Agenus Initiates Randomized Phase 2 Trial With Prophage For Melanoma

(RTTNews) - Agenus Inc. (AGEN) announced initiation of a randomized Phase 2 trial with Prophage for melanoma, and Bristol-Myers Squibb's (BMY) Yervoy (ipilimumab) for the treatment of Stage III and IV metastatic melanoma. The combination has the potential to trigger a more effective immune response against the tumor than Yervoy alone.

The company said that the Phase 2, randomized, open label, single-center, investigator-sponsored trial is designed to evaluate the safety, feasibility and immunogenicity of the combination of Prophage vaccine and Yervoy with or without low dose cyclophosphamide (a chemotherapy agent used in this study as an immunomodulator of regulatory cells) in 25 patients with unresectable Stage III or IV metastatic melanoma. The trial will be conducted at the University of Texas Health Science Center at Houston and led by clinical investigator Jorge Quesada, M.D.

The company said that, in order to fully understand the effects of Prophage vaccine and Yervoy, the study will include translational studies characterizing anti-cancer immune responses, in addition to clinical outcomes.