Showing posts with label Oxigene Inc. Show all posts
Showing posts with label Oxigene Inc. Show all posts

Monday, December 12, 2011

OXiGENE and Azanta A/S Establish Partnership to Provide ZYBRESTAT™

OXiGENE and Azanta A/S Establish Partnership to Provide ZYBRESTAT™Orlando, FL 12/12/11 (StreetBeat) -- OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, and Azanta Danmark A/S, a specialty pharmaceutical company focused on oncology, women's health and addiction medicine, have established a partnership agreement to provide access to ZYBRESTAT for the treatment of patients in Europe and Canada with anaplastic thyroid cancer (ATC) on a compassionate use basis. OXiGENE's newly-formed Named Patient Program (NPP), to be managed by Azanta, provides a regulatory mechanism to allow healthcare professionals in Europe and Canada to prescribe ZYBRESTAT to individual ATC patients while it is still in development.

Under the terms of the agreement, OXiGENE will provide ZYBRESTAT to Azanta. Azanta will serve as exclusive distributor for ZYBRESTAT in the specified territory for this purpose and will provide ZYBRESTAT to physicians solely to treat ATC on a compassionate use basis in the territory covered by the agreement until such time as ZYBRESTAT may obtain marketing approval in that territory. The territory includes the European Union, including the Nordic countries and Switzerland, and Canada, and the agreement may also be expanded to include other countries on a country-by-country basis. OXiGENE and Azanta will cooperate on regulatory activities relating to ZYBRESTAT for the treatment of ATC within the territory. There will be no transfer of ownership of intellectual property rights for ZYBRESTAT to Azanta under the terms of the agreement.

Commented Peter J. Langecker, M.D., Ph.D., Chief Executive Officer of OXiGENE: "This agreement represents a critical milestone in the ongoing development of ZYBRESTAT, reflecting OXiGENE's commitment to facilitate access to this potentially valuable therapy by ATC patients who have no other treatment options. We are delighted to work in partnership with Azanta, a privately held European specialty pharmaceutical company with specialized technical and regulatory expertise in implementing compassionate use programs. While Azanta focuses on our Named Patient Program, we will continue to pursue a global regulatory strategy for ZYBRESTAT in ATC, including seeking additional financing for the FACT 2 study, with the goal of initiating this pivotal trial in 2012."

Commented Claus Moeller, Chief Executive Officer of Azanta: "Partnering with OXiGENE to distribute ZYBRESTAT to European and Canadian ATC patients under appropriate regulatory auspices reflects our strategy to build industry leadership by making innovative developmental therapies available to patients in international markets. We believe that ZYBRESTAT has generated an impressive body of safety and activity data, with a suggested survival benefit in ATC, and has significant therapeutic and commercial potential. We are pleased to make our distribution and regulatory expertise available to help advance this promising therapeutic option, and we look forward to a productive collaboration."

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Wednesday, December 7, 2011

OXiGENE Presents Data From FAVOR Study of ZYBRESTAT in PCV

OXiGENE Presents Data From FAVOR Study of ZYBRESTAT in PCVTallahassee, FL 12/7/11 (StreetBeat) --OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that Dr. Timothy Lai, MD, FRCS, FRCOphth, Honorary Clinical Associate Professor of Ophthalmology from the Chinese University of Hong Kong, presented encouraging data from the FAVOR study of ZYBRESTAT in polypoidal choroidal vasculopathy (PCV) at the 6th Asia-Pacific VitreoRetina Society (APVRS) Congress in Hyderabad, India on December 2, 2011.

FAVOR is a Phase 2 study investigating the use of a single intravenous injection of ZYBRESTAT at different doses compared to placebo in patients with PCV, followed by imaging of the retina on days 2, 8, 15, and 28. PCV is a potentially blinding eye disease that involves the growth of tiny, abnormal blood vessels under the retina. The data showed that ZYBRESTAT was well tolerated in the study. The primary objective of the study was to observe the change in the number of polyps from baseline following administration of ZYBRESTAT. Although this number was essentially unchanged, there were some suggestions of activity with a decrease in polyp activity and a reduction in subretinal fluid and retinal edema in patients receiving ZYBRESTAT.

Dr. Lai commented, "It is important to differentiate neovascular age-related macular degeneration (AMD) from PCV, as the polyps in PCV do not generally respond to anti-VEGF monotherapy. The current treatment of choice for PCV is photodynamic therapy, but this procedure carries the possibility of recurrence and hemorrhage after treatment. These results suggest that continued evaluation of ZYBRESTAT in patients with PCV is warranted, possibly with a topical formulation that has undergone initial preclinical testing"

"We are encouraged by the results of the FAVOR study and believe that a vascular targeting agent applied topically could one day prove to be a major breakthrough in treating retinal diseases," said Peter J. Langecker, M.D., Ph.D., Chief Executive Officer of OXiGENE. "Our strategy for ZYBRESTAT in ophthalmology is to continue to seek a partner with strong expertise and experience in ophthalmic drug development to advance this promising clinical program."

The FAVOR study was multicenter, placebo-controlled, double-masked study in Asian patients (N=20) evaluating the use of intravenous ZYBRESTAT for the treatment of PCV, which is seen in approximately 30% of Asian patients presenting with neovascular age-related macular degeneration.

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