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From the Clinical Pharmacology Unit, Massachusetts General Hospital, Boston, Massachusetts, and the Medical Service, Veterans Administration Hospital, Kansas City, Missouri. Presented in part at the 78th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, Dallas, Texas, March 24, 1977. Supported in part by Grant MH-12279 from the USPHS, and by the Medical and Research Services, Veterans Administration Hospital, Kansas City, Missouri. Received November 21, 1977; revision accepted January 3, 1978. Draft Technical Guidance--Substantive Revision DEP ID: 253-0300-100. Title: Pennsylvania's Land Recycling Program Technical Guidance Manual--Section IV General Guidance. Description: The substantive revisions proposed to Pennsylvania's Land Recycling Program Technical Guidance Manual--Section IV General Guidance include the addition of several regulated substances to the ``short list'' in Table IV-9 for several petroleum products and mineral insulating oils containing PCBs. It is only these regulated substances or ``chemicals of concern'' identified in the ``short list'' that need to be tested for to demonstrate attainment under any of the Act 2 standards when there is a release of these petroleum products, uncontaminated by other sources. The addition of new regulated substances to the short list will result in more extensive remediation for certain petroleum products. Written comments: The Department is seeking comments on the substantive revisions to draft technical guidance #253-0300-100. Interested persons may submit written comments on this draft technical guidance document by September 4, 2007. Comments submitted by facsimile will not be accepted. The Department will accept comments submitted by e-mail. A return name and address must be included in each e-mail transmission. Written comments should be submitted to David Crownover, Department of Environmental Protection, Office of Community Revitalization and Local Government Support, Voluntary Cleanup and Standards Section, Rachel Carson State Office Building, 10th Floor, P. O. Box 8471, Harrisburg, PA 17105-8471, dcrownoverstate.pa . Contact: Questions regarding the draft technical guidance document should be directed to David Crownover at 717 ; 783-7502, dcrownover state.pa . Effective Date: Upon publication of notice as final in the Pennsylvania Bulletin. KATHLEEN A. MCGINTY, Secretary, for instance, prevacid and pregnancy. Controlled treatment, the mean FEV1 of the patients in the trial was about 65% of predicted. Over the randomized active treatment period, there was a 1015% improvement in the FEV1 group receiving zafirlukast, 40 mg bid, which was significantly greater than the improvement noted in the placebo treatment group Figure 2 ; . The magnitude of the therapeutic effect was directly proportional to the plasma levels of zafirlukast. There were also statistically significant improvements in asthma symptoms and a decrease in rescue -agonist use. Thirteen- and 26-wk treatment trials in which the effects of zileuton on asthma control in patients with chronic stable asthma, whose average FEV1 was about 60% of predicted on enrollment, have been reported 137, 138 ; . In these trials, treatment with zileuton resulted in a 1520% improvement in the FEV1 that was sustained for the duration of the trial. Active treatment was associated with an improvement in asthmaspecific quality of life, decreased rescue -agonist use, and, most important, a more than twofold reduction in the number of asthma exacerbations requiring oral corticosteroid rescue Figure 3.

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MEDI 247 Protease inhibitors for treating pulmonary inflammatory disorders: Focus on chymase and cathepsin G Bruce E. Maryanoff, M. N. Greco, M. J. Hawkins, E. T. Powell, L. De Garavilla, and H. R. Almond Jr., Johnson & Johnson Pharmaceutical Research and Development, Welsh and McKean Roads, Spring House, PA 19477-0776, Fax: 215-628-4985, bmaryano prdus.jnj Asthma involves airway inflammation that includes the recruitment of neutrophils, eosinophils, and mast cells to sites of injury. Neutrophils are also important in chronic obstructive pulmonary disease COPD ; , for which there is a large unmet medical need. Leukocyte serine proteases such as cathepsin G Cat G ; and chymase can degrade extracellular matrix and trigger the release of pro-inflammatory mediators. Neutrophil Cat G degrades matrix proteins, damages airway epithelial celIs, and stimulates vascular permeability; mast cell chymase plays an important role in the pathogenesis of asthma. With the aid of structure-based drug design, we discovered a nonpeptide, dual inhibitor of Cat G and chymase JNJ-10311795 ; and a selective, nonpeptide chymase inhibitor, both possessing novel chemotypes. These compounds were advanced into preclinical development. JNJ-10311795 markedly reduced neutrophil counts in a rat peritonitis model iv ; and was efficacious in the sheep model of asthma it ; . The chymase inhibitor was orally efficacious in a hamster model of cutaneous inflammation and the sheep asthma model. MEDI 248 Discovery of AMG 009: A CRTH2 and DP dual-antagonist Julio C. Medina1, Jiwen Liu1, Zice Fu1, Michael Schmitt2, Yingcai Wang1, Marshall C. Derek1, H. Lucy Tang3, Timothy Sullivan3, George Tonn1, and Tassie Collins1. 1 ; Amgen Inc, 1120 Veterans Blvd., South San Francisco, CA 94080, Fax: 650 ; 244-2015, 2 ; Amgen Inc, South San Francisco, CA, 3 ; Amgen Inc, South San Francisco CRTH2 chemoattractant receptor-homologous molecule expressed on Th2 cells ; and DP D prostanoid ; are G protein coupled receptors that share the same ligand, prostaglandin D2 PGD2 ; . However, these receptors are expressed in different cell types and may play complimentary roles. CRTH2 is expressed on eosinophils, basophils, and T helper 2 Th2 ; lymphocytes and activation by PGD2 induces chemotaxis and eosinophil degranulation. DP is expressed on airway epithelium, smooth muscle and platelets and upon stimulation increases the level of cAMP and mediates flushing, sneezing, mucosal plasma exudation, and nasal blockage. Since PGD2 is released by mast cells in large amounts during asthmatic responses, it has been postulated that blocking CRTH2 and DP could be therapeutically valuable to asthma and other allergic diseases. In this presentation, we will disclose the optimization and evaluation in in vivo asthma models of a series of phenylacetic acid derivatives with potent activity against the CRTH2 and DP receptors that led to the selection of AMG 009 as a preclinical development compound.
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