Phase 2 clinical trial results of IMO-2055 announced

www.iderapharma.comSep 28 2009

Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), today announced the presentation of final data from a clinical trial evaluating IMO-2055, an agonist of Toll-like Receptor (TLR) 9, as monotherapy in patients with Renal Cell Carcinoma (RCC). The data are being presented during the Eighth International Kidney Cancer Symposium being held in Chicago, September 25-26, 2009.

In this phase 2 open-label, non-controlled clinical trial, treatment-naïve and second-line patients with RCC were randomly assigned to receive IMO-2055 subcutaneously at 0.16 mg/kg/week or 0.64 mg/kg/week. 89 patients were evaluable for efficacy (intent-to-treat population).

“This clinical trial of IMO-2055 monotherapy in RCC has provided us data that have been helpful in developing the strategy for clinical studies of IMO-2055 in combination with approved anti-cancer agents. Currently IMO-2055 is being evaluated in combination with Tarceva^® and Avastin^® in non-small cell lung cancer and in combination with Erbitux^® and a Camptosar^®-containing regimen in colorectal cancer,” said Alice Bexon, MBChB, Vice President of Clinical Development. “As previously announced, the primary objective based on RECIST was not achieved in this trial; however, we are encouraged by the progression-free survival compared to published reports with interferon alpha treatment. We have seen prolonged treatment durations in several patients.”

Based on the final data analysis:

• Progression-free survival (PFS) medians for treatment-naïve patients were 4.5 months at 0.16 mg/kg/week and 1.9 months at 0.64 mg/kg/week
• PFS medians for second-line patients were 3.4 months at 0.16 mg/kg/week and 4.3 months at 0.64 mg/kg/week
• Median overall survival was 23.5 months overall, although medians were not estimable in 2 of the 4 treatment groups
• 7 patients received weekly IMO-2055 treatment for at least 1 year
• 2 patients (1 second-line and 1 treatment-naïve), each receiving 0.64 mg/kg/week, had confirmed partial responses
• 52 patients (58%) across all groups had stable disease
• IMO-2055 treatment was generally well-tolerated: neither dosage was associated with any dose-limiting toxicity, although the relative dose intensity was higher with the 0.16 mg/kg dosage
• The most common treatment-related adverse events (any grade across groups) were fatigue (51%), nausea (46%), chills (45%), headache (37%), and pyrexia (33%), consistent with IMO-2055-related immune stimulation

The oral and poster presentations, entitled “A phase 2 multicenter, randomized, open-label study of two dose levels of IMO-2055 in patients with metastatic or recurrent renal cell carcinoma”, are being made by Timothy Kuzel, M.D. Dr. Kuzel is the Director of the Clinical Research Office for the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and Professor of Medicine within the Division of Hematology/Oncology of the Department of Medicine at Northwestern University’s Feinberg School of Medicine in Chicago, IL.