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Pervasis Therapeutics Announces New Animal Study Results Supporting Vascugel(TM) 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, Mass. -- Pervasis Therapeutics, Inc., a pioneer in regenerative cell-based therapies and devices, today announced the publication of new animal data for its Vascugel[TM] product under investigation to aid in healing, function, and remodeling of traumatized veins and arteries.

The study suggested that Vascugel[TM], 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 vasculature /vas·cu·la·ture/ (vas´ku-lah-chur)
1. circulatory system.

2. any part of the circulatory system.


vas·cu·la·ture
n.
, and reduced vascular narrowing, in tests utilizing a porcine porcine /por·cine/ (por´sin) pertaining to swine.

porcine

pertaining to pig. See also hog (1), swine.


porcine circovirus 1
a nonpathogenic virus.
 model of arteriovenous arteriovenous /ar·te·rio·ve·nous/ (-ve´nus) both arterial and venous; pertaining to or affecting an artery and a vein.

ar·te·ri·o·ve·nous
adj.
Abbr.
 (AV) grafts.

In August, Pervasis completed patient enrollment for two Phase II clinical trials of Vascugel[TM] in human subjects for end-stage renal disease End-stage renal disease (ESRD)
Total kidney failure; chronic kidney failure is diagnosed as ESRD when kidney function falls to 5-10% of capacity.

Mentioned in: Chronic Kidney Failure

end-stage renal disease 
 (ESRD ESRD end-stage renal disease.
ESRD
End-stage renal disease; chronic or permanent kidney failure.

Mentioned in: Dialysis, Kidney

ESRD End-stage renal disease, see there
) who require arteriovenous access for hemodialysis. Initial safety results for Phase I clinical trials of Vascugel[TM], 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 pa·ten·cy
n.
The state or quality of being open, expanded, or unblocked.



patency

the condition of being open.
 rate of only 50 percent at one year. The goal of this animal study was to examine the role of perivascular perivascular /peri·vas·cu·lar/ (-vas´ku-lar) near or around a vessel.

perivascular

around a vessel.


perivascular cellulitis
 endothelial endothelial /en·do·the·li·al/ (-the´le-al) pertaining to or made up of endothelium.
Endothelial
A layer of cells that lines the inside of certain body cavities, for example, blood vessels.
 implants in venous remodeling and stenosis. The results of this published research strongly suggest that Vascugel[TM] played a major role in significantly increasing venous lumen gain, and reduced stenosis by 81 percent in porcine models of AV grafts."

Stephen 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[TM], 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[TM] through human clinical trials."

The publication, titled, "Adventitial adventitial /ad·ven·ti·tial/ (ad?ven-tish´al) pertaining to the tunica adventitia.

ad·ven·ti·tial
adj.
1. Of or relating to the adventitia of an organ or blood vessel.

2.
 Endothelial Implants Reduce Matrix Metalloproteinase-2 Expression and Increase Luminal Diameter in Porcine Arteriovenous Grafts," is 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 ASAIO American Society for Artificial Internal Organs  Annual Innovation Conference "Biologic Therapy of Uremia uremia (yrē`mēə), condition resulting from advanced stages of kidney failure in which urea and other nitrogen-containing wastes are found in the blood. ".

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 fistula (fĭs`chlə), abnormal, usually ulcerous channellike formation between two internal organs or between an internal organ and the skin.  procedures performed each year.

About Vascugel[TM]

Vascugel[TM] is a novel allogeneic allogeneic /al·lo·ge·ne·ic/ (-je-ne´ik)
1. having cell types that are antigenically distinct.

2. in transplantation biology, denoting individuals (or tissues) that are of the same species but antigenically
 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, 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 USRDS United States Renal Data System
USRDS US Robotics Dual Standard (modem) 
), 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 Highland Capital Partners is a global venture capital firm with offices located in Boston, Silicon Valley, Geneva, and Shanghai. Since its inception in 1988, the firm has invested in more than 180 early and growth stage companies and taken a sector-focused approach to investing in . 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.
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Publication:Business Wire
Article Type:Report
Date:Sep 17, 2007
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