West Coast Editor

Having reported in June that preliminary data were positive, Endovasc Inc. said full results of the Phase II trial of Liprostin for peripheral vascular disease (PVD) are encouraging as well.

The news was enough to boost Montgomery, Texas-based Endovasc's stock (OTC BB:EVSC) up 29.6 percent to close at 14 cents Thursday. Endovasc said it is exploring "a number of financial strategies" for getting Liprostin into Phase III trials.

"Until now, we haven't had anything hard-core that suggests the drug is active," said Diane Dottavio, president and CEO of Endovasc.

"We would welcome any kind of licensing or co-development strategies, and we are being contacted, but we're just in the talking stages," she added. The firm reported $120,000 in cash and equivalents at the end of June, with current liabilities totaling more than $1.1 million.

"It is a pretty daunting project ahead of us," Dottavio acknowledged. "Obviously we hope that with the data we have, we will interest a mid-size or large pharmaceutical company, and we've gotten a lot more positive response from places like Japan and Europe where [prostaglandin products such as Liprostin] are used pretty abundantly" as vasodilators, she said.

PVD patients taking part in the Liprostin trial suffered conditions including critical limb ischemia and intermittent claudication (leg pain). They were classified as Stage IIa, IIb or III in Fontaine's staging system, and mostly were more than 40 years of age.

Results in 73 patients completing the three-month trial showed significant improvements in the primary endpoints of mean walking distance and pain-free walking distance. Ten patient visits took place over 12 weeks, with baseline abilities determined in the first two visits.

Thanks to Liprostin, which is a liposome-encapsulated form of prostaglandin E-1 (PGE-1), maximum walking distance increased more than 100 percent and the average pain-free maximum walking distance jumped almost 200 percent.

Patient responses to a questionnaire showed significant day-to-day quality-of-life improvements, as indicated by an increase in their overall walking distance and walking speed, the company said.

While walking distance increased, pain went down after six treatments, the company said, and patients continued to improve during the third month, even after they no longer received the drug.

The market potential of Liprostin is estimated to be in excess of $100 million dollars annually. In the U.S., as many as 10 million Americans older than 40 are afflicted with peripheral arterial disease, including about 20 percent of those age 55 and older.

Scientists will mine the Phase II data, and Endovasc intends to publish the findings in a journal. Meanwhile, Dottavio said would-be partners might also find allure in Liprostin's potential promise in such conditions as diabetic neuropathy and wound healing. Since the drug is given intravenously and works systemically, it might benefit the heart, she added.

"There's pressure in the company to move forward to a Phase III trial, but I think we would have an arm to look at dosing, and certainly the Phase III will look at the long-term effect," she said. "We hadn't anticipated this continual improvement [in PVD patients], so we didn't carry it out long enough."

Last month, the firm told shareholders during an update that it had "reached a new stage in its business model," and had made the transition from a firm that "identifies drug candidates and drug delivery methods" to a firm that boasts a pipeline, albeit one that needs work.

Endovasc has worldwide rights to Angiogenix, an isomer of nicotine found to stimulate angiogenesis in oxygen-deprived tissue, and the company is working with the Texas Heart Institute in Houston to determine whether the compound might stimulate stem cells for therapeutic regeneration of tissues.

Also in the lineup is the Prostent coating for cardiac and peripheral stents (with PGE-1 as its active ingredient) as a possible anti-restenosis candidate. Endovasc is developing a formulation of the coating.

The company has a pair of joint ventures with TissueGen Inc., of Arlington, Texas. One is focused on developing a bioresorbable, drug-eluting cardiac stent. The other is to devise biodegradable stents for urethral and prostate applications.

Endovasc's wholly owned subsidiary, Nutraceutical Development Corp., has a naturally occurring plant alkaloid to enhance muscle mass and reduce body fat, a formulation of which has been licensed in a development deal to Western Holdings, a subsidiary of Salt Lake City-based Basic Research, until October 2004.

Dottavio told BioWorld Today that, if no partner surfaces, Endovasc plans to set up a wholly owned subsidiary, name it after Liprostin, and try to raise money for Phase III trials through an initial public offering.

"We're in the process of doing that, and we think that will happen in the first of next year," she said, expressing hope that investors by then will understand the story well enough to buy into the PVD drug.

"I'm old school; I believe if you have a good product, that will sell your company," she said. "And [PVD] is an unmet need."