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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.