 |
 |
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 [log in to unmask] Internet addresses: http://www.guilfordpharm.com 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, [log in to unmask] /Company News On-Call: http://www.prnewswire.com/comp/112882.html URL: http://www.guilfordpharm.com http://www.prnewswire.com SOURCE: PR Newswire / Macro*World Investor http://www.mworld.com/m/m.w?lp=GetStory&id=73745661 Reference: Guilford Pharmaceuticals Inc. Celebrates 10-Year Anniversary. SOURCE: Market Wire / Macro*World Investor http://www.mworld.com/m/m.w?lp=GetStory&id=71514091 * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn