Company* (Symbol) | Product | Description | Indication | Status (Date) |
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CANCER |
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Antisoma plc (UK; LSE:ASM) | Theragyn | Murine monoclonal antibody HMFGI, and chemical linker that binds to yttrium-90; targets polymorphic epithelial mucin (PEM), an abnormal form of mucine produced by tumor cells of the epithelium | Ovarian cancer in remission | Antisoma plans to resume enrollment of new patients into its Phase III pivotal trial after temporarily delaying recruitment following preliminary review of unaudited information about a similar product suggesting a survival advantage for the control group (7/11) |
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Avax Technologies Inc.(AVXT) | M-Vax | Haptenized autologous cell vaccine | Metastatic melanoma | Vaccine cleared for marketing and commercially available in Australia for individuals with Stage III melanoma (7/18) |
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Axcan Pharma Inc. (Canada; TSE:AXP) | Photofrin (FDA-approved) | Photosensitive drug (porfimer sodium; produces toxic oxygen compound when light-activated) | Palliative treatment of advanced lung and esophageal cancer | Medical Products Agency of Sweden approved product for the palliative treatment of obstructive esophageal cancer as well as obstructing non-small-cell lung cancer; the Italian and Irish Health authorities approved product for similar indications (7/18) |
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Cel-Sci Corp.(AMEX:CVM) | Multikine | Natural mixture of human cytokines, including inter-leukin-2 | Head and neck cancer | Polish Health Authorities granted permission to start Phase II trials in head and neck cancer patients (7/26) |
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Hollis-Eden Pharmaceuticals Inc. (HEPH) | HE2000 | Compound thought to act by a mechanism of action that affects energy regulation in the host cell | HIV infection | Presented data from South African Phase I/II trial at World AIDS Conference (7/11) |
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KS Biomedix plc* (UK) | KS-6H9Chi | Chimeric sheep monoclonal antibody labeled with iodine-131 | Colon cancer patients with secondary metastases | Filed for approval to initiate clinical trial in Malaysia (7/10) |
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Ligand Pharmaceuticals Inc. (LGND) | Panretin Gel (FDA-approved) | Alitretinoin 0.1% (topical); chemically synthesized version of 9-cis-retinoic acid(derived from vitamin A) | Topical treatment of cutaneous lesions in Kaposi's sarcoma patients | European Committee for Proprietary Medicinal Products recommended approval for marketing(7/17) | |
Onyx Pharmaceuticals Inc. (ONXX) and Bayer Corp.(unit of BayerAG; Germany) | | Small-molecule ras pathway inhibitor | Cancer | Initiated Phase I trial in Germany (7/18) |
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StressGen Biotechnologies(TSE:SSB) | HspE7 | Recombinant fusion product composed of heat shock protein 65 (Hsp65) from Mycobacterium bovis BCG and the protein E7, derived from the human papilloma virus dysplasia | Anal | Presented positive preliminary Phase II data at the 18th International Papillomavirus Conference in Barcelona (7/26) |
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Vion Pharmaceuticals Inc. (VION) | Tapet | Tumor-amplified protein expression therapy; Salmonella vector consisting of highly attenuated bacteria that preferentially replicate tumors | Cancer | Expanded Phase I trial to Europe(7/24) |
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CENTRAL NERVOUS SYSTEM |
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Proneuron Biotechnologies* | | Autologous activated macrophage therapy | Complete spinal cord injury | Initiated treatment in Phase 1 study in Israel (7/31) |
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INFECTION |
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BioChem Pharma Inc. (Canada;BCHE) and Glaxo Wellcome plc (UK; NYSE:GLX) | Trizivir | Triple combination tablet; incorporates Biochem's 3TC/Epivir, plus abacavir sulphate and zidovudine | HIV infection | European Union's Committee for Proprietary Medicinal Products recommended approval in the 15 member states of the European Union (7/18) |
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Biovector Therapeutics SA* (France) and BioChem Pharma Inc. (Canada; BCHE) | | Nasally administered influenza vaccine; incorporates inactivated influenzantigens with licensed Biovector delivery technology | Influenza | Reported results from second Phase I trial (7/5) |
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Immune Response Corp. (IMNR) | Remune | Envelope-depleted, inactivated AIDS virus (emulsified with adjuvant); therapeutic vaccine in combination with antiviral drug therapy | HIV infection | Presented preliminary results of Phase II trial in Spain at the World AIDS conference (7/13) |
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The Immune Response Corp.(IMNR) and Trinity Medical Co. Ltd.* | Remune | Envelope-depleted, inactivated AIDS virus (emulsified with adjuvant); therapeutic vaccine | HIV infection | Trinity presented follow-up data on a Phase II trial conducted in Thailand at World AIDS Conference (7/14) |
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Synsorb BiotechInc. (Canada;[SYBB]) | Synsorb Cd | Product that binds to toxins secreted by bacteria in the gastrointestinal tract | Prevention of recurrent Clostridium difficile antibiotic-associated diarrhea | Reported positive final Phase II results (7/6) |
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VaxGen Inc.(VXGN) | AIDSVAX B/E | Bivalent vaccine composed of recombinant gp120 (envelope protein) from two strains of HIV-1 that are prevalent in Southeast Asia and the Pacific Rim | Prevention of HIV infection and AIDS | Described initiation of Phase III trial and social harm monitoring in Thailand at the World AIDS Conference (7/10) |
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MISCELLANEOUS |
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Alizyme plc(UK; LSE:AZM) | ATL-962 | Lipase inhibitor | Obesity | Completed Phase Ia trial in healthy volunteers (7/7) |
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Atrix Laboratories (ATRX) and Block Drug Company Inc. | Atridox (FDA-approved) | Doxycycline 8.8% product applied as a gel to affected area, where it conforms to the shape of the periodontal pocket and solidifies, releasing doxycycline over a period of about 7 days | Periodontal disease | Approved for marketing in Canada (7/6) |
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Genzyme General(GENZ) | Fabrazyme | Agalsidase beta; enzyme replacement therapy | Fabry disease | European Agency for the Evaluation of Medicinal Products validated marketing authorization;product received orphan drug designation in Europe (7/00) |
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Hemosol Inc.(Canada; TSE:HML) | Hemolink | Hemoglobin replacement product derived from red blood cells | Avoidance of transfusion of donor red blood cells in coronary artery bypass | Filed new drug submission with the Canadian Therapeutics Program of Health Canada to seek marketing approval in Canada(7/31) | |
NicOx SA(France; Nouveau Marche: NICOX) | HCT 1026 | Nitric oxide derivative of flubriprofen | Methyl-nicotinate induced contact urticaria | Reported data from Phase I/II trial in France and initiated second Phase I/II trial in dermatology (7/3) |
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QLT Photo-Therapeutics Inc. (Canada;QLTI) and CIBA Vision (unit of Novartis AG [Switzerland;NYSE:NVS]) | Visudyne (FDA-approved) | Photodynamic therapy activated by specially designed laser that produces low-level non-thermal 689 nm light | Age-related macular degeneration | Granted marketing authorization from the European Commission(7/28) | |
Transkaryotic Therapies Inc.(TKTX) | Replagal | Agalsidase alfa; enzyme replacement therapy | Fabrydisease | European Medicines Evaluation Agency accepted marketing authorization application for review (7/19) |