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Biotech / Medical : Guilford (GLFD) - Steadily Rising -- Ignore unavailable to you. Want to Upgrade?

To: rkrw who wrote (411)	4/9/2002 5:21:41 PM
From: tuck	Read Replies (1) \| Respond to of 496

>>BALTIMORE, April 9 /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc. (Nasdaq: GLFD - news) announced today that Phase I clinical data for AQUAVAN(TM) Injection were presented at the Annual Meeting of the European Society of Anesthesiology in Nice, France. The data presented, in addition to earlier Phase I studies, suggest that AQUAVAN(TM) Injection can induce sedation and anesthesia without causing serious side effects. AQUAVAN(TM) Injection is a proprietary, patented, water-soluble prodrug of propofol, which is currently the world's best selling anesthetic. DIPRIVAN® Injectable Emulsion, the trade name for propofol, is widely used to induce and maintain anesthesia during surgery, and to sedate patients undergoing diagnostic and therapeutic procedures. Because it is formulated in a lipid- based emulsion, propofol may be associated with certain disadvantages, which include: pain upon injection, excessive lipid intake, and IV line cracking and clogging during long-term infusion, and the potential for microbial contamination. Propofol has also been associated with other side effects that may include depressed respiration and excessively low blood pressure. The data presented are from a Phase I dose escalation infusion study of AQUAVAN(TM) Injection conducted in Europe. The objective of the Phase I study was to compare the pharmacokinetic and pharmacodynamic properties of propofol from AQUAVAN(TM) Injection to propofol from DIPRIVAN® Injectable Emulsion. During the Phase I study, volunteers received DIPRIVAN® Injectable Emulsion as a target controlled infusion to achieve three different plasma concentrations of propofol over a sixty minute period. Two weeks later, the same volunteers received target-controlled infusions of AQUAVAN(TM) Injection to achieve identical propofol concentrations. The infusion scheme was a linear increasing propofol concentration up to 5 micrograms/ml for the first 20 minutes, 3 micrograms/ml for the following 20 minutes and a target propofol plasma concentration of 1.5 micrograms/ml for 40 to 60 minutes. At 60 minutes the infusion was stopped. The results of the study suggest that AQUAVAN(TM) Injection can induce and maintain stable levels of sedation and anesthesia, and that propofol from AQUAVAN(TM) Injection is more potent than propofol from DIPRIVAN® Injectable Emulsion. Although comparable plasma concentrations of propofol were achieved in both groups, there was a greater decrease in the median EEG frequency for propofol from AQUAVAN(TM) Injection, EC50 2 micrograms/ml, compared to DIPRIVAN® Injectable Emulsion EC50 3 micrograms/ml, (p<0.05). ``We continue to be impressed by the results of our clinical studies of AQUAVAN(TM) Injection,'' commented Craig R. Smith, Chairman and Chief Executive Officer. ``Our Phase I studies have already demonstrated proof of principle that AQUAVAN(TM) Injection can induce and maintain sedation and anesthesia in humans. More recent data suggest that AQUAVAN(TM) Injection has unique pharmacological characteristics, which may make it suitable for a variety of indications, including: anesthesia induction, anesthesia maintenance, ICU sedation and Monitored Anesthesia Care. We look forward to continuing our clinical development program for AQUAVAN(TM) Injection and commencing pivotal European Phase II studies.'' About AQUAVAN(TM) Injection AQUAVAN(TM) Injection is a proprietary water-soluble prodrug of propofol in development by Guilford. Unlike DIPRIVAN® Injectable Emulsion, which is propofol formulated in an oil or lipid-based emulsion, AQUAVAN(TM) Injection is formulated in a clear aqueous solution and is rapidly converted, by an enzyme in the body called alkaline phosphatase, into propofol after intravenous injection. Because of its water-soluble formulation and unique properties, Guilford anticipates that AQUAVAN(TM) Injection may minimize or obviate many of the side effects associated with propofol, including: cardiovascular side effects, such as decreased blood pressure, depressed respiration, elevated blood lipid levels, injection site pain, and the potential for bacterial contamination. Despite some of the associated side effects, propofol is widely used in hospitals and out-patient settings to induce and maintain anesthesia during surgery, or to sedate patients undergoing diagnostic or medical procedures. DIPRIVAN® Injectable Emulsion was launched in the United States in 1989 and is currently the world's leading anesthetic agent. Estimated worldwide sales of propofol in 2001 were approximately $650 million.<< snip Cheers, Tuck