Idera Pharmaceuticals Shares Positive Results from Investigator-Sponsored Trial in Melanoma Patients at Amsterdam UMC
– Enrollment Stopped Early for Efficacy –
Excerpt from the Press Release:
EXTON, Pa., May 17, 2022 (GLOBE NEWSWIRE) — Idera Pharmaceuticals, Inc. (“Idera,” “we,” and “our”) (Nasdaq: IDRA) today shared positive interim results from Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands, regarding its investigator-sponsored trial, INTRIM 1, involving tilsotolimod, Idera’s synthetic Toll-like receptor 9 agonist. Based on these results, the trial has been stopped early.
INTRIM 1 is a randomized, double-blind, placebo-controlled Phase 2 trial among patients with localized, excised melanoma (pathological tumor stage 3-4) with no regional metastases detected and no evidence of distant metastasis. The trial involved a single, intradermal injection of 8 mg tilsotolimod or saline placebo given at the primary tumor excision site, followed by re-excision and sentinel lymph node (SLN) biopsy 7-10 days later. Noting that there were more patients with ulcerated lesions in the placebo arm compared to the tilsotolimod arm, topline interim results of the respective SLN-positivity rates showed a 70% lower SLN+ rate among patients injected with tilsotolimod as compared to those injected with placebo; the placebo SLN+ rate was in the mid-40%s. Statistical significance exceeded the pre-specified p-value of 0.008. Adverse reactions included injection site reactions, malaise, fever and flu-like symptoms.
“This is an exciting result from tilsotolimod, and we are pleased for the patients and their families to whom it offers hope for the future,” said Vincent Milano, Idera’s Chief Executive Officer. “These results, together with data supporting tilsotolimod’s mechanism of action and encouraging safety profile from across the array of earlier pre-clinical and clinical work, reinforce the potential of tilsotolimod to offer benefit to patients with certain cancers. As a result, we plan to actively pursue a strategic partnership for tilsotolimod so that its full potential for patients may continue to be explored.”
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