Xcovery Vision Presents VEGFR/PDGFR Oral Inhibitor X-82 Preliminary Data for Wet AMD at ARVO

Tue May 7, 2013 3:45pm EDT

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Xcovery Vision Presents VEGFR/PDGFR Oral Inhibitor X-82 Preliminary Data for Wet AMD at ARVO

  • Pilot Clinical Data Shows Dose Well Tolerated, Potentially Efficacious
  • Oral, Once Daily VEGFR/PDGFR Pilot Clinical Study Enrolling

Xcovery Vision, a privately held biopharmaceutical company focused on creating the next generation of eye therapeutics, today presented preliminary data from the Phase I/II clinical trial of its dual VEGFR/PDGFR inhibitor, X-82, for the treatment of neovascular “wet” age-related macular degeneration (AMD) at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO).

Chris Liang, PhD, executive vice president and chief scientific officer for Xcovery Vision, presented the data in a poster presentation entitled, “Rationale for Treating Wet AMD in Humans Using an Oral Pill Consisting of X-82, a VEGFR/PDGFR Inhibitor” during the AMD: New Drugs, Delivery Systems, and Mechanisms of Action session. ARVO is the largest eye and vision research organization in the world.

“Presenting this data at ARVO is testament to the significant strides made in developing X-82 with low toxicity for ophthalmologic indications,” said Sheridan G. Snyder, chairman and chief executive officer of Xcovery Holding Company. Xcovery Vision is a subsidiary of Xcovery Holding. As Xcovery Vision studies X-82 for wet AMD, Tyrogenex, an affiliated company, is studying it for solid tumors.

Xcovery Vision’s Phase I/II trial, which dosed its first patient in November 2012, is designed to assess the preliminary safety and tolerability of X-82, a unique tyrosine kinase inhibitor (TKI) in an oral formulation that acts by blocking pathologic blood vessel growth. The study (see www.clinicaltrials.gov Identifier: NCT01674569) currently is enrolling patients at participating centers: New England Retina Associates of New London, Conn; Elman Retina Group of Baltimore; Retina Consultants of Houston; Retina-Vitreous Associates Medical Group of Beverly Hills, California; and Retina Research Institute of Texas in Abilene.

In November 2012, Xcovery Vision’s development of X-82 was named to Elsevier Business Intelligence’s (EBI) prestigious 2012 Top Projects to Watch list in the Hot Space category for ophthalmology.

“The data shows that 50mg of X-82 once daily achieves exposures well above the concentration required to inhibit new blood vessel formation which suggests that the dose should be well tolerated and could be efficacious in treating wet AMD patients,” said Dr. Liang. Dr. Liang is one of the developers of Sutent and scientific founder of Xcovery Vision.

The orally administered X-82 targets a basic biologic process - neovascularization which is relevant to ophthalmic indications, such as AMD and diabetic retinopathy. In cancer indications, VEGFR tyrosine kinase inhibitors have characteristically demonstrated benefit in a variety of cancers, though it has been well documented that the dosage and use of this class in combination with other therapies has been limited by side effects. Xcovery previously presented preliminary data at the American Society of Clinical Oncology (ASCO) meeting in June 2012 that showed X-82 was well tolerated, did not exhibit any dose-limiting toxicity and demonstrated preliminary signs of anti-tumor activity, including a complete response in a patient with pancreatic cancer and stable disease in five other cancer patients.

About AMD

AMD is the leading cause of blindness for people over the age of 50 in the United States and Europe. There are two forms of the disease, namely "dry" and "wet" AMD. The "wet" form is characterized by the growth of new blood vessels into the central region of the retina. These new vessels cause severe visual loss due to retinal damage caused by subsequent leakage and scar formation. Anti-VEGF therapies and photodynamic therapies have been approved for "wet" AMD. "Dry" AMD accounts for up to 90 percent of all cases of AMD. There is no approved therapy for "dry" AMD, which afflicts 8 million patients in the United States and an additional 8 million in Europe. Visual loss in "dry" AMD is typically not as severe as "wet" AMD, however, over time, dry AMD can progress to the wet form of the disease.

About Xcovery Holding Company, LLC

Xcovery is a holding company focused on the development of next-generation targeted therapeutics for cancer and ophthalmology funded by Biocatalyst International, a closely held early-stage venture fund. Xcovery Holding has developed a broad portfolio of small molecule kinase inhibitors and has several active collaborations with leading academic and clinical centers to further validate the use of these candidates in a number of disease indications and in various combinations.

About Xcovery Vision

Xcovery Vision is an ophthalmology-focused subsidiary of Xcovery Holding, a clinical-stage company developing novel therapies for cancer and inflammatory diseases. Xcovery Vision's goal is to develop innovative therapies to address unmet healthcare needs and improve the standard of care in the field of ophthalmology. Xcovery Vision is developing a comprehensive pipeline of ophthalmology therapies that target basic mechanisms of eye disease, including angiogenesis, fibrosis and inflammation. Xcovery Vision was recently named Elsevier Business Intelligence’s (EBI) prestigious 2012 Top Projects to Watch list in the Hot Space category for ophthalmology.

About Tyrogenex

Tyrogenex is affiliated with Xcovery Holding Company. It was founded by Sherry Snyder through Biocatalyst International in partnership with Dr. Chris Liang. Through this partnership, Tyrogenex has developed a novel, patented cancer therapeutic, X-82. The compound, a dual VEGFR/PDGFR inhibitor, is being studied in a clinical trial for the treatment of advanced solid tumors.

EDITOR’S NOTE: Poster presentation available upon request.

Media Contact:
LaVoie Group
David Connolly, 617-374-8800 x104
dconnolly@lavoiegroup.com
or
Business Development Contact:
Xcovery
Cheryl Calhoun, 561-659-1945
Vice President
ccalhoun@biocatalystintl.com