New Phase 1 trial

A board to discuss future MS therapies in early stage (Phase I or II) trials.

New Phase 1 trial

Postby dignan » Wed May 11, 2005 6:36 am

OK, techinically this trial is for ulcerative colitis, but they mention that their pre-clinical work suggested a number of potential targets for this drug, including MS...plus it's a monoclonal antibody and those are attracting a lot of attention these days, so I thought it was worth posting.


Medarex Announces Phase I Clinical Trial of MDX-1100, a Fully Human Anti-IP10 Antibody, for the Treatment of Ulcerative Colitis

May 11, 2005 - PRNewswire-FirstCall - Medarex, Inc. today announced the allowance of an Investigational New Drug (IND) application filed with the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical trial for MDX-1100, a fully human monoclonal antibody that targets IP-10 (also known as CXCL10), for the treatment of ulcerative colitis. IP-10 is a chemokine that that is associated with the pathogenesis of multiple inflammatory diseases, including ulcerative colitis.

The multi-center, single-dose, dose-escalation Phase I clinical trial is expected to enroll up to 32 patients with ulcerative colitis. The trial is designed to collect safety and initial efficacy data. Subject to patient enrollment, data from the Phase I clinical trial is expected in the second half of 2006.

"We are pleased to see MDX-1100, the twenty-third UltiMAb(R)-derived antibody product candidate, enter into the clinic," said Donald L. Drakeman, President and CEO of Medarex. "We believe that by targeting IP-10, MDX-1100 has the broad potential to address multiple autoimmune and inflammatory diseases."

About MDX-1100

MDX-1100 is a fully human antibody that is designed to target IP-10 (also known as CXCL10), a chemokine involved in the migration of activated T cells and monocytes into sites of inflammation and associated with multiple autoimmune disorders and inflammatory diseases such as rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease. Preclinical studies demonstrate that antibodies targeting IP-10 neutralize the effects of IP-10 and attenuate disease progression in animal models of ulcerative colitis and inflammatory bowel disease, as well as multiple sclerosis and rheumatoid arthritis.

Medarex acquired full rights to MDX-1100 as part of its acquisition of Ability Biomedical Corporation in August 2004.

About Medarex

Medarex is a biopharmaceutical company focused on the discovery, development and potential commercialization of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune disorders and infectious diseases. Medarex applies its UltiMAb 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-three of these therapeutic products derived from Medarex technology are currently in human clinical testing, with two of the most advanced products presently in Phase III clinical trials. Medarex is committed to building value by developing a diverse pipeline of antibody products to address the world's unmet healthcare needs.

http://www.pharmalive.com/News/index.cf ... egoryid=21
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Postby DenverCO » Thu Jul 28, 2005 7:24 pm

From what I've read, this drug was developed with MS primarily in mind but they chose ulcerative colitis for the Phase I trial because the endpoints of the study are more attainable. I interpreted that to mean that there are fewer wierd disease variables to cloud the study results.
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Postby dignan » Fri Jul 29, 2005 8:25 am

That's interesting info. I guess anything that establishes a drug's safety fast is a good thing since you only need to do one phase I study, then you can move on to doing phase II studies of as many things as you can justify to the regulator.
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