a member of the platinum family of compounds. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally bioavailable compound and is given as capsules that patients can take at home.

In December 2005, GPC Biotech said it completed accrual to the Sparc trial that is evaluating satraplatin in combination with prednisone as second-line chemotherapy in patients with hormone refractory prostate cancer.

Also in December 2005, GPC Biotech said it began the rolling submission of an NDA for satraplatin with the FDA.

The company has a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corp., under which Pharmion has been granted exclusive commercialization rights to satraplatin for Europe and certain other territories.

Satraplatin has been studied in clinical trials involving a range of tumors, and phase 2 trials have been completed in hormone-refractory prostate cancer, ovarian cancer and small cell lung cancer.

Other trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in various other cancers are underway or planned, officials said.

The company in-licensed satraplatin from Spectrum Pharmaceuticals, Inc. in 2002.

GPC is a Munich, Germany, biopharmaceutical company.

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