GPC Biotech AG has completed the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for satraplatin for the treatment of patients with androgen independent (hormone refractory) prostate cancer (HRPC) who have failed prior chemotherapy.
The company submitted the third and final portion of the NDA - the clinical section, which is based primarily on data from the SPARC phase 3 registrational trial. The trial enrolled 950 patients and showed highly statistically significant results for prolonging progression-free survival (PFS). The FDA has up to 60 days to determine whether the application meets the regulatory requirements for filing and thus will be reviewed by the agency. The company will also be notified during that timeframe if priority review status has been granted.
"The submission of the NDA for satraplatin capsules is a major milestone in the corporate history of GPC Biotech," said Bernd R. Seizinger, M.D., Ph.D., chief executive officer. "We will work closely with the FDA during the review process to move the application forward as expeditiously as possible. We believe that, if approved, satraplatin has the potential to become an important new treatment option for advanced prostate cancer patients who today have very little hope. We are currently building our commercial infrastructure in the US to prepare for the potential launch of satraplatin so that it will be available for these patients as quickly as possible."
Prostate cancer is the most common cancer among men in the U.S. and Europe. Approximately 219,000 men in the US are expected to be diagnosed with the disease in 2007 and over 27,000 men are expected to die from the disease. In the European Union, over 200,000 new cases are expected to be diagnosed, and over 60,000 patients are expected to die each year. Since the incidence of prostate cancer increases with age, the aging of the overall population is expected to further increase the number of prostate cancer patients.
Most patients diagnosed with prostate cancer initially receive surgery or radiation therapy, and some of these patients are cured. For many others, though, the disease recurs. At this point, the recurrent disease is treated with hormone therapy, and most patients initially respond well to this treatment. Eventually, however, the tumour cells become resistant to the hormones - or "hormone-refractory" - and the tumour again progresses. Increasingly, chemotherapy is being used as an effective first-line treatment for hormone-refractory prostate cancer. However, it is not a cure, and so this is creating a need for effective therapeutic options for these patients once they have progressed.
Satraplatin, an investigational drug, 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 bioavailable compound and is given as capsules that patients can take at home.
In September 2006, GPC Biotech announced positive topline results from the double-blinded, randomized satraplatin Phase 3 registrational trial, the SPARC trial (Satraplatin and Prednisone Against Refractory Cancer). The trial is evaluating satraplatin plus prednisone versus placebo plus prednisone as a second-line treatment in 950 patients with hormone-refractory prostate cancer. The study data show that the results for PFS are highly statistically significant (p<0.00001) using the protocol-specified log-rank test. PFS is the primary endpoint for submission for accelerated approval in the U.S. and will also serve as the primary basis for a Marketing Authorization Application (MAA) in Europe. The Company has a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, under which Pharmion has been granted exclusive commercialization rights to satraplatin for Europe and certain other territories.
The most common adverse reactions in the SPARC trial consisted of myelosuppression (bone marrow functions, such as lowered platelet count or lowered white blood cell count); gastrointestinal events, such as nausea, constipation and diarrhea; and fatigue. These adverse reactions were mostly mild to moderate in severity. No significant degradation of renal function or worsening of neuropathy was noted.
Satraplatin has been studied in clinical trials involving a range of tumoUrs. Trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in a number of cancer types are underway or planned. GPC Biotech in-licensed satraplatin from Spectrum Pharmaceuticals, Inc. in 2002.
GPC Biotech AG is a publicly traded biopharmaceutical company focused on discovering, developing and commercializing new anticancer drugs. GPC Biotech's lead product candidate - satraplatin - is an oral platinum-based compound that has shown highly statistically significant results for progression-free survival in a phase 3 registrational trial as a second-line chemotherapy treatment in hormone-refractory prostate cancer.