Non-U.S. Clinical Trials And Regulatory Actions: June 2007
Company* (Country; Symbol) | Product | Description | Indication | Status (Date) |
AUTOIMMUNE | ||||
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Abbott Laboratories (NYSE:ABT) | Humira (FDA-approved) | Adalimumab; tumor necrosis factor-alpha blocker agonist | Crohn's disease | Received marketing authorization from the European Commission (6/7) |
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Centocor Inc. (unit of Johnson & Johnson) and Schering-Plough Corp. | Remicade (FDA-approved) | Infliximab; monoclonal antibody that targets tumor necrosis factor alpha | Crohn's disease | European Commission approved Remicade (6/7) |
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Isotechnika Inc. (Canada; TSX:ISA) | ISA247 | Immunosuppressive agent | Moderate to severe psoriasis | Received approval from Polish regulators for participation in the ongoing Phase III European/Canadian trial (6/6) |
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CANCER | ||||
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Celgene International Sarl (Switzerland; subsidiary of Celgene Corp.; CELG) | Revlimid (FDA-approved) | Lenalidomide | Multiple myeloma | Was granted full marketing authorization by the European Commission for use in combination with dexamethasone (6/19) |
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Cephalon Inc. (CEPH) | Treanda | Bendamustine; hybrid cytotoxic alkylating agent | Chronic lymphocytic leukemia | European Phase III trial met its primary endpoint of overall response rate (6/28) |
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Favrille Inc. (FVRL) | FavId | Patient-specific immuno-therapy | Indolent B-cell non-Hodgkin's lymphoma | Phase II data from the European trial showed clinical responses with FavId (6/11) |
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Oncolytics Biotech Inc. (Canada; ONCY; TSX:ONC) | Reolysin | Formulation of the human reovirus | Advanced cancers | Started enrolling patients in its UK trial (6/11) |
Onyx Pharmaceuticals Inc. (ONXX) and Bayer HealthCare Pharmaceuticals Inc. | Nexavar (FDA-approved) | Sorafenib tablets | Hepatocellular carcinoma | Bayer submitted an MAA (6/19) |
Pharmion Corp. (PHRM) | Satraplatin | Oral platinum compound | Metastatic hormone-refractory prostate cancer | Submitted an MAA with the EMEA for satraplatin in combination with prednisone (6/26) |
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Pharmion Corp. (PHRM) | Thalomid | Thalidomide | Multiple myeloma | French authorities granted a temporary authorization for use (6/4) |
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Vakzine Projekt Management GmbH* (Germany) | VPM4001 | Immunotherapeutic | Hormone-resistant prostate cancer | Phase I/II data showed that 73% of patients responded positively to therapy (6/1) |
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Wex Pharmaceuticals Inc. (Canada; TSX:WXI) | Tectin | Tetrodotoxin; non-narcotic agent | Cancer-related pain | Received a No Objection letter from Health Canada for a 120-patient Phase III trial (6/13) |
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YM BioSciences Inc. (Canada; AMEX:YMI; TSX:YM) | Nimotuzumab | A humanized monoclonal antibody that targets the epidermal growth factor receptor | Colorectal cancer | YM received a No Objection letter from Health Canada to its proposed Phase II trial of the therapy with irinotecan (6/4) |
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CARDIOVASCULAR | ||||
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Speedel Holding AG (Switzerland; SWX:SPPN) and Novartis AG (Switzerland) | SPP100 | Rasilez; a first-in-class once-daily direct renin inhibitor | Hypertension | Received a positive opinion recommending European Union approval of SPP100 (6/22) |
CENTRAL NERVOUS SYSTEM | ||||
7TM Pharma A/S* (Denmark) | Obinepitide | TM30338; an analogue of two hormones released in connection with food intake | Obesity | Started a 180-patient Phase II trial in Sweden (6/12) |
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Alexion Pharmaceuticals Inc. (ALXN) | Soliris (FDA-approved) | Eculizumab | Paroxysmal nocturnal hemoglobinuria | European Commission approved Soloris (6/22) |
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Labopharm Inc. (Canada; DDSS) | Tramadol | Once-daily formulation | Moderate pain | Received a notice of compliance from Health Canada for 100-mg, 200-mg and 300-mg tablets (6/18) |
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DIABETES | ||||
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Living Cell Technologies Ltd.* (Australia) | DiabeCell | Pig pancreatic cell product | Type I diabetes | Dosed the first patient in a Phase I/IIa trial in Moscow (6/14) |
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INFECTION | ||||
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Basilea Pharmaceutica Ltd. (Switzerland; SWX:BSLN) and Janssen-Cilag International NV (Belgium) | Ceftobiprole | Broad-spectrum, anti-MRSA cephalosporin antibiotic | Complicated skin and soft tissue infections | Submitted a marketing authorization application to the EMEA (6/18) |
Dynavax Technologies Corp. (DVAX) | Heplisav | Immunostimulatory sequence-based vaccine targeting Toll-like receptor 9 | Hepatitis B virus | Enrollment in a pivotal study started in Germany (6/27) |
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Hemispherx Biopharma Inc. (AMEX:HEB) | Ampligen | Toll-like receptor 3 ligand designed to function as an immune system activator | Influenza | Started an Australian Phase IIb trial (6/26) |
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Shire plc (UK) | Elaprase (FDA-approved) | A human enzyme replacement therapy | Hunter syndrome | Health Canada approved Elaprase (6/14) |
Notes: | ||||
* Privately held. | ||||
CMPH = Committee for Medicinal Products for Human Use; EMEA = European Medicines Agency; MAA = Marketing authorization application; MRP = Mutual Recognition Procedure. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; NYSE = New York Stock Exchange; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange. | ||||