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Pervasis Therapeutics Successfully Completes
Enrollment for Vascugel™ Phase II Clinical Trials
Pioneer in regenerative cell-based therapies and devices rapidly fulfills
patient recruitment goals for its Multi Arm Phase II Clinical Trials of the first
cell-based treatment for damaged arteries
Cambridge, Massachusetts – August 13, 2007 – Pervasis Therapeutics, Inc., a
pioneer in regenerative cell-based therapies and devices, today announced that
it has successfully completed patient recruitment for its two Phase II clinical
trials involving the company’s first product, Vascugel™.
The Phase II clinical studies are to evaluate the continued safety of Vascugel™
as well as its efficacy in the maintenance of vascular patency after creation of
arteriovenous (AV) access grafts and AV fistulae in patients undergoing dialysis
for treatment of end-stage renal disease (ESRD). Recent Phase I results for
Vascugel™ demonstrated that all primary endpoints of the study were achieved,
with no significant safety issues.
Vascugel™ is a novel allogeneic cell therapy product that may restore natural
repair and regeneration pathways in traumatized human vasculature. The
biological activity of Vascugel™ enables its application to a broad array of
vascular procedures, in which poor medical outcomes are determined by
intimal hyperplasia, stenosis and loss of patency at or near the site of
intervention.
Steve Bollinger, President of Pervasis Therapeutics, said, “Vascugel™’s two
Phase II studies have gotten off to a promising start, as we have completed full
patient enrollment in a very short time. We are certain these study arms hold
strong potential for creating innovative and highly useful metrics and methods
for evaluating the efficacy of this unique class of therapies for vascular
disease.”
He added, “We are confident of seeing intriguing results in terms of further
safety and efficacy as the two Vascugel™ trials progress. We will examine the
possibility of expanding its projected use for further indications in peripheral
and coronary vascular diseases later this year.”
Dr. Marc Glickman, Vascular & Transplant Specialists, Norfolk, Virginia, and
President-Elect of the Vascular Access Society of the Americas (VASA) said,
“Vascugel™ has shown great promise in its initial target population in the Phase
I Clinical Trial to date, and we anticipate strong findings as it progresses
through the current Multi Arm Phase II AVF and AVG studies throughout 2007.
The promise of utilizing human endothelial cells to maintain vascular patency
encompasses a growing range of potential indications, and we look forward to
validating Vascugel™’s continued safety with this clinical trial.”
Added Dr. John Ross, Chief of Surgery, Bamberg County Hospital, Bamberg,
South Carolina, “The technology we are studying today potentially holds the
keys to a better quality surgical intervention, be it invasive or minimally
invasive, and shows early promise as a truly revolutionary platform
technology.”
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 Multi Arm 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 and unique allogeneic cell therapy product under
investigation for enhancing repair and preventing clinical failure of the
vasculature after 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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