Healthcare Industry News: Vidaza
News Release - April 25, 2006
Independent Data Monitoring Board Recommends That Satraplatin Phase 3 Trial Continue as PlannedData Monitoring Board Reports Design and Conduct of Trial Remain Sound
SPARC Trial Passes Futility Analysis
Full Progression Free Survival Data Expected in Fall 2006
Pharmion's Projected EMEA Filing for Satraplatin Remains on Track for Q107
BOULDER, Colo., April 25 (HSMN NewsFeed) -- Pharmion Corporation (Nasdaq: PHRM ) today announced that the independent Data Monitoring Board (DMB) for GPC Biotech's satraplatin Phase 3 registrational trial SPARC (Satraplatin and Prednisone Against Refractory Cancer) in second-line chemotherapy for hormone-refractory prostate cancer has held its planned meeting to review interim safety and efficacy data from the study. As expected, the DMB recommended that the trial should continue to completion.
The DMB analyzed the efficacy data as assessed by the blinded independent progression review panel on the first 354 progression-free survival (PFS) events and also reviewed the safety data from the first 593 patients who had been randomized in the trial and had completed at least one cycle of treatment. After reviewing the data, the DMB reported that the design and conduct of the trial remained sound. In addition, the DMB determined that the SPARC trial had also passed the pre-defined futility analysis. The SPARC trial, therefore, continues to completion and GPC Biotech and Pharmion remain blinded to the study data.
Pharmion licensed the European and other international marketing rights to satraplatin from GPC Biotech in December 2005.
"We are pleased with the progress of the SPARC trial and the recommendation of the independent DMB to continue this study," said Patrick J. Mahaffy, Pharmion's president and chief executive officer. "We are on track to see results from this study by this fall, and if the results are positive, we are planning to file a marketing authorization application early next year."
About the Data Monitoring Board
The Data Monitoring Board consists of independent oncology and statistical experts whose primary responsibility is to monitor, on a periodic basis, the data from the SPARC trial and to provide recommendations to GPC Biotech on whether the study should proceed as originally planned, be modified or be discontinued. Members of the Data Monitoring Board are independent from GPC Biotech and also do not participate as clinical investigators in the SPARC trial.
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 December 2005, GPC Biotech completed accrual to the SPARC trial and initiated the rolling submission of a New Drug Application (NDA) for satraplatin with the U.S. Food and Drug Administration (FDA). Also in December 2005, GPC Biotech signed a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, 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 HRPC, 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 in-licensed satraplatin from Spectrum Pharmaceuticals, Inc. in 2002. Additional information on satraplatin can be found in the Anticancer Programs section of the Company's Web site at www.gpc-biotech.com.
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®, 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.
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