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**ProductDescriptionIndicationType Action/DateNameCANCERAeterna 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
CARDIOVASCULARInex 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)
DIABETESAmylin 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)
INFECTIONAgouron 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
MISCELLANEOUSHemispherx 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.