BOULDER, Colo., Feb. 27 /PRNewswire-FirstCall/ -- Pharmion Corporation today announced the presentation of new clinical and preclinical data on satraplatin at the ASCO Prostate Cancer Symposium: A Multidisciplinary Approach in San Francisco, California.
A poster entitled, “A Phase I Pharmacokinetic (PK)/Food Effect and Safety Study of Satraplatin,” presented data from a study involving seventeen patients with advanced solid tumors. Most patients in the study were heavily pre-treated: the median number of prior chemotherapy treatments was three. Satraplatin appeared to be well tolerated, with no significant cardio, renal, liver or neurological toxicities observed. 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 (HRPC), and all of the HRPC patients had received Taxotere (docetaxel), with a median of three prior chemotherapy regimens. Satraplatin showed evidence of anti-tumor activity in this group: one patient had a partial response (RECIST criteria), and two patients had prolonged stable disease (durations of 3.5 and five months).
The study was designed to evaluate the effect of food on the bioavailability (i.e., the rate at which the drug is absorbed and the amount of drug absorbed) 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 approximately 20 percent following a high fat meal; however, the total amount of drug absorbed was not affected by food. 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 are not known.
A second poster entitled, “Efficacy of Satraplatin, an Oral Platinum Analogue in Prostate Cancer: Synergistic Activity with Docetaxel,” 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.
About Satraplatin
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. An oral platinum drug could offer key advantages, including ease of administration and patient convenience, in a variety of applications. To date, satraplatin is the only platinum compound that has demonstrated activity in a randomized trial in HRPC.
Patient enrollment is completed for the Phase 3 registrational trial -- the SPARC trial -- which is assessing the safety and efficacy of satraplatin in combination with prednisone as a second-line chemotherapy in patients with HRPC. GPC Biotech has initiated the rolling submission of an NDA with the U.S. Food and Drug Administration (FDA) for satraplatin in combination with prednisone as a second-line chemotherapy treatment for patients with HRPC. Assuming continued progress, GPC Biotech expects to complete the NDA filing in the second half of 2006. Data from the SPARC trial are also expected to form the basis of an MAA in Europe for this indication, and Pharmion expects to submit that application in early 2007.
Satraplatin has been studied in clinical trials involving a range of tumors, and Phase 2 trials have been completed in HRPC, 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 study evaluating this combination in patients with non-small cell lung cancer has been initiated. Several other Phase 1 and 2 studies evaluating satraplatin in combination with other therapies and in various cancers are underway or planned. Pharmion in-licensed satraplatin from GPC Biotech in 2005.
About Pharmion:
Pharmion is a pharmaceutical company focused on acquiring, developing and commercializing innovative products for the treatment of hematology and oncology patients in the U.S., Europe and additional international markets. Pharmion has a number of products on the market including the world’s first approved epigenetic cancer drug, Vidaza(R), a DNA demethylating agent. For additional information about Pharmion, please visit the company’s website at www.pharmion.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Pharmion’s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include the status and timing or regulatory approvals for Pharmion’s product candidates; the impact of competition from other products under development by Pharmion’s competitors; the regulatory environment and changes in the health policies and structure of various countries; acceptance and demand for new pharmaceutical products and new therapies, uncertainties regarding market acceptance of products newly launched, currently being sold or in development; Pharmion’s ability to successfully acquire rights to, develop and commercialize additional pharmaceutical products; failure of third-party manufacturers to produce the product volumes required on a timely basis, fluctuations in currency exchange rates, and other factors that are discussed in Pharmion’s filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made, and Pharmion undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
Pharmion Corporation
CONTACT: Breanna Burkart or Anna Sussman, Directors, Investor Relationsand Corporate Communications, Pharmion Corporation, +1-720-564-9150
Web site: http://www.pharmion.com//
