Company* (Symbol)

Product

Description

Indication

Status (Date)

CANCER

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)

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)

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)

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)

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)

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)

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)

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)

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)

CENTRAL NERVOUS SYSTEM

Proneuron Biotechnologies*

­

Autologous activated macrophage therapy

Complete spinal cord injury

Initiated treatment in Phase 1 study in Israel (7/31)

INFECTION

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)

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)

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)

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)

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)

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)

MISCELLANEOUS

Alizyme plc(UK; LSE:AZM)

ATL-962

Lipase inhibitor

Obesity

Completed Phase Ia trial in healthy volunteers (7/7)

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)

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)

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)

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)

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