WEST PALM BEACH, FL--(Marketwire - September 19, 2012) - Xcovery Holdings, the parent company of Xcovery Vision, a privately held biopharmaceutical company focused on creating the next generation of eye therapeutics, today announced that it will begin its Phase I/II clinical trial of its oral angiogenesis inhibitor, X-82, for the treatment of neovascular "wet" age-related macular degeneration (AMD).
Xcovery Holdings also announced that it has raised a total of $6M in Series B financing from large family offices with an interest in venture philanthropy and high net worth individuals.
"We're pleased with the confidence demonstrated by the investment from both our new and existing investors," said Xcovery Holdings Chairman & CEO Sheridan "Sherry" G. Snyder. "This round of financing demonstrates recognition of Xcovery's progress in the advancement of our pipeline and the company's long term opportunities developing next-generation targeted therapeutics for cancer and ophthalmology."
The initial Phase I/II trial will 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 trial will enroll a maximum of 20 patients and will be conducted at three ophthalmology centers in the US.
"We are committed to providing better therapies to patients with advanced eye disease and this trial represents an important advancement in Xcovery Vision's clinical development program," Snyder said. "The potential for an oral treatment for wet AMD is considered the ultimate therapeutic option for these patients."
X-82 inhibits both vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF), two important targets implicated in wet AMD. The compound has been designed to have a favorable toxicity profile and better tolerability as an oral medication than previous injectable drugs in this class.
"There is growing evidence that combined inhibition of VEGF and PDGF may have advantages over existing anti-VEGF therapies," said Dr. Jeffrey S. Heier, head of Xcovery Vision's advisory board and Co-Director, Tufts/OCB Vitreoretinal Fellowship at Massachusetts General Hospital. "And the prospect of an oral therapy for wet AMD is appealing to patients who may prefer taking a pill instead of an eye injection."
Dr. Ken Mandell, President and COO of Xcovery Vision, added, "Unlike current anti-VEGF injections that only treat the affected eye, our oral pill has the potential to prevent development of wet AMD in the opposite eye before disease progression."
About Xcovery Vision's Phase 1/2 Clinical Study
The goal of the Phase I/II study is to assess the preliminary safety of X-82 over a range of doses and evidence of biologic activity as measured by improvement in vision and reduction of subretinal fluid. Patients will also be provided access to the standard-of-care anti-VEGF therapy if they meet specific treatment criteria. Enrollment is planned to begin in October 2012, and the study is expected to last about 12 months.
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 Holdings
Xcovery is a holding company, which encompasses Xcovery, a clinical-stage company focused on the development of next-generation targeted therapeutics for cancer, and Xcovery Vision. X-82 was developed by Tyrogenex, an Xcovery-affiliated company funded by Biocatalyst International, a closely held early-stage venture fund.
About Xcovery Vision
Xcovery Vision is an ophthalmology-focused subsidiary of Xcovery Holdings, 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.