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Columbia University Test Results: Endovasc's Novel Angiogenic Treatment Is Safe - Studies Suggest Improved Blood Flow By Growth of New Blood Vessels to Ischemic Hearts.


Business Editors & Health/Medical Writers

MONTGOMERY, Texas--(BUSINESS WIRE)--Oct. 28, 2002

100% Of Four Different Animal Species Demonstrated Signs of New

Vascular Growth; Human Patients to Be Treated Soon

Endovasc Ltd., Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:ENVC) announced today very positive end-point findings of its animal studies and results of its latest pig study conducted at Columbia University for the company's ANGIOGENIX(TM) heart treatment - already approved for the final Phase III FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 human clinical trials. ANGIOGENIX(TM) is a simple, small molecule derived from the tobacco plant that, when given in low doses, has demonstrated remarkable results in stimulating robust growth of new vessels in four different animal experiments with simulated blood-flow deficiencies, suggesting that it will do the same in a human patient's heart and limbs.

According to the Company, EVERY test animal group demonstrated safety and angiogenesis (new blood vessels) at the effective dose with no observable side effects. This means that upon completing the Phase III human trials, ANGIOGENIX(TM) could provide relief for millions of Americans suffering from fatigue and relentless chest pain (angina) caused by severely and chronically blocked coronary arteries, or obstructed peripheral vascular limbs making walking more than a few steps extremely painful. The treatment could become publicly available within 18-24 months if early human results of 75 patients provide sufficient proof to enable the FDA to give fast-tract approval, providing many heart attack and ischemic Ischemic
An inadequate supply of blood to a part of the body, caused by partial or total blockage of an artery.

Mentioned in: Antiangiogenic Therapy, Subarachnoid Hemorrhage, Ventricular Fibrillation


ischemic
 limb victims the option of a painless and effective alternative for bypass surgery.

In Columbia's latest study, the report stated: "Columbia University conducted an uncontrolled preliminary feasibility study in which low-dose nicotine was injected into chronic ischemic porcine myocardium myocardium /myo·car·di·um/ (-kahr´de-um) the middle and thickest layer of the heart wall, composed of cardiac muscle.

hibernating myocardium  see myocardial hibernation, under
. In this study of five pigs, test animals underwent ameroid constriction placement on the circumflex circumflex /cir·cum·flex/ (serk´um-fleks) curved like a bow.

cir·cum·flex
adj.
1. Curving or bending around.

2. Bowed.



circumflex

curved like a bow.
 artery and were tested for intramyocardial effects of nicotine after induced ischemia was demonstrated in the target zone of the myocardium. The focus of the study was on measurement of myocardial myocardial /myo·car·di·al/ (-kahr´de-al) pertaining to the muscular tissue of the heart.

myocardial

pertaining to the muscular tissue of the heart (the myocardium).
 perfusion at baseline and at about five weeks after nicotine injections.

"The data showed some improvement in subendocardial perfusion in 3 of the pigs and in epicardial epicardial

pertaining to the visceral pericardium (epicardium) or to the epicardia.


epicardial receptors
receptors in the left ventricle adapted to respond to stretch and chemical stimulants.
 perfusion in 2 of the pigs. Histological evaluation showed evidence of DNA synthesis (BrdU) in relatively large vessels near injection sites, consistent with vascular growth. Different than observed with direct intramyocardial injections of other growth factors, there were no large regions of fibrosis or inflammation noted at the injection sites. There were no obvious adverse effects observed during the injections or the follow-up period."

"In plain English, this study means that our drug simply works, and it is safer and works better than anything else on the horizon for angiogenesis. The injection sites were clearly delineated by trichrome staining of endothelial and smooth muscles cells, around large areas of unmistakable vascular voids. But of interest, we saw BrdU incorporation of DNA DNA: see nucleic acid.
DNA
 or deoxyribonucleic acid

One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes.
 at considerable distance from the injection sites, which one might speculate could be evidence of lymphangiogenesis, new capillary formation, or de novo transdifferentiation of bone marrow stem cells," said Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Endovasc, Dr. David P. Summers.

"Furthermore, ANGIOGENIX(TM) works by simple injection, binding the acetylcholine receptors (nAChR) on endothelial cells and activating DNA synthesis of growth factors of the angiogenic cascade. This novel pathway was unknown until recently discovered at Stanford University, and involves processes quite different than our competitors' use of transfection viruses as vectors. We think it is safer and believe we have at least a 3-5-year lead on our nearest competitors," he said.

Endovasc's ANGIOGENIX(TM) treatment is currently the only viable angiogenesis treatment approved for Phase III trials. The company is well ahead of all other biotech firms in bringing an angiogenesis drug to the market. The company's larger competitors, Genentech (NYSE NYSE

See: New York Stock Exchange
:DNA) and Genzyme (Nasdaq:GENZ) are still in Phase II trials with their angiogenesis treatments and are experiencing various challenges, whereas Endovasc's treatment has already been approved for FDA Phase III human clinical trials.

In earlier studies, performed at Stanford University, researchers used a regional chronic ischemia model in both the mouse and the rabbit. In those tests, a same dose of ANGIOGENIX(TM) produced angiogenesis and reperfusion re·per·fu·sion
n.
The restoration of blood flow to an organ or tissue that has had its blood supply cut off, as after a heart attack.
 recovery by new blood vessels as well as a four-fold increase in stem cell recruitment and mobilization in the parabiotic mouse marked with LacZ and endothelial progenitor cell Endothelial progenitor cells are bone marrow-derived cells that circulate in the blood and have the ability to differentiate into endothelial cells, the cells that make up the lining of blood vessels.  (EPC (1) (Entertainment PC) See HTPC.

(2) (Electronic Product Code) A standard code for RFID tags administered by EPCglobal Inc. (www.epcglobalinc.org).
) markers for CD 31 receptors. ANGIOGENIX(TM) was discovered at Stanford University. The United States Patent No. 6,417,205, "Nicotine in Therapeutic Angiogenesis and Vasculogenesis," was issued to Stanford on July 9, 2002. Stanford has licensed Endovasc the exclusive worldwide rights to nicotine field of use in angiogenesis and vasculogenesis. Additionally, Endovasc has an exclusive option on PCT (Private Communications Technology) A protocol from Microsoft that provides secure transactions over the Web. See security protocol.  WO 01/08683-A1 titled "Nicotine Receptor Agonist in Stem Cell and Progenitor Cell Recruitment."

The U.S patent enjoys a patent protection until 2022. The grant of the patent to Stanford provides broad patent rights. By right of its worldwide exclusivity, Endovasc can fully negotiate sublicenses, distribution, and other rights with companies and other interested parties.

Cardiovascular and metabolic markets account for more than USD USD

In currencies, this is the abbreviation for the U.S. Dollar.

Notes:
The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion.
 69 billion in sales volume per year - 25% of the entire pharmaceutical market. Cardiovascular diseases are the number one cause of death in the western world today. They account for 50% of deaths worldwide, nearly double of those caused by cancer, the second most prevalent cause of death. It is estimated that in the United States alone, the economic cost of cardiovascular diseases is over USD 250 billion per year.

About Endovasc

Endovasc Ltd., Inc., established in 1996, is a biotechnology company focused in the area of cardiovascular disease, pioneering drug delivery technology designed to deliver and release drugs to their intended targets in an efficient and controlled manner. The company's products and processes include Liprostin(TM), ANGIOGENIX(TM) (Nicotine Receptor Agonist), PROStent(TM) stent-coating technology, and a biodegradable resorbable prosthesis prosthesis (prŏs`thĭsĭs): see artificial limb.
prosthesis

Artificial substitute for a missing part of the body, usually an arm or leg.
.

The foregoing statements are made under the "Safe Harbor" Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995 and may contain forward-looking statements that involve risks and uncertainties that may not be evident at the time of this release. For more information about Endovasc, please visit www.endovasc.com. Investor questions and requests for materials can be submitted online at investorrelations@endovasc.com.
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No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Oct 28, 2002
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