New Data Validate Vidaza(R) Response Rates in MDS and Report Results in AML
Monday December 11, 7:00 am ET
Abstracts Presented at 2006 ASH Annual Meeting Highlight Alternate Dosing Schedules in MDS and Treatment of AML
ORLANDO, Fla., Dec. 11 /PRNewswire-FirstCall/ -- Pharmion Corporation (Nasdaq: PHRM - News) announced new data presented today at the 48th Annual Meeting and Exposition of the American Society of Hematology (ASH) in Orlando, December 9-12, 2006) on Vidaza® (azacitidine for injectable suspension) as single-agent therapy for the treatment of myelodysplastic syndromes (MDS) and acute myelogenous leukemia (AML).
Data on Vidaza Use in High Risk MDS and AML Post-MDS Demonstrate Response Rates of 74 Percent (Abstract 2664, Poster 842-II)
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-risk MDS and AML post-MDS patients treated under the French ATU, which provides a temporary authorization for compassionate use of Vidaza prior to receipt of a marketing approval.
In this study of 78 patients evaluable for response 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 response 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 ongoing.
Vidaza use in this study was associated with responses similar to those reported in the pivotal CALGB study as published in the Journal of Clinical Oncology in May 2002.
Data from Vidaza Alternative Dosing Study Show Hematologic Improvement of 49 to 67 Percent without Weekend Dosing (Abstract 2662, Poster #840-II)
Roger M. Lyons, MD, of US Oncology Research, delivered a poster presentation describing interim results of a Phase 2 study designed to evaluate the treatment response and safety of three alternative subcutaneous doses of Vidaza, each of which eliminates the need 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 different arms.
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 preliminary results, all three alternative doses provide clinical benefit, including transfusion independence and hematologic improvement.
Vidaza Demonstrates Hematologic Response in Patients with AML Refractory to or Not Eligible for Intensive Chemotherapy (Abstract 1953, Poster #131-II)
Haifa K. Al-Ali, MD, of the University of Leipzig, Germany, delivered a poster presentation describing interim results of a German study underway evaluating the safety and efficacy of Vidaza in AML patients.
This study, which utilizes a dose 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 disease 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 complete responders, 11 percent partial responders, 11 percent with hematologic improvement and 11 percent with stable disease.
Pharmion Corporation has several studies currently underway evaluating Vidaza in the treatment of AML.
"We are encouraged by these data presentations on Vidaza as single-agent therapy, as they further validate its clinical activity in the treatment of hematologic malignancies," said Patrick J. Mahaffy, Pharmion's president and chief executive officer. "We continue to expand our clinical development program for Vidaza, and look forward to final data from the Vidaza survival study and an increasing body of data on Vidaza in combination studies for higher-risk MDS, AML and other malignancies."
About MDS
MDS are a group of diseases in which the bone marrow does not function normally, resulting in the production of malformed or immature blood cells. MDS affects approximately 40,000-50,000 people in the United States. The majority of patients with high-risk MDS eventually experience bone marrow failure, which can cause bleeding and infection that lead to death.<<
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Pretty good numbers for both of these indications, IMHO. Prudential upgraded this morning, as well.
Cheers, Tuck |
