Idera Pharmaceuticals has announced the results from its Phase 2 clinical trial evaluating IMO-2055 in combination with Erbitux (cetuximab) for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
The controlled Phase 2 clinical trial randomised 106 patients with SCCHN into two groups of 53 patients each.
In one group, patients were treated with IMO-2055 at a dose of 0.32mg/kg given subcutaneously once weekly in combination with weekly cetuximab, while in the other group patients were treated with cetuximab alone.
The primary endpoint of the study was progression-free survival and the secondary outcome measures included overall response rate (by RECIST), disease control rate, overall survival and safety and tolerability.
The study did not meet its primary endpoint of improved progression-free survival following treatment with IMO-2055 along with cetuximab, compared to treatment with cetuximab alone.
Based on investigator assessments, the median progression-free survival was 2.9 months in both groups, but according to the independent radiology review, it was 1.9 months in the cetuximab group and 1.5 months in the combination group.
Idera Pharmaceuticals chairman and chief executive officer Sudhir Agrawal said that the company is disappointed with the results of the trial, considering the favourable results reported earlier in 2012 from a single-arm Phase 1b study of IMO-2055 in combination with Tarceva and Avastin in patients with non-small cell lung cancer, as well as the safety profile of IMO-2055 in combination with targeted anti-cancer agents that has been observed in multiple clinical trials.
"We believe that IMO-2055 may have clinical and commercial potential for certain cancer indications and plan to seek to advance IMO-2055 through collaborations with third parties," Agrawal added.
"Additionally, we continue to validate our proprietary gene-silencing oligo technology and support our collaborative activities in the area of vaccine adjuvants for cancer, infectious diseases and Alzheimer’s disease."
The company applies its Toll-like receptor (TLR) drug discovery platform to create immunomodulatory drug candidates and has clinical development programmes in autoimmune diseases and cancer.