Placing more resources toward and greater attention on its product Liprostin for peripheral arterial occlusive disease, Endovasc Inc. decided to stop funding preclinical research of a nicotine receptor agonist (NRA) in coronary artery disease.
As part of that decision, the company's wholly owned subsidiary, Angiogenix Ltd. Inc. (not to be confused with Angiogenix Inc., of Burlingame, Calif.) terminated its five-year-old licensing agreement with Leland J. Stanford University relating to the use of NRA.
"Right now, we have a very successful trial with Liprostin, and about a year and a half ago, when I started as CEO, I decided we were going to focus all of our efforts on our primary drug and move that through," said Diane Dottavio, president and CEO of Montgomery, Texas-based Endovasc. "So, if we got it through, the earnings from that drug could support different projects."
Liprostin had positive results in a multinational Phase II trial in PAOD patients, and Endovasc is gearing up for a Phase IIb trial this year and a Phase III trial next year. If the results are good, it could reach the market in 2007.
"We do need a study in which we have a placebo arm and a different dose regimen," Dottavio told BioWorld Today. "So we're thinking of doing a small trial, in preparation for the pivotal trial."
In the completed Phase II trial, Liprostin, a liposome-encapsulated form of prostaglandin E1, increased by more than 100 percent the maximum walking distance, and by more than 200 percent the average pain-free maximum walking distance in peripheral arterial disease patients. Market potential for the product is estimated to be in excess of $100 million dollars annually, with about 8.4 million Americans affected. (See BioWorld Today, Aug. 20, 2004.)
Resources that might have been earmarked for the Angiogenix program now will go toward Liprostin.
The Angiogenix program is based on the knowledge that nicotine binds to acetylcholine receptors as a mechanism to enter cells. The idea was to find ways to support blood flow throughout the heart, allowing the heart muscle to regain function.
Endovasc received a grant to do the NRA preclinical research, but it would have spent millions of dollars to take it through the clinic on its own, Dottavio said.
On top of that, the company was having problems figuring out how to deliver the product into patients. When it originally sublicensed the technology from Stanford, it had planned to use a liquid form of nicotine and inject it directly into the heart via catheter, specifically the Microheart catheter system. The goal was to have it approved within five years. But Natick, Mass.-based Boston Scientific Corp. purchased Microheart and no longer would allow Endovasc to use the catheters. The company also could not get access to New Brunswick, N.J.-based Johnson & Johnson's catheters.
"When that avenue closed up, we had to come up with another means of administration," Dottavio said. "And clearly now we were getting into a time frame that exceeded five years."
Endovasc did not want to deliver Angiogenix systemically, or in pill form, due to the possibility of feeding cancerous tumors. The company would have needed a fairly extensive screening process to eliminate patients with such tumors from clinical trials.
So it dropped the program altogether.
"This was a decision that we decided to make in the best of the company's interests," Dottavio said. "We just simply weren't able to fulfill an unrealistic timeline for commercialization."
Endovasc uses its wholly owned subsidiaries, such as Angiogenix (named after the drug), to allow investors to place their money with particular products. Each subsidiary holds the intellectual property to the technology for which it was formed, and they all are housed in Endovasc's Texas facility.
Endovasc (OTC BB:EVSC) closed at about 6 cents Thursday.