GPC Biotech, Pharmion, Spectrum say new satraplatin clinical data shows cancer drug well-tolerated

By E. Janene Geiss

Philadelphia, June 6 - GPC Biotech AG, Pharmion Corp. and Spectrum Pharmaceuticals Inc. said Tuesday that new clinical data on their lead drug candidate, satraplatin, currently in a fully enrolled phase 3 trial, shows the drug is well-tolerated in patients with mild to moderate liver impairment.

In a phase 1 trial in patients with refractory non-hematologic cancer, 19 patients with advanced solid tumors and with varying degrees of hepatic impairment were studied, according to a company news release.

The study was designed to show the effect of hepatic impairment on the pharmacokinetics of satraplatin in patients with advanced forms of cancer. Most patients in the study were heavily pre-treated.

As this study is still ongoing, the data reported are considered preliminary, officials said.

Satraplatin appears to be well-tolerated in patients with mild to moderate liver impairment. As expected, the main toxicities observed thus far have been hematologic - anemia, thrombocytopenia (decrease in platelets in the blood) and neutropenia (decrease in white blood cells).

Non-hematologic toxicities like diarrhea, anorexia and fatigue have been mild. No significant cardio-, liver or neurological toxicities have yet been observed, officials said.

The data was presented in a poster at the annual meeting of the American Society of Clinical Oncology in Atlanta.

A second poster entitled, "Phase 1 Study of the Effects of Renal Impairment on the Pharmacokinetics and Safety of Satraplatin in Patients with Refractory Non-Hematologic Cancer," presented study data on 24 patients with advanced solid tumors and with varying degrees of renal impairment.

The study was designed to show the effect of renal impairment on the pharmacokinetics of satraplatin in patients with advanced forms of cancer. The data in this study also are considered preliminary.

Again, satraplatin appears to be well-tolerated in these patients. As expected, the main hematological toxicities observed to date have been anemia and thrombocytopenia.

As patients with advanced cancer may often have limited function of the liver and/or kidneys, it is important to understand how these impairments affect how a drug is used by the body.

Officials said the results of these two studies should help clinicians understand the tolerability and appropriate dosing of satraplatin in cancer patients whose liver or kidney function are compromised.

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. Satraplatin is an orally bioavailable compound and is given as capsules that patients can take at home.

In December 2005, GPC Biotech 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 started the rolling submission of a New Drug Application for satraplatin with the Food and Drug Administration and GPC Biotech signed a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corp., under which Pharmion was 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.

GPC Biotech said it in-licensed satraplatin from Spectrum Pharmaceuticals in 2002.

GPC Biotech is a Munich, Germany, biopharmaceutical company.

Pharmion is a Boulder, Colo., biotechnology company focused on treatment for hematology and oncology patients.

Spectrum is a specialty pharmaceutical company based in Irvine, Calif.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.