The Drug Market for Superficial Bladder Cancer is Predicted to Increase by 10% until 2012.
Superficial bladder cancers (SBC) comprise tumours with low aggressiveness but a high recurrence rate as well as lesions with a high risk of progression. All SBC are amenable to intravesical therapy and treatment failure is associated to a considerable discomfort for patients that may eventually require aggressive surgery. The current intravesical chemotherapies and immunotherapies have so far shown limitations in reversing the natural history of the disease. For these reasons a load of research has been devoted in the development of new treatment options. Close to 40 different companies has been identified with R&D related activities in this field. New intravesical chemotherapeutic drugs such us gemcitabine (that has already completed the phase II of studies) and EOquinTM (at the early phase I-II experience) have shown an excellent activity profile. From the point of view of immunotherapeutic agents, Mycobacterium cell wall DNA complex (MCC) has shown a high response rate in phase I-II studies whereas Imiquimod, a promising new compound based on preclinical studies, will soon engage in phase I human trials. Analysing the emerging therapeutic strategies shows that drugs inhibiting DNA replication and related mechanisms is the leading strategy, closely followed by immunostimulators and antiangioenetic drugs. Some minor strategies are apoptotic inducers, oncolytic viruses, tubule/microtubule binders as well as antisense technology. A number of features make intravesical molecular therapy a feasible new treatment option for SBC. As far as the field of new diagnostic and prognostic tools is concerned, methods to improve the endoscopic detection of poorly visible bladder cancers and urine biomarkers for the early detection of a recurrent tumour will enable better clinical outcomes and reduce the need for invasive procedures such us cystoscopy. The 5-aminolevulinic acid (ALA) induced fluorescence may soon become routinely adopted during endoscopic procedures. Among the urine biomarkers, the Fluorescent in-situ Hybridization (FISH) has been found to be helpful particularly in those cases (not so infrequent) where a urine cytology test has shown "atypical cells" and all the diagnostic work-up has failed to demonstrate a bladder cancer. New diagnostic opportunities will drive the need for improved therapeutic options and the market for these drugs are estimated to increase at least 10% until 2012.
Superficial bladder cancer (SBC) epidemiology Table 1. Relevant epidemiological factors for BC Risk categories of SBC and their natural history Table 2. Risk categories of superficial bladder cancer according to European Giudelines Risk category How do we approach SBC? Step 1: make the correct diagnosis Urine biomarkers Table 3. Currently FDA approved biomarkers urine tests with sensitivity and specificity values. Step 2: remove the tumour 5-aminolevulinic acid (ALA) induced fluorescence diagnosis of TCC Step 3: administer the most appropriate treatment Treatment End Points Limitations of traditional molecules for SBC Limitations in efficacy of intravesical treatment in intermediate risk SBC Limitations in efficacy of intravesical treatment in high risk SBC Side effects burden of currently-used intravesical agents Alternative treatment options Interferon (IFN) alpha Table 4. IFN and bladder cancer related R&D. Gemcitabine Table 5. Gemcitabine and bladder cancer related R&D. Investigational drugs With a cytotoxic mechanism Table 6. EOquin and bladder cancer related R&D. With an immunological mechanism Table 7. Imiquimod and bladder cancer related R&D. Molecular therapy Table 8. Antisense and bladder cancer related R&D Magnetically targeted carriers (MTC) Polymer microspheres Antiangiogenetic therapy Gene therapy Table 9. Gene therapy and bladder cancer related R&D Appendix I: Industry related R&D projects for the treatment of bladder cancer Company Profiles Abbott Laboratories Inc - Agensys Inc - AnorMED Inc. - Anthra Pharmaceuticals - Ariad Pharmaceuticals Inc - AstraZeneca AB - Avidex Ltd - Axcan Pharma Inc - Bioaccelerate Inc - Bioenvision - Bioniche Life Sciences Inc - Bristol-Myers Squibb - Cell Genesys, Inc - Cephalon Inc - Eisai Co Ltd - Eli Lilly - GlaxoSmithKline Plc - Got-A-Gene AB - Halozyme Therapeutics, Inc. - ID Biomedical Corporation - IDM S.A - Intracel Holding Corporation - Introgen Therapeutics - Madaus AG - Medarex Inc - Millennium Pharmaceuticals Inc - NeoPharma AB - Novartis International AG - OncoGenex Technologies Inc - PharmaMar SA - PhotoCure AS - Pierre Fabre Group Regulon Inc - Sanofi-Aventis - Spectrum Pharmaceuticals Inc - Sumitomo Pharmaceuticals Co Ltd - Titan Pharmaceuticals, Inc - Viscum AG - Viventia Biotech Inc
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|Date:||Nov 8, 2005|
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