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Non-U.S. Clinical Trials, Regulatory Submissions, Recommendations And Approvals: October 1998
Company** Product Description Indication Type Action (Date)
CANCER
Aphton Corp. and Gonad- Anti-gonadotropin Advanced prostate Aphton initiated Phase I/II
SmithKline Beecham immune releasing hormone cancer trial in U.K. (10/9)
plc (NYSE:SBH; U.K.) (GnRH) vaccine; consists
of synthetic peptides
bound to carrier (injection)
DepoTech Corp. Savedar Injectable, sustained- Neoplastic meningitis Withdrew European marketing
(a.k.a. release formulation of arising from solid authorization application
DepoCyt) chemotherapeutic agent tumors (additional clinical data would
cytarabine (uses Depo- be required to supplement
Foam lipid-based drug filing) (10/16)
delivery)
Ligand Panretin Gel Alitretinoin; 0.1% gel; Treatment of dermal NDA submitted and accepted
Pharmaceuticals Inc. chemically synthesized lesions in AIDS- for priority review in Canada
version of 9-cis-retinoic related Kaposi's (10/5)
acid (derived from sarcoma
vitamin A)
CARDIOVASCULAR
Hemosol Inc. Hemolink Highly purified hemo- Blood substitute in Completed Phase II trial in
(TSE:HML; Canada) globin extracted from patients undergoing U.K. (10/14)
outdated human donor orthopedic surgery
blood, then cross-linked
to form stable hemo-
globin molecule
CENTRAL NERVOUS SYSTEM
Berlex Laboratories Betaseron Recombinant human Secondary progressive European Committee for Pro-
Inc. and Chiron interferon beta-1b multiple sclerosis prietary Medicinal Products
Corp. issued positive scientific
opinion on data from European
clinical study (10/29)
DIABETES
Amylin Pramlintide Synthetic analogue of To improve glucose Announced results from two
Pharmaceuticals Inc. human pancreatic control in patients with 6-month Phase III trials in
hormone amylin Type I diabetes and in Europe and Canada; results not
insulin-using patients statistically significant in high-
with Type II diabetes est dose used (10/20)
Generex Biotech- Oralin Oral insulin (liquid; ad- Types I and II diabetes Received approval to begin
nology Corp. ministered with metered- Phase II trials in Canada
OTC Bulletin Board: dose aerosol applicator) (10/28)
GNBT; Canada)
INFECTION
Aquila Quilimmune- Vaccine that contains Prevention of malaria Announced preliminary
Biopharmaceuticals M synthetic malarial results from Phase I trial con-
Inc. peptide antigen SPf66 ducted in Colombia (10/14)
plus Stimulon adjuvant
QS-21
BioChem Vaccines Influenza Vaccine incorporates Influenza Announced results of Phase I
(subsidiary of Bio- vaccine antigens from 3 strains Canadian trial (10/28)
Chem Pharma Inc., of influenza virus in a
Canada) and Biovector supra-molecular bio-
Therapeutics SA* vector delivery tech-
(France) nology (lipid/poly-
saccharide carrier)
(nasal administration)
Medeva plc Hepagene 3rd-generation recombi- Vaccine for hepatitis B Filed pan-European PLA with
(NYSE:MDV; U.K.) nant vaccine that incor- virus infection European Agency for the
porates all 3 hepatitis B Evaluation of Medicinal
virus surface antigens Products (10/27)
(pre-S1, pre-S2 and S)
Novopharm GPI-2A Antisense therapy; HIV infection and AIDS Announced results of Phase Ia
Biotech Inc. use of antisense oligo- trial in Canada; saw unantici-
(TSE:NVO; Canada) nucleotide that blocks pated side effects with lipo-
HIV replication, delivered omes; company will select
via cationic liposomes alternate delivery system
before continuing with clinical
studies (10/30)
Vertex Pharma- Agenerase Amprenavir; 2nd- Combination therapy Glaxo submitted application
ceuticals Inc. and generation HIV protease with antiretroviral drugs for marketing approval in
Glaxo Wellcome plc inhibitor; twice-daily for HIV and AIDS Canada (10/20)
(NYSE:GLX; U.K.) dosage
MISCELLANEOUS
Allelix ALX-11 Recombinant human Postmenopausal Announced results of Phase
Biopharmaceuticals parathyroid hormone osteoporosis II North American trial (10/23)
Inc. (Canada)
Biomatrix Inc. Synvisc Elastoviscous hylan bio- Osteoarthritis of Approved for marketing in
and Novartis polymer; chemically the knee Argentina and Brazil (10/15)
Pharma AG modified version of
(Switzerland) natural hyaluronan
CollaGenex Pharma- Periostat Orally administered Adjunct to scaling and Submitted marketing authori-
ceuticals Inc. drug consisting of root planing for treating zation application with U.K.'s
subantibiotic dose of moderate to severe Medicines Control Agency
doxycycline (inhibits periodontitis in adults (10/28)
production of
collagenase)
Cortecs plc Macritonin Oral formulation of Postmenopausal Announced 1-year bone min-
(U.K.) salmon calcitonin (a osteoporosis eral density data from ongoing
peptide hormone that Phase III European trial
inhibits bone resorption) (10/29)
Pharmos Corp. Dexanabinol Non-psychotropic Severe head trauma Presented results of Phase II
synthetic analogue of trial (conducted in Israel) at
marijuana (intravenous) Congress of Neurological
Surgeons in Seattle (10/7)
Xoma Corp. hu1124 Humanized monoclonal Moderate-to-severe Completed patient enrollment
(formerly antibody to CD11a recep- plaque psoriasis in Phase II Canadian trial
anti-CD11a) tor on T cells (involved (10/6)
in both T-cell migration
and activation)
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.
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. 13-14.