FDA Recommends Endovasc Revise Phase III Plans for NRA and Simplify Liprostin Phase III Trial; Study Revisions Could Mean a Solid Future for the Company.Business Editors/Health & Medical Writers BIOWIRE2K MONTGOMERY, Texas--(BW HealthWire)--Nov. 8, 2001 Endovasc Ltd. Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :ENDV)(Berlin:ED7) today announced very encouraging results of meetings with the Food and Drug Administration (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. ) regarding Liprostin(TM) and Nicotine Receptor Agonist agonist /ag·o·nist/ (ag´ah-nist) 1. one involved in a struggle or competition. 2. agonistic muscle. 3. (NRA NRA (National Rifle Association of America) organization that encourages sharpshooting and use of firearms for hunting. [Am. Pop. Culture: NCE, 1895] See : Hunting ). FDA agreed to the company's simplifying Liprostin(TM)'s Phase III protocol for the treatment of critical limb ischemia (CLI (1) (Call Level Interface) A database programming interface from the SQL Access Group (SAG), an SQL membership organization. SAG's CLI is an attempt to standardize the SQL language for database access. ) and to proceed from NRA animal studies to Phase III clinical trials for treatment of chronic coronary ischemia which provides the company opportunities to escalate its timeline to market. Based on the results of these meetings, Endovasc is now proceeding with development of Phase III protocol, bypassing Phase I/II for the NRA product and revisions to its Phase III protocol for Liprostin(TM), which includes revised end points and extended patient enrollment. "We were extremely encouraged by these meetings," stated Dr. David Summers, 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. . "In light of our FDA meetings, changes to the protocols for both products are being initiated, which means that both Phase III trials could be in full swing during the first quarter, 2002. As we progress, we will keep everyone informed. This is great news to present at our annual meeting on Friday, Nov. 9. We have two potential "home run" products that are now in the final stage of regulatory approval. This is simply remarkable for a small company such as ours." The company stated that a revised Liprostin(TM) Phase III protocol will be submitted to the FDA by the end of this month, allowing the first patient to be treated sometime in early January 2002. The company's other product, NRA-angiogenic agent, intra-coronary injection protocol plan for chronic coronary ischemia, which calls for a single episode of injections into the blood-deficient area of the heart, is designed to stimulate growth of new blood vessels Blood vessels Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names. in the heart to relieve intractable anginal pain and improve the patient quality of life. Results from the company's large animal studies on dogs and pigs indicate that a single series of injections of the nicotine receptor agonist, all done during a single hospital procedure could stimulate a significant growth of new blood vessels. The company expects that this new blood supply will provide relief from chronic chest pain and estimates there are a minimum of 400,000 patients that could benefit from this new procedure. The company will meet with the FDA prior to the formal submission of the new Phase III protocol before the end of the year and anticipates Phase III NRA clinical trials could start in the first quarter of 2002. About the company: Endovasc Ltd. Inc. is a biopharmaceutical/biotech company pioneering liposomal drug delivery technology. In addition to Liprostin(TM) and NRA, the company is developing a stent-coating technology that has shown encouraging results in recently concluded pig studies and, a biodegradable, resorbable stent, all covered by patents, licenses and trade secrets for competing in a multi-billion dollar market. The foregoing statements are made under the "Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. " 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 Ltd. Inc., contact: |
|
||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion