Idera Announces FDA Orphan Drug Designation for IMO-8400 for the Treatment of Diffuse Large B-Cell Lymphoma
8:30 AM ET, 04/01/2015 - GlobeNewswire
CAMBRIDGE, Mass. and EXTON, Pa., April 1, 2015 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (Nasdaq:IDRA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for oncology and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for IMO-8400, an antagonist of the endosomal Toll-like receptors (TLRs) 7, 8 and 9, for the treatment of diffuse large B-cell lymphoma (DLBCL).
Idera is currently conducting a clinical trial of IMO-8400 in patients with relapsed or refractory DLBCL harboring MYD88 L265P oncogenic mutation (ClinicalTrials.gov identifier NCT02252146). Preclinical studies have shown that in B-cell lymphomas characterized by the MYD88 L265P oncogenic mutation, including DLBCL, TLR signaling is over-activated, thereby enabling tumor cell survival and proliferation. As a TLR antagonist, IMO-8400 inhibits TLR signaling.
The objectives of the trial are to evaluate the compound's safety, tolerability and clinical activity. The protocol includes three dose-escalation cohorts of IMO-8400 administered subcutaneously.
"The Orphan Drug designation granted today represents another positive milestone for our B-Cell Lymphoma clinical development program," stated James J. O'Leary, MD, Idera's interim Chief Medical Officer. "We continue to advance our efforts in DLBCL, as well as our ongoing clinical trial in Waldenstrom's macroglobulinemia (WM), which we expect to complete and have full data available in the fourth quarter of this year."
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