Healthcare Industry News: Vidaza
News Release - October 17, 2007
Pharmion Initiates Pivotal Phase 3 Study of Amrubicin in Small Cell Lung CancerBOULDER, Colo., Oct. 17 (HSMN NewsFeed) -- Pharmion Corporation (Nasdaq: PHRM ) today announced the initiation of an international pivotal Phase 3 clinical trial evaluating amrubicin, the Company's third-generation synthetic anthracycline, in the treatment of second-line small cell lung cancer (SCLC). The randomized, controlled, multi-center study will compare amrubicin to topotecan, the only approved chemotherapy for second-line treatment of SCLC in the US and EU. Enrollment in the study of 480 patients is underway.
Approximately 30,000 patients in the US and 32,000 patients in the EU will be diagnosed with SCLC this year. "The treatment of small cell lung cancer is extremely challenging, given the limited therapeutic options available," said Mark A. Socinski, Associate Professor of Medicine, Multidisciplinary Thoracic Oncology Program, Lineberger Comprehensive Cancer Center, University of North Carolina, and a principal investigator in the Phase 3 study. "Preliminary data suggest that amrubicin could represent a significant improvement in the treatment of small cell lung cancer, for which there have been no major medical advances in more than 20 years."
The study compares amrubicin and topotecan in second-line treatment of SCLC patients with sensitive or refractory disease. Sensitive disease is defined as response to first-line platinum-based therapy, with subsequent progression 90 days or more after completion of therapy. Refractory disease is defined as no objective response or progressive disease within 90 days of completion of therapy. Study participants are randomized in a 2:1 ratio to receive either IV amrubicin (40mg/m2 daily for 3 days) or topotecan (1.5 mg/m2 daily for 5 days), both starting on Day 1 of a 21-day cycle. The primary endpoint of this study is overall survival; the secondary endpoints include progression-free survival, overall response rate, duration of response and quality of life.
Pharmion has completed the Scientific Advice (SA) process with the European Medicines Agency (EMEA) and has reached Special Protocol Assessment (SPA) agreement with the US Food and Drug Administration (FDA) for the amrubicin Phase 3 SCLC study.
Interim findings from a Phase 2, multi-center clinical study of amrubicin in second-line sensitive SCLC patients provided encouraging initial results and informed the design of the pivotal study. These data were presented at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2007. Response data from 24 evaluable patients were analyzed, 15 treated with amrubicin and nine with topotecan. Of the 15 amrubicin-treated patients, 40 percent showed an objective tumor response, including two complete responses and four partial responses. All responses were confirmed. None of the nine topotecan patients showed a response to the drug. The median duration of progression free survival at the interim analysis was 4.1 months for amrubicin patients compared to 2.0 months for topotecan patients. Patients are being followed for overall survival. The major toxicity of amrubicin is myelosuppression, which is managed with standard supportive therapy and dose adjustments.
In addition to the Phase 2 study in second-line sensitive SCLC patients, Pharmion has two additional ongoing Phase 2 studies of amrubicin therapy for small cell lung cancer patients; one as single-agent therapy in patients refractory to first-line therapy; and one as single-agent or combination therapy with cisplatin versus cisplatin plus etoposide in previously untreated extensive stage patients.
"The Phase 2 studies in small cell lung cancer, in both sensitive and refractory patients, have thus far generated data fully in line with the results of the earlier Japanese studies," said Andrew R. Allen, executive vice president and chief medical officer of Pharmion Corporation. "We are pleased to see these exciting data reproduced in patients in the western hemisphere, as we expected, and we look forward to this pivotal trial and further investigating amrubicin's potential as a major advance for patients with small cell lung cancer."
Pharmion licensed the rights to amrubicin in November 2006. In 2002, amrubicin was approved and launched for sale in Japan based on Phase 2 efficacy data in both SCLC and NSCLC. Since January 2005, amrubicin has been marketed by Nippon Kayaku, a Japanese pharmaceutical firm focused on oncology, which licensed Japanese marketing rights from Dainippon Sumitomo, the original developer of amrubicin.
About Small Cell Lung Cancer
Small cell lung cancer is a disease in which malignant cells form in the tissues of the lung, and which occurs almost exclusively in people who smoke. While small cell lung cancer constitutes approximately 15 percent of all lung cancers, SCLC tends to be more aggressive and fast growing than the more common non-small cell lung cancer. Of the estimated 62,000 patients diagnosed with SCLC each year in the US and EU, approximately 60 percent of patients have extensive disease at diagnosis, and the remaining 40 percent present with localized, or limited stage, disease.
Pharmion is a leading global oncology 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 drug, Vidaza®, a DNA demethylating agent. For additional information about Pharmion, please visit the company's website at http://www.pharmion.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements relating to the planned development program for amrubicin, 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, but are not limited to, the potential failure of amrubicin, to demonstrate safety and efficacy in the Phase 3 study discussed in this release or in other clinical and non-clinical testing; the ability to complete regulatory submissions and gain regulatory approvals in a timely manner; the ability to initiate and complete trials at the referenced times; the impact of competition from other products under development by Pharmion's competitors; the uncertainty of the regulatory environment and changes in the health policies 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; failure of third-party manufacturers to produce the product volumes required on a timely basis and fluctuations in currency exchange rates. Additional risks and uncertainties relating to Pharmion and its business can be found in the "Risk Factors" section of Pharmion's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2007, its Annual Report on Form 10-K for the year ended December 31, 2006 and in our other 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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