Metastatic Melanoma - Complete and Partial Responses Observed in Phase I/II Clinical Study of MDX-010 in Combination with Il-2

Main Category: Melanoma / Skin Cancer
Article Date: 07 Mar 2005 - 11:00 PDT

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Medarex, Inc (Nasdaq: MEDX) and Bristol-Myers Squibb (NYSE: BMY) announced today results of an early clinical study with the investigational fully human anti-CTLA-4 antibody, MDX-010, in which eight of 36 patients with metastatic melanoma experienced objective clinical responses (three complete responses and five partial responses). Results from the Phase I/II clinical trial were presented at the 58th Annual Cancer Symposium of the Society of Surgical Oncology, March 3-6, 2005, in Atlanta, GA.

In the Phase I/II clinical trial, patients received MDX-010 every three weeks, with three patients per dose level at 0.1, 0.3, 1.0 and 2.0 mg/kg. Twenty-four patients received 3.0 mg/kg of MDX-010. In addition to receiving antibody, all patients received high dose IL-2 therapy.

Of the eight patients who experienced objective tumor regression, two patients in the 3.0mg/kg cohort experienced complete responses that are ongoing at over 13 months, and one patient in the 2.0 mg/kg cohort experienced a complete response that is ongoing at over 16 months. Five patients experienced partial responses, with responses ranging from seven months to the longest duration ongoing at over 19 months.

Five patients in the clinical study reported Grade III/IV adverse events, including colitis and uveitis, that were consistent with the immune-based mechanism of action, as well as pancreatitis, arthritis and laryngospasm. All patients recovered without sequelae.

About MDX-010

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. MDX-010 also has the potential to enable the immune systems of cancer patients to fight tumors. MDX-010 is currently in a Phase III clinical trial for metastatic melanoma and in multiple Phase II clinical trials to test the product activity in other tumor types. The potential use of MDX-010 outside oncology is also being explored. Further information regarding Medarex's MDX- 010 program can be found in Medarex's public disclosure filings with the U.S. Securities and Exchange Commission (SEC).

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.

About Medarex

Medarex is a biopharmaceutical company focused on the discovery and development of fully human antibody-based therapeutics to treat life- threatening and debilitating diseases, including cancer, inflammation, autoimmune 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 products for itself and its partners. Twenty-two of these therapeutic products derived from Medarex technology are currently in human clinical testing, with the most advanced product presently in a Phase III clinical trial. 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 http://www.medarex.com.

For Bristol-Myers Squibb: This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. Among other risks, there can be no guarantee that MDX- 010 will be submitted for regulatory approval, will receive regulatory approval, or, if approved, will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol- Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2004 and in our Quarterly Reports on Form 10-Q. Bristol-Myers Squibb undertakes no obligation to publicly update any forward- looking statement, whether as a result of new information, future events or otherwise.

For Medarex: 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 MDX-010 and/or IL-2 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, 2003 and subsequent Quarterly Reports on Form 10-Q. There can be no assurance that such development efforts will succeed, that MDX-010 or 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, Inc.; Bristol-Myers Squibb
http://http://www.medarex.com

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