Clinical Development Highlights
As of today, more than 90% of the planned number of patients have been enrolled in the Phase III SUNRISE trial, representing a sufficient number of patients required to trigger the two pre-planned interim analyses in addition to the final analysis for trial unblinding. The company anticipates to reach the trial’s estimated enrollment of 582 patients in the coming weeks.
Peregrine and AstraZeneca expanded their cancer immunotherapy clinical trial partnership to evaluate bavituximab in combination with AstraZeneca’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736). The companies are presently planning a global Phase II study in patients with formerly treated squamous or non-squamous NSCLC, in addition to a Phase I/Ib trial that will evaluate the safety and efficacy of bavituximab in combination with durvalumab and chemotherapy in multiple solid tumors. The company anticipates the Phase II study to be initiated in early 2016 with the Phase I/Ib study starting later in 2016.
Peregrine continues to finalize plans for its Phase II/III trial to evaluate bavituximab with chemotherapy combinations in HER2-negative metastatic breast cancer. This trial is on track to be initiated by the end of calendar year 2015.
Peregrine Pharmaceuticals, Inc., a biopharmaceutical company, researches and develops monoclonal antibodies for the treatment and diagnosis of cancer in the United States and internationally. The company’s lead immunotherapy candidate, bavituximab, which is in Phase III development stage for the treatment of formerly-treated non-small cell lung cancer together with various investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. It is also involved in the development of molecular imaging agent, 124I-PGN650, which is in exploratory clinical trial for the imaging of various solid tumor types.
