December 1, 2004
Clinical Data on REVLIMID(TM) in Multiple Myeloma and Myelodysplastic Syndromes to Be Presented at The American Society of Hematology 46th Annual Meeting
WARREN, N.J., Dec. 1 /PRNewswire-FirstCall/ -- Celgene Corporation announced today that clinical investigators from leading cancer research centers will present data from recent and on-going clinical trials of REVLIMID in multiple myeloma, myelodysplastic syndromes, other malignant blood disorders, as well as its mechanism of action at the American Society of Hematology 46TH Annual Meeting, one of the largest oncology meetings in the world, in San Diego, CA from December 2-7, 2004.
The following clinical data will be presented on REVLIMID and ACTIMID(TM) in education, oral and poster sessions:Multiple Myeloma:
* Combination Therapy with CC-5013 (Lenalidomide, REVLIMID(TM)) Plus
Dexamethasone (Rev/Dex) for Newly Diagnosed Myeloma (MM). (Oral
Session); Abstract #331
* Doxil (D), Vincristine (V), Reduced Frequency Dexamethasone (d) and
REVLIMID (R) (Dvd-R) A Phase I/II trial in advanced Relapsed/Refractory
(RMM) Multiple Myeloma Patients (Oral Session); Abstract #208
* Combination of the mTOR Inhibitor Rapamycin and REVLIMID(TM) (CC-5013)
Has Synergistic Activity in Multiple Myeloma (Poster Session); Abstract
* Multiple Myeloma Stem Cells and Plasma Cells Display Distinct Drug
Sensitivities. (Poster Session); Abstract #2476
* Endothelial Cells Induce Multiple Myeloma Cell Proliferation Protect
Against Conventional and Novel Therapies. (Poster Session); Abstract
* Alternate Day ACTIMID(TM) (CC-4047) Is Well Tolerated and Is Active
When Used to Treat Relapsed/Refractory Myeloma. (Oral Session);
* Myelodysplastic Syndromes (Education Program)
Myelofibrosis with Myeloid Metaplasia:
* A Phase II Study of CC-5013 Treatment for Myelofibrosis with Myeloid
Metaplasia: A Preliminary Report. (Poster Session); Abstract #1505
Mechanism Of Action:
* Effect of REVLIMID on the Gene Expression That Reveals Molecular
Circuitries Involved in T Cell Co-Activation. (Poster Session)
* Inhibition of Wnt Pathway Signaling by REVLIMID: Studies in a
Drosophila Model System. (Poster Session); Abstract #3356
* Enhanced Cytotoxicity of monoclonal Antibody SGN-40 and
Immunomodulatory Drug IMiD3 Against Human Multiple Myeloma. (Poster
Session); Abstract #1498
REVLIMID and ACTIMID are members of a new class of novel immunomodulatory drugs, or IMiDs which may demonstrate, in clinical studies, anticancer response. Nearly 30 clinical trials are evaluating REVLIMID in the treatment of a broad range of conditions, including; multiple myeloma, myelodysplastic syndromes (MDS) as well as solid tumor cancers. IMiDs are believed to affect multiple biological pathways within the cell, which ultimately may be responsible for the clinical response observed in multiple cancer studies. The IMiD pipeline, including REVLIMID, ACTIMID and CC-11006 are covered by a comprehensive intellectual property estate of U.S. and foreign issued patents and pending patent applications including composition-of-matter and use patents.
REVLIMID (lenalidomide), ACTIMID and CC-11006 are not approved by the FDA or any other regulatory agencies as a treatment in any indication and are 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 median 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 Multiple Myeloma
Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease. However, most patients with multiple myeloma have cells that produce a form of immunoglobulin called paraprotein (or M protein) that does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease is unknown.
Multiple myeloma is the second most common cancer of the blood, representing approximately one percent of all cancers and two percent of all cancer deaths with a worldwide prevalence of approximately 200,000 cases. In the year 2002, there were an estimated 74,000 new cases of multiple myeloma worldwide. The estimated number of deaths from multiple myeloma in 2002 was 57,370 worldwide.
Celgene Corporation, headquartered in Warren, 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 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.
CONTACT: Robert J. Hugin, Senior VP and CFO, or Brian P. Gill, DirectorPR/IR, both of Celgene Corporation, +1-732-271-1001
Web site: http://www.celgene.com/