Anticancer Programs

Satraplatin

Satraplatin, an investigational drug, is a member of the platinum family of compounds. Platinum-based drugs are a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. All platinum drugs currently on the market require intravenous administration. Satraplatin is an oral compound that clinical trial patients are able to take at home. Satraplatin is being studied in several cancer types and combinations. In clinical trials conducted by GPC Biotech and others, satraplatin has shown activity in prostate, lung and ovarian cancer.

SPARC Phase 3 Registrational Trial

Phase 1 and Phase 2 Clinical Trials

SPARC Phase 3 Registrational Trial in 2nd-Line Hormone Refractory Prostate Cancer - Completed
 
The SPARC (Satraplatin and Prednisone Against Refractory Cancer) trial evaluated satraplatin plus prednisone versus placebo plus prednisone in 950 patients with hormone-refractory prostate cancer (HRPC) that had progressed after initial chemotherapy.

Data announced in the fall of 2006 showed a statistically significant improvement in progression-free survival.  Based on these results, the Company submitted a New Drug Application (NDA) for satraplatin in the U.S. and requested accelerated approval. That submission was accepted by the U.S. Food and Drug Administration (FDA) and granted priority review status.

In July 2007 GPC Biotech withdrew the satraplatin NDA after the Oncologic Drugs Advisory Committee (ODAC) for the FDA recommended that the FDA should wait for the final survival analysis of the SPARC trial before deciding whether the satraplatin application was approvable. In October 2007 the Company announced that the trial did not achieve the endpoint of overall survival.

In June 2008 the overall survival results from the double-blind, randomized satraplatin Phase 3 SPARC trial were presented at the 44th Annual Meeting of the American Society for Clinical Oncology (ASCO) in Chicago. 

While data presented previously showed a statistically significant improvement in the progression-free survival endpoint, the trial did not achieve the endpoint of overall survival (p=0.80, log rank analysis) for the intent-to-treat (ITT) population.  The median was 61.3 weeks for the satraplatin arm compared to 61.4 weeks for the control group, and the hazard ratio, stratified by the pre-specified randomization factors[1], was 0.98 (95% CI: 0.84, 1.15).  The median in the patient group previously treated with docetaxel (Taxotere®) was 66.1 weeks for the satraplatin arm compared to 62.9 weeks for the control arm.  The stratified hazard ratio was 0.91 (95% CI: 0.72, 1.14). 

For further details please click the following link to the respective press release issued on June 2, 2008:

Data from Satraplatin SPARC Phase 3 Trial in Patients with Hormone-Refractory Prostate Cancer Progressing after Initial Chemotherapy Presented at 44th ASCO Annual Meeting

In July 2008, Celgene Corporate withdrew the Marketing Authorization Application (MAA) for satraplatin in Europe. The MAA had been submitted for satraplatin plus prednisone for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy had failed. Following the withdrawal of the MAA, in early August 2008, GPC Biotech received notice from Celgene of its decision to terminate the co-development and license agreement with GPC Biotech for satraplatin in Europe, Turkey, the Middle East, Australia and New Zealand. All rights to these territories will be returned to GPC Biotech.

GPC Biotech plans to decide in the near future the next steps regarding the development of satraplatin.

Phase 1 and Phase 2 Clinical Trials
 
GPC Biotech has conducted or has underway several clinical trials with satraplatin.  These include Phase 1 trials in combination with radiation therapy, with Taxotere® (docetaxel), with Xeloda® (capecitabine) and with Gemzar® (gemcitabine), widely used anticancer treatments.  Phase 2 studies with satraplatin conducted by GPC Biotech or others have been completed in prostate, ovarian and lung cancer.  Data from several satraplatin trials were presented at the ASCO Annual Meeting in June 2008.

For details please click the following link to the respective press release issued on June 2, 2008:

In June 2008, GPC Biotech announced the initiation of a Phase 2 study evaluating satraplatin in combination with prednisone in patients with metastatic HRPC who previously have been treated with docetaxel. The study seeks to determine if the presence of a certain gene impacts patient outcome. The study is being sponsored by the U.S. National Cancer Institute (NCI).

For further details please click the following link to the respective press release issued on June 24, 2008:

For more information on clinical trials involving satraplatin, please go to www.clinicaltrials.gov.

 

1 The three pre-specified randomization factors for the SPARC trial were:  1) performance status at study entry, 2) present pain intensity at study entry, and 3) type of disease progression on first line therapy (PSA or symptomatic).

Gemzar® (gemcitabine) is a registered trademark of Eli Lilly and Company.

Taxotere® (docetaxel) is a registered trademark of Aventis Pharma S.A.

Xeloda® (capecitabine) is a registered trademark of Hoffmann-La Roche AG.