Company** Product Description Indication Status (Date)
CANCER
Aronex Atragen Liposomal formulation of Hormone-refractory Initiated Phase II trial (11/30)
Pharmaceuticals all-trans retinoic acid; prostate cancer
Inc. induces tumor cells to
differentiate into mature
normal cells (injection)
Biomira Inc. Theratope Synthetic, carbohydrate- Metastatic breast cancer Announced results of bridging
(Canada) and vaccine based vaccine (mimic of following chemotherapy study with improved formula-
Chiron Corp. cancer antigen sialyl-Tn tion of drug (11/12); initiated in-
plus carrier molecule KLH) ternational Phase III trial (11/30)
Cell Genesys GVAX Cancer vaccine; 2nd-gen- Prostate cancer Presented results of Phase I/II
Inc. eration product that is trial at IBC International
non-patient-specific (allo- Symposium on Prostate Can-
geneic); consists of cer (11/20)
irradiated, genetically
modified prostate cancer
cells that secrete granulo-
cyte macrophage-colony
stimulating factor; intra-
dermal injection
Cell Therapeutics CT-2584 Small-molecule anti- Patients with advanced Initiated open-label Phase II
Inc. angiogenic drug that prostate cancer who have trial (11/23)
affects tumor-cell phos- failed chemotherapy and
pholipids (intravenous) hormone treatments
Enzon Inc. and PEG- Long-acting dosage form Chronic myelogenous Schering-Plough initiated
Schering-Plough Intron A of Intron A (recombinant in- leukemia Phase III trials (11/20)
Corp. (NYSE:SGP) terferon alfa-2b) conjugated
to polyethylene glycol
Human Genome MPIF Human myeloid pro- Protection of hematopoietic Initiated Phase II trial (11/18)
Sciences Inc. genitor inhibitory factor progenitor cells in bone
(genomics-derived; mem- marrow from toxic effects
ber of chemokine/inter- of chemotherapy in breast
leukin family) and ovarian cancer
Inex Onco TCS Anticancer drug; active Advanced-stage non- Announced results of Phase II
Pharmaceuticals ingredient is vincristine; Hodgkin's lymphoma trial (11/5)
Corp. (TSE:IEX; based on Transmembrane (2nd-line therapy)
Canada) Carrier Systems for drug
delivery at disease site
IntraBiotics Phar- Protegrin Synthetic analogue of Oral mucositis in cancer Initiated international Phase
maceuticals Inc.* IB-367 protegrin family of patients receiving myelo- II trial (11/12)
and Pharmacia mammalian antimicro- ablative chemotherapy
& Upjohn Inc. bial peptides
(NYSE:PNU; U.K.)
Ligand Targretin Bexarotene; synthetic Metastatic breast cancer Initiated open-label Phase II
Pharmaceuticals Capsules retinoid analogue that (2nd-line therapy) trial (11/23)
Inc. selectively activates
retinoid X receptors;
oral formulation
The Liposome Evacet Liposomal formulation Metastatic breast cancer Presented results from three
Co. Inc. (formerly of chemotherapeutic drug (1st-line therapy) Phase III trials (conducted in
TLC D-99) doxorubicin U.S. and Europe) at the Euro-
pean Society of Medical
Oncology meeting in Athens
(11/10)
Neurocrine NBI-3001 Interleukin-4 (IL-4) fusion Recurrent malignant Presented results of Phase I
Biosciences Inc. toxin that binds with high glioma (brain tumor) trial at the Society for Neuro-
affinity to IL-4 receptors Oncology meeting in San
(infused directly into tumors) Francisco; also, initiated
Phase I/II trial in U.S. and
Germany (11/25)
Onyx ONYX-015 Genetically engineered Recurrent head and neck Presented interim results of
Pharmaceuticals adenovirus that repli- cancer (combination Phase II trial at 7th Interna-
Inc. cates in and kills tumor therapy with cisplatin tional Conference on Gene
cells deficient in p53 and 5-FU) Therapy of Cancer (Gene
tumor suppressor gene Therapy conference) in San
product Diego (11/21)
OSI Pharma- CP-358,774 Orally active small-mole- Various cancers (as mono- Pfizer completed Phase I trial
ceuticals Inc. cule inhibitor of epidermal therapy or in combination and initiated Phase II trial
and Pfizer Inc. growth factor receptor with chemotherapy) (11/6)
(NYSE:PFE) (EGFr) tyrosine kinase
OXiGENE Inc. Combre- Tumor vascular targeting Various cancers (solid Initiated Phase I trial (11/11)
statin A-4 drug; destroys existing tumors)
Prodrug blood vessels in tumors
Ribozyme Angiozyme Chemically synthesized Various cancers Initiated Phase I trial (11/4)
Pharmaceuticals ribozyme; specifically
Inc. inhibits formation of
vascular endothelial growth
factor receptor (VEGFr)
Schering-Plough rAd/p53 Gene therapy; recombi- Various cancers including Presented interim results of
Research Institute nant adenovirus encoding liver cancer (intrahepatic ongoing Phase I trial at Gene
and Canji Inc. human p53 tumor administration) and ovarian Therapy conference (11/23)
(units of Schering- suppressor gene cancer (intraperitoneal
Plough Corp.; administration)
NYSE:SGP)
Sugen Inc. SU 101 Small-molecule signal Hormone-refractory Announced preliminary results
transduction inhibitor; prostate cancer of open-label Phase II trial
specifically inhibits (11/12)
platelet-derived growth
factor receptor signaling
Sugen Inc. SU 5416 Small molecule angiogen- Advanced cancers Presented interim results of
esis inhibitor targeting the (various) ongoing Phase I trial at
Flk-1/KDR signaling Biological Principles for the
pathway (found in epithel- Therapy of Human Colon
ial cells of new blood Cancer meeting in San Diego
vessels) (intravenous) (11/7)
Vertex Incel Biricodar dicitrate; small Resensitization of drug- Initiated open-label Phase II
Pharmaceuticals (VX-710) molecule drug that blocks resistant tumors to chemo- trial (11/13)
Inc. 2 chemotherapy drug efflux therapy; treatment of
pumps (MDR-1 and MRP) relapsed small cell lung
in chemotherapy-resistant cancer (combined with
tumor cells doxorubicin and vincristine)
Vertex Pharma- Incel Biricodar dicitrate; small Resensitization of drug- Presented preliminary results
ceuticals Inc. and (VX-710) molecule drug that blocks resistant tumors to chemo- of North American Phase I/II
BioChem Pharma 2 chemotherapy drug efflux therapy; treatment of soft trial at 4th annual meeting of
Inc. (Canada) pumps (MDR-1 and MRP) tissue sarcoma (combina- the Connective Tissue Oncol-
in chemotherapy-resistant tion therapy with doxo- ogy Society in Vancouver
tumor cells rubicin) (11/13)
Vical Inc. Allovectin-7 Gene encoding HLA-B7 Advanced, unresectable Initiated Phase II trial; also
(human leukocyte antigen) squamous cell cancer of presented results of Phase
complexed with lipid and the head and neck I/II trial at Mount Sinai Med-
administered by direct ical Center Chemotherapy
intratumoral injection Foundation Symposium XVI
in New York (11/12)
Leuvectin Gene encoding interleukin- Prostate cancer (admin- Presented results of Phase
2 (complexed with lipid) istered prior to surgery or I/II trial at Gene Therapy
administered by direct biopsy) conference (11/18)
intratumoral injection
CARDIOVASCULAR
Alexion 5G1.1-SC Humanized single-chain Myocardial infarction Initiated Phase I trial (11/2)
Pharmaceuticals antibody designed to
Inc. intervene in complement
cascade (complement
inhibitor)
Celtrix SomatoKine IGF-BP3 complex; Treatment of severe burns Presented results of Phase II
Pharmaceuticals recombinant version of in children, including trial (which were statistically
Inc. complex formed by improvement in cardiac significant) at American Heart
insulin-like growth function Association (AHA) annual
factor-1 and its major meeting in Dallas (11/19)
binding protein
Centocor Inc. ReoPro Chimeric monoclonal Combination use with Presented results of 1-year
(FDA- antibody fragment to stents in patients with follow-up of EPISTENT
approved) GPIIb/IIIa platelet ischemic heart disease trial (U.S. and Canada) at the
receptor (abciximab) AHA meeting (11/9)
Chiron Corp. rFGF-2 Recombinant fibroblast Severe coronary artery Initiated Phase II trial (11/9)
growth factor-2 disease
GenVec Inc.* and AdGVVEGF Direct injection of Treatment of cardiac Reported initial results of
the Parke-Davis 121.10 (gene VEGF gene (vascular ischemia as adjunct to Phase I trial at AHA meeting
Research division of therapy) endothelial growth factor; coronary bypass surgery (11/10)
Warner-Lambert in adenoviral vector) into
Co. (NYSE:WLA) heart muscle during
cardiac bypass surgery;
to induce revasculari-
zation of heart tissue
Intercardia Inc. Bextra Bucindolol HCl; non- Moderate-to-severe Data Safety and Monitoring
selective beta blocker congestive heart failure Board reviewed interim data
with vasodilating from North American Phase
properties III trial and recommended
continuation of trial (11/11)
Scios Inc. and Natrecor Nesiritide; human B-type Moderate-to-severe Presented clinical data at
Bayer AG natriuretic peptide (BNP; congestive heart failure AHA meeting (11/10)
(Germany) naturally occurring hormone
produced in heart)
Texas TBC 11251 Small-molecule drug; Moderate-to-severe Presented results of Phase IIa
Biotechnology endothelin-A receptor congestive heart failure trial at AHA meeting (11/10)
Corp. antagonist (intravenous)
CENTRAL NERVOUS SYSTEM
Gilatech Inc. GT 2331 Selective histamine H3 Treatment of central Initiated Phase I trial (11/5)
receptor antagonist nervous system disorders
involving disturbances in
cognitive function or
arousal (attention deficit
hyperactive disorder,
Alzheimer's disease,
sleep disorders)
NeoTherapeutics Neotrofin Small molecule compound Mild-to-moderate Presented results of Phase I
Inc. (AIT-082) designed to cross blood- Alzheimer's disease trial at 28th annual meeting of
brain barrier and enhance the Society for Neuroscience
nerve cell function by in Los Angeles (11/10)
increasing levels of
neurotrophic factors
DIABETES
Alteon Inc. and Pimagedine Compound designed to Treatment of Type I Announced that compound
Genentech Inc. block abnormal glucose/ diabetics with overt failed to reach statistical sig-
protein complexes nephropathy (ACTION nificance in primary endpoint
(advanced glycosylation I trial) in North American Phase III
end-products) that lead trial (11/16)
to diabetic complications
Generex Biotech- Oralgen Oral insulin (liquid; Types I and II diabetes FDA cleared protocol for
nology Corp. administered with metered Phase II and III trials (11/24)
(OTC Bulletin Board: dose aerosol applicator)
GNBT; Canada)
Inhale Therapeu- -- Dry powder formulation of To improve glycemic Pfizer initiated North Ameri-
tic Systems Inc. recombinant insulin, control in Types I and II can Phase III trials (11/10)
and Pfizer Inc. delivered via pulmonary diabetes
(NYSE:PFE) delivery system
Neurobiological Memantine Orally administered Diabetic peripheral Initiated Phase IIb trial (11/2)
Technologies Inc. NMDA receptor antagonist neuropathy
(OTC Bulletin (prevents over-activation
Board:NTII) of the receptor)
Organogenesis Apligraf Living human skin Diabetic foot ulcers Completed patient enrollment
Inc. (FDA- equivalent, composed of in pivotal trial (11/16)
approved) living human keratino-
cytes and fibroblasts
(epidermis and dermis,
isolated from infant
foreskins) cultured in
a 3-dimensional system
Vertex Pharma- VX-853 Timcodar dimesylate; orally Diabetic neuropathy Initiated Phase II trial (11/10)
ceuticals Inc. and active small molecule that
Schering AG promotes neurite out-
(Germany) growth (neurophilin ligand)
INFECTION
Bristol-Myers Lobucavir Broad-spectrum nucleo- Treatment of chronic Initiated international Phase
Squibb Co. side analogue (oral dosage) hepatitis B virus infection; III trials; presented results of
(NYSE:BMY) also herpes infections early Phase II trial (in hepatitis
(oral, genital and zoster) B infection) at the American
Association for the Study of
Liver Diseases meeting
(AASLD) in Chicago (11/9)
Digene Corp. Hybrid DNA-based assay that Monitoring of patients Presented trial results at
Capture II quantifies hepatitis B virus with chronic HBV infect- AASLD meeting (11/11)
HBV DNA (HBV) viral load ion who are receiving anti-
Test viral therapy
Gilead Sciences -- Adefovir dipivoxil; reverse Chronic hepatitis B Presented results of 2 North
Inc. transcriptase inhibitor (oral) virus infection American Phase II trials at
AASLD meeting (11/8)
Gilead Sciences GS4104 Neuraminidase inhibitor Treatment of viral influ- Reported clinical trial results
Inc. and F. Hoff- (oral formulation) enza (all strains) at Infectious Disease Society
mann-La Roche of America annual meeting in
Ltd. (Switzerland) Denver (11/15)
Planet CaroRx Secretory immunoglobulin Prevention of infection by Initiated Phase I/II trial (11/3)
Biotechnology A (SIgA) monoclonal anti- Streptococcus mutans (oral
Inc.* body produced in trans- bacterium that causes
genic tobacco plants tooth decay)
(plantibody)
Ribozyme Gene Use of ribozymes tar- HIV infection Initiated Phase II trial (11/24)
Pharmaceuticals therapy geted against HIV; retro-
Inc., Chiron Corp., viral construct containing
City of Hope multiple ribozymes tar-
National Medical geting different sites in
Center and HIV is used to transduce
Children's Hos- CD34+ stem cells from
pital Los Angeles HIV-positive patient
ex vivo; cells then infused
back into patient as part of
bone marrow transplant
Schering-Plough Rebetron Combination of Intron A Combination therapy for Presented results of two Phase
Corp. (NYSE:SGP) (FDA- (recombinant human inter- treating chronic hepatitis III trials at AASLD meeting
approved) feron alfa-2b; injection) C virus infection in patients (11/9)
and Rebetol (ribavirin; who have not received prior
synthetic nucleoside with alpha-interferon therapy
antiviral activity; oral) (treatment-naive)
Schering-Plough Rebetron Combination of Intron A Combination therapy for Results of two Phase III trials
Corp. (NYSE:SGP) (FDA- (recombinant human inter- treating chronic hepatitis published in 11/19/98 issue of
approved) feron alfa-2b; injection) C virus infection in patients The New England Journal of
and Rebetol (ribavirin; who have not received prior Medicine (11/19)
synthetic nucleoside with alpha-interferon therapy
antiviral activity; oral) (treatment-naive) and in
patients who have relapsed
after alpha-interferon
therapy (relapse patients)
Triangle Phar- FTC Nucleoside reverse Hepatitis B virus Reported preliminary results
maceuticals Inc. transcriptase inhibitor infection from ongoing Phase I/II trial (11/13)
Trimeris Inc. T-20 Antiviral fusion- HIV infection Results of Phase I/II trial
inhibiting compound published in 11/98 issue of
(delivered by contin- Nature Medicine (11/3)
uous subcutaneous
infusion via pump)
Vertex Pharma- Agenerase Amprenavir; 2nd-genera- Combination therapy with Results of pilot study present-
ceuticals Inc. and tion HIV protease inhibitor; a 2nd protease inhibitor for ed at 4th International Con-
Glaxo Wellcome twice-daily dosage HIV infection in treatment- gress on Drug Therapy in HIV
plc (NYSE:GLX; U.K.) naive and treatment- Infection in Glasgow, Scotland
experienced patients (11/9)
ViroPharma Inc. Pleconaril Oral liquid formulation of Severe meningococcemia Announced results of 1st of 4
a small molecule inhibitor (viral meningitis) in Phase III trials; product did
of several RNA viruses children not achieve statistical signifi-
(blocks replication) cance in primary endpoint (11/5)
MISCELLANEOUS
Abgenix Inc. ABX-IL8 Fully human mono- Moderate-to-severe Initiated Phase I/II trial (11/30)
clonal antibody that psoriasis
binds to interleukin-8
Alliance FloGel Thermo-reversible Reduction of incidence Initiated pilot trial (11/16)
Pharmaceutical surfactant of surgical adhesions in
Corp. female patients undergoing
laparoscopic surgery
LiquiVent Perflubron; oxygen- Acute lung injury and Initiated international Phase
carrying liquid that is acute respiratory distress III trials (11/16)
used in partial liquid syndrome
ventilation method
Oxygent Perflubron-based To reduce need for donor Initiated international Phase
emulsion; intravascular blood transfusions in non- III trials (11/16)
oxygen carrier cardiac surgery patients
Amarillo -- Low-dose oral alpha Dry mouth in Sjogren's Initiated 1st of 2 Phase III
Biosciences Inc. interferon syndrome patients (auto- trials (11/24)
immune disorder)
Boston Life Therafectin Synthetic carbohydrate- Rheumatoid arthritis Presented results of Phase III
Sciences Inc. based drug (amprilose; trial at 62nd annual meeting
oral formulation) of the American College of
Rheumatology (ACR) in San
Diego (11/10)
Centocor Inc. Remicade Infliximab; chimeric Advanced, severe Presented results of Phase III
(FDA- monoclonal antibody to rheumatoid arthritis trial at ACR meeting (11/9)
approved) tumor necrosis factor-alpha (combination therapy with
methotrexate)
Circe Biomedical HepatAssist Extra-corporeal bio- To provide temporary Expanded Phase II/III trials
Inc. (wholly owned artificial liver system essential liver functions in to include 3 more clinical sites
subsidiary of W.R. consisting of membranes patients suffering from (11/3)
Grace; NYSE:GRA) and porcine liver cells acute liver failure
Connetics Corp. Olux Foam formulation of Severe scalp psoriasis Announced results of Phase
clobetasol proprionate III trials (statistically signi-
0.05% (super-high potency ficant) (11/11)
corticosteroid)
Cypress Prosorba Disposable filter that Moderate-to-severe Presented clinical data at
Bioscience Inc. Column uses Protein A to remove rheumatois arthritis in ACR meeting (11/9)
(FDA- circulating immune com- patients who have failed
approved) plexes from patient's blood 2nd-line therapy
Genentech Inc.; rhuMAb-E25 Recombinant, humanized Seasonal allergic rhinitis Presented preliminary results
Tanox Biosystems monoclonal antibody to (hay fever) of Phase II/III trial at American
Inc.* and Novartis IgE College of Allergy, Asthma
Pharma AG and Immunology meeting in
(Switzerland) Philadelphia (11/9)
The Immune IR 501 Vaccine consisting of Active rheumatoid arthritis Results of Phase II trial pub-
Response Corp. 3 T cell receptor peptides lished in 11/98 issue of
(Vb3, Vb14 and Vb17) Arthritis & Rheumatism
combined with adjuvant (11/24)
(intramuscular injection)
Immunex Corp. Enbrel Recombinant, soluble Juvenile rheumatoid Presented trial results at
p75 tumor necrosis factor arthritis ACR meeting (11/9)
receptor (TNFr) linked
to the Fc portion of
human IgG1
Enbrel Recombinant, soluble Moderate-to-severe Two-year follow-up results
p75 tumor necrosis factor active rheumatoid arthritis presented at ACR meeting
receptor (TNFr) linked in adults (11/12)
to the Fc portion of
human IgG1
Lifecore Intergel Hyaluronate gel Prevention of adhesion Completed patient enrollment
Biomedical Inc. formation following abdom- in 1st of 2 international trials
inal surgical procedures in (11/10)
women performed by
laparotomy
Ortec Composite Bioengineered bovine Wound healing in burns Results on 11 patients in
International Inc. Cultured collagen matrix seeded pilot trial presented at 10th
Skin with epidermal and Congress of the International
dermal cells (biologi- Society for Burn Injuries in
cally active wound Jerusalem (11/3)
dressing)
NOTES:
TSE = Toronto Stock Exchange
* Private companies are indicated with an asterisk.
** Unless otherwise noted, the trading symbols for publicbiotechnology companies can be found by referring to the BioWorld StockReport For Public Biotechnology Companies on pp. 11-12.