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MATEON ANNOUNCES ENROLLMENT OF FIRST PATIENT IN PHASE 2 PORTION OF PAZOFOS STUDY IN RECURRENT OVARIAN CANCER
SOUTH SAN FRANCISCO, Calif., July 21, 2016 (GLOBE NEWSWIRE) -- Mateon Therapeutics, Inc. (Nasdaq:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, today announced that the first patient has been enrolled into the Phase 2 portion of the PAZOFOS Study. The PAZOFOS Study is a Phase 1b/2 clinical trial in patients with recurrent ovarian cancer that will assess the efficacy and safety of the combination of Mateon's investigational drug CA4P plus Novartis' approved tyrosine kinase inhibitor pazopanib (Votrient®) compared to pazopanib alone. The primary outcome measure of the Phase 2 portion of the study is progression free survival measured by RECIST; secondary endpoints include safety, overall survival, objective response rate and relevant biomarkers. The study is designed to enroll 128 patients at ten sites in the United Kingdom.

"The advancement of the PAZOFOS Study into the Phase 2 portion is an important milestone for the continued development of CA4P," stated William D. Schwieterman, M.D., President and Chief Executive Officer of Mateon. "There are a number of parallels between the PAZOFOS Study and the completed GOG-0186I Study, each in recurrent ovarian cancer and evaluating CA4P in combination with an established anti-angiogenic agent. We believe combination vascular targeted therapy with a VDA and an anti-angiogenic has the potential to be a powerful approach to fight cancer, and we look forward to receiving data on this trial as it becomes available."

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 (portion of the East and North Hertfordshire NHS Trust). CA4P and pazopanib are being provided by Mateon and Novartis, respectively.
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Source: press release, 7/21/16. http://investor.mateon.com/releasedetail.cfm?ReleaseID=980540

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OXIGENE ANNOUNCES POSITIVE INITIAL DATA FROM PHASE 1B STUDY OF CA4P IN COMBINATION WITH PAZOPANIB IN PATIENTS WITH ADVANCED RECURRENT OVARIAN CANCER

-- BASED ON POSITIVE SAFETY DATA AND PRELIMINARY SIGNS OF EFFICACY, STUDY EXPECTED TO ADVANCE TO PHASE 2 PORTION IN EARLY 2016 --

SOUTH SAN FRANCISCO, Calif., Nov. 5, 2015 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, today announced 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. 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.

"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.
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Source: press release, 11/05/15. http://investor.oxigene.com/releasedetail.cfm?ReleaseID=941114

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A Phase Ib and Randomised Phase II Trial of Pazopanib With or Without Fosbretabulin in Advanced Recurrent Ovarian Cancer
Estimated Enrollment: 128
Study Start Date: September 2014
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. https://clinicaltrials.gov/ct2/show/NCT02055690?term=Ca4p&rank=5

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
CA4P (fosbretabulin disodium) OncologyOvarian CancerMicrotubule polymerization and VE-cadherin duel inhibitorTubulin dimers and VE-cadherin

Mechanism of action: CA4P (fosbretabulin disodium) is the disodium salt of a water-soluble phosphate derivative of a natural stilbenoid phenol derived from the African bush willow (Combretum caffrum) with potential vascular disrupting and antineoplastic activities. Upon administration, the prodrug fosbretabulin is dephosphorylated to its active metabolite, the microtubule-depolymerizing agent combretastatin A4, which binds to tubulin dimers and prevents microtubule polymerization, resulting in mitotic arrest and apoptosis in endothelial cells. In addition, this agent disrupts the engagement of the endothelial cell–specific junctional molecule vascular endothelial-cadherin (VE-cadherin) and so the activity of the VE-cadherin/β-catenin/Akt signaling pathway, which may result in the inhibition of endothelial cell migration and capillary tube formation. As a result of fosbretabulin's dual mechanism of action, the tumor vasculature collapses, resulting in reduced tumor blood flow and ischemic necrosis of tumor tissue.

Phase of Development: I/II

Event Type: Data: Phase I/II trial results

Dates: 2018-01-01 - 2018-03-31

Results: Pending