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Tuesday May 21, 6:18 pm Eastern Time
Press Release
SOURCE: Medarex, Inc.
Medarex Announces Promising Results of Phase 1/2 Studies of MDX-010 Fully Human Antibody in Metastatic Melanoma and Prostate Cancer
Clinical Results Presented at the American Society of Clinical Oncology Annual Meeting
PRINCETON, N.J., May 21 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) today announced the results of a single dose clinical trial of MDX-010 in which tumor reductions were observed in patients with metastatic melanoma and in patients with hormone refractory prostate cancer. All patients received a single dose of three mg/kg of MDX-010, a fully human monoclonal antibody that blocks CTLA-4, which is a receptor on T- cells responsible for suppressing the immune response. These results were presented earlier today at the Annual Meeting of the American Society of Clinical Oncology.
Of the 17 metastatic melanoma patients, two patients achieved partial responses, per the RECIST (Response Evaluation Criteria In Solid Tumors) definition: one patient experienced a decrease of greater than 90% of tumor volume, lasting over five months; a second patient experienced a decrease of greater than 60% of tumor volume lasting over five months. A third patient achieved a minor response, defined as tumor shrinkage of less than a partial response, lasting for three months. In addition, two patients experienced stable disease lasting four months. Additional mixed responses were seen. Of the 17 patients treated in the Phase 1/2 trial with a single dose of MDX-010, nine had failed prior immunotherapy and five had failed prior chemotherapy.
MDX-010 was also studied in 14 patients with hormone refractory prostate cancer (HRPC). After receiving a single dose of MDX-010, two of seven patients who were chemotherapy naive experienced a greater than 50% reduction in serum prostate specific antigen (PSA) measurement that lasted from three to five months, and one patient with bone pain experienced significant improvement in his symptoms. An elevated PSA level is considered a marker of disease burden in prostate cancer patients.
The data indicated that the product was generally well tolerated. Across both studies, mild to moderate adverse events, including a rash or itching, were experienced by 11 (35%) patients. Further signs of immunologic activity directed at tumors included tumor necrosis, inflammatory reactions at tumor sites and immune mediated rash.
"Although the purpose of this trial was to evaluate the safety of MDX-010, we are extremely pleased that the data also indicated that a single dose of the antibody alone could induce tumor regression in some patients without requiring repeated doses in combination with other agents. It is encouraging that one dose of MDX-010 showed signs of activating the immune system and that none of the patients in this study experienced serious adverse events. It is remarkable that a cancer product is able to induce some partial tumor regressions with a single dose. We are eager to see the results of this product from the next phase studies," said Thomas A. Davis, M.D., Senior Director of Clinical Science at Medarex.
"We are excited that this initial trial of MDX-010 has led to such promising signs of tumor regression in metastatic melanoma and prostate cancer," said Donald L. Drakeman, President and CEO of Medarex. "Based on these results we believe that MDX-010 has the potential to play a pivotal role in a variety of cancer treatments we are actively pursuing."
Medarex will conduct a live webcast to discuss these studies on Wednesday, May 22, 2002 at 4:30 PM Eastern time. The webcast may be accessed through the Company's website at www.medarex.com. Investors interested in listening to the webcast should log on before the presentation begins in order to download any software required. An archive version will be available on the Medarex website for at least 14 days. An audio replay will be available until midnight Eastern time, June 5, 2002. The audio archive may be accessed by dialing 1-800-428-6051 within the U.S. or 1-973-709-2089 outside the U.S.
About MDX-010
MDX-010 is a fully human antibody against human CTLA-4, a molecule on T cells that is responsible for suppressing the immune response. Studies in mice have demonstrated that an antibody against CTLA-4 is able to strengthen the innate immune response against certain tumors, leading to the reduction of and, in some cases, the elimination of well-established tumors. In preclinical research, MDX-010 has been shown to enhance immune responses and prevent tumor growth.
According to the American Cancer Society, cancer of the skin is the most common of all cancers. Melanoma accounts for about 4% of skin cancer cases, but it causes about 79% of skin cancer deaths. The American Cancer Society estimates that in 2002 there will be about 53,600 new cases of melanoma in the United States, and about 7,400 people will die of this disease.
According to the American Cancer Society, other than skin cancer, prostate cancer is the most common type of cancer found in American men and is the second leading cause of cancer deaths in men, exceeded only by lung cancer. The American Cancer Society estimates that in 2002 there will be about 189,000 new cases of prostate cancer in the United States, and about 30,200 men will die of the disease.
Medarex is a biopharmaceutical company focused on the discovery and development of therapeutics to treat life-threatening and debilitating diseases. Medarex's UltiMAb Human Antibody Development System(SM) is a unique combination of human antibody technologies that the Company believes enables the rapid creation and development of fully human antibodies to a wide range of potential disease targets for therapeutic antibody products, including products for the treatment of cancer, inflammation, autoimmune and infectious diseases. Medarex's product pipeline is based on a variety of therapeutic antibody products developed through the use of its UltiMAb technology. Medarex creates and develops fully human antibodies for itself and others, offering a full range of antibody related capabilities, including pre-clinical and clinical development supported by cGMP manufacturing services. For more information about Medarex, visit its website at www.medarex.com.
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"; "believes"; "anticipates"; "intends"; "plans"; "expects"; "estimates"; 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 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, 2001 and subsequent Quarterly Reports on Form 10-Q. There can be no assurance that such development efforts will succeed, that such 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, UltiMAb(TM) and UltiMAb Human Antibody Development System(SM) are trademarks and service marks of Medarex, Inc. All rights are reserved.
SOURCE: Medarex, Inc. |
