GLFD Guilford Pharmaceuticals (MM)

Guilford Pharmaceuticals Begins Phase III Clinical Trials of AQUAVAN(R) Injection First Phase III Trial Will Assess AQUAVAN(R) in Patients Undergoing Colonoscopy BALTIMORE, Sept. 20 /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc. (NASDAQ:GLFD) today announced the initiation of a Phase III, randomized, open-label, blinded-evaluator study to assess the safety and overall efficacy of AQUAVAN(R) Injection versus midazolam HCl for sedation in patients undergoing colonoscopy procedures. The trial will enroll up to 267 patients at approximately 30 sites throughout the United States. This is the first of several Phase III studies Guilford expects to commence in its AQUAVAN(R) development program. Craig R. Smith, M.D., Guilford's President and Chief Executive Officer, remarked, "We expect to seek approval for AQUAVAN(R) for procedural sedation for brief diagnostic and therapeutic procedures such as colonoscopy, bronchoscopy, interventional cardiology, and minor surgical and therapeutic procedures. This is a large and growing market opportunity; already more than 50 million brief diagnostic and therapeutic procedures requiring sedation occur each year in the United States. This number is expected to increase as the population ages and advancements in medical technology continue to shift a greater number of procedures into the outpatient setting. Our current development program for AQUAVAN(R) includes several Phase III clinical trials. Results from some of these studies are expected to be available beginning in the first half of next year." Ron Pruitt, M.D., President and Medical Director, Nashville Medical Research Institute, Chairman of Gastroenterology, Saint Thomas Hospital, Nashville, Tennessee and an investigator in the study, commented, "Previous results with AQUAVAN(R) suggest that it has an ideal profile for use in providing procedural sedation in patients undergoing elective procedures such as colonoscopy. I have been very impressed that patients receiving AQUAVAN(R) have been able to leave the endoscopy suite clear-headed and able to follow post-operative instructions. Patient satisfaction is particularly relevant in an elective procedure and could strongly influence patient acceptance and physician adoption of AQUAVAN(R)." Phase III Trial Design The first Phase III trial will assess the safety and overall efficacy of AQUAVAN(R) versus midazolam HCl following pretreatment with the analgesic agent, fentanyl citrate injection. Patients aged 18-65 undergoing elective colonoscopy will be enrolled and randomly assigned to receive either midazolam HCl or AQUAVAN(R) according to a pre-defined fixed-dose regimen. Sedation will be measured using the Modified Observer's Assessment of Alertness/Sedation (Modified OAA/S) scale. The primary efficacy endpoint in the trial is success of sedation, defined as: three consecutive Modified OAA/S scores less than or equal to 4, and completing the procedure without employing alternative sedative medications and without requiring manual or mechanical ventilation. Secondary efficacy endpoints include: duration of sedation; time to recovery and fully alert following the procedure; and patients' and physicians' ratings of the procedure. To avoid observer bias, an individual who is blinded to the treatment assignments (AQUAVAN(R) or midazolam HCl) will administer the pre- and post- sedation cognitive assessments; sedation assessment (OAA/S) and patient satisfaction surveys. Patients will be continuously monitored for adverse events and vital signs throughout the study. Previous Phase II Findings Results from Guilford's confirmatory fixed-dose, open-label, multi-center Phase II study of AQUAVAN(R) in combination with fentanyl citrate suggest that AQUAVAN(R) provides rapid onset and rapid recovery from procedural sedation in a convenient dosing regimen and without significant adverse events in patients undergoing colonoscopy. The majority of patients and physicians reported a high level of satisfaction with AQUAVAN(R), with over 90% of patients responding indicating they would use the drug again. Patients also recovered quickly after the procedure and left the endoscopy suite alert and able to follow post-operative instructions. The most common adverse event experienced in the Phase II study was a transitory itching or tingling sensation, often called paresthesias. Of the patients reporting paresthesias, over 70% rated the event as mild to moderate discomfort. The paresthesias were not considered a significant adverse event, and did not affect patients' acceptance of or satisfaction with the drug. Brief episodes of apnea, defined as a lack of spontaneous breathing for at least 15 seconds, were reported in 5% of patients and successfully resolved without medical intervention. No patients required respiratory support or endotracheal intubation. There was no pain at the injection site reported, and 1.8% of patients experienced transient hypotension that was self- resolving. About AQUAVAN(R) Injection AQUAVAN(R) 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(R) 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. About Guilford Guilford Pharmaceuticals Inc. is a pharmaceutical company engaged in the research, development and commercialization of proprietary drugs that target the hospital and neurology markets. Presently, Guilford markets two commercial products, GLIADEL(R) Wafer (polifeprosan 20 with carmustine implant), for the treatment of brain cancer, and AGGRASTAT(R) Injection (tirofiban hydrochloride), a glycoprotein GP IIb/IIIa receptor antagonist, for the treatment of acute coronary syndrome (ACS). Guilford's product pipeline includes AQUAVAN(R) Injection, a novel sedative/anesthetic and drugs for treating peripheral nerve injury. For full prescribing information, please visit http://www.guilfordpharm.com/ under Products / Marketed Products. This press release contains forward-looking statements that involve risks and uncertainties, including those described in the section entitled "Risk Factors" contained in the Company's Quarterly Report on Form 10-Q filed with the SEC on August 9, 2004, that could cause the Company's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. Among other things, there can be no assurance that the Phase III clinical program for AQUAVAN(R) will be successful, that the product candidate will receive regulatory approval from the FDA, or that if the product candidate is approved, the Company will be able to successfully commercialize the product candidate. Contact: Stacey Jurchison / 410-631-5022 / DATASOURCE: Guilford Pharmaceuticals Inc. CONTACT: Stacey Jurchison, Guilford Pharmaceuticals, +1-410-631-5022, Web site: http://www.guilfordpharm.com/ Company News On-Call: http://www.prnewswire.com/comp/112882.html

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