Company** Product Description Indication Type Action (Date)
CANCER
Biomira Inc. Tru-Scint AD Technetium-99m- In vivo imaging agent Canadian regulatory
(Canada) labeled monoclonal for detecting recurrent agency informed com-
antibody that reacts breast cancer and pri- pany that the data in its
with most adeno- mary residual or recur- new drug application (NDA)
carcinomas rent ovarian cancer (filed 5/96, seeking expe-
dited approval) were insuf-
ficient for determining sta-
tistical significance; com-
pany will not resubmit NDA
(12/1)
Cel-Sci Corp. Multikine Natural mixture of Head and neck cancer Expanded clinical trials
human cytokines, treatment prior to sur- in Canada (12/3)
including interleukin-2 gery or radiation therapy
Immuno-Designed MAK Cell Macrophage-activated Single therapy (or com- Initiated Phase II trials in
Molecules SA* Therapy killer cell therapy (uses bination therapy with France (12/10)
(France) point-of-care cell bispecific antibodies) for
processor to isolate ovarian and bladder
mononuclear cells from cancer
patient's blood; cells
activated ex vivo)
Novopharm NOVOMAb- Recombinant, pan- Progressive non-Hodg- Initiated Phase I trial in
Biotech Inc. G2 scFv carcinoma-specific kin's B cell lymphoma Canada (12/17)
(TSE:NVO; Canada) human monoclonal
antibody
(2nd generation)
Maxim Maxamine H2 receptor agonist that Combination therapy Results of ongoing clini-
Pharmaceuticals blocks phagocyte signal with interleukin-2 for cal trial (being conducted
Inc. that leads to death of improving relapse- in Sweden) published in
natural killer T cells remission in acute 12/97 issue of Leukemia
myelogenous leukemia and Lymphoma (12/2)
CARDIOVASCULAR
BioTime Inc. Hextend Blood plasma volume Replacement of blood Completed Phase III
expander volume during surgery trials in U.K. (12/8)
in which substantial
amounts of blood are lost
Hemosol Inc. Hemolink Highly purified hemo- For use in orthopedic Expanded sites for Phase
(TSE:HML; Canada) globin extracted from surgery (primary hip and II Canadian trials to in-
outdated human donor primary knee replace- clude the Maritimes
blood, then cross-linked ments) (12/22)
to form stable hemo-
globin molecule (red
blood cell substitute)
Hemosol Inc. Hemolink Highly purified hemo- To enhance effective- Canadian health author-
(TSE:HML; Canada) globin extracted from ness of erythropoietin ities approved protocol
outdated human donor therapy in patients for additional Phase II
blood, then cross-linked with chronic anemia trial (12/18)
to form stable hemo- associated with kidney
globin molecule (red failure
blood cell substitute)
CENTRAL NERVOUS SYSTEM
Chiroscience Chirocaine Levobupivacaine; chiral Broad usage in local, Submitted European mar-
Group plc (U.K.) version of approved drug regional or spinal keting authorization
bupivacaine anesthesia application (in Sweden)
(12/4)
DIABETES
Cortecs Macrulin Oral capsule formulation Type II diabetes Reported data from Phase
International Ltd. of porcine insulin (insulin II trial on 6 patients in
(U.K.) peptide coated with an the Netherlands (12/10)
amphipathic molecule)
Scotia Holdings plc Tarabetic Gamma-linolenic acid Diabetic neuropathy U.K.'s Medicines Control
(Scotland) (based on evening Agency rejected marketing
primrose oil) application (for the 2nd
time) based on wide var-
iation in results from 12
clinical trial centers;
company will not conduct
more trials (12/19)
INFECTION
Aquila Malaria Vaccine containing the Malaria Initiated Phase I trial in
Biopharmaceuticals vaccine synthetic peptide SPf66 Colombia (cosponsored
Inc. (hybrid molecule contain- by the Colombian govern-
ing antigenic domains ment and the World
from 2 life cycle stages Health Organization) (12/1)
of malaria parasite), plus
the Stimulon adjuvant
QS-21
Aronex Pharma- Nyotran Liposomal formulation Systemic fungal Filed marketing author-
ceuticals Inc. and of the antifungal agent infections ization application
Grupo Ferrer Inter- Nystatin in Spain (12/19)
nacional SA (Spain)
Aviron and Smith- -- Vaccine based on Vaccine for infectious Initiated Phase I trial in
Kline Beecham single surface antigen mononucleosis (caused Belgium (12/3)
Biologicals responsible for most of by EBV)
(Belgium; unit of the neutralizing antibodies
SmithKline Beecham plc; stimulated by Epstein-
NYSE:SBH; U.K.) Barr virus (EBV) infection,
together with SmithKline's
adjuvant technology
The Liposome Abelcet Amphotericin B lipid Severe, invasive fungal Approved for marketing
Co. Inc. complex (injection) infections (2nd-line in Norway (12/29)
therapy)
Novopharm GPI-2A Antisense therapy; HIV infection and Initiated Phase I trial in
Biotech Inc. use of antisense oligo- AIDS Canada (12/9)
(TSE:NVO; Canada) nucleotide that blocks
HIV replication,
delivered via cationic
liposomes
Synsorb Biotech Synsorb Pk Orally delivered carbo- Prevention of serious Received approval to
Inc. (Canada) hydrate attached to inert, complications from begin Phase III trials in
insoluble support; binds E. coli infections, Argentina (12/2)
to toxins secreted by including hemolytic
bacteria in the gastro- uremic syndrome
intestinal tract
MISCELLANEOUS
Aeterna Psovascar Shark cartilage extract Moderate-to-severe Health Canada approved
Laboratories Inc. with anti-angiogenic psoriasis protocol for Phase I/II
(TSE:AEL; Canada) and anti-inflammatory trial (12/17)
properties
Biomatrix Inc. Hylaform Hylan B gel tissue Correction of facial Approved for marketing
augmentation product wrinkles and depressed in Canada and Israel
scars (12/31)
Hyal Pharma- Hyanalgese-D Diclofenac 3% gel Pain relief in osteo- Announced that product
ceutical Corp. (formulated in drug arthritis did not achieve statistic-
(TSE:HPC; Canada) delivery system) ally significant results in
Phase III Canadian trial;
company will discontinue
product development
(12/17)
Integra Integra Product consists of Wound healing in burns; Approved for marketing
LifeSciences Corp. Artificial Skin bovine tendon-derived also, use in plastic and in People's Republic of
implantable matrix with reconstructive surgery China (12/8)
an outer layer of a
silicone-based substitute
for epidermis
Life Medical Piliel Serum-free combina- Topical gel for hair Company terminated the
Sciences Inc. tion of nutrients and regrowth and reduction European clinical trials on
(NASDAQ:CHAI) hormones applied in of hair loss in men this product, saying it had
situ; thought to stimulate sufficient information that
cell growth, form blood the product would not
vessels and improve yield the desired benefit
blood flow (12/17)
NPS Pharma- KRN-568 Orally active small Primary Kirin initiated Phase II
ceuticals Inc. and (R-568) molecule drug that acts hyperparathyroidism trial in Japan (12/11)
Kirin Pharma- at calcium receptors on
ceuticals (division of surface of parathyroid
Kirin Brewery; Japan) cells
Oxford OGT 918 Orally active small Gaucher's disease U.K.'s Medicines Control
GlycoSciences plc* molecule that inhibits (lysosomal storage Agency approved clinical
(U.K.) glycolipid formation disease) trial protocol (12/31)
SangStat Medical Bulk cyclo- Ingredient in SangStat's Immunosuppressive Approved for manufactur-
Corp. and Gensia sporine cyclosporine generic drug; used to prevent ing in European Union
Sicor Inc. substance drug graft rejection in (12/11)
organ transplantation
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 12/97. It does not cover ongoing clinical trials for which no news was issued that month.
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.