Clinical Data On Pharmion Corporation's Marketed And Pipeline Products To Be Presented At The American Society of Clinical Oncology 42nd Annual Meeting
BOULDER, Colo., June 1 /PRNewswire-FirstCall/ -- Pharmion Corporation reported today that data from 26 abstracts from studies investigating the company's marketed and pipeline products will be presented at the American Society of Clinical Oncology (ASCO) 42nd Annual Meeting in Atlanta (June 2-6, 2006). These abstracts, one of which will be the topic of a 2006 ASCO meeting plenary session, include summaries of data from several studies evaluating the benefits of thalidomide in newly-diagnosed multiple myeloma.
Pharmion licenses commercialization rights for thalidomide in Europe and additional international markets and shares joint development responsibility for the drug. Data from a first-line study supported by Pharmion will be the subject of an ASCO plenary session. Thalidomide data accepted for presentation at the 2006 ASCO meeting will highlight the effects of this compound in combination with other approved therapies for use in newly-diagnosed multiple myeloma.
Pharmion currently markets Vidaza(R) (azacitidine for injectable suspension) in the U.S. The drug was approved in May 2004 for the treatment of all five sub-types of Myelodysplastic Syndromes (MDS). Abstracts presented at this year's ASCO meeting will report data from studies investigating the use of Vidaza in a variety of combination therapies for the treatment of MDS, secondary MDS, AML, advanced cancers and ovarian cancer. Additionally, accepted abstracts will address the effects of alternate dosing regimens of Vidaza in patients with MDS, as well as blood transfusion independence associated with Vidaza.
In January of this year, Pharmion entered a licensing and collaboration agreement for MethylGene, Inc.'s histone deacetylase (HDAC) inhibitors in North America, Europe, Middle East and certain other markets. This collaboration includes MethylGene's lead oncology HDAC inhibitor, MGCD0103, as well as the company's pipeline of second-generation HDAC inhibitor compounds for oncology indications. Two oral presentations on studies of MCGD0103 in advanced solid tumors and leukemia and MDS will be presented during ASCO.
Satraplatin, the oral platinum compound for which Pharmion licensed the commercial rights in Europe and certain international markets from GPC Biotech AG in December 2005, will be the subject of two abstracts at the conference. Pharmion maintains a co-development agreement with GPC Biotech for satraplatin.
The following clinical data will be presented during the ASCO 2006 annual meeting:
Thalidomide
Superiority of melphalan-prednisone (MP) + thalidomide (THAL) over MP and autologous stem cell transplantation in the treatment of newly diagnosed elderly patients with multiple myeloma
Abstract ID: 1 T Facon, MD; IFM, France Oral Presentation, Plenary Session Time: June 4, 2006; 2:00-2:15 p.m.
A multi-center, randomized, double-blind, placebo-controlled trial of thalidomide plus dexamethasone versus dexamethasone alone as initial therapy for newly diagnosed multiple myeloma
Abstract ID: 7517 V Rajkumar, MD, Mayo Clinic, USA Oral Presentation Time: June 4, 2006; 9:30 -9:45 a.m.
A multi-center prospective randomized study testing non-inferiority of thalidomide 100 mg/day as compared with 400 mg/day in patients with refractory/relapsed multiple myeloma: results of the final analysis of the IFM 01-02 study
Abstract ID: 7520
I Yakoub-Agha, MD; IFM, France: UAM d'Allogreffe de Cellules Souches Hematopietiques
Oral Presentation Time: June 4, 2006; 10:30 -10:45 a.m. Thalidomide increases thrombin generation in multiple myeloma patients Abstract ID: 7602 Dulcinea Candelaria, University of New Mexico, USA Poster #X3 Time: June 2, 2006; 8:00 a.m.-12:00 p.m.
Bendamustine in combination with thalidomide and prednisone (BPT) in patients with refractory or relapsed multiple myeloma: Results of a phase 1 clinical trial
Abstract ID: 7620 Wolfram Poenisch, MD, University of Leipzig, Germany Poster #Y10 Time: June 3, 2006; 8:00 a.m.-12:00 p.m.
Regression of chemotherapy-refractory metastaci tumor from CD117-negative prostate sarcoma with imatinib mesylate plus thalidomide
Abstract ID: 9557 Victor C Kok, National Cheng Kung University, Taiwan Poster #J9 Time: June 5, 2006; 1:00 - 5:00 p.m.
A prospective, randomized phase 3 double-blind, placebo-controlled study of thalidomide in extended-disease (ED) SCLC patients after response to chemotherapy (CT): An intergroup study FNCLCC Cleo04-IFCT 00-01
Abstract ID: 7057
Jean Louis Pujol, MD, Ph.D, Hopital Arnaud de Villeneuve, Montpellier, France
Poster #1
Time: Monday, June 5, 2006; 1:00 - 5:00 p.m.
Phase II study of the combination of thalidomide and irinotecan in patients with recurrent anaplastic gliomas not on enzyme inducing anticonvulsants.
Abstract ID: 1564 Vinay K Puduvalli, MD, MD Anderson Cancer Center, USA Poster #E13 Time: Sunday, June 4, 2006; 8:00 a.m. - 12:00 p.m.
Prospective neurocognitive effects and quality of life (QOL) in patients with multiple brain metastases receiving whole brain radiation (WBRT) ± thalidomide on radiation therapy oncology group (RTOG) trial 0118.
Abstract ID: 8589 Sherry Fox, Ph.D, University of Virginia Health System, USA Poster #X1 Time: Saturday, June 3, 2006; 2:00 PM - 6:00 PM
Development of neuropathy in patients (pts) with multiple myeloma (MM) treated with thalidomide (thal) -- Patterns of occurrence and the role of electrophysiologic monitoring.
Abstract ID: 7618 Linda R Mileshkin, MBBS, FRACP, Peter MacCallum Cancer Centre, Australia Poster #Y8 Time: Saturday, June 3, 2006; 8:00 AM - 12:00 PM
Randomized phase II study of low (100mg) versus intermediate (400mg) doses of thalidomide plus DTIC in metastatic melanoma (MM).
Abstract ID: 8048 Roger Von Moos, MD, Ratisches Kantons-Und Regionalspital, Switzerland Poster #C3 Time: Monday, June 5, 2006; 1:00 PM - 5:00 PM
A Phase II Trial of Neoadjuvant GM-CSF and Thalidomide in Patients with Localized Prostate Cancer
Abstract ID: 4564 Jorge A Garcia, MD, Cleveland Clinic, USA Poster #12 Time: Monday, June 5, 2006; 2:00 PM - 6:00 PM
Correlation of bone marrow angiogenesis and response to thalidomide dexamethasone in multiple myeloma.
Abstract ID: 7621 Shaji Kumar, Mayo Clinic, USA Poster #Y11 Time: Saturday, June 3, 2006; 8:00 AM - 12:00 PM
A combination of capecitabine and thalidomide in patients with hepatocellular carcinoma.
Abstract ID: 4142 Woondong Jeong, MD, New York Medical College, USA Poster #H11 Time: Saturday, June 3, 2006; 8:00 a.m. - 12:00 p.m. Vidaza and Thalidomide
Low dose Vidaza and thalidomide is an effective combination for patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML)
Abstract ID: 6570 P Westervelt; University of Massachusetts Medical Center; USA Poster #CC2 Time: June 3, 2006; 8:00 a.m.-12:00 p.m. Vidaza
Phase I/II study of the combination of 5-azacytidine (5-AC), all-trans retinoic acid (ATRA) and valproic Acid (VPA) in patients with myelodysplastic syndrome (MDS) and leukemia
Abstract ID: 6563 A Soriano; MD Anderson Cancer Center; USA Poster #BB7 Time: June 3, 2006; 8:00 a.m.-12:00 p.m.
Transfusion independence assessed using three alternative dosing schedules of azacitidine in patients with myelodysplastic syndromes
Abstract ID: 6574 S Anthony, MD; US Oncology; USA Poster #CC6 Time: June 3, 2006; 8:00 a.m.-12:00 p.m.
Transfusion independence in patients with myelodysplastic syndromes treated with azacitidine
Abstract ID: 6576 L Silverman, MD; Mount Sinai Medical Center; USA Poster #CC8 Time: June 3, 2006; 8:00 a.m.-12:00 p.m.
Response to Azacitidine (AZA) in patients with Secondary Myelodysplastic Syndrome
Abstract ID: 6578 H Abdulhaq, MD; Western Pennsylvania Medical Center; USA Poster #CC10 Time: June 3, 2006; 8:00 a.m.-12:00 p.m.
A phase I study of a hypomethylating agent azacitidine in combination with carboplatin in patients with platinum resistant epithelial ovarian cancer
Abstract ID: 5087 S Fu, MD; MD Anderson Cancer Center; USA Poster #Q5 Time: June 3, 2006; 2:00-6:00 p.m.
Phase I study of low-dose hypomethylating agent Azacitidine (5-AC) combined with the histone deacetylase inhibitor Valproic Acid (VPA) in patients with advanced cancers
Abstract ID: 3060 F Braiteh, MD; MD Anderson Cancer Center; USA Poster #Y1 Time: June 4, 2006; 2:00-6:00 p.m. MGCD0103
Phase I study of isotype-selective histone deacetylase (HDAC) inhibitor MGCD0103 given as three-times weekly oral dose in patients (pts) with advanced solid tumors
Abstract ID: 3007 M Carducci, MD; Johns Hopkins Medical Center, USA Oral Presentation Time: June 3, 2006; 9:00-9:15 a.m.
Clinical activity and safety of the histone deacetylase inhibitor MGCD0103. Results of a Phase I study in patients with leukemia or myelodysplastic syndromes (MDS)
Abstract ID: 6500 G Garcia-Manero, MD; MD Anderson Cancer Center, USA Oral Presentation Time: June 5, 2006; 3:30-3:45 p.m. Satraplatin
Phase I study of the effects of hepatic impairment on the pharmacokinetic (PK) and safety of satraplatin in patients (Pts) with refractory non-hematologic cancer
Abstract ID: 2045 RF Setlik, Brooke Army Medical Center, San Antonio, TX; USA Poster #A10 Time: June 4, 2006; 2:00-6:00 p.m.
Phase I study of the effects of renal impairment on the pharmacokinetic (PK) and safety of satraplatin in patients (Pts) with refractory non-hematologic cancer
Abstract ID: 2044 DS Hong, MD Anderson Cancer Center, Houston, TX; USA Poster #A9 Time: June 4, 2006; 2:00-6:00 p.m. Innohep
Tinzaparin prophylaxis against thromboembolic complications in brain tumor patients
Abstract ID: 1539 J Vredenburgh, MD, Robert Preston Tisch Brain Tumor Center; USA Poster #A11 Time: Sunday, June 4, 2006; 8:00 a.m. - 12:00 p.m. About Pharmion
Pharmion is a biotechnology 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 therapy, Vidaza(R), a DNA demethylating agent. For additional information about Pharmion, please visit the company's website at www.pharmion.com.
For more information or complete prescribing information about Vidaza, please call 1-866-PHARMION.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: The anticipated presentations described in this release will contain forward-looking statements, including summary statements relating to the results of clinical trials involving Pharmion's marketed and pipeline products. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the final results to differ significantly from the results summarized by such statements. The clinical trials that are the subject of the presentations described in this release are being conducted by independent investigators and Pharmion does not control and cannot predict the final results of those trials. Top line results may not be confirmed upon full analysis of the detailed results of a trial and additional information relating to the safety, efficacy or tolerability of Pharmion's products may be discovered upon further analysis of clinical trial data and upon review and analysis of additional clinical trial data. 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 March 31, 2006, its Annual Report on Form 10-K for the year ended December 31, 2005 and in Pharmion's 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. Pharmion also disclaims any duty to comment upon or correct information that may be contained in reports published by the investment community.
2006 (C) Pharmion Corporation. All rights reserved.
Pharmion CorporationCONTACT: Breanna Burkart or Anna Sussman, Directors, Investor Relationsand Corporate Communications of Pharmion Corporation, +1-720-564-9150
Web site: http://www.pharmion.com/