We don't know the current SUNRISE enrollment figures or any of the details concerning the 2 early lookins! But any speculation about the SUNRISE results may be pre-empted by interim results from the Phase 1b melanoma Bavi/Yervoy clinical trial. This is an open label study which has been running for over seven months now. Here is part of the news release about this trial.
"This is an open label, two-arm, randomized, single-center Phase Ib trial of bavituximab plus ipilimumab (Yervoy®), in patients with advanced melanoma. Up to 24 patients will be randomized into the following two treatment groups:
•Group A will enroll up to 16 patients to receive 2 weekly doses of bavituximab (3mg/kg) followed by combination therapy of ipilimumab (up to four cycles at 3mg/kg every 3 weeks) plus bavituximab (3mg/kg weekly for 12 weeks)
•Group B will enroll up to 8 patients to receive standard ipilimumab alone (up to four cycles at 3mg/kg every 3 weeks)
The primary endpoint of the trial will be safety and secondary endpoints will include measurements of disease control rate (DCR) and overall survival (OS). In addition, tumor biopsies will be collected at screening to measure changes in myeloid-derived suppressor cells (MDSC), tumor-associated macrophages (TAM), T-regulatory cells (Treg) and peripheral blood cytokines. For more information on this trial please visit ClinicalTrials.gov using the identifier NCT01984255.
Preclinical Combination Data of PS-Targeting Antibody and Anti-CTLA-4 Antibody
Preclinical data have shown that phosphatidylserine (PS)-targeting antibodies reactivate tumor immunity at multiple levels and that the combination of a PS-targeting antibody equivalent to bavituximab and an anti-CTLA-4 antibody, an FDA-approved immunotherapy, resulted in superior tumor growth inhibition than with either antibody alone, with no additional toxicity following multiple treatment doses. In addition, histopathological analysis showed the combination produced more inflammatory cell infiltration and tumor destruction than anti-CTLA-4 alone."
"The refusal of the real is the number one dogma of our time" Rene Girard
