Biomedical subjects
Publications and source records attributed to Peter Norman.
Tercica, under license from Genentech, has developed and launched mecasermin, recombinant human insulin-like growth factor-1 (rhIGF-1), for the treatment of growth failure in children with primary IGF deficiency or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.
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Traumatic coagulopathy manifests as a hypocoagulable state associated with hypothermia, acidosis, and coagulation factor dilution. The diagnosis must be made clinically because traditional coagulation tests are neither sensitive nor specific and take too long to be used for intraoperative monitoring. We hypothesized that the activated coagulation time (ACT) would reflect the global coagulation status of traumatized patients and would become elevated as coagulation reserves become exhausted. A prospective protocol was used to study 31 victims of major trauma who underwent immediate surgical Intervention. Victims of major head trauma were excluded and patients were selected at random over an 8-month period. At least two serial intraoperative blood samples were obtained at 15-min intervals via indwelling arterial catheters. A Hemochron model 801 coagulation monitor was used to measure the ACT. Of the 31 patients studied, 7 became clinically coagulopathic and 24 did not. The ACT measurements of coagulopathic and noncoagulopathic trauma patients were significantly different by multiple statistical comparisons. Both groups differed from normal, nontraumatized patients. The coagulopathic trauma patients had significantly elevated values when compared with other trauma patients or to normal values. We conclude that a low ACT reflects the initial hypercoagulability associated with major trauma and an elevated ACT is an objective indicator that the coagulation system reserve is near exhaustion. An elevated ACT may represent an indication for considering damage control maneuvers or more aggressive resuscitation.
SomatoKine, a recombinant fusion of insulin-like growth factor-1 and its binding protein, BP-3, is being developed by Insmed (formerly Celtrix Pharmaceuticals) for the potential treatment of growth hormone insensitivity syndrome (GHIS), and as a potential injectable insulin sensitizer for the management of type 1 and type 2 diabetes in patients who are less sensitive to insulin therapy. By July 2002, the FDA had granted SomatoKine Orphan Drug status for the treatment of GHIS. Also at this time, a phase II trial in children suffering from GHIS was initiated. In September 2002, Insmed expected to initiate a further clinical trial in GHIS in early 2003, and planned to continue phase II development in type 1 and type 2 diabetes.
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A critical issue in drug development remains the failure to identify toxicological problems in new chemical entities sufficiently early in development to avoid the expense of terminating drugs in late-stage clinical development. The Society of Chemical Industry's BioActive Sciences Group arranged a one-day meeting in London, United Kingdom, on February 27, 2003, devoted to progress in the development of in silico modeling and expert systems. The meeting provided an assessment of the progress that has been made in the development of models that can be used to evaluate chemical libraries at the design stage, or to predict potential toxic effects while chemical projects are still in the lead optimization stage. Although success in developing such models might reduce the number of new chemical entities progressing to clinical development, its potential for reducing the high attrition rate (approximately 50%) in late-stage (phase II and later) clinical development could produce a substantial cost saving and might also shorten the time frame of drug development.
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Janssen is developing tipifarnib (formerly known as R-1 15777), an inhibitor of RAS farnesylation, for the potential treatment of neoplasia [287030], [289610]. Janssen commenced clinical trials in the US, in conjunction with the National Cancer Institute, in April 1997 [287030], [289610], and by May 1999, phase II trials in patients with advanced non-small cell lung cancer were being planned [325960]. By February 2001, phase III trials for the potential treatment of pancreatic cancer and leukemia had been initiated [399065], and by June 2001, it was in phase II trials for RAS-dependent solid tumors [412618]. In November 2001, Credit Lyonnais Securities predicted NDAfilings in 2002 and 2003 for pancreatic cancer and other cancers, respectively, and projected US introductions for these indications in 2004 and 2005, respectively [436939].
Atrasentan is a selective endothelin ET(A) receptor antagonist under development by Abbott for the potential treatment of cancer, particularly prostate cancer, for which it is in phase III trials [413197]. In July 2002, phase II trials for renal, ovarian, lung, colorectal, breast and brain cancers were being initiated [457800]. Atrasentan has been granted Fast Track status, allowing for a rolling NDA [414666], [443479]; the company was planning to begin filing for prostate cancer in late 2003. Atrasentan has also been in phase I trials for hypertension [319405], [326268], but development for this indication had been halted by 2001 [407049].
Drugs from Natural Products III, held July 1416, 2002, in Dublin, Ireland, was organized by the Royal Society of Chemistry's Industrial Affairs Division and Biological and Medicinal Chemistry Sector. The program included presentations by several of the United Kingdom's most eminent chemists and a wide-ranging lecture on the use of natural products to provide leads for the development of novel therapies for the treatment of neurodegenerative disorders. (c) 2002 Prous Science. All rights reserved.
The Second Annual Cutting Edge Approaches to Drug Design meeting, held March 13, 2002, in London, United Kingdom, was organized by the Royal Society of Chemistry's Molecular Modelling Group and the Structural Biology Group of the Biochemical Society. The emphasis was switched from last year's focus, the advances in structural biology and molecular modeling, to the role of bioinformatics in identifying and defining potential drug targets and the application of rational, computationally based techniques in library design and lead generation. Topics included the impact of bioinformatics on drug discovery, advances in chemical lead discovery and pharmacophore-based approaches to drug design. (c) 2002 Prous Science. All rights reserved.
The 13th Annual Symposium on Medicinal Chemistry in Eastern England, organized by the Biological and Medicinal Chemistry group of the Royal Society of Chemistry, was held in Hatfield, United Kingdom on April 18, 2002. Speakers from Pfizer, AstraZeneca, the Institute of Cancer Research, Celltech, Merck Sharp & Dohme, Xenova, GlaxoSmithKline and Bristol University described current medicinal chemistry programs, and posters were presented. Highlights of the meeting are discussed. (c) 2002 Prous Science. All rights reserved.
Third RSC-SCI Symposium on Proteinase Inhibitor Design: Proteinase 2002, held May 13-14, 2002, in London, United Kingdom, drew an audience of about 140 scientists to the SCI's Belgrave Square headquarters to hear 17 speakers address various aspects of this theme. There was considerable emphasis placed upon the use of X-ray crystallography of enzyme-inhibitor complex as an integral tool in the design of improved protease inhibitors. This biennial meeting has established a reputation for being a key forum for the disclosure of new compounds, and this year's meeting was no exception, with much of the emphasis placed on novel inhibitors of either serine or cysteine proteases. (c) 2002 Prous Science. All rights reserved.
The Royal Society of Chemistry in collaboration with the Novartis Foundation held a meeting November 15, 2002, in London, United Kingdom, to discuss chemotherapeutic strategies in cancer treatment. The meeting also marked the presentation of the George and Christine Sosnovsky award, given to Prof. Malcolm Stevens, the inventor of temozolomide. Speakers included representatives from Novartis AG, the University of Nottingham, the University of Newcastle, Bart's and the London Queen Mary's Medical School, the Institute of Cancer Research, the Mario Negri Institute for Pharmacological Research and the University of Leicester. Highlights of the meeting are discussed. (c) 2002 Prous Science. All rights reserved.