Pharmion Corporation
(Nasdaq: PHRM) announced young information presented today at the 48th Annual
Engagement and Interpretation of the American Sisterhood of Hematology (ASH) in
Orlando, December 9-12, 2006) on Vidaza(R) (azacitidine for injectable
suspension) as one-agent therapy for the treatment of myelodysplastic
syndromes (MDS) and wise myelogenous leukemia (AML).
Observations on Vidaza Abhor in High Risk MDS and AML Fill someone in on-MDS Manifest
Feedback Rates of 74 Percent.
Claire Fabre, MD, of the Groupe Francophone des Myelodysplasies (GFM),
Hopital Avicenne in Bobigny, France, delivered a poster presentation
describing results of a study of high-endanger MDS and AML post-MDS patients
treated under the French ATU, which provides a pro tem authorization for
compassionate use of Vidaza prior to receipt of a marketing approval.
In this work of 78 patients evaluable for comeback after four cycles
of Vidaza, overall response was 74 percent, including 14 percent complete
responders, 29 percent partial responders, and 28 percent who demonstrated
hematologic improvement.
Median overall reply duration was six months, including 7.5 months
for complete responders, nine months for partial responders and two months
for patients who demonstrated hematologic improvement. Accrual in this
study is evolving.
Vidaza use in this office was associated with responses be like to those
reported in the pivotal CALGB lucubrate as published in the Journal of Clinical
Oncology in May 2002.
Evidence from Vidaza Surrogate Dosing Study Show Hematologic Improvement
of 49 to 67 Percent without Weekend Dosing.
Roger M. Lyons, MD, of US Oncology Investigate, delivered a poster
presentation describing interim results of a Phase 2 mull over designed to
assess the treatment response and security of three alternative
subcutaneous doses of Vidaza, each of which eliminates the fundamental for weekend
dosing.
Of the 130 patients randomized, 99 had received two or more cycles of
Vidaza at the time of evaluation. Hematologic improvement was demonstrated
in 57 percent of those patients, with a range of 49 to 67 percent in the
many arms.
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Also, of 46 baseline RBC transfusion-dependent patients, 70 percent
became transfusion independent, with a range of 58 to 80 percent in the
different arms.
Based on overture introduction results, all three option doses require
clinical benefit, including transfusion self-assurance and hematologic
rehabilitation.
Vidaza Demonstrates Hematologic Response in Patients with AML
Refractory to or Not Eligible seeking Intensive Chemotherapy.
Haifa K. Al-Ali, MD, of the University of Leipzig, Germany, delivered a
poster conferring describing interim results of a German study underway
evaluating the safety and efficacy of Vidaza in AML patients.
This study, which utilizes a measure of 75 mg/m2 per day for five days
every 28 days, had enrolled 18 patients at the time of analysis. Eight
patients were ineligible for chemotherapy, and 10 had relapsed or
refractory cancer after standard chemotherapy.
After a median follow up of 23 weeks, 67 percent of patients responded
after a median of four treatment cycles; this included 33 percent entire
responders, 11 percent partial responders, 11 percent with hematologic
improvement and 11 percent with established disease.
Pharmion Corporation has several studies currently underway evaluating
Vidaza in the treatment of AML.
“We are encouraged by these evidence presentations on Vidaza as
single-power treatment, as they further validate its clinical enterprise in the
treatment of hematologic malignancies,” said Patrick J. Mahaffy, Pharmion’s
president and chief executive officer. “We continue to expand our clinical
enlargement program in the course of Vidaza, and look nourish to final materials from the
Vidaza survival study and an increasing league of text on Vidaza in
combination studies for the sake of higher-risk MDS, AML and other malignancies.”
About MDS
MDS are a squad of diseases in which the bone marrow does not function
normally, resulting in the drama of malformed or immature blood cells.
MDS affects approximately 40,000-50,000 people in the United States. The
the better of patients with principal-risk MDS eventually experience bone marrow
deficiency, which can cause bleeding and infection that lead to death.
About Vidaza
In May 2004, Vidaza became the first place deaden approved by the FDA representing the
treatment of patients with Myelodysplastic Syndromes (MDS). The FDA
approved Vidaza, the before all in a late-model class of drugs called demethylation
agents, for the treatment of all five MDS subtypes, which include both
low-risk and loaded-risk patients. These subtypes include: refractory anemia
(RA) or refractory anemia with ringed sideroblasts (RARS) if accompanied by
neutropenia or thrombocytopenia or requiring transfusions; refractory
anemia with overkill debauchery blasts (RAEB), refractory anemia with excess blasts in
transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
Vidaza is believed to exert its antienoplastic effects by causing
hypomethylation of DNA and turn cytotoxicity on abnormal hematopoietic
cells in the bone marrow. The concentration of azacitidine required for
maximum defence mechanism of DNA methylation in vitro does not cause significant
check of DNA amalgamation. Hypomethylation may refurbish sane function
to genes that are critical for differentiation and proliferation. The
cytotoxic effects of azacitidine cause the extirpation of like blazes dividing cells,
including cancer cells that are no longer responsive to run-of-the-mill cultivation
control mechanisms. Non-proliferating cells are relatively insensitive to
Vidaza.
Notable Security Message
Vidaza is contraindicated in patients with a known hypersensitivity to
azacitidine or mannitol and in patients with advanced malignant hepatic
tumors.
In clinical studies, the most commonly occurring adverse reactions were
nausea (70.5%), anemia (69.5%), thrombocytopenia (65.5%), vomiting (54.1%),
pyrexia (51.8%), leukopenia (48.2%), diarrhea (36.4%), tire (35.9%),
injection site erythema (35.0%), constipation (33.6%), neutropenia (32.3%)
and ecchymosis (30.5%). Other adverse reactions included dizziness (18.6%),
trunk pain (16.4%), febrile neutropenia (16.4%), myalgia (15.9%), injection
site reaction (13.6%), aggravated fatigue (12.7%) and malaise (10.9%).
Because treatment with Vidaza is associated with neutropenia and
thrombocytopenia, unabated blood counts should be performed as needed to
CRT comeback and toxicity, but at a littlest, prior to each dosing
cycle.
Because azacitidine is potentially hepatotoxic in patients with severe
pre-existing hepatic impairment, admonition is needed in patients with liver
infirmity. In addition, azacitidine and its metabolites are substantially
excreted by the kidneys and the risk of toxic reactions to this drug may be
greater in patients with impaired renal function. Because old-age pensioners patients
are more appropriate to enjoy decreased renal function, it may be useful to
monitor renal function.
Vidaza may cause fetal abuse. While receiving treatment with Vidaza,
women of childbearing covert should avoid becoming meaningful, and men
should keep fathering a toddler. In addition, women treated with Vidaza
should not nurse.
Nigh Pharmion
Pharmion is a biotechnology body focused on acquiring, developing
and commercializing innovation products for the treatment of hematology and
oncology patients in the U.S., Europe and additional supranational markets.
Pharmion has a number of products on the Stock Exchange including the world’s before
approved epigenetic sedate, Vidaza(R), a DNA demethylating go-between. Appropriate for
additional information about Pharmion, please visit the company’s website
at http://www.pharmion.com.
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