Endovasc Ltd Inc announced that in accordance with its new business model, the company has established a new subsidiary, Angiogenix Development Corporation, for its potential blockbuster nicotinic acetylcholine receptor agonist drug - Angiogenix. Endovasc is well ahead of all other biotech firms in bringing an angiogenesis drug to the market. The company''''s larger competitors, Genentech and Genzyme 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.
Angiogenix is a new and revolutionary nicotine-based drug that may grow new blood vessels and promote angiogenesis and subsequent renewal of heart function. In recent studies, test animals actually grew new blood vessels in their heart after blood flow was constricted to produce a condition modeling chronic myocardial ischemia, which afflicts millions of Americans. Angiogenix was co-developed by Professor John P. Cooke of Stanford University, which has granted Endovasc a worldwide, exclusive license to the patent for the treatment.
In addition, any funding received by Angiogenix Development Corporation will not dilute Endovasc stock, nor will it create debt for Endovasc. In the future, by board resolution, Endovasc shareholders of record will receive a distribution of stock, subject to the customary regulatory approvals and the filing of the necessary registration statement.
According to its new business model, Endovasc focuses on taking on promising drug candidates at the end of the discovery phase and then conducting a fast track program for the technical and early clinical development phases, covering Phases I and II of the compound. The fact that Endovasc has been able to get two potential blockbuster drugs all the way to Phase III trials without incurring any significant debt, in near record time, proves this model shows tremendous potential.
Currently, the company has two products approved for Phase III FDA human clinical trials: Angiogenix, a nicotine based treatment that grows new heart vessels, and Liprostin, a liposomal prostaglandin based treatment that studies suggest will prevent restenosis (re-blockage of arteries), increase circulation, and reduce leg pain due to poor blood flow. Endovasc''''s other products include biodegradable stents, drug-delivery stents and newly discovered nutriceutical applications that may accelerate development of muscle mass and treat obesity in overweight diabetic women. Endovasc believes that its nutriceutical nicotine-based drinks, fitness bars or capsules (which, according to the company, will contain nicotine levels too low to be habituating or to cause the typical euphoria effects from smoking) combined with high protein complexes could become blockbuster nonprescription products, producing positive cash flow even sooner than its later stage drugs because they are not subject to the FDA approval process.
One of Endovasc''''s closest competitors, Collateral Therapeutics, was acquired earlier this year by Schering AG in a transaction that put Collateral Therapeutics'''' valuation at approximately $200 million when earlier cash infusions are factored in - even though its angiogenesis treatment actually failed in its FDA Phase II tests.