IDERA STARTS ONCOLOGY TRIAL OF HYB2055

Idera Pharmaceuticals has initiated a new Phase I/II clinical trial of HYB2055 in combination with the chemotherapy agents gemcitabine and carboplatin. The trial is now open to patient enrollment at the Georgetown University Medical Center in Washington, D.C. HYB2055 (also known as IMO-2055 or IMOxine) is Idera's lead toll-like receptor 9 agonist for the treatment of cancer and is based on Idera's proprietary immune modulatory oligonucleotide technology.

The trial is a two-phase, open-label, dose-escalation study of the safety and efficacy of HYB2055 combined with a standard gemcitabine/carboplatin treatment regimen. The primary endpoint of the Phase I portion of the trial is to establish an appropriate HYB2055 dose in combination with a fixed dose of gemcitabine/carboplatin in patients with solid tumors. In the Phase II portion of the study, the primary endpoint is overall response rate and toxicity of the triplet combination in previously untreated, advanced non-small cell lung cancer patients. HYB2055 will be administered by subcutaneous injection once per week. Intended Phase I dose levels are 4, 12, and 36 mg per week.