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Biotech / Medical : MEDX ... anybody following? -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (619)	10/29/2002 6:32:44 AM
From: Icebrg	Read Replies (1) \| Respond to of 2240

Medarex Initiates Phase II Clinical Trials of MDX-010 for Metastatic Melanoma and Prostate Cancer Tuesday October 29, 6:03 am ET - Enrollment Completed in 2 Phase I/II Melanoma Trials - PRINCETON, N.J., Oct. 29 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) today announced the initiation of two Phase II clinical trials of MDX-010, one in patients with metastatic melanoma and one in patients with hormone refractory prostate cancer. The two randomized, multi-dose Phase II studies are designed to assess the potential anti-tumor activity of MDX-010. The metastatic melanoma Phase II trial will study MDX-010 both as a single agent and in combination with DTIC (dacarbazine). The trial is expected to initially accrue a total of 46 chemotherapy naive patients with metastatic disease. MDX-010 will be given in a regimen of four monthly intravenous infusions of 3.0 mg/kg alone or in combination with DTIC. Patients will be followed until tumor progression and will be evaluated based on objective tumor responses. The prostate cancer Phase II trial will study MDX-010 as a single agent and in combination with Taxotere® (docetaxel). The trial is expected to initially accrue 40 chemotherapy naive patients with hormone refractory prostate cancer. MDX-010 will be given in a regimen of four monthly intravenous infusions of 3.0 mg/kg alone or in combination with Taxotere. Patients will be followed until tumor progression and will be evaluated based on decreases in serum prostate specific antigen (PSA) and tumor regression as well as time to tumor progression. An elevated PSA level is considered a marker of disease burden in prostate cancer patients. These Phase II studies are in addition to Medarex's ongoing trials with MDX-010 in combination with three different melanoma vaccines. A Phase II trial of MDX-010 in combination with a melanoma peptide vaccine based on gp100 is open to accrue up to 55 patients with metastatic melanoma. In this trial patients receive MDX-010 every three weeks together with the melanoma peptide vaccine. A Phase I/II trial of MDX-010 in combination with a different melanoma peptide vaccine based on multiple melanoma antigens has completed the full enrollment of 19 patients with advanced resected melanoma. Medarex also has completed enrollment of all 14 patients in a Phase I/II study of MDX-010 in combination with the Melacine® vaccine for melanoma. "By releasing the immune system's emergency brake, we believe that MDX-010 has broad potential for the treatment of a variety of cancers," said Donald L. Drakeman, President and CEO of Medarex. "We look forward to the opportunity to test this novel product further in these Phase II clinical trials." Recent Clinical Data Phase I/II data presented earlier this year by Medarex at the American Society of Clinical Oncology (ASCO) meeting indicated that a single 3.0 mg/kg dose of MDX-010 alone may induce tumor regression in some patients with metastatic melanoma and hormone refractory prostate cancer. Of the 17 patients in the metastatic melanoma trial, two patients achieved partial responses, per the RECIST (Response Evaluation Criteria in Solid Tumor) definition, one of which experienced a decrease of greater than 90% of tumor volume lasting over five months. One patient achieved a minor response lasting four months, and two patients experienced stable disease lasting three months. Additional mixed responses were seen. Of the 14 patients in the hormone refractory prostate cancer trial, two of seven chemo-naive patients experienced a greater than 50% reduction in serum PSA measurement that lasted from five months, and one patient with bone pain experienced significant improvement in his symptoms. 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. 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 has the potential 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 Web site at medarex.com.