Galena: IDMC Suggests Reduction Of Cardiac Toxicity Monitoring For NeuVax Trial

(RTTNews) - Galena Biopharma, Inc. (GALE) announced that the Independent Data Monitoring Committee has recommended to the company that it can reduce the cardiac toxicity monitoring for patients in its NeuVax (nelipepimut-S) Phase 3 PRESENT clinical trial.

NeuVax is a HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting. NeuVax is currently in an international, Phase 3 PRESENT study under a Special Protocol Assessment granted by the FDA. The IDMC meets periodically and advises Galena regarding the continuing safety of trial patients, and efficacy.

Mark Schwartz, CEO, said, "We are pleased to see that cardiac events have not appeared as a safety issue thus far in the study, relative to published reports of cardiac toxicity associated with other HER2 directed therapies. Importantly, the recommendation by the IDMC to reduce the frequency of cardiac assessments, per the protocol, facilitates the ongoing compliance and patient retention on trial."