CAMBRIDGE, Mass., April 7 /PRNewswire/ Pervasis Therapeutics announced today that it enrolled the first patient in a new Phase 1/2 clinical study exploring the potential of PVS-10200 to prevent restenosis in patients who undergo an angioplasty and stent procedure for the treatment of peripheral arterial disease (PAD).
The open-label dose escalation trial will enroll patients at three medical centers in France. Primary endpoints include safety and the impact of PVS-10200 on the incidence of major adverse events. Secondary endpoints include the rate of primary patency and restenosis, and the time to re-intervention. Initial results are expected in the second half of 2010.
"We are tremendously excited to advance our second major pipeline program into clinical testing, targeting a critical need for patients affected by PAD," said Fred Chereau, chief executive officer, Pervasis Therapeutics. "Peripheral arterial disease remains a poorly controlled condition, leading to an estimated 75,000 limb amputations each year in the United States. Based on the positive clinical results of our lead product Vascugel, combined with our compelling PAD preclinical results, we are encouraged that PVS-10200 may play an important role in improving the care of PAD, either as an adjunct to stents and catheters or as a stand-alone therapy."
The Phase 1/2 trial for PVS-10200 is ongoing in France, led by Dr. Jean-Marc Alsac at Hopital Europeen Georges Pompidou, Dr. Yves Castier at Hopital Bichat, 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. Preclinical results for PVS-10200 published in the December 2009 Journal of Vascular and Interventional Radiology (Nugent et al. J Vasc Interv Radiol 2009; 20(12):1617-1624) demonstrated that administration at the time of angioplasty and stent placement enhanced blood vessel healing compared to angioplasty and stents alone in a porcine model.
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, causing the restriction of blood flow. PAD has significant health implications, including high blood pressure, reduced ability to walk, 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