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Pharmion to Present Clinical Data on Key Hematology Products at American Society of Hematology (ASH) Annual Meeting
Data Presentations Highlight Overall Survival Results of Vidaza(R) in
Higher-risk Myelodysplastic Syndromes (MDS), Thalidomide in Multiple
Myeloma
BOULDER, Colo., Dec. 6 /PRNewswire-FirstCall/ -- Pharmion Corporation
( PHRM) reported today 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(R) (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(R)
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.
SOURCE Pharmion Corporation













