PRNewswire - November 30, 2004

WARREN, N.J., Nov. 30 /PRNewswire-FirstCall/ -- Celgene Corporation (Nasdaq: CELG) announced today that clinical investigators from leading cancer research centers will present data from recent and on-going clinical trials of thalidomide in newly diagnosed as well as all stages of multiple myeloma at the American Society of Hematology 46th Annual Meeting, one of the largest oncology meetings in the world, in San Diego, CA from December 3-7, 2004. Furthermore, investigators will discuss and present data on thalidomide being evaluated as a single agent or in combination therapy for multiple hematological cancers and malignant blood disorders.

The following clinical research abstracts on thalidomide will be presented in oral or poster sessions as an exchange of scientific and clinical information being presented by clinical investigators at the American Society of Hematology proceedings. The listing of these abstract titles do not represent or imply that THALOMID(R) is a safe or effective treatment in these diseases. THALOMID is not approved by the Food and Drug Administration or any other regulatory authorities as a treatment in these diseases.

Amyloidosis:

-- Risk-adapted Intravenous Melphalan (M) Followed by Adjuvant Dexamethasone (D) and Thalidomide (T) for Newly Diagnosed Patients with Systemic AL Amyloidosis (AL): Interim Results of a Phase II Study; Abstract #0542

-- Low Dose Single Agent Thalidomide Is Tolerated in Patients with Primary Systemic Amyloidosis, but Responses Are Limited; Abstract #4920

Lymphoma

-- Phase II Study of Thalidomide in Escalating Doses for Follicular (F- NHL) and Small Lymphocytic Lymphoma (Sll): CALGB Study 50002; Abstract #3284

Myelodysplastic Syndromes (MDS):

-- Thalidomide for the treatment of low risk myelodysplasia. The Thal-SMD- 200 trial from the French Group of Myelodysplasia (GFM); Abstract #1438

-- Arsenic trioxide (Trisonex(R)) with/without thalidomide in patients with Myelodysplastic Syndromes (MDS) produces Hematologic Improvement (HI); Abstract #4710

Myelofibrosis with Myeloid Metaplasia (MMM):

-- Phase II Study of the Combination of Low-Dose Thalidomide, Prednisone, and Etanercept (PET regimen) in the Treatment of Anemia, Splenomegaly, and Constitutional Symptoms Associated with Myelofibrosis with Myeloid Metaplasia (MMM); Abstract #1520

Safety

-- FDA Policies Should Be Amended To Allow Pharmaceutical Manufacturers To Disseminate Information Regarding Potentially Fatal Toxicities That Occur with Off-Label Use of Oncology Agents: A Policy Recommendation Based on Review of Thalidomide-Associated Thromboembolism Cases by the RADAR Project; Abstract #0265

-- Safety of Total Therapy III for Newly Diagnosed Multiple Myeloma: Preliminary Analysis of 62 Consecutive Patients; Abstract #0935

-- Newly Diagnosed Myeloma Patients Are at Risk of Venous Thrombotic Events -- High Risk Patients Need To Be Identified and Receive Thromboprophylaxis: The MRC Experience; Abstract #2395

-- Aspirin Decreases the Thrombotic Complications (DVT) of Liposomal Doxorubicin, Vincristine, Decreased Frequency Dexamethasone and Thalidomide (DVd-T) Treatment of Multiple Myeloma (MM); Abstract #2397

-- Avascular Necrosis of Bone after Therapy for Multiple Myeloma: A Study of 561 Consecutive Patients; Abstract #3467

-- Thalidomide-Induced Peropheral Neuropathy in Newly Diagnosed and Pre- Treated Multiple Myeloma Patients; Abstract #4898

-- Protective Effect of VELCADE(R) on Thalidomide-Associated Deep Vein Thrombosis (DVT); Abstract #4914

Multiple Myeloma (MM):

-- Total Therapy 3 (TT 3) for newly diagnosed myeloma, incorporating Velcade into remission induction with DT PACE: early results regarding efficacy, PBSC mobilization and toxicities; Abstract #538

-- Thalidomide Plus Dexamethasone Versus Dexamethasone Alone in Newly Diagnosed Multiple Myeloma (E1A00): Results of a Phase III Trial Coordinated by the Eastern Cooperative Oncology Group; Abstract #0205

-- Randomized Clinical Trial Comparing Melphalan-Prednisone (MP), MP- Thalidomide (MP-THAL) and High-Dose Therapy Using Melphalan 100 MG/M(2) (MEL100) for Newly Diagnosed Myeloma Patients Aged 65-75 Years. Interim Analysis of the IFM 99-06 Trial on 350 Patients; Abstract #0206

-- A prospective randomized trial of oral melphalan, prednisone, thalidomide (MPT) vs oral melphalan, prednisone (MP): an interim analysis; Abstract #0207

-- VTD (Velcade, Thalidomide, Dexamethasone) as Primary Therapy for Newly- Diagnosed Multiple Myeloma; Abstract #0210

-- Results of A Multi-Center Randomized Phase II Trial of Thalidomide and Prednisone Maintenance Therapy For Multiple Myeloma Following Autologous Stem Cell Transplant; Abstract #0335

-- Maintenance Treatment with Thalidomide after Autologous Transplantation for Myeloma: First Analysis of a Prospective Randomized Study of the Intergroupe Francophone du Myelome (IFM 99 02); Abstract #0535

-- Total Therapy 2 (TT 2) for newly diagnosed patients with multiple myeloma (MM): examination of dose effect of thalidomide (T) among those randomized to T; Abstract #0934

-- Marked activity of Velcade plus thalidomide (V+T) in advanced and refractory multiple myeloma (MM); Abstract #1480

-- Primary Treatment with Pulsed Melphalan, Dexamethasone, Thalidomide (MDT) for Symptomatic Patients with Multiple Myeloma less than or equal to 75 Years of Age; Abstract #1482

-- Management of patients with multiple myeloma (MM) failing Total Therapy 2 (TT 2) according to thalidomide (THAL) randomization; Abstract #1483

-- Superiority of First-Line Thalidomide-Dexamethasone over Vincristine- Doxorubicin-Dexamethasone in Preparation for Autologous Stem Cell Transplantation for Multiple Myeloma; Abstract #1489

-- Combination Chemotherapy with Cyclophosphamide, Thalidomide and Dexamethasone Achieves a High Response Rate in Patients with Newly Diagnosed, VAD-Refractory and Relapsed Myeloma; Abstract #1499

-- Low Dose Thalidomide and Donor Lymphocyte Infusion as Adoptive Immunotherapy after Allogeneic Stem Cell Transplantation in Patients with Multiple Myeloma; Abstract #1646

-- Thalidomide and Dexamethasone Is an Effective Salvage Regimen for Myeloma Patients Relapsing after Autologous Transplant; Abstract #2396

-- Bortezomib (Velcade(TM)) + Adriamycin(TM) + Thalidomide + Dexamethasone (VATD) as an Effective Regimen in Patients with Refractory or Relapsed Multiple Myeloma (MM); Abstract #2399

-- Phase II Trial of Oblimersen Sodium (G3139), Dexamethasone (Dex) and Thalidomide (Thal) in Relapsed Multiple Myeloma Patients (Pts); Abstract #2400

-- Doxorubicin and Dexamethasone Followed by Thalidomide and Dexamethasone (AD-TD) as Initial Therapy for Symptomatic Patients with Multiple Myeloma; Abstract #2409

-- t(4;14) Positive Multiple Myeloma Is Chemosensitive to Dexamethasone and/or Thalidomide but Not Alkylating Agents: Rapid Relapse and Not Primary Drug Resistance Explains Poor Outcomes; Abstract #2417

-- A Phase II Study of Velcade (V), Doxil (D) in Combination with Low-Dose Thalidomide (T) as Salvage Therapy for Patients (pts) with Relapsed (rel) or Refractory (ref) Multiple Myeloma (MM) and Waldenstorm Macroglobulinemia (WM): Encouraging Preliminary Results; Abstract #2421

-- VAD-t (vincristine, adriamycin, dexamethasone and low-dose thalidomide) is an effective initial therapy with high response rates for patients with treatment naive multiple myeloma (MM); Abstract #3463

-- Bendamustine in Combination with Thalidomide and Prednisolone (BPT) in Patients with Refractory or Relapsed Multiple Myeloma (MM): Preliminary Results of a Phase I Clinical Trial; Abstract #4901

-- No Influence of Previous Thalidomide Administration on Peripheral Blood Stem Cell Collection in Patients with Multiple Myeloma; Abstract #4902

-- Low Dose Dexamethasone and Thalidomide with Higher Frequency Zoledronic Acid (dtZ) for Multiple Myeloma; Abstract #4915

-- The Clinical Characteristics and Therapeutic Status of Multiple Myeloma in China -- a 23 Years Retrospective Analysis in One Single Center; Abstract #4919

-- Intermittent Low Doses of Thalidomide in the Maintenance Treatment of Multiple Myeloma; Abstract #4927

-- First-Line Treatment of Multiple Myeloma with a Combination of Thalidomide, Dexamethasone, and Zoledronate (TDZ) in an Inner-City Population with High HIV Prevalence; Abstract #4932

-- Thalidomide +/- Corticosteroids for the Treatment of Multiple Myeloma Patients less than or equal to 70 Years of Age; Abstract #4934

-- Effect of the Proteasome Inhibitor Bortezomib in Combination with "DT- PACE" on Stem Cell Collection and Engraftment in Newly Diagnosed Multiple Myeloma (MM) Patients (Pts); Abstract #5007

-- Collection of Peripheral Blood Stem Cells in 668 Patients with Multiple Myeloma Treated on Total Therapy II (UARK 98-026); Abstract #5236

Chronic Lymphocytic Leukemia:

-- Thalidomide (T) in combination with Fludarabine (F) as initial therapy for patients (pts) with treatment naive chronic lymphocytic leukemia (CLL): Results of a phase I trial; Abstract #3476

-- Thalidomide is active alone and in combination with fludarabine in fludarabine-relapsed and refractory chronic lymphocytic leukemia; Abstract #4835

Waldenstrom's

-- Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia; Abstract #1484

In -- Vitro:

-- Effect of Thalidomide and Revlimid on the Gene Expression That Reveals Molecular Circuitries Involved in T Cell Co-Activation; Abstract #2472

-- Inhibition of Wnt Pathway Signaling by Thalidomide and Revlimid: Studies in a Drosophila Model System; Abstract #3356

-- An Experimental Study of Gene Expressing Profile in Human Myeloma Cell Line RPMI8226 Induced by Thalidomide; Abstract #4357

Safety Notice

If thalidomide is taken during pregnancy, it can cause severe birth defects or death to an unborn baby. Thalidomide should never be used by women who are pregnant or who could become pregnant while taking the drug. Even a single dose, one capsule (50 mg, 100 mg and 200 mg), taken by a pregnant woman can cause severe birth defects. Because thalidomide is present in the semen of male patients, males receiving thalidomide must always use a latex condom during sexual contact with women of childbearing potential even if he has undergone a successful vasectomy. Thalidomide can only be marketed under a special restricted distribution program. This program is called the "System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.(R)). Under this program, only registered prescribers and pharmacists may dispense the drug. In addition, patients must be advised of, agree to and comply with the requirements of S.T.E.P.S.

Thalidomide is known to cause nerve damage that may be permanent. Peripheral neuropathy is a common, potentially severe, side effect of treatment with thalidomide that may be irreversible. Patients with neoplastic and various inflammatory conditions being treated with thalidomide in combination with other agents may have an increased incidence of thromboembolic events such as pulmonary embolism, deep vein thrombophlebitis, thrombophlebitis, or thrombosis. Decreased white blood cell counts, including neutropenia, have been reported in the clinical use of thalidomide. In placebo controlled clinical trials of HIV-seropositive patient populations, there have been reports of increased plasma HIV RNA levels associated with thalidomide therapy. The most common adverse events observed in clinical use in ENL and HIV-seropositive patient populations are rash, maculo-papular rash, drowsiness/somnolence, peripheral neuropathy, dizziness/orthostatic hypotension, neutropenia, and increased HIV-viral load. Patients should be advised about these associated adverse events and routinely monitored by a physician during treatment with thalidomide. Patients should be instructed to not extensively handle or open thalidomide capsules and to maintain storage of capsules in blister packs until ingestion.

About THALOMID

THALOMID (thalidomide), manufactured by Celgene Corporation, received U.S. Food and Drug Administration (FDA) clearance on July 16, 1998 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. Thalidomide is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis. Thalidomide currently has a pending regulatory application (NDA) under review by the Food and Drug Administration (FDA) to confirm efficacy and safety for use in multiple myeloma, thalidomide is not presently indicated or approved by the FDA for use in the disease or any other related cancer.

About Celgene

Celgene Corporation, headquartered in Warren, New Jersey, is a fully integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel 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.

SOURCE Celgene Corporation

Web Site: http://www.celgene.com

041130
PR041143

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2004. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .