Pervasis receives $920,000 in grants under QTDP program

Nov 8 2010

Pervasis Therapeutics, Inc. today announced that it has been awarded over $920,000 in grants through the U.S. government's Qualifying Therapeutic Discovery Project, which provides tax credits and grants to projects that show significant potential to produce new therapies, reduce long-term health care costs, or significantly advance the goal of curing cancer within the next 30 years.  

Pervasis is a clinical stage company focused on developing breakthrough therapies with the potential to improve outcomes following common vascular surgical and interventional procedures, such as arteriovenous access, angioplasties, stents and peripheral and coronary bypass grafts—the failure of which result in serious complications and a significant increase in medical costs. There are no currently approved therapies that directly target the underlying physiological processes leading to serious vascular complications, including inflammation, thrombosis (the formation of a blood clot inside a blood vessel) and restenosis (the re-narrowing of a coronary artery after it has been treated with angioplasty or stenting).

Pervasis' therapies harness the power of the endothelium, the thin layer of cells that lines the interior surface of blood vessels, which has a well-understood role in regulating many of the body's healing processes, including vascular repair. Because these endothelial formulations secrete several key factors involved in combating inflammation and restenosis, they may also be applicable to other therapeutic fields where surgical or interventional procedures are required, including inflammatory disease, orthopedic injury and cancer.

The grants awarded to Pervasis span several therapeutic fields for which the company's therapies have application including:

• Development of PVS-10200 for Peripheral Artery Disease ($244,479.25)       
• Development of Vascugel® to Sustain Arteriovenous Access for Hemodialysis ($244,479.25)       
• Development of Tissue-Engineered Endothelial Cell Therapy to Supplement Orthopedic Procedures ($244,479.25)       
• Development of Tissue-Engineered Endothelial Cell Therapy for Brain and Prostate Cancer  ($191,420.94)

"The awarding of these grants validates our belief that our breakthrough therapies offer fundamentally new approaches to improving outcomes for vascular surgical and interventional procedures, as well as the potential to address unmet needs associated with several other critical disease areas, such as cancer," said Frederic Chereau, president and chief executive officer of Pervasis. "We look forward to continuing our research and development of these important therapies in order to bring them to patients as quickly as possible."

A Phase I/II study is currently underway in France to evaluate PVS-10200, an investigational new drug under development by Pervasis to prevent restenosis in patients with peripheral arterial disease who undergo an angioplasty and stent procedure in the superficial femoral artery. The company's most advanced program, Vascugel®, has demonstrated proof of concept and safety in two Phase 2 trials in patients undergoing arteriovenous access procedures for hemodialysis. Earlier this year, Pervasis announced that it had reached an agreement with the U.S. Food and Drug Administration (FDA) for its Phase 3 clinical trial of Vascugel under the FDA's Special Protocol Assessment (SPA) procedure. Through the SPA procedure, FDA formalized its agreement that the design of the Phase 3 trial was acceptable to support a regulatory submission seeking new drug approval.

The Qualifying Therapeutic Discovery Project, established under section 48D of the Internal Revenue Code, is a $1 billion fund, available to firms with no more than 250 employees. The credit or grant covers up to 50 percent of the cost of qualifying biomedical research.