Company** | Product | Description | Indication | Type Action (Date) |
CANCER | ||||
Aeterna | Neovastat | Shark cartilage extract | Patients with meta- | Preliminary results of |
Laboratories Inc. | with anti-angiogenic | static lung cancer who | Canadian Phase I/II trial | |
(TSE:AEL; Canada) | properties | are no longer respond- | presented at meeting on | |
ing to conventional | Angiogenesis and Cancer, | |||
therapy | in Orlando (1/27) | |||
Chiroscience | D 2163 | 2nd-generation matrix | Solid tumors | Initiated Phase I trial in |
Group plc (U.K.) | metalloproteinase | U.K. (1/5) | ||
inhibitor | ||||
DepoTech Corp. | Savedar | Injectable, sustained- | Neoplastic meningitis | Submitted marketing |
(a.k.a. | release formulation of | arising from solid tumors | authorization applica- | |
DepoCyt) | chemotherapeutic agent | tion in Europe (1/20) | ||
cytarabine (uses Depo- | ||||
Foam lipid-based drug | ||||
delivery) | ||||
Genetronics | Electroporation | Drug delivery method | Squamous cell carci- | Canadian Health Protec- |
Biomedical Ltd. | therapy | that uses electric fields | noma of the head and | tion Branch cleared proto- |
(TSE:GEB) | to open pores in human | neck in patients who | col for Phase II trials | |
cells to allow easier and | have failed conventional | (1/21) | ||
more efficient delivery | therapies | |||
of chemotherapeutic | ||||
drug bleomycin | ||||
Genetronics | Electroporation | Drug delivery method | Pancreatic cancer and | French regulatory author- |
Biomedical Ltd. | therapy | that uses electric fields | liver cancer | ities cleared protocols for |
(TSE:GEB) | to open pores in human | clinical trials (1/5) | ||
cells to allow easier and | ||||
more efficient delivery | ||||
of chemotherapeutic | ||||
drug bleomycin | ||||
Guilford Pharma- | Gliadel | Biodegradable polyan- | Treatment of newly | Initiated confirmatory |
ceuticals Inc. and | hydride polymer wafer | diagnosed primary brain | Phase III trial in Europe | |
Rhone-Poluenc Rorer | containing carmustine | tumor (malignant gli- | (1/14) | |
(subsidiary of Rhone- | (implant) | oma), used in conjunc- | ||
Poulenc SA; France) | tion with surgery and | |||
radiation therapy | ||||
QLT PhotoThera- | Photofrin | Photosensitive drug | Treatment of superficial | Submitted marketing |
peutics Inc. (Canada) | (produces toxic oxygen | endobronchial non-small | authorization applica- | |
and Beaufour Ipsen | compound when light- | cell lung cancer in pa- | tions in the U.K., Ireland, | |
Group (France) | activated) | tients not indicated for | Spain, Portugal, Belgium, | |
surgery or radiation; | Denmark, Sweden, Fin- | |||
palliative treatment of | land and Greece (1/6) | |||
obstructing non-small cell | ||||
lung cancer; and palliative | ||||
treatment of obstructing | ||||
esophageal cancer | ||||
Theratechnologies | TH 9402 | Photodynamic ex vivo | To restore bone marrow | Filed investigational |
Inc. (MSE:TH; Canada) | purging process; bone | function in patients | new drug application | |
marrow or peripheral | with chronic myeloid | in Canada (1/6) | ||
blood withdrawn from | leukemia | |||
patient, saturated with | ||||
photosensitive molecule | ||||
TH 9402 and purged by | ||||
exposing to activated | ||||
light; cells reinfused | ||||
into patient | ||||
CARDIOVASCULAR | ||||
AtheroGenics Inc.* | AGI 1067 | Composite vascular | Onset and progression | Initiated Phase I trial in |
protectant; oral small | of coronary artery | Scotland (1/26) | ||
molecule compound | disease | |||
that targets regulatory | ||||
signals for genes in- | ||||
volved in inflammatory | ||||
and proliferative diseases | ||||
Molecular | Optison | 2nd-generation ultra- | To aid in detection of | European Union's Com- |
Biosystems Inc. and | sound contrast imaging | cardiac disease | mittee for Proprietary | |
Mallinckrodt Inc. | agent; contains perflu- | Medicinal Products recom- | ||
(NYSE:MKG) | orocarbon | mended approval (1/29) | ||
Protein Design | YM 337 | SMART (humanized) | Treatment of certain | Yamanouchi initiated |
Labs Inc. and | monoclonal antibody | cardiovascular disorders | Phase I trial in Europe | |
Yamanouchi Phar- | fragment to the GPIIb/ | (1/12) | ||
maceutical Co. | IIIa receptor that mediates | |||
Ltd. (Japan) | platelet aggregation | |||
Sonus | SonoGen | 2nd-generation fluoro- | Contrast | Reported results of |
Pharmaceuticals | carbon-based ultra- | echocardiography | Phase I trial in U.K. | |
Inc. | sound contrast agent | (1/12) | ||
(charge-stabilized | ||||
emulsion) | ||||
Sonus Pharma- | EchoGen | Fluorocarbon-based | Contrast | Reported results of |
ceuticals Inc. and | Emulsion | ultrasound contrast | echocardiography | Phase I trial in Japan |
Daiichi Pharma- | agent | (1/12) | ||
ceutical Co. Ltd. | ||||
(Japan) | ||||
CENTRAL NERVOUS SYSTEM | ||||
Amrad Corp. Ltd. | AM 424 | Leukemia inhibitory | Motor neuron disease | Completed Phase I trial |
(Australia) | factor | in U.K. (1/28) | ||
The Ares-Serono | Rebif | Recombinant interferon | Multiple sclerosis | European Union's Com- |
Group (Switzerland) | beta-1a | (relapsing-remitting) | mittee for Proprietary | |
Medicinal Products recom- | ||||
mended approval (1/7) | ||||
Cambridge | CNS 5161 | Small molecule com- | Treatment of neuro- | Announced results of |
NeuroScience Inc. | pound that blocks the | pathic pain and migraine | Phase I trial in Scotland | |
NMDA (N-Methyl | (1/6) | |||
D-Aspartate) ion channel | ||||
Elan Corp. plc | Antegren | Humanized monoclonal | Multiple sclerosis, | Announced results of |
(Ireland) | antibody directed | Crohn's disease and | Phase II U.K. trial (in | |
against the alpha-4- | ulcerative colitis | multiple sclerosis) as well | ||
beta-1 integrin expressed | as results of 2 separate | |||
in certain white blood | U.K.-based pilot studies | |||
cells (to block their | in Crohn's disease and | |||
migration into the brain) | ulcerative colitis (1/22) | |||
INFECTION | ||||
Agouron Pharma- | Viracept | Synthetic small mole- | Combination therapy | Approved for marketing |
ceuticals Inc. and | cule designed to inhibit | with nucleoside ana- | in European Union (1/22) | |
F. Hoffmann- | HIV protease | logues for treating HIV | ||
La Roche Ltd. | infection in adults and | |||
(Switzerland) | children | |||
The Immune | Remune | Envelope-depleted, | HIV infection and AIDS; | Initiated clinical trial in |
Response Corp., | inactivated AIDS virus | combination therapy | Switzerland (1/27) | |
F. Hoffmann- | (emulsified with | with 1 retroviral drug | ||
La Roche Ltd. and | adjuvant) | and 2 protease inhibitors | ||
Glaxo Wellcome plc | (Abacavir, Viracept and | |||
Saquinavir or Abacavir, | ||||
Amprenavir and Viracept) | ||||
The Liposome | Abelcet | Amphotericin B lipid | Severe, invasive fungal | Approved for marketing |
Co. Inc. | complex (injection) | infections; 1st-line ther- | in Hong Kong (1/26) | |
apy for candidiasis; | ||||
2nd-line therapy for | ||||
other fungal infections | ||||
Maxim | Maxamine | H2 receptor agonist that | Combination therapy | Reported interim data |
Pharmaceuticals | blocks phagocyte signal | with interferon-alpha | from Phase I trial in | |
Inc. | that leads to death of | (Intron A) for treating | Sweden (1/14) | |
natural killer T cells | chronic hepatitis C | |||
infection in patients who | ||||
are non-responders to | ||||
previous interferon | ||||
therapy | ||||
SciClone Pharma- | Zadaxin | Synthetic version of | Monotherapy for treat- | Schering-Plough has been |
ceuticals Inc. and | (thymosin | naturally occurring pep- | ing chronic hepatitis B | cleared to initiate pivotal |
Schering-Plough | alpha 1) | tide hormone thymosin | infection | Phase III trials in Japan |
K.K. (Japan; subsidiary | (immunomodulator) | (1/20) | ||
of Schering-Plough | ||||
Corp.; NYSE:SGP) | ||||
MISCELLANEOUS | ||||
BIORA AB (Sweden) | Emdogain | Gel formulation con- | Periodontal flap surgery; | Approved for marketing |
and Seikagaku Corp. | taining a porcine protein | promotes the regain of | in Japan (1/27) | |
(Japan) | that mimics the human | tooth-supporting tissues | ||
protein amellogenin, or | and reattachment of the | |||
enamel matrix derivative | tooth | |||
Gliatech Inc. and | Adcon-L | Anti-adhesion barrier | To inhibit postopera- | Chugai filed marketing |
Chugai Pharma- | gel (semisynthetic | tive peridural scars | application in Japan | |
ceutical Co. Ltd. | carbohydrate polymer) | (following lumbar disc | (1/7) | |
(Japan) | surgery) | |||
Icos Corp. | IC 351 | Selective phosphodi- | Male erectile | Initiated Phase II cross- |
esterase 5 inhibitor | dysfunction | over study "overseas" | ||
(thought to reinforce | (1/13) | |||
normal physiological | ||||
signals to increase | ||||
blood flow) | ||||
Vertex | VX-497 | Oral small molecule | Autoimmune diseases, | Initiated Phase I trial in |
Pharmaceuticals | drug designed to inhibit | especially psoriasis | U.K. (1/13) | |
Inc. | inosine monophos- | |||
phate dehydrogenase | ||||
(and thus inhibit lympho- | ||||
cyte recruitment and | ||||
proliferation) | ||||
NOTES: | ||||
This chart is intended to provide a monthly update on the clinical and regulatory status of biotech and biotech-related products in development in countries other than the U.S., whether those products are being developed by U.S.-based or non-U.S.-based firms. It covers only those events that were announced in 1/98. It does not cover ongoing clinical trials for which no news was issued that month. | ||||
MSE = Montreal Stock Exchange; TSE = Toronto Stock Exchange | ||||
* Private companies are indicated with an asterisk. | ||||
** Unless otherwise noted, the trading symbols for public biotechnology companies can be found by referring to the BioWorld Stock Report For Public Biotechnology Companies on pp. 10-11. |