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December 4, 2013
07:32 EDTIDRAIdera Pharmaceuticals opens enrollment for Phase 1/2 IMO-8400 trial
Idera Pharmaceuticals announced that enrollment is open for a Phase 1/2 clinical trial of IMO-8400 in patients with Waldenström’s macroglobulinemia, following acceptance of its Investigational New Drug application by the U.S. Food and Drug Administration. The objectives of the trial are to evaluate the compound’s safety, tolerability, and potential clinical activity. The IND application for the Phase 1/2 trial was supported by preclinical research conducted by Idera, which the company intends to present at one or more scientific meetings in 2014. The IND was further supported by clinical safety data from a Phase 1 trial of IMO-8400, in which dosages up to 0.6 mg/kg were well-tolerated and inhibited immune responses mediated through TLR7, TLR8, and TLR9. The Phase 1/2 clinical trial will enroll patients with Waldenström’s macroglobulinemia who have a history of relapse or failure to respond to one or more prior therapies. The protocol includes three dose-escalation cohorts to evaluate the safety and tolerability of IMO-8400 and a provision to expand enrollment at selected dose levels to allow further evaluation of clinical activity. Idera expects to enroll a total of approximately 30 patients. Idera previously announced that it intends to submit a protocol to the FDA to conduct a Phase 1/2 trial in patients with diffuse large B-cell lymphoma in the first quarter of 2014.
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April 22, 2014
12:00 EDTIDRAIdera Pharmaceuticals rises 16.2%
Idera Pharmaceuticals is up 16.2%, or 46c, to $3.30

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