rkrw,
You wrote:>>GLFD's aquavan product is what investors should be looking at. Aquavan bolus (onset) results are due out in April is the big if. Even if unfavorable in onset compared to propofol, there's still a sizable market opportunity for the product esp given such a small market cap for glfd. I think glfd is a very interesting stock at this price.<<
Any numerical approximation of the market size? I would think trials would go quickly, though no timeline is given for this PII. However, some of the endpoints look fuzzy to me; I wonder if this trial is large enough to achieve significance, and how big the PII will have to be. It could be that these endpoints are standard for evaluating anesthetics; I won't pretend to know much about the indication. Perhaps one of Stefaan's colleagues can help here.
>>BALTIMORE, Feb. 13 /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc. (Nasdaq: GLFD - News) announced today that it has commenced in the United States a Phase II clinical trial of AQUAVAN(TM) Injection, a novel, rapid acting sedative/hypnotic, in patients undergoing conscious sedation during colonoscopy. Part 1 of the Phase II trial is a dose ranging pilot study to determine the optimal sedative dose of AQUAVAN(TM) Injection for use in achieving conscious sedation in patients. Once the optimal dose is identified, the Company will initiate Part 2 of the study, comparing AQUAVAN(TM) Injection to midazolam HCI in patients undergoing colonoscopy. Midazolam HCI is currently the most widely used sedative/hypnotic for these types of procedures.
About the Phase II Clinical Trial
Initial clinical studies of AQUAVAN(TM) Injection suggest that it may provide many of the advantages of midazolam HCI, including rapid onset of effect and enhanced safety, with the potential for more convenient dosing, faster recovery, and enhanced post-procedural patient satisfaction.
In addition to determining the optimal sedative dose, Part 1 of the Phase II clinical trial will determine the safety and tolerability of AQUAVAN(TM) Injection, as well as the safety and tolerability of pre-treatment with fentanyl citrate injection or celecoxib (CELEBREX®) capsules in conjunction with AQUAVAN(TM) Injection.
In the study, AQUAVAN(TM) Injection will be administered intravenously to produce the desired sedative effect. Patients will be continuously monitored and various hemodynamic measures will be taken, including blood pressure, heart rate and respiratory rate.
In Part 2 of the clinical study, approximately 110 patients will be enrolled and randomly assigned to receive either AQUAVAN(TM) Injection or midazolam HCI in combination with fentanyl citrate injection or celecoxib (CELEBREX®) capsules. The primary objectives of the study are to determine the time to full recovery for patients receiving AQUAVAN(TM) Injection as compared to midazolam HCI, and to determine the safety and tolerability of AQUAVAN(TM) Injection following pre-treatment with fentanyl citrate injection or celecoxib (CELEBREX®) capsules. Secondary objectives include determining the time to sedation, time to discharge, and level of patient and physician satisfaction.
"The unique pharmacological profile of AQUAVAN(TM) Injection, shown in our previous Phase I studies, suggests multiple benefits for patients undergoing conscious sedation, such as reduced prolonged amnesia or `hangover effect' and fewer restrictions on post-procedure activities," commented Valerie Riddle, M.D., the Company's Vice President, Medical Affairs and Clinical Research. "As our program progresses through clinical trials, a primary goal will be to demonstrate the utility of AQUAVAN(TM) Injection in diverse settings, including conscious sedation and ICU sedation."
About AQUAVAN(TM) Injection
AQUAVAN(TM) Injection is a proprietary water-soluble prodrug of propofol exclusively licensed by Guilford from ProQuest Pharmaceuticals. Unlike propofol, which is 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 current sedatives and anesthetics, including cardiovascular side effects (such as decreased blood pressure), depressed respiration, elevated blood lipid levels, injection site pain, and the potential for bacterial contamination.<<
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Cheers, Tuck |
