Tuesday October 30, 6:01 am Eastern Time
Press Release
SOURCE: Medarex, Inc.
Medarex Reports Interim Findings of Ongoing Phase I/II Clinical Trials of Fully Human Antibody for Melanoma and Prostate Cancer
Initial Results of First Human Clinical Trial Using MDX-010 Announced
PRINCETON, N.J., Oct. 30 /PRNewswire/ -- Medarex, Inc. (Nasdaq: MEDX - news) today reported interim findings of ongoing Phase I/II clinical trials of a fully human antibody product, MDX-010, in patients with advanced melanoma or prostate cancer. The findings were presented at the Strategic Research Institute Anti-Cancer Drug Discovery and Development Summit held last week in San Francisco, CA.
In the initial human clinical trials, 18 patients with metastatic melanoma and 14 patients with hormone refractory prostate cancer received a single 3 mg/kg dose of the antibody. The data indicate that the product was generally well tolerated. Of adverse events reported, more than 97% were mild to moderate (grade 1 and 2). Signs of immunologic activity included tumor necrosis, inflammatory reactions at tumor sites and relief of symptoms. In addition, after receiving a single dose of MDX-010, two patients with prostate cancer experienced a greater than 50% reduction in serum prostate specific antigen (PSA) measurement that lasted from 3 to 6 months. PSA levels are generally considered to be a marker of disease progression in prostate cancer patients. Based upon this experience, further clinical trials are being initiated that will test repeated dosing of the antibody used alone, as well as combinations of the antibody and other anti-cancer therapies.
``Although these initial single dose trials were designed to test primarily for safety, we are excited that the interim results also showed evidence of anti-tumor activity,'' said Donald L. Drakeman, President and CEO of Medarex.
MDX-010 (formerly MDX-101) 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.
Medarex, Inc. is a biopharmaceutical company developing monoclonal antibody-based therapeutics to fight cancer and other life-threatening and debilitating diseases. Medarex has assembled a broad platform of patented technologies for antibody discovery and development, including the UltiMAb Human Antibody Development System(SM) for the creation of high-affinity, fully human antibodies; T-12 Development(SM) offering the potential to move from target to trial in approximately 12 months; and Trans-Phage Technology(SM) combining high throughput screening with fully human antibody development. 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 . |
