Healthcare Industry News:  hemodialysis 

Biopharmaceuticals Regenerative Medicine

 News Release - March 19, 2007

Pervasis Therapeutics Launches Enrollment for Two Phase II Clinical Trials for Vascugel(TM)

Pioneer in regenerative cell-based therapies and devices kicks off patient recruitment for Phase II clinical safety trials of first biologically-active treatment to ameliorate acute vascular injury in multiple disease states

CAMBRIDGE, Mass.--(HSMN NewsFeed)--Pervasis Therapeutics, Inc., a pioneer in regenerative cell-based therapies and devices, today announced that it has begun enrolling patients in two Phase II clinical trials of the company's first product, Vascugel(TM).

The upcoming Phase II studies are to evaluate the continued safety of Vascugel(TM) as well as benefit for the maintenance of vascular patency after creation of arteriovenous (AV) access graft and AV fistula, respectively, for patients undergoing dialysis for the treatment of end-stage renal disease (ESRD). Recent Phase I results for Vascugel(TM) demonstrated that all primary endpoints of the study were achieved, with no significant safety issues.

Vascugel(TM) is a novel allogeneic cell therapy product that restores natural repair and regeneration pathways in the vasculature. The biological activity of Vascugel(TM) 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.

Steve Bollinger, President of Pervasis Therapeutics, said, "We are delighted at the successful results of Vascugel(TM)'s two Phase I clinical trials, and are encouraged as we enter our two Phase II studies. We look forward not only to evaluating the further safety and efficacy of Vascugel(TM) in a broader study environment, but also to developing groundbreaking new methods for measuring efficacy for this entirely new class of vascular therapeutic."

He added, "Based on the latest successful clinical results for Vascugel(TM), Pervasis has the option to expand into additional indications including peripheral and coronary vascular diseases as early as the second half of 2007."

Jeffrey H. Lawson, MD, Assistant Professor of Surgery at Duke University Medical Center, said, "All clinical evaluations to date for Vascugel(TM) appear to confirm that the product has a broad impact on the local biology of the vasculature, with a unique immunology and activity profile. The concept of stimulating natural regenerative healing with an active endothelial-cell implant has great promise in a broad array of vascular applications, and there is compelling evidence to expand the scope of this therapeutic approach."

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 II clinical trials in patients with ESRD that require a permanent AV access for hemodialysis. Vascugel(TM) 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. 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.

About Vascugel(TM)

Vascugel(TM) is a novel allogeneic cell therapy product for enhancing repair and preventing clinical failure of vascular surgery and intervention. Vascugel(TM) 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(TM) 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(TM), is a cell-based therapeutic gel currently being developed to help 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.

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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: Pervasis Therapeutics

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