Peregrine’s Phase II lung cancer trial meets primary endpoint

The open-label, Simon two-stage study is designed to evaluate the safety and efficacy of the combination of bavituximab with the chemotherapy drugs carboplatin and paclitaxel in non-small cell lung cancer (NSCLC) patients.

Approximately 17 of the 21 patients enrolled in stage A were deemed evaluable for tumor response by the end of four treatment cycles, with six patients achieving partial tumor responses and one patient achieving a complete tumor response, according to response evaluation criteria in solid tumors (RECIST) criteria. These preliminary results exceed the pre-specified benchmark criteria established for enrolling an additional 28 patients in stage B of this trial, up to a total of 49 patients.

The primary objective of the multi-center Phase II clinical trial in patients with previously untreated locally advanced or metastatic NSCLC is to assess the overall tumor response rate. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters.

Steven King, president and CEO of Peregrine, said: We are very pleased with the promising early results from this pilot Phase II lung cancer trial and will now move forward to initiate the second stage of the study. We are encouraged by the number of tumor responses seen at this early time point of approximately 12 weeks in patients with NSCLC.

As these patients continue on treatment, we will be assessing them for further signs of anti-tumor activity, and we look forward to sharing more data from this study as patient treatment and follow-up progress.