Company** Product Description Indication Type Action/Date
CANCER
Cel-Sci Corp. Multikine Natural mixture of Treatment of head and Results of small trial
human cytokines, neck cancer prior to conducted in Israel pre-
including interleukin-2 surgery or radiation sented at 1998 Interna-
therapy tional Head And Neck
Cancer Congress in
Hong Kong (6/8)
Cytogen Corp. Quadramet Samarium-153 EDTMP Relief of bone pain in Approved for marketing
(intravenous radio- patients with multiple in Canada (6/24)
pharmaceutical) osteoblastic skeletal
metastases (bone
cancer)
Genta Inc. G3139 Anticode (antisense) Stage III and IV meta- Initiated Phase I/IIa trial
compound; synthetic static malignant mela- in Austria (6/18)
DNA strands that bind noma (combination
to mRNA for bcl2 gene therapy with dacarbazine)
(proto-oncogene)
GlycoDesign Inc.* GD 0039 Orally active small Advanced or metastatic Canadian regulatory
(Canada) molecule compound renal cell carcinoma agency cleared protocol
that inhibits key for Phase II trial (6/9)
carbohydrate proces-
sing enzymes
Idec Pharma- MabThera Rituximab; genetically Relapsed or refractory Approved for marketing
ceuticals Corp. (a.k.a. engineered chimeric low-grade or follicular in all 15 member states
and F. Hoffmann- Rituxan) pan-B monoclonal anti- non-Hodgkin's lymph- of European Union (6/3)
La Roche Ltd. body that targets CD20 oma
(Switzerland) antigen on B-cell surface
Sugen Inc. SU 5416 Angiogenesis inhibitor; Blockage of tumor Initiated Phase I/II trial
small molecule inhib- angiogenesis in in U.K. (6/17)
itor of tyrosine kinase advanced malignancies
Flk-1/KDR receptor (to
which vascular endo-
thelial growth factor
binds, thus activating
angiogenesis)
CARDIOVASCULAR
Baxter Healthcare HemAssist Blood substitute; Severe traumatic Suspended enrollment in
Corp. (subsidiary of diaspirin cross-linked hemorrhagic shock European clinical trial
Baxter International hemoglobin (made from (product not showing
Inc.; NYSE:BAX) unused human donor stastically significant
blood) benefit) (6/2)
Draximage Inc. Fibrimage Technetium-99m- Imaging of active Draxis received approval
(subsidiary of Draxis labeled recombinant thrombus in deep vein to initiate Phase II trials
Health Inc.; Canada) polypeptide with high thrombosis in Canada (6/8)
and Bio-Technology affinity for fibrin
General Corp. (based on fibrin
binding domain)
Hemosol Inc. Hemolink Highly purified hemo- Blood substitute for Canadian regulatory
(TSE:HML; Canada) globin extracted from patients undergoing agency cleared protocol
outdated human donor coronary artery bypass for Phase II trials (6/8)
blood, then cross-linked graft surgery
to form stable hemo-
globin molecule (red
blood cell substitute)
Hemolink Highly purified hemo- Blood substitute for Completed 1st Phase II
globin extracted from patients undergoing trial in Canada (6/4)
outdated human donor orthopedic surgery
blood, then cross-linked
to form stable hemo-
globin molecule (red
Intercardia Inc. Bextra Bucindolol HCl; non- To prolong survival in Initiated BEAT clinical
and BASF Pharma/ selective beta blocker patients who have study in Denmark and
Knoll AG (Germany) with vasodilating reduced left ventricular U.K.; to be conducted by
properties systolic function within BASF (6/25)
7 days following acute
myocardial infarction
CENTRAL NERVOUS SYSTEM
Angiotech — Micellular paclitaxel Secondary progressive Initiated Phase I trial in
Pharmaceuticals (generic version of multiple sclerosis Canada (6/29)
Inc. (Canada) active ingredient in
anti-cancer drug Taxol)
The Ares-Serono Rebif Recombinant interferon Multiple sclerosis Reported results of high-
Group (Switzerland) beta-1a (relapsing-remitting; dose international trials
also transitional) (PRISMS trials) at annual
meeting of European
Neurological Society
(ENS) in Nice, France (6/9)
Chiron Corp. and Betaseron Recombinant human Secondary progressive Presented data from inter-
Berlex Labora- (FDA- interferon beta-1b multiple sclerosis im analysis of European
tories Inc. (sub- approved) (injection) trial at ENS meeting; pro-
sidiary of Schering duct delayed progression
AG; Germany) of disability (6/9)
CytoTherapeutics — Cell therapy; implant Chronic pain in cancer Companies resumed
Inc. and Astra AB (formerly contains bovine adrenal patients patient enrollment in
(Sweden) CereCRIB) cells that secrete natural- Phase IIb trial in Europe
ly occurring analgesics (incorporating modifica-
(catecholamines, opioid tions to surgical proced-
peptides); device implant- ure) (6/15)
ed at base of spine
INFECTION
Cel-Sci Corp. HGP-30W Synthetic peptide Prevention of HIV Initiated Phase II trial in
derived from the p17 infection the Netherlands (6/17)
region of the AIDS virus;
contains 30 amino acids
(common to most common
HIV subtypes worldwide)
Glaxo Wellcome Ziagen Abacavir; nucleoside HIV infection and AIDS Submitted marketing
plc (NYSE:GLX; U.K.) (formerly analogue reverse trans- in children and adults authorization application
1592) criptase inhibitor (oral; (combination therapy in European Union (6/25)
tablet and liquid) with Epivir and Retrovir)
Immunex Corp. Leukine Yeast-derived Combination therapy Results of Phase III trial
(FDA- recombinant human with AZT or nucleoside conducted in Brazil
approved) granulocyte macro- analogues for treating presented at 12th Inter-
phage-colony stim- HIV infection and AIDS national AIDS Confer-
ulating factor ence in Geneva, Switzer-
land (6/30)
Maxim Maxamine H2 receptor agonist that Combination therapy Reported preliminary
Pharmaceuticals blocks phagocyte signal with alpha-interferon results of Phase I trial in
Inc. that leads to death of for treating hepatitis C Europe (6/9)
natural killer T cells virus infection in patients
who were nonresponders
to previous alpha-inter-
feron therapy
NeXstar AmBisome Liposomal formulation 1st line therapy in Broad expansion of label
Pharmaceuticals of amphotericin B severe confirmed sys- approved in Spain (6/11)
Inc. temic fungal infections;
empirical treatment of
fungal infections in
severely neutropenic
patients; treatment of
visceral leishmaniasis
in immunocompormised
patients
AmBisome Liposomal formulation 2nd line therapy for Approved for marketing
of amphotericin B systemic fungal infect- in France (6/10)
ions and for visceral
leishmaniasis
North American DTaP-IPV Combines Certiva, a Vaccination for pertus- Completed registration
Vaccine Inc. Vaccine DTP vaccine, with sis, diphtheria, tetanus process for marketing
injectable inactivated and polio in infants and authorization in Austria,
polio vaccine children Germany, Sweden and
Finland (6/11)
Novopharm GPI-2A Antisense therapy; HIV infection and AIDS Completed patient enrol-
Biotech Inc. use of antisense oligo- lment in Phase Ia trial in
(TSE:NVO; Canada) nucleotide that blocks Canada (6/3)
HIV replication, delivered
via cationic liposomes
Protein Design Ostavir (a.k.a. Fully human anti- Combination therapy Initiated Phase IIa trial
Labs Inc. OST577) hepatitis B virus with antiviral nucleoside in Europe (6/8)
antibody analogue lamivudine for
treating chronic hepatitis
B virus infection
Vertex Pharma- Amprenavir HIV protease Combination therapy Reported interim results
ceuticals Inc. and (formerly inhibitor with Retrovir and of Phase II trial in France
Glaxo Wellcome VX-478) Epivir in HIV infection at 8th annual Neuro-
plc (NYSE:GLX; U.K.) and AIDS science of HIV confer-
ence in Chicago (6/5)
MISCELLANEOUS
Alteon Inc. ALT-711 AGE crosslink-breaker; To reverse deterioration Initiated Phase I trial in
orally active compound of cardiovascular system Europe (6/14)
that breaks cross-linked seen with aging
advanced glycosylation
end products
Insmed INS-1 D-chiro inositol; small, To increase ovulation Presented results of pilot
Pharmaceuticals carbohydrate-based in patients with poly- clinical study conducted
Inc.* molecule (oral) cystic ovarian syndrome in Venezuela at 58th
annual meeting of the
American Diabetes
Association in Chicago
(6/15)
Isis ISIS 2302 Antisense inhibitor of Steroid-dependent Results of Phase II trial in
Pharmaceuticals intercellular adhesion Crohn's disease Canada published in 6/98
Inc. molecule-1 (ICAM-1) issue of Gastroenterology
(6/10)
NeuroSearch A/S NS2359 Synthetic small mole- Cocaine addiction Initiated Phase I trial in
(Denmark) cule compound that acts U.K. (6/9)
as mixed monoamine
reuptake inhibitor
Theratechnol- ThGRF-1-29 Growth hormone- Growth hormone Announced results of
ogies Inc. (MSE:TH; releasing factor deficiency in adults Phase I trial conducted
Canada) and the analogue by Beaufour in Europe
Beaufour Ipsen (6/15)
Group (France)
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 June 1998. It does not cover ongoing clinical trials for which no news was issued in 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. 19-20.