Medarex Initiates Phase I Clinical Trial of MDX-010 in HIV
Wednesday June 11, 6:00 am ET
PRINCETON, N.J., June 11 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) today announced the initiation of a Phase I clinical trial of MDX-010, a fully human anti-CTLA-4 antibody, for patients infected with HIV, the causative agent of AIDS.
This multi-center, open-label clinical trial is expected to enroll up to 18 patients with HIV who have an extensive treatment history but whose virus is no longer suppressed by highly active antiretroviral therapy (HAART). Patients are expected to receive two monthly doses of the MDX-010 antibody in this dose-escalation study. The trial is designed to establish safety and tolerability of MDX-010 in patients infected with HIV, and to preliminarily evaluate clinical efficacy. The trial will include assessments of viral load and CD4 counts in patients, as well as immune responses to HIV and other antigens.
"We believe that MDX-010 is showing promise in cancer treatment, and that it may also have the potential to enhance the immune systems of AIDS patients," said Donald L. Drakeman, President and CEO of Medarex.
"The ability to boost the potency of the cellular immune response against HIV could be crucial in allowing patients to control the virus with their own immune systems," said Israel Lowy, M.D. Ph.D., Director of Infectious Diseases at Medarex. "If MDX-010 can boost anti-HIV immunity, this may allow patients to require less medication, or perhaps be weaned from the necessity of lifelong HAART, with its attendant challenges of treatment toxicities and requirements for strict adherence."
About MDX-010 and HIV
CTLA-4 is believed to be an important molecule in regulating an immune response. Expressed on CD4 and CD8 T cells, CTLA-4 is believed to be responsible for suppressing the defensive activities of these T cells against disease or infectious agents. In HIV-infected patients, where T cell response is poor in controlling the virus, excess amounts of CTLA-4 have been found on the T cells; this overexpression of CTLA-4 may facilitate susceptibility to the HIV virus and contribute to the immune suppression found in AIDS patients. Pre-clinical studies have shown that blocking CTLA-4 with an antibody can lead to potent immune responses to various types of viruses, bacteria and cancer.
MDX-010 is a fully human anti-CTLA-4 antibody. By blocking the suppressive activity of CTLA-4 in HIV-infected patients, MDX-010 may enhance an anti-HIV immune response and the ability to control HIV.
According to the Centers for Disease Control, at the end of 2001 there were 160,000 people in the U.S. living with HIV infection and 342,000 living with AIDS.
About MDX-010 and Cancer
The use of MDX-010 to block CTLA-4 also has the potential to enable the immune systems of cancer patients to more effectively fight tumors. MDX-010 is currently in multiple Phase II clinical trials to test the product for use in patients with melanoma and prostate cancer. A webcast presentation discussing the potential use of MDX-010 to treat cancer can be found at www.medarex.com/Investor/Webcasts.htm. |
