Home » Non-U.S. Clinical Trials, Regulatory Submissions, Recommendations And Approvals: August 1998
Non-U.S. Clinical Trials, Regulatory Submissions, Recommendations And Approvals: August 1998
Sep. 21, 1998
Company**
Product
Description
Indication
Type Action/Date
Name
CANCER
Aeterna
Neovastat
Shark cartilage extract
Refractory lung and
Presented results of
Laboratories Inc.
(AE-941)
with anti-angiogenic
prostate cancer
Phase I trial (conducted in
(TSE:AEL; Canada)
and anti-inflammatory
Canada and U.S.) at Euro-
properties
pean Association for
Cancer Research meeting
in Stockholm (8/20)
Biomira Inc.
BLP25
Synthetic MUC-1
Non-small cell
Initiated Phase I trial in
(Canada)
therapeutic vaccine;
lung cancer
Canada (8/5)
consists of 25 amino
acid sequence of the
MUC-1 cancer mucin,
encapsulated in lipo-
somes; suppresses
tumor angiogenesis
Chiron Corp. and
Proleukin
Aldesleukin; recombi-
Metastatic renal cell
Approved for marketing
Hyup Jin Corp.
nant human interleu-
carcinoma
in South Korea (8/12)
(South Korea)
kin-2
CARDIOVASCULAR
Inex Pharma-
INX-3280
Antisense compound
Cardiovascular resten-
Presented results of
ceuticals Corp.
that blocks function of
osis (administered via
Phase II trial (conducted
(TSE:IEX; Canada) and
c-myc gene (bolus
local delivery catheter
in the Netherlands) at
Schwarz Pharma
injection)
directly into coronary
20th Annual Congress
AG (Germany)
artery)
of the European Society
of Cardiology in Vienna,
Austria (8/24)
DIABETES
Amylin Pharma-
AC2993
Exendin-4; synthetic
Type II diabetes
Initiated Phase I trial in
ceuticals Inc.
version of protein
U.K. (8/18)
originally isolated from
saliva of Gila monster;
(has 50% structural
homology with human
hormone glucagon-
like peptide-1)
INFECTION
Agouron Pharma-
Viracept
Nelfinavir mesylate;
HIV infection and
Approved for marketing
ceuticals Inc.
HIV protease inhibitor
AIDS in adults and
in Canada (8/12)
(synthetic small
children; combination
molecule)
therapy with reverse
transcriptase inhibitors
BioChem Pharma
Zeffix
Lamivudine; nucleoside
Chronic hepatitis B
Approved for marketing
Inc. (Canada) and
analogue (oral)
virus infection
in the Philippines (8/20)
Glaxo Wellcome
plc (NYSE:LX; U.K.)
The Immune
Remune
Envelope-depleted
HIV infection and
Results of open-label
Response Corp
inactivated AIDS virus
AIDS
trial conducted in Thai-
and Agouron
(emulsified with
land (60-week follow-up)
Pharmaceuticals
adjuvant)
published in Vol. 12 1998
Inc.
issue of AIDS (8/25)
MedImmune Inc.
Synagis
Palivizumab; human-
Prevention of serious
Submitted marketing
and Abbott Labor-
ized monoclonal anti-
RSV disease in certain
authorization application
atories (NYSE:ABT)
body to respiratory
high-risk infants and
in the European Union
syncytial virus (RSV);
children (causes pneu-
(8/11)
binds to fusion protein
monia, bronchiolitis)
on viral surface (intra-
muscular injection)
NeXstar Pharma-
AmBisome
Liposomal formulation
Empirical treatment of
U.K.'s Medicines Control
ceuticals Inc.
of amphotericin B
presumed fungal infec-
Agency approved ex-
tions in febrile neutro-
panded label (new
penic patients
indication) (8/18)
SciClone Pharma-
Zadaxin
Synthetic version of
Chronic hepatitis C
Approved for marketing
ceuticals Inc.
(thymosin
naturally occurring pep-
virus infection
in the Philippines (8/27)
alpha 1)
tide hormone thymosin
(immunomodulator)
SciClone Pharma-
Zadaxin
Synthetic version of
Chronic hepatitis B
Approved for marketing
ceuticals Inc.
(thymosin
naturally occurring pep-
virus infection
in Myanmar (formerly
alpha 1)
tide hormone thymosin
Burma) (8/27)
(immunomodulator)
SciClone Pharma-
Zadaxin
Synthetic version of
Chronic hepatitis B
Filed marketing applica-
ceuticals Inc.
(thymosin
naturally occurring pep-
virus infection
tions in Laos and Taiwan
alpha 1)
tide hormone thymosin
(8/27)
(immunomodulator)
Synsorb Biotech
Synsorb Pk
Orally delivered carbo-
Co-administration with
Takeda said that its clin-
Inc. (Canada) and
hydrate attached to inert,
antibiotics to treat child-
ical study in Japan has
Takeda Chemical
insoluble support; binds
ren infected with vero-
been completed (8/18)
Ltd. (Japan)
to toxins secreted by
toxigenic Escherichia
bacteria in the gastro-
coli
intestinal tract
MISCELLANEOUS
Hemispherx Bio-
Ampligen
Double-stranded syn-
Chronic fatigue
Submitted marketing
Pharma Inc.
thetic RNA compound
syndrome/myalgic
application in European
(AMEX:HEB)
poly I:poly C12U
encephalomyelitis
Union (8/18)
Hyal Pharma-
Solarase
3% diclofenac gel
Actinic keratosis
Australian Drug Evalua-
ceutical Corp.
(topical)
(precancerous skin
tion Committee did not
(TSE:HPC; Canada)
lesions caused by
approve product market-
exposure to sun)
ing application (8/12)
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 events that were announced in August 1998. It does not cover ongoing clinical trials for which no news was issued in that month.
** 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. 11-12.