Celsion Corporation announced initiation of a nationwide enrollment program in its Phase 1/2 trial for the use of ThermoDox (liposomal intravenous doxorubicin) for the treatment of recurrent chest wall (RCW) breast cancer. This open-label, dose-escalating trial (entitled DIGNITY) will evaluate the safety and efficacy of ThermoDox in combination with hyperthermia. The DIGNITY trial’s primary endpoint is durable complete local response at the tumor site. It is expected to enroll 100 patients in the U.S. within the 2010 calendar year.
ThermoDox is a heat-activated doxorubicin, an anthracycline compound approved for the treatment of a wide range of cancers including breast cancer. Localized mild hyperthermia (39.5-42 degrees Celsius) releases the entrapped doxorubicin from its liposome, enabling the release of high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
For more information call (410) 290-5390 or visit www.celsion.com.