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Two JDRF Autoimmunity Treatments Fail in Phase III Trials | Scientific Studies & Research | Diabetes Living Today® ~ No Sugar Added® Open Forums
Post edited 2:50 pm – March 13, 2011 by Scott Strumello
As you may know, the Juvenile Diabetes Research Foundation (JDRF) has invested considerable resources in industry partnerships that are meant to bring advancements in treatments and/or cure-related therapies to market. When it comes to research categories, autoimmunity treatments designed to "re-train" the body's immune system to make it "self-tolerant" of the insulin-producing beta cells. (see JDRF's "Industry Partnerships" page at http://www.jdrf.org/index.cfm?….._id=111304 for more details)
Not all investments will pan out, but two of the most advanced autoimmunity treatments both failed in late-stage clinical trials. In October 2010, the Macrogenics/Lilly drug called teplizumab failed, and in March 2011, a similar treatment from Tolerx/GlaxoSmithKline also failed. The news for these items are at the following links:
MacroGenics And Lilly Announce Pivotal Clinical Trial Of Teplizumab Did Not Meet Primary Efficacy Endpoint
What does anyone think of these failures? For example, does JDRF have in it's contracts with these companies that all study results will be shared with the organization so that we can learn whether the treatments worked in certain populations? Were the efficacy endpoints, particularly for the Macrogenics/Lilly drug appropriate measures — for example, a lower HbA1c is not necessarily a measure of a fully-funtioning beta cell, especially for the limited study duration — some critics have said that C-Peptide alone was the only appropriate measure. Regardless, the Tolerx/GSK drug failed on that, too.