On November 5, 2015 OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, reported initial data from a Phase 1b/2 study of the company’s lead investigational drug, CA4P, in combination with the anti-angiogenic agent Votrient (pazopanib) in patients with advanced recurrent ovarian cancer (Press release, OXiGENE, NOV 5, 2015, View Source [SID:1234508054]). The data are from the ongoing "PAZOFOS" study and were presented at the 19th International Meeting of the European Society of Gynaecological Oncology (ESGO) in Nice, France.

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"The initial results we’ve seen to date from the Phase 1b portion of PAZOFOS are encouraging and we expect to move into the phase 2 portion of the study in early 2016," said Professor Gordon Rustin, Director of Medical Oncology, Mount Vernon Cancer Centre and a chief investigator for the trial. "We are excited about continuing our clinical evaluation of this complementary combination—a combination that utilizes the potential synergistic effects of CA4P and pazopanib and could offer a new treatment approach for patients with relapsed ovarian cancer."

Dr. Rustin reported that 12 patients have been enrolled in the phase 1b portion of the study. Nine of the patients were evaluated for objective response using RECIST criteria, showing two partial responses, five stable diseases and two progressive diseases. Eight of the ten patients with evaluable data demonstrated decreases in the tumor marker CA125, with three achieving a response according to CGIC criteria. Dr. Rustin also noted that four patients were still on treatment, and that the efficacy data are currently preliminary and unverified. Safety data showed that the combination of CA4P and pazopanib was generally well tolerated with no Grade 4-5 adverse events (AEs). The most commonly reported AEs were hypertension, fatigue, and pain. The Development Safety Update Report #1 submitted to the regulatory body stated that no definitive conclusions can be made regarding the benefit of treatment in the small subset of patients treated so far.

"The results seen thus far with CA4P combined with pazopanib broaden and strengthen the body of evidence indicating that CA4P can be effectively used as a component of combination therapy for patients with solid tumors," said William D. Schwieterman, MD, OXiGENE’s President and CEO. "We look forward to the continued results from this trial, and to advancing CA4P in combination with Avastin in phase 2/3 studies in platinum-resistant ovarian cancer and glioblastoma multiforme in 2016."

PAZOFOS is a randomized, controlled clinical study consisting of a phase 1b dose escalation portion (CA4P plus pazopanib) and a phase 2 portion comparing CA4P plus pazopanib versus pazopanib alone. The study is designed to enroll up to 128 patients at up to ten sites in the United Kingdom. The primary endpoint for the phase 2 portion is progression-free survival; secondary endpoints include safety, overall survival, objective response rate and relevant biomarkers.

PAZOFOS is sponsored by The Christie NHS Foundation Trust and coordinated by the Manchester Academic Health Science Centre, Trials Coordination Unit (MAHSC-CTU) with additional support from The University of Manchester, the Royal Marsden NHS Foundation Trust and Mount Vernon Cancer Centre (part of the East and North Hertfordshire NHS Trust). CA4P and pazopanib are being provided by OXiGENE and GlaxoSmithKline/Novartis, respectively.

About CA4P

CA4P (also known as fosbretabulin) is a vascular disrupting agent and is OXiGENE’s lead investigational drug. CA4P exerts its anti-tumor effects by targeting an established tumor’s immature endothelial cells within the tumor’s blood vessels, compromising the tumor vasculature and leading to widespread ischemia and necrosis of the cells within the central core of the tumor. OXiGENE plans to advance CA4P in clinical development in combination with approved anti-angiogenic agents which prevent the growth of new tumor blood vessels. Following an extensive clinical review, OXiGENE recently announced its plans to focus on initiation of two late-stage clinical programs for CA4P in 2016. These planned programs combine CA4P with standard-of-care in platinum-resistant ovarian cancer and in glioblastoma multiforme. In addition to PAZOFOS, CA4P is also being evaluated in an ongoing study in neuroendocrine tumors.