Guilford Announces Clinical Results From Confirmatory Phase II Trial Of AQUAVAN(R) Injection
18 June 2004 - 2:28AM
PR Newswire (US)
Guilford Announces Clinical Results From Confirmatory Phase II
Trial Of AQUAVAN(R) Injection BALTIMORE, June 17
/PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc.
(NASDAQ:GLFD) announced today that it has completed a second Phase
II trial of AQUAVAN(R) Injection in patients undergoing
colonoscopy. In this confirmatory Phase II study, AQUAVAN(R)
provided rapid onset and rapid recovery from procedural sedation
without serious adverse effects. The confirmatory Phase II clinical
trial was an open label, multi-center study of a fixed dose regimen
of AQUAVAN(R) to provide procedural sedation in patients undergoing
elective colonoscopy. The study enrolled healthy adults aged 20 to
85 who were pre-treated with fentanyl citrate, an analgesic
commonly used for pain relief during brief diagnostic procedures.
Five minutes after receiving fentanyl, patients were given an
intravenous bolus dose of AQUAVAN(R). AQUAVAN(R) was administered
by medical personnel as dictated by local hospital guidelines;
administration by an anesthesiologist was not required. Phase II
Trial Background In the first dose-ranging Phase II trial, a total
of 91 patients were evaluated. Drug dosing was based on an
individual's weight and consisted of three dose groups of
AQUAVAN(R) (7.5, 10, and 12.5 mg/kg) and three dose groups of
fentanyl (0.5, 1.0, and 1.5 ug/kg), resulting in a total of nine
AQUAVAN(R)/fentanyl dose-combinations. The purpose of the
dose-ranging study was to identify the optimal dosing combination
of AQUAVAN(R) and fentanyl for evaluation in a confirmatory study.
Confirmatory Trial Design The confirmatory Phase II study enrolled
a total of 64 patients undergoing elective colonoscopy. Patients
were dosed according to a pre-defined fixed- dose regimen. Sedation
was measured using the Modified Observer's Assessment of
Alertness/Sedation (OAA/S) scale. The desired sedative effect was
defined as one that consistently provided procedural sedation, or a
Modified OAA/S score of between 1 and 4. Patients were continuously
monitored for adverse events and vital signs throughout the study.
Measurements of safety, tolerability and patient and physician
satisfaction were also assessed. Confirmatory Phase II Trial
Results Following bolus administration of AQUAVAN(R), the median
time to achieve sedation was two minutes. The median time to full
alertness after removal of the colonoscope was twelve minutes, and
the median time to full recovery, defined as the ability to stand
without instability or assistance, was twenty minutes.
Gastroenterologists rated 94% of patients as adequately sedated by
AQUAVAN(R) for the duration of the procedure. The most common
adverse event experienced in the study was a transitory itching or
tingling sensation, often called paresthesias, reported by 89% of
patients in the confirmatory study. Of the patients reporting
paresthesias, 73% rated the event as mild to moderate discomfort.
The paresthesias were not considered a serious adverse event, and
did not affect the patients' acceptance of or satisfaction with the
drug. Brief episodes of apnea, defined as lack of spontaneous
breathing for more than 15 seconds, were reported in 5% of patients
and were successfully resolved without medical intervention. No
patients required respiratory support or endotracheal intubation.
There was no pain at the injection site reported. There were three
episodes of mild, transient hypotension, all of which were
successfully treated with a short course of fluids or ephedrine.
Following the procedure, the majority of patients and physicians
reported a high level of satisfaction with AQUAVAN(R). In the
confirmatory study, 94% of patients responding indicated they would
use the drug again. On a scale of 0 to 100 (100 representing highly
satisfied and 0 representing dissatisfied), 74% of patients rated
their experience better than 90. Gastroenterologists rated 100% of
the patients' experiences as good to excellent. In the confirmatory
study, most patients were adequately sedated with a single bolus
dose for the duration of the procedure. Patients recovered quickly
after the procedure, had a feeling of mild euphoria and left the
endoscopy suite alert, and able to follow post-operative
instructions. Dr. Ron Pruitt, President and Medical Director,
Nashville Medical Research Institute, Chairman of Gastroenterology,
Saint Thomas Hospital, Nashville, Tennessee and an investigator in
the study, commented, "The most recent results confirm the findings
from an earlier Phase II study combining AQUAVAN(R) and fentanyl
citrate. AQUAVAN(R) has shown a distinctly favorable profile for
use in procedural sedation. The fact that we have seen strong
patient satisfaction is particularly relevant when we realize that
these patients are considering an elective procedure. I believe
that the use of AQUAVAN(R) could increase patient acceptance of
elective colonoscopy, ultimately contributing to patient welfare."
Craig Smith, M.D., Chairman, President and Chief Executive Officer
of Guilford, remarked, "Our registration strategy for AQUAVAN(R)
will involve four pivotal Phase III trials, as well as several
smaller supportive studies. A total of 900 patients will be
enrolled in the Phase III program for AQUAVAN(R). The goal of this
broad clinical program is to allow us to seek registration for
AQUAVAN(R) Injection for an indication in procedural sedation
during brief diagnostic and therapeutic procedures such as
colonoscopy, bronchoscopy, interventional cardiology and minor
surgical and therapeutic procedures." About AQUAVAN(R) Injection
AQUAVAN(R) 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) is formulated as a clear aqueous solution and
the prodrug 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 pharmacological
properties, Guilford anticipates that AQUAVAN(R) may overcome many
of the limitations and side effects associated with current
sedatives and anesthetics. About Guilford Guilford Pharmaceuticals
Inc. is a fully integrated pharmaceutical company engaged in the
research, development and commercialization of products that target
the hospital market. Presently, Guilford markets two commercial
products, GLIADEL(R) Wafer, for the treatment of brain cancer, and
AGGRASTAT(R) Injection, a glycoprotein GP IIb/IIIa receptor
antagonist used for the treatment of acute coronary syndrome (ACS).
Guilford's product pipeline includes a novel anesthetic, AQUAVAN(R)
Injection, and drugs for treating Parkinson's disease and
post-prostatectomy erectile dysfunction. For additional prescribing
information about GLIADEL(R) Wafer, please visit
http://www.guilfordpharm.com/ under Products / Marketed Products/
GLIADEL; and for AGGRASTAT, please see http://www.aggrastat.com/.
Contact: Guilford Pharmaceuticals Inc. Stacey Jurchison
410.631.5022 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 May 10, 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 AQUAVAN(R) Injection will continue
to advance through clinical development or receive regulatory
approval for commercialization either in the United States or in
international markets. DATASOURCE: Guilford Pharmaceuticals Inc.
CONTACT: Stacey Jurchison, Guilford Pharmaceuticals Inc.,
+1-410-631-5022 Web site: http://www.guilfordpharm.com/
http://www.aggrastat.com/ Company News On-Call:
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