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Medarex, Inc. Release: Ipilimumab (MDX-010) Safety And Clinical Response Data In Lymphomas And Leukemia Presented At The 48th American Society of Hematology Annual Meeting

Published: Dec 12, 2006

PRINCETON, N.J., Dec. 11 /PRNewswire-FirstCall/ -- Medarex, Inc. today announced safety and response data in patients treated with ipilimumab (also known as MDX-010) for lymphomas and leukemia from two separate Phase I and Phase I/II clinical trials. These data were presented during the 48th American Society of Hematology (ASH) Annual Meeting and Exposition, December 9-12, 2006, in Orlando, FL.

Oral Presentation Reports Clinical Responses from Ipilimumab Phase I Trial in Patients Failing Bone Marrow Transplant (Abstract #410)

In a single dose, dose-escalation Phase I trial of ipilimumab, complete or partial responses were observed in two of 17 patients who were treated with ipilimumab after relapse of their tumor following allogeneic hematopoietic stem cell transplantation. One patient with Hodgkin's lymphoma experienced a complete response that is ongoing at over two months duration, and one patient with mantle cell Non-Hodgkin's lymphoma experienced a partial response of three months duration. Additional anti-tumor responses were experienced by two patients with leukemia, one in which circulating leukemic cells were reduced, and another who maintained molecular remission of chronic myeloid leukemia after stopping standard therapy (imatinib).

In the Phase I clinical trial, 17 patients with lymphomas (Hodgkin's, Non- Hodgkin's), myeloma, leukemia (chronic myeloid, chronic lymphocytic, acute myeloid), renal and breast cancers received a single dose of ipilimumab ranging from 0.1 mg/kg to 3.0 mg/kg. The data showed that the treatment was generally tolerable and without dose-limiting toxicities or clinically important graft-versus-host disease, an immune complication that may increase following transplantation. Two possible immune-related adverse events included one Grade II thyroid function test abnormalities (without clinical symptoms) and one Grade III polyarthropathy in a patient with acute myeloid leukemia following donor lymphocytic infusion, a treatment that can also cause this adverse event and which resolved with corticosteroids. Further studies with higher doses of ipilimumab are planned.

Poster Presentation Shows Response Data from Ipilimumab Phase I/II Trial in Patients with Relapsed or Refractory Follicular Lymphoma (Abstract #2729)

In an initial group of 12 patients with relapsed or refractory follicular lymphoma in an ongoing Phase I/II clinical trial, one patient of six who had been previously treated with a lymphoma vaccine experienced a partial response of multiple abdominal nodules that is ongoing at over ten months duration.

In the Phase I/II clinical trial, patients with relapsed or refractory follicular lymphoma received an initial dose of 3.0 mg/kg of ipilimumab, followed by 1.0 mg/kg of ipilimumab given monthly for up to three doses, with plans to escalate to 3.0 mg/kg of ipilimumab given monthly for up to four doses. Enrollment is stratified into two cohorts, with half of the patients required to be previously treated with a lymphoma vaccine. Results of this trial to date show that ipilimumab was generally tolerable. Six instances of Grade III adverse events were reported in the clinical trial, including diarrhea (four), fatigue (one) and neutropenia (one), all similar to adverse events previously reported with anti-CTLA-4 antibody therapy and consistent with the immune-based mechanism of action of ipilimumab. The second group of patients to be treated with 3.0 mg/kg of ipilimumab given monthly for four doses is currently enrolling patients.

"The encouraging data presented at the ASH meeting continue to support our belief that ipilimumab may represent a potentially new therapeutic with broad application in solid and liquid tumors," said Irwin Lerner, Chairman of the Board of Directors and Interim President and CEO of Medarex.

About ipilimumab

Ipilimumab (also known as MDX-010) is a fully human antibody against human CTLA-4, a molecule on T cells that is believed to be responsible for suppressing the immune response. Medarex and Bristol-Myers Squibb are investigating the potential of ipilimumab to enable the immune systems of cancer patients to help suppress tumor growth. Ipilimumab is currently in three separate registrational studies for metastatic melanoma as a second-line monotherapy treatment, as a first-line treatment in combination with dacarbazine, and as a second-line treatment in combination with a melanoma- peptide vaccine. Ipilimumab is also involved in multiple Phase II clinical trials to investigate the product's potential activity in other tumor types, as well as in combination studies with other chemotherapy, immunotherapy and vaccines. Further information regarding Medarex's ipilimumab program can be found in Medarex's public disclosure filings with the U.S. Securities and Exchange Commission (SEC).

About Medarex

Medarex is a biopharmaceutical company focused on the discovery, development and potential commercialization of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune disorders and infectious diseases. Medarex applies its UltiMAb(R) technology and product development and clinical manufacturing experience to generate, support and potentially commercialize a broad range of fully human antibody product candidates for itself and its partners. Thirty-four of these therapeutic product candidates derived from Medarex technology are in human clinical testing or have had INDs submitted for such trials, with six of the most advanced product candidates currently in Phase III clinical trials. Medarex is committed to building value by developing a diverse pipeline of antibody products to address the world's unmet healthcare needs. For more information about Medarex, visit its website at www.medarex.com.

Medarex Statement on Cautionary Factors

Except for the historical information presented herein, matters discussed herein may constitute forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including statements preceded by, followed by, or that include the words "potential"; "believe"; "anticipate"; "intend"; "plan"; "expect"; "estimate"; "could"; "may"; or similar statements are forward-looking statements. Medarex disclaims, however, any intent or obligation to update these forward-looking statements. Risks and uncertainties include risks associated with product discovery and development, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of ipilimumab in patients, uncertainties related to product manufacturing as well as risks detailed from time to time in Medarex's public disclosure filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the fiscal year ended December 31, 2005 and subsequent Quarterly Reports on Form 10-Q. There can be no assurance that such development efforts will succeed or that other developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. Copies of Medarex's public disclosure filings are available from its investor relations department.

Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks of Medarex, Inc. All rights are reserved.

Medarex, Inc.

CONTACT: Laura S. Choi, Investor Relations, +1-609-430-2880, x2216, orJean Mantuano, Corporate Communications (media), +1-609-430-2880, x2221,for Medarex, Inc.

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