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REVLIMID(R)(Lenalidomide) Study in Chronic Lymphocytic Leukemia Presented at 2005 ASCO

ORLANDO, Fla., May 15 /PRNewswire-FirstCall/ -- Celgene Corporation (Nasdaq: CELG - News) announced that clinical data from a REVLIMID study in Chronic Lymphocytic Leukemia (CLL) were presented at the 2005 American Society Clinical Oncology (ASCO) Meeting in Orlando, Florida, at a poster session, on Saturday, May 14. Clinical results were presented on REVLIMID as a potential new approach for treating patients with relapsed or refractory CLL.

Chronic Lymphocytic Leukemia is a hematological cancer that affects approximately 60,000 people in the U.S. About 9,000 new cases of CLL are diagnosed each year and about 5,000 Americans are expected to die of CLL in 2005.

Dr. Chanan-Khan, of the Roswell Park Cancer Institute, Buffalo, New York, reported that twelve out of fourteen relapsed or refractory CLL patients responded to treatment with REVLIMID experiencing a decrease in absolute lymphocyte count (ALC), a measure of tumor burden. Three patients achieved complete response (CR); one CR and two Cytopenic CR (bone marrow biopsy pending), two patients achieved partial response (PR) and nine patients achieved stable disease (SD). Progressive disease (PD) had not been observed in any patients.

"This initial experience is encouraging and these results are consistent with those being observed in a larger cohort of patients from this ongoing trial," stated Dr. Chanan-Khan.

About the Phase II Trial

This Phase II trial evaluated the clinical benefits of REVLIMID in patients with relapsed or refractory CLL. Eighteen relapsed or refractory CLL patients, median age of 66 years (range: 58-74) were enrolled in the trial with all patients available for toxicity and fourteen patients available for response evaluation. REVLIMID was given at 25mg orally every day for 21 days followed by 7 days of rest on a 28-day cycle. Absolute lymphocyte count at days 0, 7 and 30 were taken to determine direct anti-CLL effect of REVLIMID. Response was assessed at day 30, and then monthly using the National Cancer Institute -Working Group criteria. CLL patients with SD or better response continued on therapy for a maximum of one year while those with PD will receive Rituximab at (375mg/m2) added to REVLIMID. Twelve out of fourteen patients responded, at day 30, with a decrease of 61% in absolute lymphocyte count, (range: 55-70%). Three patients achieved CR; one CR and two Cytopenic CR (bone marrow biopsy pending), two patients achieved PR and nine patients achieved SD. One patient withdrew consent and was not available for evaluation. Progressive disease has not been observed in any patient and therefore Rituximab has not yet been administered to any of the patients.

Toxicity profile was predictable and manageable. The most common side effect was fatigue and rash in six patients. Flare reaction (tender swelling of lymph nodes) was noted in 73% of the patients while 2 patients were reported to have tumor lysis syndrome. Grade 3 / 4 toxicities included thrombocytopenia, anemia and neutropenia. Further follow-up and analysis will ascertain the durability of these responses and establish the role of REVLIMID as a potential treatment of patients with CLL. Accrual is ongoing and updated results of this phase II study are expected to be presented at the American Society of Hematology meeting in December 2005.

"Based on the results of this poster and the data from additional patients under study we are preparing regulatory strategies for CLL," said Sol J. Barer, Ph.D., President and Chief Operating Officer of Celgene Corporation.

About REVLIMID®

REVLIMID is a member of a new class of novel immunomodulatory drugs, or IMiDs®. 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 pending patent 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 Chronic Lymphocytic Leukemia

Chronic lymphocytic leukemia results from an acquired (not inherited) injury to the DNA of a single cell, a lymphocyte, in the bone marrow. This injury is not present at birth. Scientists do not yet understand what produces this change in the DNA of CLL patients. This change in the cell's DNA confers a growth and survival advantage on the cell, which becomes abnormal and malignant (leukemic). The result of this injury is the uncontrolled growth of lymphocytic cells in the marrow leading invariably to an increase of abnormal lymphocytes in the blood and the bone marrow. These lymphocytes do not perform their functions as normal ones would and interfere with the production of other blood cells necessary for the normal functioning of the blood, leading to a host of complications like deficiency of the immune system, coagulation problems, swollen lymph nodes, and many other conditions.

About Celgene

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.

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Source: Celgene Corporation

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