CAMBRIDGE, Mass., June 22 /PRNewswire/ -- Pervasis Therapeutics announced today that the first cohort of patients has been fully enrolled in the Phase 1/2 clinical study of PVS-10200, an investigational new drug under development to prevent restenosis in patients with peripheral arterial disease (PAD) who undergo an angioplasty and stent procedure in the superficial femoral artery. Initial study results from this patient cohort are expected at the end of 2010.
"PAD is now being recognized as a national public health threat, as evidenced by the recent introduction of the U.S. Congressional PAD Resolution to improve diagnosis and care," said Fred Chereau, chief executive officer, Pervasis Therapeutics. "Currently available treatment options for PAD are limited, and the rate of restenosis following stent and angioplasty procedure is high. Based on preclinical data for PVS-10200 and positive clinical results from our lead product, Vascugel®, we believe PVS-10200 has the potential to improve outcomes for patients with PAD."
"The Phase 1/2 study of PVS-10200 will help evaluate this therapy as an adjunct to an angioplasty and stent procedure in real-world practice," stated Dr. Jean-Marc Alsac of Hopital Europeen Georges Pompidou, Paris. "New therapies that could help re-establish healthy vasculature, such as PVS-10200, would provide a valuable treatment option for physicians and patients. PVS-10200 is quickly and easily administered through a minimally invasive procedure and does not extend hospitalization time for patients."
The open-label dose escalation trial will evaluate the safety and impact of PVS-10200 on the incidence of major adverse events. Secondary endpoints will include the rate of primary patency and restenosis, and the time to re-intervention. The first cohort includes 11 patients. Approximately 20 patients are expected to enroll in the second cohort and will receive a higher dose of PVS-10200.
The study is being conducted at three medical centers in France and is led by Dr. Jean-Marc Alsac at Hopital Europeen Georges Pompidou, Dr. Yves Castier at Hopital Bichat, Paris, and Dr. Marie-Antoinette Sevestre at Centre Hospitalier Universitaire d'Amiens.
PVS-10200 is a biologically active therapy developed using tissue-engineered allogeneic endothelium, and is designed to reestablish healthy vasculature following common interventions to treat PAD and potentially other conditions. PVS-10200 builds on the same proprietary endothelial technology and mechanism of action underlying Vascugel®, Pervasis' investigational new drug for the prevention of hemodialysis access graft failure. In February 2010, the company announced that it received approval of a Special Protocol Assessment from the U.S. Food and Drug Administration to conduct one Phase 3 pivotal trial of Vascugel®.
About Peripheral Arterial Disease
More than eight million Americans over the age of 50 have peripheral arterial disease (PAD), a serious condition in which plaque builds up in arteries, restricting blood flow. PAD has significant health implications, including high blood pressure, reduced ability to walk, leg pain, and increased risk for heart attack and stroke.
When lifestyle changes and medication are not enough, treatment often involves surgical intervention, such as angioplasty or stent placement. In the U.S., approximately 300,000 peripheral stent or angioplasty procedures occur annually. However, in many cases, the artery does not heal properly following intervention, which can lead to restenosis and cause serious complications, including limb amputation.
Pervasis Therapeutics, Inc. is a clinical stage company developing a broad portfolio of biologically active therapeutics. Building on its deep understanding of the specialized role that the endothelium plays in regulating natural healing and repair processes associated with disease, Pervasis is advancing groundbreaking new therapies to dramatically improve the outcomes of common vascular interventions, 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. 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. Pervasis is also applying its platform technology to develop products in therapeutic areas beyond vascular disease, such as inflammatory, oncology and orthopedic diseases.
Pervasis is a privately held company with funding from Flagship Ventures, Polaris Venture Partners, Highland Capital Partners and the Richter Family Fund. For more information, please visit www.pervasistx.com.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such statements are only predictions and the company's actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the timing of clinical trials, the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in clinical trials and the risk that the company will not obtain approval to market its products.
Pervasis Therapeutics, Inc.
Jaren Irene Madden
Feinstein Kean Healthcare
SOURCE Pervasis Therapeutics, Inc.