Company* (Symbol) | Product | Description | Indication | Status (Date) |
CANCER |
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Biomira Inc. (BIOM) | BLP25 | Synthetic MUC-1 therapeutic vaccine; consists of 25-amino-acid sequence of the MUC-1 cancer mucin, encapsulated in liposomes; suppresses tumor angiogenesis | Advanced non-small-cell lung cancer | Initiated a multicenter Phase IIb trial expected to involve 166 patients at 10 Canadian sites (8/9) |
Cel-Sci Corp. (AMEX:CVM) | Multikine | Natural mixture of human cytokines, including interleukin-2 | Head and neck cancer | Company received permission to start a Phase II trial in the Czech Republic in conjunction with clinical centers in Poland (8/21) |
Elan Corp. (Ireland; NYSE:ELN) | Myocet | Liposomal formulation of doxorubicin | Metastatic breast cancer | European Commission granted the company marketing authorization (8/1) |
LifeTime Pharmaceuticals* | Beta LT | Beta-alanyl cysteamine disulfide; synthetic small- molecule immune stimulator | Cancer | Announced results of a Phase I/II trial at McGill University in Mon- treal; data were presented at the International Society of Hematology meeting in Toronto (8/28) |
Ligand Pharmaceuticals Inc. (LGND) | Targretin Capsules and Gel (FDA- approved) | Bexarotene; synthetic retinoid analogue that selectively activates retinoid X receptors; oral formulation | Cutaneous T-cell lymphoma | Reported results from Phase II/III trials in Australia for Targretin capsules and gel at the 28th World Congress of the Intern- ational Society of Hematology; has plans for a Phase I/II study in Tufts New England Medical Center (8/29) |
Novogen Ltd. (Australia; NVGN) | NV-06 | Anticancer product administered via once weekly via injection | Solid metastatic cancers | Received clearance to begin Phase I/II trial in Australia (8/29) |
Theratechnologies (TSE:TH) | Theralux | Ex vivo photodynamic cell therapy system that treats patient's blood with photosensitive molecule TH 9402 and a light source to eradicate cancer cells and preserve healthy ones | Non-Hodgkin's lymphoma | Company filed an application with the Health Protection Branch in Ottawa to begin the clinical validation of Theralux (8/9) |
CARDIOVASCULAR |
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Aventis Behring LLC (unit of Aventis SA [France; NYSE: AVE]) | Helixate NexGen | Recombinant, non-plasma- derived Factor VIII product | Hemophilia A | The European Commission approved Helixate NexGen in a new formulation that does not include human albumin and has added solvent detergent treatment (8/10) |
BioTime Inc. (AMEX:BTX) | Hextend | Physiologically-balanced plasma volume expander | To replace blood volume | Company submitted application to sell Hextend in Sweden (8/29) |
Cerus Corp. (CERS) and Baxter Healthcare Corp. (NYSE:BAX) | Intercept Platelet System | Pathogen inactivation system that targets and inactivates bloodborne pathogens, while leaving the therapeutic properties of platelets intact; process uses light-activated psoralen compound, S-59, which disables nucleic acid | To protect against the transmission of disease through blood transfusions | Announced results of the European Phase III trial; data supports a regulatory submission in Europe (8/22) |
D-Pharm Ltd.* (Israel) | DP-b99 | Membrane-activated chelator designed to control apoptotic processes by regulating intracellular homeostasis divalent metal ions; intravenously delivered | Acute stroke | Completed first stage of a Phase I placebo-controlled, randomized safety study, conducted in Germany (8/1) |
CENTRAL NERVOUS SYSTEM |
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| Cyberonics Inc. (CYBX) |
The Neuro- Cybernetic Prosthesis | Stimulates left cervical vagus nerve to improve memory | Alzheimer's disease | Company said the first patient in pilot study was implanted with the NeuroCybernetic Prosthesis System at the Sahlgrenska University Hospital in Gothenburg, Sweden (8/3) |
NeuroSearch A/S (Denmark) and Glaxo Wellcome plc (UK; NYSE:GLX) | NS2389 (GW650 250A) | Monoamine reuptake inhibitor; combines inhibi- tion of noradrenalen and serotonin reuptake with stimulation of dopaminergic system | Depression | Companies temporarily suspend ed the Phase II studies due to animal-based toxicology results that are inconsistent with previous results (8/17) |
NeuroSearch A/S (Denmark) | NS2359 | Synthetic small-molecule compound that acts as mixed monoamine reuptake inhibitor | Cocaine addiction | Company said the National Institute of Drug Abuse agreed to fund the next stage of development; Phase II trials will begin in October (8/28) |
INFECTION |
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| Chiron Corp. (CHIR) |
Menjugate | Conjugate vaccine against Neisseria meningitidis serogroup C | Prevention of meningococcal C disease | Cleared for marketing in Ireland (8/8) |
Gilead Sciences Inc. (GILD) and Hoffmann-La Roche Ltd. (Switzerland) | Tamiflu (FDA- approved) | Oseltamivir phosphate; oral neruaminidase inhibitor | Treatment and prophylaxis of influenza A and B infection in adults | Roche submitted the product for regulatory approval in Japan (8/2) |
SciClone Pharmaceuticals Inc. (SCLN) | Zadaxin | Thymosin alpha 1; synthetic version of naturally occurring peptide hormone thymosin (immunomodulator) | Hepatitis B and C infection | Received expanded marketing approval in Argentina; company plans Phase III trial in the U.S. by year's end (8/7) |
Tularik Inc. (TLRK) | T902611 | Oral inhibitor of cytomegalo- virus enzyme essential for for initiating synthesis of viral DNA as part of the repli- cation process | Cytomegalovirus | Initiated a Phase I study in the UK (8/14) |
VaxGen Inc. (VXGN) | AIDSVAX | 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 | Completed enrollment of the preventive HIV vaccine trial held in Bangkok, Thailand; Phase III trial enrolled 2,500 patients (8/31) |
Viragen Inc. (AMEX:VRA) | Omniferon | Natural, multi-subtype alpha interferon | Hepatitis C | Company expects to enroll an additional 100 patients in Phase II European trials; it will file an IND with the FDA by year's end (8/10) |
Virax Holdings Ltd. (Australia; ASX:VHL) | VIR201 | Recombinant avipox virus designed to co- express genes for immunogenic but highly conserved parts of the HIV virus in conjunction with a human cytokine (interferon gamma) | HIV/AIDS | Company received approval to conduct clinical trials in Australia to test the vaccine; the Phase I/IIa trial will be conducted at Melbourne's Alfred Hospital (8/31) |
MISCELLANEOUS |
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Atlantic Technology Ventures Inc. (ATLC) | CT-3 | Ajulemic acid; synthetic derivative of trahydrocannabinol (THC-11-oic acid) | Inflammation | Completed a Phase I trial of CT-3 at the Aster Clinical Research Center in Paris (8/28) |
BioTransplant Inc. (BTRN) | BTI-322 | Murine monoclonal antibody that binds to CD2 antigen receptor on T cells and natural killer cells | Liver transplant rejection | Company said Phase I/II study results showed BTI-322, in con- junction with Prograf (tacrolimus) immuno-suppressive therapy, reduces the incidence of rejection in the immediate post-operative period by 70% as compared to Prograf alone; data were pre- sented at teh International Con- gress of The Transplantation Society in Rome (8/30) |
Hemispherx Biopharma Inc. (AMEX:HEB) | Ampligen | Double-stranded synthetic RNA compound poly I; poly C12U | Severe chronic fatigue syndrome | Company said its European subsidiary filed for orphan drug designation in Europe (8/1) |
Isotechnika Inc. (Canada; VSE:ISA) | ISAtx247 | Immunosuppressive therapy based on cyclosporine | Prevention of organ rejection following transplantation (8/28) | Presented preclinical and Phase I results of trial held in Canada at the International Congress of the Transplant Society in Rome |
SangStat Medical Corp. (SANG) | Thymoglobuline | Anti-thymocyte globulin; polyclonal antibody produced in rabbits | Prophylaxis of transplant rejection and therapy for acute kidney rejection | Cleared for marketing in Italy (8/31) |
Serono SA (Switzerland; SWX:SEO) | Luveris | Recombinant human luteinizing hormone, lutropin alfa | Female infertility | The committee for Proprietary Medicinal Products recommended approval in Europe (8/15) |
Teva Pharmaceutical Industries Ltd. (TEVA) | Copaxone (FDA- approved) | Glatiramer acetate for injection; four-amino-acid peptide derived from myelin basic protein | Relapsing- remitting multiple sclerosis | Cleared for marketing in the UK, allowing Teva to file for approval throughout the Euro- pean Union, under the mutual recognition procedure (8/13) |
Theratechnologies Inc. (Canada; MSE:TH) |
ThGRF 1-44 | Analogue of growth hormone releasing factor | Chronic obstructive pulmonary disease | Company filed an IND with the Health Protection Branch in Ottawa to begin a Phase II, double-blind, randomized and placebo-controlled study to be conducted on 90 patients (8/22) |
| Transkaryotic Therapies Inc. and Aventis Pharma AG (unit of Avents SA [France; NYSE:AVE]) |
Dynepo (formerly GA-EPO) | Gene-activated erythro- poietin; gene in human cells is activated in situ to produce EPO | Anemia in patients with chronic renal failure | Aventis filed in the U.S. and Europe for marketing approval (8/3) |
Unigene Laboratories Inc. (OTCBB: UGNE) |
Forcaltonin | Injectable recombinant calcitonin | Osteoporosis, Paget's disease and hypercalcemia | Company received a pre-approval letter to market the product in Switzerland (8/15) |
Zonagen Inc. (ZONA) and Schering-Plough Corp. (NYSE:SGP) | Vasomax | Immediate-release, oral formulation of phentolamine mesylate | Erectile dysfunction | The UK's Medicines Control Agency sent Schering-Plough a letter saying the product poses no carcinogenic threat to humans; the findings lifted the suspension of clinical testing (imposed in 1999 based on a rat study) |
Notes: |
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* Privately held |
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Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. |
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AMEX = American Stock Exchange; ASX = Australian Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; TSE = Toronto Stock Exchange; VSE = Vancouver Stock Exchange |
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