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North Tustin, CA, United States

Digumarti R.,Nizams Institute of Medical Sciences | Bapsy P.P.,Apollo Hospitals | Suresh A.V.,Yashoda Hospital | Bhattacharyya G.S.,Orchid Nursing Home | And 3 more authors.
Lung Cancer | Year: 2014

Objective: Bavituximab is a phosphatidylserine (PS)-targeting monoclonal antibody with immune-modulating and tumor-specific vascular targeting properties. Preclinical studies have shown activity against numerous solid tumors and at least an additive effect in combination with chemotherapy. This study evaluated bavituximab in combination with paclitaxel and carboplatin in patients with previously untreated, locally advanced or metastatic non-small-cell lung cancer (NSCLC). Patients and methods: This phase II, open-label study (NCT00687817) was conducted in 49 patients with stage IIIB/IV NSCLC utilizing a Simon two-stage design. Patients were treated with up to six cycles of carboplatin area under the concentration-time curve (AUC) 5 plus paclitaxel 175mg/m2 every 21 days with weekly bavituximab 3mg/kg followed by bavituximab monotherapy until progression or unacceptable toxicity. Results: The primary efficacy endpoint of overall response rate (ORR) was 40.8% (complete response [CR] 2.0%, partial response [PR] was 38.8%). Median progression-free survival (PFS) and overall survival (OS) were 6.0 and 12.4 months, respectively. Treatment-related adverse events (AEs) occurred in 40.8% of patients. The most common treatment-related AEs were anemia (10.2%), asthenia, vomiting, paresthesia, anorexia, and fatigue (6.1% each). One patient with a central, cavitating squamous tumor developed fatal hemoptysis and aspiration. Conclusion: Bavituximab in combination with paclitaxel-carboplatin as first-line therapy demonstrated a tolerable safety profile and potential efficacy in this single-arm phase II trial in patients with advanced local or metastatic NSCLC. Randomized trials with this regimen are in progress. ClinicalTrials.gov identifier: NCT00687817. © 2014 Elsevier Ireland Ltd.

Gerber D.E.,University of Texas Southwestern Medical Center | Stopeck A.T.,Arizona Cancer Center | Wong L.,Scott and White Hospital | Rosen L.S.,Premiere Oncology | And 3 more authors.
Clinical Cancer Research | Year: 2011

Purpose: Bavituximab is a chimeric immunoglobulin G1 phosphatidylserine- targeting monoclonal antibody that triggers vascular disruption and enhances antitumor immune response. This phase I study assessed the safety and pharmacokinetics of bavituximab in patients with advanced solid tumors. Experimental Design: Patients with refractory advanced solid tumors were enrolled into four sequential dose-escalation cohorts (0.1, 0.3, 1, or 3 mg/kg bavituximab weekly) with two dosing schedules. Patients in the 0.1 and 0.3 mg/kg cohorts received bavituximab on days 0, 28, 35, and 42. Patients in the 1 and 3 mg/kg cohorts were administered bavituximab on days 0, 7, 14, and 21. Safety, pharmacokinetics, and tumor response were assessed. Results: Twenty-six patients were accrued. No maximum tolerated dose was reached. Six serious adverse events occurred in five patients, including one pulmonary embolism at 3 mg/kg, which was the only dose-limiting toxicity (DLT) in the study. Bavituximab half-life ranged from 37 to 47 hours, with no accumulation seen following administration of multiple doses. Activated partial thromboplastin time was modestly prolonged in vitro at the highest dose tested. As assessed on day 56, a total of 18 patients were evaluable for efficacy, of whom 10 had disease progression and none had an objective response. Conclusions: Bavituximab was well tolerated at doses ranging up to 3 mg/kg weekly. Pharmacokinetic studies support a weekly dosing regimen. Additional phase I and II clinical trials are in progress to investigate bavituximab in combination with chemotherapy and other molecularly targeted agents. ©2011 AACR.

Peregrine Pharmaceuticals Inc. | Date: 2015-09-28

Pharmaceutical preparations, namely, antibodies for the treatment and diagnosis of cancer, infectious diseases and diseases and disorders in which phosphatidylserine (PS) is a marker.

Peregrine Pharmaceuticals Inc. | Date: 2016-03-24

Pharmaceutical preparations, namely, antibodies for the treatment and diagnosis of cancer, infectious diseases and diseases and disorders in which phosphatidylserine (ps) is a marker.

Affitech AS and Peregrine Pharmaceuticals Inc. | Date: 2011-09-06

Disclosed are human antibodies that specifically inhibit VEGF binding to only one (VEGFR2) of the two primary VEGF receptors. The antibodies effectively inhibit angiogenesis and induce tumor regression, and yet have improved safety due to their specificity. The present invention thus provides new human antibody-based compositions, methods and combined protocols for treating cancer and other angiogenic diseases. Advantageous immunoconjugate compositions and methods using the new VEGF-specific human antibodies are also provided.

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