Idera asks to amend renal carcinoma phase II trial in response to high enrollment

By E. Janene Geiss

Philadelphia, Oct. 20 - Idera Pharmaceuticals, Inc. announced Thursday that it has submitted to the Federal Drug Administration a protocol amendment for its phase II trial of HYB2055 for metastastic or recurrent clear cell renal carcinoma.

In a company news release, officials said there was a higher-than-expected enrollment rate of treatment-naïve patients. The company's original goal for the trial's stage A was to enroll 50 patients to meet the requirement for 23 second-line patients in each of two dose groups.

But about 40% of the 52 patients enrolled by Oct. 14 were treatment-naïve, which is markedly higher than the company said it anticipated.

The amendment provides for enrollment of up to 23 treatment-naïve patients at each of the two dose levels being used in the trial, in addition to the 23 second-line patients at per dose level described in the original study design, officials said.

The amendment allows the company to continue enrollment recruitment into the first half of 2006 so it can obtain the number of both treatment-naïve and second-line patients it needs to meet the statistical design, officials said.

HYB2055 is Idera's lead Toll-like Receptor 9 agonist for the treatment of cancer and based on Idera's proprietary Immune Modulatory Oligonucleotide technology.

Cambridge, Mass.-based Idera is a biotechnology company focused on development and commercialization of targeted immune therapies based on modulation of Toll-like receptors.

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