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Pervasis Therapeutics announces New Animal
Study Results Supporting Vascugel™ in Promoting
Healing after Blood Vessel Injury
Pioneer in regenerative cell-based therapies and devices announces new
research results suggesting major role by biologically-active implants in
successfully increasing lumen diameter in damaged blood vessels and
preventing stenosis
Cambridge, Massachusetts – September 17, 2007 – Pervasis Therapeutics,
Inc., a pioneer in regenerative cell-based therapies and devices, today
announced the publication of new animal data for its Vascugel™ product under
investigation to aid in healing, function, and remodeling of traumatized veins
and arteries.
The study suggested that Vascugel™, a biologically active matrix of endothelial
cells that is placed directly on damaged blood vessels to stimulate natural
repair and regeneration, was instrumental in significantly increasing the
diameter of injured vasculature, and reduced vascular narrowing, in tests
utilizing a porcine model of arteriovenous (AV) grafts.
In August, Pervasis completed patient enrollment for two Phase II clinical trials
of Vascugel™ in human subjects for end-stage renal disease (ESRD) who require
arteriovenous access for hemodialysis. Initial safety results for Phase I clinical trials of Vascugel™, announced in November, showed encouraging results, with
all primary safety endpoints of the study achieved.
Dr. Helen Nugent, Co-Founder and Vice President of Research and
Development, of Pervasis Therapeutics, said “Vascular access dysfunction is a
major problem in hemodialysis patients. Arteriovenous grafts have a patency
rate of only 50 percent at one year. The goal of this animal study was to
examine the role of perivascular endothelial implants in venous remodeling and
stenosis. The results of this published research strongly suggest that Vascugel™
played a major role in significantly increasing venous lumen gain, and reduced
stenosis by 81% in porcine model of AV grafts.”
Steve Bollinger, President of Pervasis Therapeutics, said, “The results of the
animal study are extremely encouraging, and alongside the successful initial
safety results of our Phase I study for Vascugel™, indicate that biologically
active treatments for repairing blood vessels are a very promising therapeutic
pathway. We look forward to similar positive data as we continue to advance
Vascugel™ through human clinical trials.”
The publication, titled, “Adventitial Endothelial Implants Reduce Matrix
Metalloproteinase-2 Expression and Increase Luminal Diameter in Porcine
Arteriovenous Grafts,” will be published in the September issue of the Journal
of Vascular Surgery. Data from the study have also been presented at the
American Association of Anatomists Annual Meeting in Washington, DC and at
the ASAIO Annual Innovation Conference “Biologic Therapy of Uremia”.
Pervasis is conducting its “V-HEALTH” (Vascular intimal Hyperplasia: E xtending 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™ 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™
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, which may promote a natural healing process and
prevent 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.
Press Contact:
Michele Rozen
Pure Communications, Inc.
Email: michele@purecommunicationsinc.com
Phone: 617-730-8284
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