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Pervasis Therapeutics' Vascugel(TM) Initiates U.S. Clinical Trials Following Successful FDA IND Review

Posted on: Wednesday, 27 September 2006, 09:01 CDT

Pervasis Therapeutics, Inc., a pioneer in regenerative cell-based

therapies and devices, today announced that it has been enrolling

patients in two Phase I clinical trials of the company's

first product, Vascugel™. The company's

Investigational New Drug (IND) application was successfully reviewed by

the U.S. Food and Drug Administration (FDA) in May. The two clinical

studies approved under the IND are evaluating the safety and feasibility

of Vascugel™ 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).

Vascugel™ is a novel allogeneic cell therapy

product that restores natural repair and regeneration pathways in the

vasculature. Extensive preclinical studies at leading academic

institutions suggest Vascugel™ has the

potential to allow traumatized vasculature to return to homeostasis by

simultaneously reducing intimal hyperplasia (thickening of the vessel

wall - i.e. scar tissue formation), inflammation and thrombosis. The

biological activity of Vascugel™ allows its

application to a broad array of vascular procedures where poor medical

outcomes are determined by loss of patency at the site of intervention.

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.

Steve Bollinger, President of Pervasis Therapeutics, said, "We

are excited by the speed with which Vascugel™

has entered the clinic -- less than one year

after identifying our first application, executing an additional

preclinical study and then gaining IND approval to proceed with the

clinical program. This represents a major milestone in Pervasis'

rapid progress towards introducing important advancements in patient

care."

He added, "Our preclinical data strongly

suggests that Vascugel™ could fundamentally

change the management of vascular and other critical diseases. We expect

to expand our indications for use as we continue clinical development."

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. "The

biological problem of scarring and abnormal tissue growth is the number

one critical issue limiting all types of vascular interventions today,

both surgical and catheter-based. The need is most pressing in the

dialysis access population, where vessel narrowing leads to a large

number of repeat hospitalizations and procedures on a national scale."

He added, "While other approaches, such as

gene therapy and drug-eluting devices have been investigated for this

problem, Vascugel™ is truly novel in that it

employs the natural biological properties of human endothelial cells.

These cells maintain vascular health by producing a spectrum of

activities that could never be duplicated by single or even multiple

gene and/or drug therapies. The potential range of Vascugel™

is evidenced by the fact that we are treating two fundamentally

different types of interventions, both AV grafts and AV fistulas, with

these initial trials."

Following the Phase I study of Vascugel™,

Pervasis will initiate a series of Phase II studies aimed at expanding

the clinical indications into multiple programs for different disease

states.

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 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.

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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