Guilford Announces Clinical Results From Confirmatory Phase II Trial Of AQUAVAN(R) Injection

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.,

[phone]



Web site:  http://www.guilfordpharm.com/

http://www.aggrastat.com/ 



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