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. |