Guilford Pharmaceuticals Announces Phase III AQUAVAN(R) Trial Meets Primary Endpoint

Guilford Pharmaceuticals Announces Phase III AQUAVAN(R) Trial
Meets Primary Endpoint 


BALTIMORE, March 24  /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc.
(NASDAQ:GLFD) today announced that a Phase III study of AQUAVAN(R) Injection in
patients undergoing elective colonoscopy procedures met its primary efficacy
endpoint without any serious adverse events.  The results were based on a
randomized, open-label study designed to assess the efficacy of AQUAVAN(R) and
its safety versus midazolam HCl for sedation in patients undergoing colonoscopy
procedures.  A total of 278 patients were enrolled and randomly assigned to
receive AQUAVAN(R) (N=209) or midazolam (N=69).

The primary efficacy endpoint in the trial was success of sedation, defined as
three consecutive Modified Observer's Assessment of Alertness/Sedation (MOAA/S)
scores less than or equal to 4, and completing the procedure without employing
alternative sedative medications and without requiring manual or mechanical
ventilation.  Treatment with AQUAVAN(R) resulted in a sedation success rate of
96%.  In general, patients who received AQUAVAN(R) experienced deeper levels of
sedation for longer sustained periods than patients who received midazolam,
which led to a higher level of adverse events in the AQUAVAN(R) treatment
group.  Patients treated with AQUAVAN(R) showed a median time to sedation of 2
minutes and a median time to full recovery from the end of the procedure of 11
minutes.

Dean J. Mitchell, President and Chief Executive Officer of Guilford, remarked,
"Market research supports the need for a new procedural sedation agent that
provides rapid onset and recovery from sedation, is easy to administer and
control, and can be safely administered without the need for a dedicated
anesthesiologist.  Based on these results, we believe AQUAVAN(R) can satisfy
that product profile; however, a lower dose than used in this Phase III trial
would be more appropriate to meet the characteristics of a drug ideal for
procedural sedation.  Our intention is to ensure the highest probability of
regulatory and commercial success for AQUAVAN(R).  Accordingly, we have
voluntarily suspended enrolling patients in our ongoing clinical trials in
order to review dosing levels.  With the dosing level data, in addition to the
colonoscopy data, we plan to meet with the Food and Drug Administration within
the next several weeks to determine the optimal clinical plan to obtain
approval and achieve our desired label.  While these activities may modestly
extend our timeline for filing the NDA, we think it will best enhance the
product's commercial opportunity."

Webcast

A detailed review of the results of the Phase III trial will be presented via
webcast on April 6th, 2005 beginning at approximately 12:15 p.m. ET.  To
participate in the webcast, log on to Guilford's website at
http://www.guilfordpharm.com/ at least 10 minutes prior to the start of the
webcast.  An icon that will launch the webcast will be available under the
'Investors' section under 'Presentations.'

About AQUAVAN(R) Injection

AQUAVAN(R) Injection is a proprietary water-soluble prodrug of propofol. Unlike
propofol, which is formulated in an oil or lipid-based emulsion, AQUAVAN(R) 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 pharmaceutical
products that target the hospital and neurology market.  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 used for the treatment of acute coronary syndrome (ACS).  For
additional information about GLIADEL(R) and AGGRASTAT(R), please see
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 Annual Report on Form 10-K filed with the SEC on
March 7, 2005, 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 is a significant risk
that AQUAVAN(R) would not gain regulatory approval without further studies at a
lower dose level, there is uncertainty that the Company will be successful in
designing a clinical program that meets the regulatory requirements of FDA or
achieves an appropriate dose level and there can be no assurance that the NDA
filing will not be significantly delayed.

Contact:  Stacey Jurchison / 410-631-5022 /  

DATASOURCE: Guilford Pharmaceuticals Inc.



CONTACT:  Stacey Jurchison of Guilford Pharmaceuticals, [phone]

or 



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



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