Pharmion To Present Clinical Data On Key Hematology Products At American Society Of Hematology (ASH) Annual Meeting

Main Category: Blood / Hematology
Also Included In: Lymphoma / Leukemia / Myeloma
Article Date: 07 Dec 2007 - 14:00 PDT

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Pharmion Corporation (NASDAQ: PHRM) reported that data from 36 abstracts of studies investigating the company's marketed and pipeline hematology products will be presented at the American Society of Hematology's (ASH) 49th Annual Meeting and Exposition in Atlanta (December 8-11, 2007). These abstracts include summaries of data from studies of several key products in the company's commercial and development portfolio for a variety of indications, including Myelodysplastic Syndromes (MDS), acute myeloid leukemia (AML), multiple myeloma (MM), Hodgkin's lymphoma (HL), and two forms of non-Hodgkin's lymphoma (NHL).

"ASH promises to be a very exciting meeting for us, with a focus on the detailed presentation of data from the Vidaza overall survival study, which demonstrate an unprecedented survival benefit compared to conventional care regimens, as well as other compelling study data on Vidaza, Thalidomide and MGCD0103," said Patrick J. Mahaffy, president and chief executive officer of Pharmion. "The data from 36 abstracts, including 23 posters and 13 oral presentations, to be presented demonstrates the progress of our pipeline and we are very enthusiastic about our participation this year."

Studies presented at this year's ASH meeting will report the complete Phase 3 data set from a study demonstrating that Vidaza® (azacitidine for injection) provides a significant survival benefit beyond that provided by conventional care regimens for higher-risk MDS patients. Other data to be presented at the meeting include alternate dosing schedules of Vidaza and the use of Vidaza as a maintenance therapy for patients with higher-risk MDS and AML.

Additionally, data from a study of Vidaza in combination with MGCD0103 in MDS and AML will be presented at ASH, as will poster presentations featuring study results from two ongoing single-agent Phase 2 MGCD0103 trials, one in refractory/relapsed classical HL patients and the other in diffuse large B cell lymphoma and follicular lymphoma, two forms of NHL.

"The data on Pharmion's products being presented at ASH clearly demonstrate the importance of epigenetic therapy in the treatment of hematologic malignancies and Pharmion's leadership position in the field of epigenetics," said Andrew R. Allen, chief medical officer of Pharmion. "In particular, the data being presented confirming the clinical responses with Vidaza, MGCD0103 and their combination suggest a promising synergistic treatment approach using epigenetic therapies."

Pharmion's portfolio of epigenetic therapies includes three developmental programs: Vidaza and oral azacitidine, both DNA demethylating agents; MGCD0103, a HDAC inhibitor; and sirtuin inhibitors, Pharmion's newest epigenetic research program. Pharmion currently markets Vidaza, the parenteral formulation of Azacitidine, in the U.S. and several additional countries for the treatment of patients with MDS, and as previously mentioned the full data set from the Phase 3 study of Vidaza's effect on overall survival in higher-risk MDS patients will be presented at the meeting.

Data from a study evaluating the addition of Thalidomide to front-line melphalan/prednisone (MP) therapy in newly diagnosed elderly patients with multiple myeloma will be the subject of an oral presentation at ASH, where two oral presentations and three posters on Thalidomide studies will be presented.

The following data will be presented during the 49th Annual ASH Meeting and Exposition:

Vidaza®

Date / Time / Location: December 11, 2007; 7:30-9:00 a.m., Thomas B Murphy Ballroom 4, Georgia World Congress Center
Session: Myelodysplastic Syndromes: Advances in Therapeutic Options
Oral Session 7:30 a.m.: Azacitidine (AZA) Treatment Prolongs Overall Survival (OS) in Higher-Risk MDS Patients Compared with Conventional Care Regimens (CCR): Results of the AZA-001 Phase III Study (Abstract #817).
Oral Session 7:45 a.m.: Maintenance Treatment with Azacytidine for Patients with High Risk Myelodysplastic Syndromes or Acute Myeloid Leukemia in Complete Remission after Intensive Chemotherapy (Abstract #818).
Oral Session 8:00 a.m.: Results of the Initial Treatment Phase of a Study of Three Alternative Dosing Schedules of Azacitidine (Vidaza) in Patients with Myelodysplastic Syndromes (MDS) (Abstract #819).

Date / Time / Location: December 8, 2007; Viewing 9:00 a.m.-7:30 p.m.,
Presentation 5:30 -7:30 p.m., Hall B4 of Georgia World Congress Center
Session: Acute Myeloid Leukemias: Therapy, Excluding Transplantation I
Poster Board No. 65-I: Report of a Phase I/II Study of 5-Azacitidine and Cytarabine in Patients with Relapsed, Refractory Acute Myelogenous Leukemia (Abstract #911).

Date / Time / Location: December 8, 2007; Viewing 9:00 a.m.-7:30 p.m., Presentation 5:30-7:30 p.m., Hall B4 of Georgia World Congress Center
Session: Myeloproliferative Syndromes: Biological
Poster Board No. 699-I: Hypermethylation of CXCR4 Promoter, and Its Reactivation by Hypomethylating Agent, in CD34+ Cells from Primary Myelofibrosis Patients (Abstract #1545).

Date / Time / Location: December 8, 2007; Viewing 9:00 a.m.-7:30 p.m., Presentation 5:30-7:30 p.m., Hall B4 of Georgia World Congress Center
Session: Myelodysplastic Syndromes: Clinical Studies, Including Transplantation
Poster Board No. 603-I: Outcomes of MDS Patients with Chromosome 7 Abnormalities Treated with 5-Azacytidine (Abstract #1449).
Poster Board No. 605-I: A Phase II Study of Intravenous Azacitidine Alone in Patients with Myelodysplastic Syndromes (Abstract #1451).
Poster Board No. 606-I: Therapy of Myelodysplastic Syndrome (MDS) with Azacitidine Given in Combination with Etanercept: A Phase II Study (Abstract #1452).
Poster Board No. 612-I: Preliminary Results from a Phase I Study of Revlimid (Lenalidomide) in Combination with Vidaza (Azacitidine) in Patients with Advanced Myelodysplastic Syndromes (MDS) (Abstract #1458).

Date / Time / Location: December 9, 2007; Viewing 9:00 a.m.-8:00 p.m., Presentation 6:00-8:00 p.m., Hall B4 of Georgia World Congress Center
Session: Acute Myeloid Leukemias: Therapy, Excluding Transplantation II
Poster Board No. 25-II: 5-Azacytidine Augments the Cytotoxicity of Mylotarg toward AML Blasts In Vitro and In Vivo (Abstract # 1835).
Poster Board No 39-II: Treatment of AML with Azacytidine (AZA): Current Results of the French ATU Program (Abstract #1849).

Date / Time / Location: December 9, 2007; Viewing 9:00 a.m.-8:00 p.m., Presentation 6:00-8:00 p.m., Hall B4 of Georgia World Congress Center
Session: Myelodysplastic Syndromes: Molecular Biology and Pathogenesis
Poster Board No 638-II: PI-PLCbeta1 Expression in Patients with High-Risk Myelodysplastic Syndromes Is Affected by Azacitidine Treatment (Abstract #2448).

Date / Time / Location: December 9, 2007; Viewing 9:00 a.m.-8:00 p.m., Presentation 6:00-8:00 p.m., Hall B4 of Georgia World Congress Center
Session: Myelodysplastic Syndromes: Prognosis and Clinical Correlative Studies

Poster Board No. 656-II: FISH-Analyses of Circulating CD34+ Cells in MDS-Patients - A Suitable Method to Measure and Predict Response to 5-Azacytidine (Abstract #2466).

Date / Time / Location: December 9, 2007; Viewing 9:00 a.m.-8:00 p.m., Presentation 6:00-8:00 p.m.., Hall B4 of Georgia World Congress Center
Session: Disordered Epigenetic Regulation in Hematologic Malignancy
Poster Board No. 312-II: DNA Methylation Analysis of 807 Genes in Chronic Myeloid Leukemia and Acute Promyelocytic Leukemia (Abstract #2122).
Poster Board No. 402-III: Up-Regulation of miR-195 Expression Leads to Decreased Expression of Basic Fibroblast Growth Factor in CLL Patients Treated with DNA Methylation Inhibitors (Abstract #3183).

Date / Time / Location: December 10, 2007; 1:30-3:00 p.m., Rooms B216-B217, Georgia World Congress Center
Session: Thalassemia: Pre-Clinical and Clinical Advances:
Oral Session 1:45 p.m.: Neither DNA Hypomethylation or Changes in the Kinetics of Erythroid Differentiation Account for 5-Azacytidine's Ability To Induce Human Fetal Hemoglobin (Abstract 572).

Date / Time / Location: December 10, 2007; 1:30 -3:00 p.m., Rooms A411-A412, Georgia World Congress Center
Session: Acute Myeloid Leukemias: Therapy, Excluding Transplantation-Novel Therapies
Oral Session 2:45 p.m.: Phase I/II Study of MGCD0103, an Oral Isotype-Selective Histone Deacetylase (HDAC) in Combination with 5-Azacitidine in Higher-Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML) (Abstract #444).

Date / Time / Location: December 10, 2007; Viewing 10:30 a.m.-7:00 p.m., Presentation 5:00-7:00 p.m., Hall B4 of Georgia World Congress Center
Session: Clinical Care: Transplantation Regimen Toxicities and Engraftment II
Poster Board No. 231-III: A Dose and Schedule Finding Study of Maintenance Therapy with Low-Dose 5-Azacitidine (AZA) after Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for High-Risk AML or MDS (Abstract #3012).
Poster Board No. 232-III: Efficacy of Azacytidine (5-AC) Given as Maintenance of Salvage Therapy for Patients with Acute Leukemia Post Allogeneic Stem Cell Transplantation (HSCT) (Abstract #3013).

MGCD0103

Date / Time / Location: December 9, 2007; Viewing 6:00 p.m.-8:00 p.m., Presentation 6:00 p.m., Hall B4 of Georgia World Congress Center
Session: New Agents and Treatment Approaches in Non-Hodgkin Lymphoma
Poster Board No. 756-II: Isotype Selective HDAC Inhibitor MGCD0103 Decreases Serum TARC Concentrations and Produces Clinical Responses in Heavily Pretreated Patients with Relapsed Classical Hodgkin Lymphoma (Abstract #2566).
Poster Board No. 761-II: Treatment of Relapsed or Refractory Lymphoma with the Oral Isotype-Selective Histone Deacetylase Inhibitor MGCD0103: Interim Results from a Phase II Study (Abstract #2571).

Date / Time / Location: December 10, 2007; 1:30 -3:00 p.m., Rooms A411-A412, Georgia World Congress Center
Session: Acute Myeloid Leukemias: Therapy, Excluding Transplantation-Novel Therapies
Oral Session 2:45 p.m.: Phase I/II Study of MGCD0103, an Oral Isotype-Selective Histone Deacetylase (HDAC) in Combination with 5-Azacitidine in Higher-Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML) (Abstract #444).

Date / Time / Location: December 9, 2007; Viewing 9:00 a.m.-8:00 p.m., Presentation 6:00-8:00 p.m., Hall B4 of Georgia World Congress Center
Session: Disordered Epigenetic Regulation in Hematologic Malignancy
Poster Board No. 320-II: Analysis of Class I and II Histone Deacetylase Fails To Identify a Human Leukemia Specific Expression Profile (Abstract # 2130).

Thalidomide

Date / Time / Location: December 9, 2007; 4:30-6:00 p.m.; Rooms C303-C305, Georgia World Congress Center
Session: Myeloma: Firstline Phase III Trials in Multiple Myeloma
Oral Presentation - 4:30 p.m.: Velcade-Thalidomide-Dexamethasone (VTD) vs Thalidomide-Dexamethasone (TD) in Preparation for Autologous Stem-Cell Transplantation (ASCT) in Newly Diagnosed Multiple Myeloma (Abstract #73).
Oral Presentation - 5:00 p.m.: Melphalan-Prednisone-Thalidomide (MP-T) Demonstrates a Significant Survival Advantage in Elderly Patients ≥75 years with Multiple Myeloma Compared with Melphalan-Prednisone (MP) in a Randomized, Double-blind, Placebo-controlled Trial, IFM 01/01 (Abstract #75).
Oral Presentation - 5:45 p.m.: Melphalan-Prednisone-Thalidomide to Newly Diagnosed Patients with Multiple Myeloma: A Placebo Controlled Randomized Phase 3 Trial (Abstract #78).

Date / Time / Location: December 10, 2007; 7:30-9:00 a.m.; Rooms C303-C305, Georgia World Congress Center
Session: Myeloma: Frontline Therapy in Newly Diagnosed Multiple Myeloma
Oral Presentation - 7:45 a.m.: A Phase II Study of Velcade, Cyclophosphamide, Thalidomide and Dexamethasone as First-Line Therapy for Multiple Myeloma (Abstract #188).

Date / Time / Location: December 10, 2007; 1:30-3:00 p.m.; Rooms C306-C308, Georgia World Congress Center
Session: Autologous Transplantation for Myeloma: Induction, Mobilization, and Biologic Correlates
Oral Presentation - 2:00 p.m.: Incorporation of Thalidomide into Up-Front Double Autologous Stem Cell Transplantation (ASCT) for Multiple Myeloma Improves Outcome in Comparison with Double ASCT without Thalidomide. Analysis of Baseline Factors Predictive of Outcome (Abstract #447).

Date / Time / Location: December 10, 2007; 1:30-3:00 p.m.; Rooms C303-C305, Georgia World Congress Center
Session: Myeloma: Maintenance, Consolidation and Bone Disease in Multiple Myeloma
Oral Presentation - 1:45 p.m.: Consolidation with Bortezomib, Thalidomide, and Dexamethasone Induces Molecular Remissions in Autografted Multiple Myeloma Patients (Abstract #530).
Oral Presentation - 2:15 p.m.: Thalidomide-Dexamethasone vs Interferon-Dexamethasone as Maintenance Treatment after ThaDD induction for Multiple Myeloma: Final Analysis of a Prospective, Randomized Study (Abstract #532).

Date / Time / Location: December 9, 2007; Viewing 9:00 a.m.-8:00 p.m., Presentation 6:00-8:00 p.m., Hall B4 of Georgia World Congress Center Session: Myeloma: Relapsed and Refractory Multiple Myeloma
Poster Board No. 915-II: Longer Duration of Thalidomide Monotherapy Results in Improved Outcome in Relapsed/refractory Multiple Myeloma (Abstract #2725).
Poster Board No. 905-II: A Phase I/II Trial on Melphalan, Prednisone, Thalidomide, and Defribotide Combination in Relapsed/Refractory Multiple Myeloma Patients (Abstract #2715).
Poster Board No. 908-II: Prolonged Progression Free Survival Does Not Relate to Quality of Response to Treatment with Thalidomide in Patients with Relapsed Multiple Myeloma (Abstract #2718).
Poster Board No. 919-II: ThaDD-V Treatment for Patients with Relapsed/Refractory Multiple Myeloma: A Feasibility/Activity Study (Abstract #2729).
Poster Board No. 924-II: Effect of Thrombotic Events on Overall Survival in Patients with Newly Diagnosed Myeloma: Analysis from a Randomized Phase III Trial of Thalidomide plus Dexamethasone vs Dexamethasone in Newly Diagnosed Multiple Myeloma (E1A00) (Abstract #2734).

Date / Time / Location: December 10, 2007; Viewing 10:30 a.m.-7:00 p.m., Presentation 5:00-7:00 p.m., Hall B4 of Georgia World Congress Center
Session: Myeloma: Novel Therapies
Poster Board No 812-III: Thalidomide Combinations Improve Response Rates; Results from the MRC IX Study (Abstract 3593).

About Pharmion

Pharmion is a leading global oncology company uniquely 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(R), 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, including summary statements relating to the interim or preliminary results of clinical trials involving Vidaza, Thalidomide Pharmion, and MGCD0103. 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. Preliminary results may not be confirmed upon final 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 from this or other clinical trials. 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 September 30, 2007, its Annual Report on Form 10-K for the year ended December 31, 2006 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.

Pharmion Corporation