GPC, Pharmion announce new data that shows satraplatin effective in prostate cancer patients

By E. Janene Geiss

Philadelphia, Feb. 27 - GPC Biotech AG and Pharmion Corp. said Monday that new clinical and preclinical data shows its lead drug candidate, satraplatin, produces anticancer activity and is well-tolerated in prostate cancer patients.

These results were presented this weekend in two posters at the ASCO Prostate Cancer Symposium in San Francisco.

A study involving 17 heavily pretreated patients with advanced solid tumors showed satraplatin was well tolerated, with no significant cardio-, renal, liver or neurological toxicities observed, according to a company news release.

Other common toxicities like nausea, vomiting and diarrhea were mild-to-moderate and were reported to be controlled with prophylactic oral anti-emetic therapy.

Seven patients in the study had hormone-refractory prostate cancer and all of the patients had received Taxotere (docetaxel) with a median of three prior chemotherapy regimens.

Satraplatin showed evidence of antitumor activity in this group: one patient had a partial response and two patients had prolonged stable disease for durations of 3.5 and 5 months, officials said.

The study was designed to evaluate the effect of food on the bioavailability of satraplatin. Such data are useful in determining the best way for patients to take an oral drug. In this study, the peak plasma concentrations of satraplatin were decreased by about 20% following a high fat meal; however, the total amount of drug absorbed was not affected by food, officials said.

The clinical implications of the reduced peak drug concentrations in the face of equivalent total amounts of drug absorbed in patients taking satraplatin following a high fat meal are not known, officials said.

A second presentation reviewed the preclinical results of studies evaluating the cell-killing effect of satraplatin and its metabolite on prostate cancer cells.

In vivo and in vitro data showed that satraplatin and its active metabolite, JM-118, inhibited the growth of prostate cancer cells in a dose-dependent fashion. In addition, when satraplatin or JM-118 was combined in vitro with Taxotere, a synergistic effect was demonstrated in prostate cancer cells. This synergistic effect was strongest when Taxotere was followed by JM-118, officials said.

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, officials said.

An oral platinum drug could offer key advantages, including ease of administration and patient convenience, in a variety of applications.

GPC said it has completed patient enrollment in a phase 3 registrational trial that is assessing the safety and efficacy of satraplatin in combination with prednisone as second-line chemotherapy in patients with prostate cancer.

In December, the company said it began the rolling submission of a New Drug Application with the Food and Drug Administration.

Also in December, GPC signed a co-development and licensing agreement with Pharmion for 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 prostate cancer, ovarian cancer and small cell lung cancer. Other trials evaluated the effects of adding satraplatin to radiation therapy, a clinical application in which satraplatin's oral bioavailability could be particularly advantageous.

A phase 1/ 2 trial evaluating this combination in patients with non-small cell lung cancer has been initiated, officials said.

Several other phase 1 and 2 studies evaluating satraplatin in combination with other therapies and in various cancers are underway or planned.

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

Pharmion is a Boulder, Colo., pharmaceutical company focused on acquiring, developing and commercializing innovative products for the treatment of hematology and oncology patients in the United States, Europe and additional international markets.

GPC is a Munich, Germany, biopharmaceutical company discovering and developing new anticancer drugs.

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