Thursday, July 7, 2011

Merck halts Idera cancer drug development due to safety issues

By Julie M. Donnelly, Boston Business Journal

Idera Pharmaceuticals Inc. (Nasdaq: IDRA) said its partner, German drug maker Merck KGaA, has halted development on a joint drug candidate to treat cancer, due to safety concerns.

In a Phase 1B trial testing a combination of three drugs on patients with squamous cell carcinoma of the head and neck, the Idera drug candidate was shown to cause an increased incidence of neutropenia and electrolyte imbalances. Neutropenia affects the body’s ability to fight off infections and is a common side effect of chemotherapy. This study has now been terminated.

Another Phase 1B study has also been halted, evaluating the potential therapy, known as IMO-2055, in combination with two other drugs to treat colorectal cancer.

But Merck KGaA does plan to complete an ongoing Phase 2 study on IMO-2055, in combination with one other drug, to treat squamous cell carcinoma patients that have failed another treatment. No serious safety concerns have been observed in that trial.

Cambridge-based Idera says the collaboration between the two companies remains intact. Merck has also agreed to evaluate other promising drug candidates from Idera using the same mechanism.

The collaboration between Idera and Merck KGaA dates back to 2007 and covers the research, development and commercialization of several drug candidates with the same mechanism, including IMO-2055, for the potential treatment of certain cancers. Idera received an upfront payment of $40 million as part of the deal, with the possibility of milestone payments of up to $381 million.

Idera announced in April that it was delaying a Phase 2 trial of IMO-2125, a treatment for a specific type of hepatitis C, because early data showed certain types of cancerous growth in lab rats.