Company** Product Description Indication Type Action/Date
CANCER
AltaRex Corp. OvaRex Anti-idiotype induction Late-stage ovarian Initiated open-label
(Canada) Therapeutic vaccine; consists of cancer in patients who Phase II trial in Canada
Vaccine modified murine mono- have relapsed after (7/9)
clonal antibody that surgery and/or chemo-
binds to CA125 antigen therapy
Antisoma plc* Theragyn Murine monoclonal Adjuvant therapy for U.K. Medicines Control
(U.K.) antibody HMFG1, ovarian cancer Agency granted approval to
linked to yttrium-90 initiate Phase III trials (7/1)
CARDIOVASCULAR
Genentech Inc. Alteplase Activase; recombinant Acute ischemic stroke Reported preliminary
and Boehringer tissue plasminogen (administered 0-6 hours results of ECASS II trial
Ingelheim GmbH activator (t-PA) from symptom onset) (Phase III; conducted in
(Germany) Europe, Australia and
New Zealand); product
failed to show statistically
significant benefit vs.
placebo (7/10)
CENTRAL NERVOUS SYSTEM
Allelix Biophar- ALX-0646 Selective serotonin Migraine headaches Completed Phase Ia trial
maceuticals Inc. agonist; designed to act in U.K. (7/23)
(Canada) on specific receptors
in brain (oral dosage)
DIABETES
Generex Biotech- Oralin Liquid (oral) formula- Types I and II diabetes Submitted IND in Canada
nology Corp. tion of insulin, admin- for Phase II and III trials
(OTC Bulletin Board: istered via metered dose (7/10)
GNBT; Canada) aerosol application
INFECTION
Advanced Viral Reticulose Peptide-nucleic acid HIV infection and Mexican authorities
Research Corp. compound; stimulates AIDS (combination approved clinical trial
(OTC Bulletin cytocidal arm of the therapy with antiretro- (7/21)
Board:ADVR) immune system and viral drugs, including
activates production a protease inhibitor)
of cytokines
Cel-Sci Corp. HGP-30W Synthetic peptide Prevention of HIV Completed enrollment
derived from the p17 infection in HIV- for Phase II trial in the
region of the AIDS negative individuals Netherlands (7/22)
virus; contains 30 amino
acids (common to most
common HIV subtypes
worldwide)
The Liposome Co. Abelcet Amphotericin B lipid 1st-line treatment of Expanded use approved
Inc. complex (injection) candidiasis for marketing in Sweden
(7/2)
Shaman Provir Oral formulation of Acute watery diarrhea Reported that product
Pharmaceuticals compound SP-303, (traveler's diarrhea; achieved statistically sig-
Inc. which is isolated from also indigenous infec- nificant results in 2 sep-
the croton plant; it is tion) arate Phase II trials in
thought to act by Jamaica and Mexico
inhibiting secretion of (traveler's diarrhea) and
chloride from intestinal in Venezuela (indigenous)
cells (7/30)
MISCELLANEOUS
GelTex Pharma- RenaGel Non-absorbed polymer- Control of elevated Submitted marketing
ceuticals Inc. and based compound that phosphorus levels in authorization application
Genzyme Corp. binds to and eliminates pre-dialysis chronic to European Agency for
target substances from kidney failure Evaluation of Medicinal
the intestinal tract Products (7/7)
Noven — 2nd-generation trans- Menopausal symptoms Submitted marketing
Pharmaceuticals dermal estrogen system authorization application
Inc. (transdermal 17-beta in U.K. (7/1)
estradiol)
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 July 1998. It does not cover ongoing clinical trials for which no news was issued in that month.
* 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. 8-9.