Neurex And SNX-111 in Ischemia; Go-Ahead Given To Resume Phase II Clinical Studies; FDA lifts clinical hold for head trauma and bypass graft Studies.MENLO PARK, Calif.--(BUSINESS WIRE)--May 8, 1995--Neurex Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : NXCO) announced today that the clinical hold imposed by the 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. earlier this year on the intravenous administration of SNX-111 has been lifted. The compound in this program is targeted for the prevention of brain damage following closed head trauma and coronary artery bypass graft coronary artery bypass graft n. Abbr. CABG A surgical procedure in which a section of vein or other conduit is grafted between the aorta and a coronary artery below the region of an obstruction in that artery. (CABG CABG coronary artery bypass graft. CABG abbr. coronary artery bypass graft CABG Coronary artery bypass graft, see there ) surgery. The Company has previously announced that the FDA had imposed a clhnical hold while it reviewed the protocols and profile of the compound. Neurex has now been cleared to resume Phase II studies, with only a few revisions to the clinical protocols. The occurrence of recumbent hypotension (reduced blood pressure) in certain patients treated in the Phase II studies precipitated the clinical hold. "The original response we made to the FDA following the imposition of the hold not only demonstrated the mechanism by which the recumbent hypotension was occurring in these patients, but also indicated how to treat this adverse event effectively when it occurred," commented Dr. Paul Goddard, Chairman and Chief Executive Officer of Neurex. He added, "We can now proceed with our development program to establish the treatment effect of SNX-111 in these patient populations. Currently there is no effective treatment to prevent brain damage due to ischemia following head trauma or CABG." SNX-111 is currently in Phase II clinical studies for the treatment of these 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 indications in conjunction with Neurex' corporate partner Warner-Lambert Parke-Davis (NYSE NYSE See: New York Stock Exchange : WLA). SNX-111 is also in clinical development for the treatment of a variety of pain syndromes when administered by the intrathecal intrathecal /in·tra·the·cal/ (-the´k'l) within a sheath; through the theca of the spinal cord into the subarachnoid space. Intrathecal route. This program was not affected by this clinical hold; recumbent hypotension has not been seen in patients treated for pain, nor was it anticipated. About Neurex Neurex is building a portfolio of product development candidates in the acute care area focused on treatments in the emergency room, Intensive Care Unit and pain clinic. In addition to its lead compound SNX-111, Neurex has also licensed rights to Corlopam(R) (fenoldopam) from SmithKline Beecham for the treatment of a range of acute care indications. Pro-urokinase, licensed through the acquisition of Creagen, Inc., is also targeted for acute care indications. Neurex' underlying discovery efforts are directed toward the development of therapeutics which modulate the activities of the central and peripheral nervous system peripheral nervous system: see nervous system. by regulating nerve cell communication. The Company's proprietary neuromodulation technology focuses on methods of selectively blocking different classes of neuron specific calcium channels and thereby regulating the release of specific neurotransmitters. Current research programs are focused on developing therapeutics for a wide range of neurological and psychiatric indications. CONTACT: Neurex Corp., Menlo Park Dr. Paul Goddard, 415/833-1288 |
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