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|REVLIMID(R) Study in Myelodysplastic Syndromes With Deletion 5Q Chromosomal Abnormality Presented at ASCO Plenary Session|
ORLANDO, Fla., May 15 /PRNewswire-FirstCall/ -- Celgene Corporation (Nasdaq: CELG) announced that REVLIMID clinical data were presented at a plenary session during the 2005 American Society Clinical Oncology (ASCO) Meeting in Orlando, Florida, on Sunday, May 15. The presentation provided results, based on available data as of March 31, 2005, on REVLIMID (lenalidomide) as an innovative approach for MDS patients with deletion 5q chromosomal abnormalities.
At an ASCO Plenary Session, Alan List, M.D., Professor of Medicine and Program Leader Hematologic Malignancies at H. Lee Moffitt Cancer Center, Tampa, Florida highlighted an intent-to-treat analysis of the Celgene Phase II trial evaluating REVLIMID in MDS patients with deletion 5q chromosomal abnormalities (MDS-003).
"In 20 years that I have been working with these patients the response to REVLIMID(R) is the highest ever observed with a striking increase in hemoglobin," said Dr. List, the study's lead investigator. "I am delighted that the primary endpoint of this trial was achieved. In many patients the response was accompanied by an unprecedented normalization of the bone marrow both histologically and cytogenetically."
About the Phase II Trial (MDS-003)
The analysis was based on clinical data available up to March 31, 2005. This trial will continue and be updated on an ongoing basis. Dr. List reported that 148 MDS deletion 5q patients with median age of 71 years (range, 37-95) and a median time from diagnosis of 3.4 years entered the study. Ninety-seven patients (66 %) became transfusion independent (TI), defined according to International Working Group (IWG) as 8 weeks without blood transfusion. The median increase in hemoglobin, another objective measure of major erythroid response, was 5.3 grams per deciliter. The median duration of response after a median follow-up of 58 weeks of follow-up had not been reached. Bone marrow histology normalized in 36% of patients.
Myelosuppression grade 3 or higher was the most common adverse event (AE) and was dose-dependent. The most common non-hematologic AE's for all National Cancer Institute Common Toxicity Criteria grades included pruritus, rash, diarrhea, and fatigue. Fifteen (8.8%) patients died of whom two (1.4%) patient deaths were suspected to be drug related.
"We are pleased that the updated data from this trial were selected to be presented at such an important forum. The data from this trial are the key component of our New Drug Application to the FDA which was submitted early last month," said Jerome B. Zeldis, M.D., Ph.D., Chief Medical Officer and VP, Medical Affairs of Celgene.
REVLIMID is a member of a new class of novel immunomodulatory drugs, or IMiDs(R). Celgene is evaluating treatments with REVLIMID for a broad range of hematology and oncology conditions, including; multiple myeloma, the malignant blood cell disorders known as myelodysplastic syndromes (MDS) as well as solid tumor cancers. REVLIMID affects multiple intracellular biological pathways. The IMiD pipeline, including REVLIMID, is covered by a comprehensive intellectual property estate of U.S. and foreign issued and patent-pending applications including composition-of-matter and use patents.
REVLIMID (lenalidomide) is not approved by the FDA or any other regulatory agencies as a treatment in any indication and is currently being evaluated in clinical trials for efficacy and safety for future regulatory applications.
About Myelodysplastic Syndromes
Myelodysplastic syndromes (MDS) are a group of hematologic malignancies that affect approximately 300,000 people worldwide. Myelodysplastic syndromes occur when blood cells remain in an immature or "blast" stage within the bone marrow and never develop into mature cells capable of performing their necessary functions. Eventually, the bone marrow may be filled with blast cells suppressing normal cell development. According to the American Cancer Society, 10,000 to 20,000 new cases of MDS are diagnosed each year in the United States, with mean survival rates ranging from approximately six months to six years for the different classifications of MDS. MDS patients must often rely on blood transfusions to manage symptoms of anemia and fatigue until they develop life-threatening iron overload and/or toxicity, thus underscoring the critical need for new therapies targeting the cause of the condition rather than simply managing its symptoms.
About 5q Deletion Chromosomal Abnormality
Chromosomal (cytogenetic) abnormalities are detected in more than half of patients with myelodysplastic syndrome (MDS), and involve a deletion in all or part of one or more specific chromosomes. The most common cytogenetic abnormalities in MDS are deletions in the long arm of chromosomes 5, 7, and 20. Another common abnormality is an extra copy of chromosome 8. A deletion involving the 5q chromosome may be involved in 20 to 30% of all MDS patients. The World Health Organization has also recently identified a unique subset of MDS patients with a "5q- Syndrome" where the only chromosomal abnormality is a specific portion of the 5q chromosome.
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at http://www.celgene.com .
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.