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news.Idera Pharmaceuticals has dosed the first patient in a Phase Ib trial evaluating IMO-2055, a novel agonist of Toll-like receptor 9 in combination with Tarceva and Avastin in patients with non-small cell lung cancer. Tarceva and Avastin are targeted agents approved by the FDA for this indication.
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The Phase Ib trial evaluating IMO-2055 is being conducted in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on first line chemotherapy. The trial is designed to assess safety of the IMO-2055, Tarceva and Avastin combination and to determine the recommended dose of IMO-2055 for use in the subsequent Phase II trial. Three doses of IMO-2055 are being investigated with standard doses and schedules of Tarceva and Avastin. IMO-2055 is administered subcutaneously once a week. The target enrollment for the trial is 40 patients.
Sudhir Agrawal, CEO and chief scientific officer, said: “Initiation of this Phase Ib trial in NSCLC is part of our previously announced oncology clinical development strategy. Following analysis of the Phase Ib results, we plan to conduct a four-arm randomized, placebo-controlled Phase II trial evaluating Tarceva alone, IMO-2055 and Tarceva, Tarceva and Avastin and IMO-2055, Tarceva and Avastin. Our preclinical studies have demonstrated increased antitumor activity when IMO-2055 is combined with approved targeted agents such as Avastin and Tarceva compared to the activity of any of these agents alone.”