BALTIMORE: Research Grants Totaling $5.7 Million Awarded for Evaluation of Guilford Pharmaceuticals' Technologies.

[Murray Charters <mcharters@xxxxxxxxxxxxxx>]

BALTIMORE: Research Grants Totaling $5.7 Million Awarded for Evaluation of 
Guilford Pharmaceuticals' Technologies.

BALTIMORE, Sep 23, 2003 /PRNewswire-FirstCall via COMTEX/ -- Guilford 
Pharmaceuticals Inc. (Nasdaq: GLFD) announced
today that grants totaling approximately $5.7 million have been awarded for 
research and development of the Company's
technologies. These include a $5.5 million award by the National Institutes of 
Health to support a four-year Program
Project Grant at The Johns Hopkins University Department of Neurology to study 
novel applications of Guilford's
neuroimmunophilin ligand technology, and approximately $0.2 million in research 
funding to support preclinical
development of the Company's NAALADase and PARP inhibitor technologies.

In the NIH-supported project, The Johns Hopkins team will evaluate one of 
Guilford's neuroimmunophilin ligands in
preclinical cell culture and animal models of sensory neuropathy, as well as 
clinical studies in patients with HIV-
related sensory neuropathy. It is estimated that approximately 30 percent of 
patients with HIV develop sensory
neuropathy, which is an intensely uncomfortable burning sensation in the limbs. 
Neuroimmunophilin ligands have
previously demonstrated efficacy in preclinical studies of peripheral nerve 
injury, and may have application for the
treatment of HIV-related sensory neuropathy. Over the next four years, Guilford 
will receive $400,000 of the amount
awarded by the NIH.

Also today, Guilford announced that it has been awarded a $140,000 Phase I 
Small Business Innovation Research Grant
from the National Cancer Institute to fund research in prostate cancer. The 
grant will be aimed at evaluating the
feasibility of using a novel NAALADase inhibitor to provide targeted prostate 
cancer chemotherapy.

NAALADase is the same protein as prostate specific membrane antigen (PSMA), a 
protein found on the surface of prostate
cancer cells. Guilford has previously shown that its NAALADase inhibitors may 
have utility for diagnostic or
therapeutic purposes in prostate cancer. The goal of the NCI-funded research 
program will be to determine the effect of
combining a NAALADase inhibitor with the chemotherapeutic drug taxol, to 
provide targeted cancer chemotherapy.

Guilford was also recently awarded $75,000 from the Ataxia Telangiectasia 
Children's Project. Ataxia-telangiectasia,
or, A-T, is a progressive, degenerative disease that affects a variety of 
bodily systems. Children with A-T tend to
develop malignancies of the blood system almost 1,000 times more frequently 
than the general population. Lymphoma and
leukemia are particularly common types of cancer seen in these patients, 
although the frequencies of many other cancers
are elevated. Ironically, another facet of the disease is an extreme 
sensitivity to radiation, which means that A-T
patients cannot tolerate the therapeutic radiation usually given to cancer 
patients.

The ATCP grant will be used to fund research in Guilford's PARP inhibitor 
program, specifically to evaluate the use of
PARP inhibitors as potential chemosensitizers to enhance the effects of 
chemotherapy.

Dr. Barbara Slusher, Senior Vice President of Research at Guilford commented, 
"By finding alternative sources of
funding for our earlier-stage, proprietary research programs we can ensure that 
our pipeline is continuously nurtured
and exciting research is supported, while Guilford focuses a larger portion of 
its resources on the clinical
development of our later-stage NIL and AQUAVAN(R) Injection programs. In 
addition to the grant awards announced today,
we have submitted five additional SBIR applications. While these grants are 
still under consideration, we have received
notice that two of them have received fundable scores, which could mean that 
additional promising work can continue to
be supported at the Company."

About Neuroimmunophilin Ligands

Neuroimmunophilin ligands are small molecules that in preclinical experiments 
have been shown to be orally
bioavailable, cross the blood-brain barrier, and repair and regenerate damaged 
nerve terminals without affecting normal
nerves.

In November 2002, Guilford Pharmaceuticals initiated a Phase II clinical trial 
of the company's lead neuroimmunophilin
ligand, GPI 1485. The trial is a multicenter, randomized, double-blind, 
placebo-controlled evaluation of the safety,
pharmacokinetics and efficacy of GPI 1485 in patients with mild to moderate 
Parkinson's disease. In addition, in
December 2002, GPI 1485 was selected for inclusion in a comprehensive clinical 
investigation of new therapies for
Parkinson's disease being conducted by the NIH's National Institute of 
Neurological Disorders and Stroke.

In addition to Parkinson's disease, neuroimmunophilin ligands may have 
application in the treatment of a broad range of
other indications, including: spinal cord injury, brain trauma, and peripheral 
nerve injury, including post-
prostatectomy erectile dysfunction and HIV-related sensory neuropathy. In 
addition to the ongoing Phase II clinical
trial for Parkinson's disease, later this year, Guilford expects to begin a 
second Phase II study of GPI 1485 for the
treatment post-prostatectomy erectile dysfunction.

About NAALADase Inhibitors

NAALADase is a membrane-bound enzyme believed to play a role in modulating the 
release of glutamate, one of the most
common chemical messengers between nerves. During conditions of acute injury or 
chronic neurodegenerative disorders,
there may be a large increase in glutamate release that incites a cascade of 
biochemical events, ultimately leading to
cell injury and death. Guilford has created several unique classes of NAALADase 
inhibitors and evaluated their
potential therapeutic application in preclinical models of various acute and 
chronic neurodegenerative disorders,
including diabetic peripheral neuropathy, neuropathic pain, Lou Gehrig's 
Disease (ALS), head and spinal cord trauma,
and stroke. In May, Guilford announced that it had signed an exclusive license 
agreement with Pfizer for the clinical
and commercial development of its NAALADase inhibitors. Under the agreement, 
Guilford retained the right to continue to
conduct and pay for the development of NAALADase inhibitors not under 
development by Pfizer for prostate cancer, head
and spinal cord injury, and drug addiction. Pfizer has the exclusive right in 
the future to acquire, for certain
consideration, any products developed by Guilford for these indications.

About PARP Inhibitors

Guilford's Poly (ADP-ribose) polymerase (PARP) inhibitor program aims at 
developing proprietary PARP inhibitors for
treating cancer and ischemia. The essential role of PARP in facilitating DNA 
repair, mediating cell death and
regulating immune response make the enzyme a novel drug target candidate for a 
broad spectrum of diseases. In various
cancer models, Guilford's PARP inhibitors have been shown to potentiate 
radiation therapy and chemotherapy by
increasing apoptosis of cancer cells, limiting tumor growth, decreasing 
metastasis, and prolonging the survival of
tumor-bearing animals.

About Guilford

Guilford Pharmaceuticals Inc. is a fully integrated pharmaceutical company 
engaged in the research, development and
commercialization of products that target the hospital and neurology markets. 
Presently, Guilford markets one
commercial product, GLIADEL(R) Wafer, for the treatment of brain cancer, and 
has a product pipeline, which includes a
novel anesthetic, AQUAVAN(R) Injection, and drugs for treating Parkinson's 
disease and post-prostatectomy erectile
dysfunction.

Contact:

Guilford Pharmaceuticals Inc.
Stacey Jurchison 410.631.5022
jurchisons@xxxxxxxxxxxxxxxxx

Internet addresses:  

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 Current 
Report on Form 8-K filed with the SEC on June
11, 2003, 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 GPI
1485, or other neuroimmunophilin ligands, or other NAALADase inhibitor 
compounds will successfully complete preclinical
or clinical testing or be granted regulatory approval to be sold and marketed 
as pharmaceutical products in the United
States or elsewhere.

SOURCE Guilford Pharmaceuticals Inc.

CONTACT:

Stacey Jurchison of Guilford Pharmaceuticals Inc.,
+1-410-631-5022, jurchisons@xxxxxxxxxxxxxxxxx
/Company News On-Call:  

URL:




SOURCE: PR Newswire / Macro*World Investor


Reference:

Guilford Pharmaceuticals Inc. Celebrates 10-Year Anniversary.
SOURCE: Market Wire / Macro*World Investor


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