Towards Clinical Proof of PrincipleBPX-101 is under investigation in a first in human, single site, Phase I/II dose escalation trial in patients with metastatic castrate resistant prostate cancer. Patients are dosed every other week for six doses (“induction phase”), with the possibility of booster vaccinations every eight weeks for up to one year. Enrollment of patients in the formal 3+3 dose escalation study is complete, but the high dose cohort may be expanded to further study the safety and efficacy profile of the treatment. Interim data for the first six patients reported at AACR in April 2010 shows the combination of BPX-101 and AP1903 to be safe and well tolerated in all subjects treated at low and mid doses, with no unexpected drug-related adverse events reported. While the response varied between patients and there is no assurance of clinical benefit, treatment with BPX-101 and AP1903 demonstrated:
The current trial was initiated in May 2009, and completion is expected by late 2010, with randomized Phase II trials expected to start in mid 2011. Preparation for Phase II is in progress, including GMP manufacturing campaigns for vaccine components. |
