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Pervasis Therapeutics Announces Successful Initial Safety Results of Phase I Trials of Vascugel(TM) Cell-Based Gel to Repair Arteries

Posted on: Wednesday, 15 November 2006, 12:00 CST

Pervasis Therapeutics, Inc., a pioneer in regenerative cell-based therapies and devices, today announced the successful initial safety results of two Phase I clinical trials of the company's first product, Vascugel™. The trials were designed to study the safety of Vascugel™ in maintaining vascular patency in patients with arteriovenous access fistulas (AVF) and arteriovenous access grafts (AVG) for dialysis treatment of end-stage renal disease (ESRD).

Vascugel™ is a novel allogeneic cell therapy product that restores natural repair and regeneration pathways in the vasculature. The biological activity of Vascugel™ allows its application to a broad array of vascular procedures where poor medical outcomes are determined by intimal hyperplasia, stenosis and loss of patency at the site of intervention.

Michael S. Conte, MD, Associate Professor of Surgery at Harvard Medical School and Director of Vascular Surgery Research at Brigham and Women's Hospital, is serving as Co-Lead Investigator in the Pervasis study. Dr. Conte said, "Early results for Vascugel™ in its target patient populations are promising to date. All 30-day primary endpoints of the study were achieved, with no significant safety issues. There was no incidence of local wound infection, and related complications were within normal limits. This is a very encouraging initial result, and we look forward to continuing development of this novel therapy."

Steve Bollinger, President of Pervasis Therapeutics, said, "The Pervasis team is very pleased and encouraged by the initial results of our two Phase I 'V-HEALTH' trials of Vascugel™. We are also delighted to report that the Data Monitoring Committee has recommended that Vascugel™ proceed to Phase II trials, following review of one-month data."

He added, "We anticipate initiating Phase II studies in 2007, moving into broader safety trials, as well as studying new and efficient methods for measuring efficacy of this new class of therapy, in the two unique and distinct patient populations for our initial ESRD indication. This groundbreaking work will lead to larger pivotal studies, to look at expanding the clinical indications for Vascugel™ into multiple programs for a variety of vascular disease states, including peripheral and coronary artery diseases."

Pervasis is conducting its "V-HEALTH" (Vascular intimal Hyperplasia: Extending Arterial and venous patency, Limiting vascular Trauma, and inhibiting Hyperplasia while re-establishing vascular health) Phase I clinical trials in patients with ESRD that require a permanent AV access for hemodialysis. Vascugel™ is the first therapy being developed to simultaneously improve outcomes for the two primary forms of surgical arteriovenous access, namely, AV grafts and AV fistulas. Safety and feasibility trials are planned to evaluate the safety, tolerability, and general performance of Vascugel™. There are over 300,000 patients undergoing hemodialysis in the United States today, with an estimated annual growth rate of nearly 5% for new AV graft and AV fistula procedures performed each year.

The "V-HEALTH" trials were conducted at four U.S. sites, comprising St. Mary's Hospital (Tucson, Arizona), Duke University Medical Center (Durham, North Carolina), University of Miami (Miami, Florida), and Brigham and Women's Hospital (Boston, Massachusetts).

About Vascugel™

Vascugel™ is a novel allogeneic cell therapy product for enhancing repair and preventing clinical failure of vascular surgery and intervention. Vascugel™ builds on concepts of tissue engineering to enable implantation of allogeneic endothelial cells in a controlled state. When wrapped around an injured blood vessel, Vascugel™ endothelial cells provide growth regulatory compounds to the underlying blood vessel, promoting a natural healing process and preventing excessive scar tissue formation, inflammation and thrombosis.

About Vascular Access Failure

Vascular access failure is a major complication in providing care to patients on hemodialysis to treat end-stage renal disease (ESRD). The prevalent ESRD population in the U.S. is expected to grow to 1.3 million by 2030. According to Medicare reports, total ESRD costs reached $20.1 billion in 2004 - with total ESRD costs reaching $32.5 billion from all sources.

According to the United States Renal Data System (USRDS), the number of ESRD patients requiring hemodialysis in 2004 reached over 300,000. According to Medicare data, vascular access complications account for up to 25 percent of all hemodialysis patient admissions, leading to about $1.5 billion in annual Medicare expenditures.

About Pervasis Therapeutics, Inc.

Pervasis Therapeutics, Inc. is a pioneer in regenerative cell-based therapies and devices. Pervasis is currently developing technologies to restore natural blood flow to critical organs. The company's flagship product, Vascugel™, is a cell-based therapeutic gel currently being studied for efficacy in helping reverse acute vascular injury.

Pervasis' investors include Polaris Venture Partners, Flagship Ventures and Highland Capital Partners. The company was founded by Elazer Edelman, Robert Langer, Joseph Vacanti, and Helen Nugent.

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.

Source: Business Wire

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