ATLANTA, Dec. 12 /PRNewswire-FirstCall/ -- Celgene Corporation announced that clinical data from a REVLIMID study in Chronic Lymphocytic Leukemia (CLL) were reported at an oral presentation during the 47th American Society of Hematology (ASH) Meeting in Atlanta, GA on Monday, December 12, 2005. The study reported that sixteen out of nineteen evaluable patients achieved stable disease or better after treatment with REVLIMID, and experienced a median decrease of 61 percent in absolute lymphocyte count (ALC), a measure of tumor burden. Five patients achieved complete response (CR), two of the five patients achieving molecular (CR). Ten patients achieved partial response (PR) and three patients achieved stable disease (SD). Progressive disease (PD) was reported in three patients.
Chronic Lymphocytic Leukemia is a hematological cancer that affects approximately 75,000-100,000 people in the U.S. About 10,000 new cases of CLL are diagnosed each year and an estimated 5,000 Americans are expected to die of CLL this year.
About the Trial
The lead author of this presentation was Asher Chanan-Khan, M.D., Roswell Park Cancer Institute, Buffalo, New York. Dr. Chanan-Khan reported thirty-two relapsed or refractory CLL patients, median age of 64 years (age range: 47-75) were enrolled in the trial with all patients available for toxicity and nineteen 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 (ALC) 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 until CR and those with PD then received Rituximab at (375mg/m2) added to REVLIMID. Sixteen out of nineteen patients responded with a median decrease of 61% in absolute lymphocyte count (ALC), (range: 55-70%). Three patients achieved CR with 2 achieving a molecular CR, ten patients achieved PR and three patients achieved SD. Four patients on treatment are too early for response assessment. Two patients withdrew consent and five patients received less than two months of therapy due to toxicity. Progressive disease has been observed in three patients, and therefore have received Rituximab. All three patients have responded to the combination therapy.
Toxicity profile was clinically manageable. The most common side effect was a flare reaction (tender swelling of lymph nodes and/or rash) in almost all patients, and tumor lysis syndrome was noted in two patients. Grade 3 / 4 toxicities included hematologic toxicities in seven patients and febrile neutropenia in three patients. While the longest follow up is 12 months, 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.
“Based on the study results we are moving ahead with clinical studies and preparing regulatory strategies for REVLIMID in CLL,” said Sol J. Barer, Ph.D., President and Chief Operating Officer of Celgene Corporation.
About REVLIMID(R)
REVLIMID is a member of a group of proprietary novel compounds, IMiDs(R), which are being evaluated by Celgene as a treatment for a broad range of hematology and oncology conditions, including; multiple myeloma, myelodysplastic syndromes (MDS), chronic lymphocytic leukemia 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(R) is not approved by the FDA or any other regulatory agencies as a treatment for 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 pharmaceutical 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 forward-looking statements which are subject to 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 expressed or 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 other factors described in the Company’s filings with the Securities and Exchange Commission such as our 10K, 10Q and 8K reports.
Celgene Corporation
CONTACT: Robert J. Hugin, Senior VP and CFO, +1-908-673-9102, or Brian P.Gill, Director PR/IR, +1-908-673-9530, both of Celgene Corporation
Web site: http://www.celgene.com/
