Clinical Trial Update: October 1998 | ||||
Company** | Product | Description | Indication | Status (Date) |
CANCER | ||||
Biomira Inc. | Theratope | Synthetic, carbohydrate- | Metastatic breast cancer | FDA cleared protocol for |
(Canada) and | vaccine | based vaccine (mimic of | following chemotherapy | Phase III trial (10/26) |
Chiron Corp. | cancer antigen sialyl-Tn | |||
plus carrier molecule KLH) | ||||
Cell Genesys | GVAX | Cancer vaccine; 1st-genera- | Advanced metastatic | Results of Phase I trial pub- |
Inc. | tion product that is patient- | melanoma | lished in 10/27/98 issue of | |
specific (autologous); patient's | Proceedings of the National | |||
cells are genetically modified | Academy of Sciences (10/26) | |||
ex vivo with gene for granu- | ||||
locyte macrophage-colony | ||||
stimulating factor, then | ||||
infused back into patient | ||||
Cell Pathways | Prevatac | Exisulind; orally active | To prevent recurrence of | Completed patient enrollment |
Inc. | (formerly | drug designed to induce | prostate cancer | in Phase II/III trial (10/7) |
FGN-1) | apoptosis in precancer- | |||
ous cells | ||||
Cell | Lisofylline | Compound designed to | To prevent or reduce inci- | Initiated open-label Phase |
Therapeutics | inhibit production of | dence of mucositis in pa- | I trial (10/20) | |
Inc. | phosphatidic acid and | tients receiving combined | ||
reduce oxidative damage | radiation and chemotherapy | |||
(protects epithelial cells | for advanced head and neck | |||
from damage by free | cancer | |||
radicals; anti-inflammatory) | ||||
Coulter | Bexxar | Iodine I-131 tositumomab; | Non-Hodgkin's lymphoma | Announced results of Phase |
Pharmaceutical | murine monoclonal anti- | in patients refractory to | III trial, which were statistic- | |
Inc. | body against CD20 antigen | chemotherapy | ally significant for primary | |
on B cells, labeled with I-131 | and secondary endpoints (10/20) | |||
Hybridon Inc. | GEM 231 | 2nd generation antisense | Refractory solid tumors | Presented data from Phase I |
(OTC Bulletin | product; 18-mer RNA/ | trial at Nature Biotechnology's | ||
Board:HYBN) | DNA hybrid antisense | Antisense 98 Conference in | ||
oligonucleotide that | London; also, initiated Phase | |||
inhibits expression of | II trial (10/9) | |||
R1-alpha subunit of | ||||
protein kinase A | ||||
Idec | Rituxan | Rituxan is genetically engi- | Relapsed or refractory | Presented final results of |
Pharmaceuticals | (FDA- | neered chimeric pan-B | B-cell non-Hodgkin's | Phase I/II trial at annual meet- |
Corp. | approved) | monoclonal antibody that | lymphoma | ing of the American Society |
and | targets CD20 antigen on | for Therapeutic Radiology | ||
IDEC-Y2B8 | B-cell surface; IDEC-Y2B8 is | and Oncology (ASTRO) in | ||
murine monoclonal antibody | Phoenix (10/27) | |||
(that also targets CD20 | ||||
antigen), conjugated to | ||||
isotope yttrium-90 | ||||
ImClone | C225 | Chimeric monoclonal | Combination therapy with | Reported data from Phase Ib/ |
Systems Inc. | antibody to epidermal | radiation for treating | IIa trial at ASTRO meeting | |
growth factor receptor | squamous cell head and | (10/27) | ||
neck cancer | ||||
Immunomedics | CEA-Scan | Fragment of murine mono- | In vivo imaging of breast | Summary of trial results pre- |
Inc. | (FDA- | clonal antibody to tumor | cancer (diagnostic) | sented at 7th Conference on |
approved) | marker carcinoembryonic | Radioimmunodetection and | ||
antigen (CEA), labeled with | Radioimmunotherapy of | |||
technetium-99m | Cancer in Princeton, N.J. (10/16) | |||
The Liposome | TLC ELL-12 | Formulation of ether | Advanced solid tumors | FDA cleared protocol for |
Co. Inc. | lipid (L-ET-18-OCH3) | Phase I trial (10/27) | ||
that acts as signal trans- | ||||
duction modulator | ||||
ProScript Inc.* | PS-341 | Small molecule inhibitor | Various solid tumors | Initiated Phase I trial (10/14) |
of ubiquitin-proteasome | ||||
pathway (fundamental | ||||
pathway for intracellular | ||||
protein processing) | ||||
Targeted | tgDCC-E1A | E1A tumor suppressor gene | Single-agent therapy in | Initiated open-label trials |
Genetics Corp. | product; consists of E1A | patients with recurrent | (10/5) | |
gene formulated in lipid- | head and neck squamous | |||
based gene delivery system; | cell carcinoma | |||
intratumoral injection | ||||
Techniclone | TNT | Tumor necrosis therapy; | Newly diagnosed and | Initiated Phase II trial (10/1) |
Corp. | chimeric monoclonal | recurrent malignant glioma | ||
antibody that targets DNA- | (interstitial delivery) | |||
associated histone antigens, | ||||
labeled with I-131 (targets | ||||
necrotic center of tumor) | ||||
Vimrx | VIMRxyn | Synthetic version of | Glioblastoma | Completed Phase I/II North |
Pharmaceuticals | hypericin (a natural | American trial (10/28) | ||
Inc. | botanical compound | |||
from St. John's wort); | ||||
oral administration | ||||
CARDIOVASCULAR | ||||
Amgen Inc. | NESP | Novel erythropoiesis | To raise levels of red blood | Presented results from 2 |
stimulating protein | cells in anemic dialysis | Phase II trials at annual meeting | ||
(recombinant) | patients | of the American Society of Neph- | ||
rology in Philadelphia (10/26) | ||||
Centocor Inc. | ReoPro | Chimeric monoclonal | Combination use with | Presented results of 6-month |
(FDA- | antibody fragment to | stents in patients under- | follow-up of EPISTENT | |
approved) | GPIIb/IIIa platelet | going coronary inter- | trial (U.S. and Canada) at the | |
receptor (abciximab) | ventions | Transcatheter Cardiovascular | ||
Therapeutics Conference in | ||||
Washington (10/8) | ||||
Emisphere | -- | Oral formulation of | Prevention of deep vein | Results of 3 Phase I trials pub- |
Technologies Inc. | heparin (anticoagulant) | thrombosis in patients | lished in 10/20/98 issue of | |
and Elan Corp. plc | undergoing surgery for | Circulation (10/20) | ||
hip replacement | ||||
CENTRAL NERVOUS SYSTEM | ||||
Anergen Inc. | AG 284 | AnergiX therapeutic; | Secondary, chronic pro- | Presented results of Phase I |
combines major histo- | gressive multiple sclerosis | trial at annual meeting of | ||
compatibility complex | (MS) | America's Committee for | ||
molecule (HLA-DR2) | Treatment and Research in | |||
with fragment of myelin | Multiple Sclerosis in Mon- | |||
basic protein believed to | treal (10/19) | |||
induce autoimmune | ||||
response in MS | ||||
CoCensys Inc. | Ganaxolone | Synthetic version of | Moderate-to-severe | Announced results of Phase II |
naturally occurring | migraine headaches | trial, which were not statisti- | ||
neuroactive steroids | cally significant except in one | |||
(epalons) that bind to | patient subgroup; company | |||
gamma amino butyric | will not pursue further pro- | |||
acid (GABA)-A | duct development without | |||
receptors in brain | partner (10/16) | |||
(tablet formulation) | ||||
NeoTherapeutics | Neotrofin | Small molecule compound | Mild-to-moderate | Completed patient enrollment |
Inc. | (AIT-082) | designed to cross blood- | Alzheimer's disease | in Phase I trial (10/5) |
brain barrier and enhance | ||||
nerve cell function by | ||||
increasing levels of | ||||
neurotrophic factors | ||||
DIABETES | ||||
Amylin | AC2993 | Exendin-4; synthetic | Type II diabetes | Announced results of Phase I |
Pharmaceuticals | version of protein | trial (10/20) | ||
Inc. | originally isolated from | |||
saliva of Gila monster | ||||
(has 50% structural | ||||
homology with human | ||||
hormone glucagon- | ||||
like peptide-1) | ||||
INFECTION | ||||
Aquila Biophar- | Quilim- | Vaccine containing | Prevention of pneu- | Announced preliminary |
maceuticals Inc. | mune-P | polysaccharide antigens | mococcal infection | results of Phase II trial |
from 23 different | (10/14) | |||
Streptococcus | ||||
pneumoniae strains | ||||
plus Stimulon | ||||
adjuvant QS-21 | ||||
The Immune | Remune | Envelope-depleted | Combination therapy | Announced results from |
Response Corp. | inactivated AIDS virus | with highly active anti- | Phase II trial (10/26) | |
and Agouron | (emulsified with | retroviral therapy (HAART) | ||
Pharmaceuticals | adjuvant) | for HIV infection and AIDS | ||
Inc. | ||||
Nabi | StaphVAX | Capsular polysaccharide | Treatment of S. aureus | After safety evaluation of 1st |
conjugate vaccine for | infections in hemodialysis | 20 patients enrolled in pivotal | ||
Staphylococcus aureus | patients | Phase III trial, Data Safety | ||
infections | Monitoring Board said that | |||
patient enrollment should be | ||||
continued (10/14) | ||||
Palatin | LeuTech | Radiolabeled, mono- | In vivo detection and | Initiated pivotal Phase III |
Technologies | clonal antibody-based | diagnosis of equivocal | trials (10/1) | |
Inc. | system for imaging | appendicitis | ||
infection (product binds | ||||
specifically to white | ||||
blood cells) | ||||
MISCELLANEOUS | ||||
Alkermes Inc. and | Nutropin | Sustained-release formu- | Treatment of previously | Announced preliminary |
Genentech Inc. | Depot | lation of Genentech's | untreated children with | results of Phase III trial (10/22) |
recombinant human | growth hormone deficiency | |||
growth hormone based | ||||
on Alkermes' ProLease | ||||
injectable delivery | ||||
system (administered | ||||
once or twice/month) | ||||
Amgen Inc. | Leptin | Recombinant form of | Obesity | Reported that preliminary |
leptin, the natural human | data from 2 Phase II trials | |||
protein produced by the | were not statistically signifi- | |||
obese gene (ob) and made | cant except in a subset of | |||
in fat cells | patients, which will be the | |||
subject of future trial (10/27) | ||||
BioMarin | -- | Alpha-L-iduronidase | Enzyme replacement | Presented results of pivotal |
Pharmaceutical | (enzyme required for | therapy for mucopoly- | clinical trial at annual meeting | |
Inc.* and Genzyme | breakdown of complex | saccharidosis I (genetic | of the American Society of | |
Corp. | carbohydrates) | disorder) | Human Genetics in Denver | |
(10/30) | ||||
Gliatech Inc. | Adcon-P | Anti-adhesion barrier | To inhibit scarring and ad- | FDA cleared protocol for |
solution (semisynthetic | hesions following peri- | pivotal trial; also, presented | ||
carbohydrate polymer) | toneal cavity surgery | results of international pilot | ||
trial at joint conference of the | ||||
16th World Congress on Fer- | ||||
tility and Sterility and the | ||||
54th annual meeting of the | ||||
American Society for Repro- | ||||
ductive Medicine in San | ||||
Francisco (10/7) | ||||
Hemispherx | Ampligen | Double-stranded syn- | Chronic fatigue syndrome | Presented additional data from |
Bio-Pharma Inc. | thetic RNA compound | ongoing Phase II trial at the | ||
(AMEX:HEB) | poly I:poly C12U | American Association for | ||
Chronic Fatigue Syndrome | ||||
meeting in Cambridge, Mass. | ||||
(10/19) | ||||
Idec Pharma- | IDEC-114 | Primatized anti-B7-1 | Psoriasis | Initiated Phase I trial (10/27) |
ceuticals Corp. | monoclonal antibody; blocks | |||
and Mitsubishi | binding of B7-1 ligand on | |||
Chemical Corp. | antigen-presenting cells to | |||
(Japan) | CD28 receptor on T cells | |||
La Jolla | LJP 394 | Molecule (toleragen) that | Nephritis in patients with | Completed enrollment in |
Pharmaceutical | binds to surface of B cells | systemic lupus erythe- | North American Phase II/III | |
Co. | and shuts off production | matosus | trials (10/5) | |
of antibodies to double- | ||||
stranded DNA | ||||
Megabios Corp. | GR213487B | Gene therapy; uses Mega- | Cystic fibrosis | Presented results of Phase I/II |
and Glaxo | bios' aerosol plasmid | trial at 12th annual North | ||
Wellcome plc | system to deliver normal | American Cystic Fibrosis | ||
(NYSE:GLX; U.K.) | cystic fibrosis transmem- | Conference (CF) in Montreal | ||
brane regulator gene | (10/15) | |||
(CFTR) to nasal passages | ||||
NPS Pharma- | -- | 2nd-generation calcimi- | Primary hyperpara- | Amgen initiated Phase II |
ceuticals Inc. | metic; small orally active | thyroidism | trial (10/6) | |
and Amgen Inc. | molecule that suppresses | |||
secretion of excessive | ||||
amounts of parathyroid | ||||
hormone | ||||
Targeted | tgAAV-CF | Gene therapy; use of adeno- | Cystic fibrosis | Presented preliminary results |
Genetics Inc. | associated virus to deliver | of Phase II trial at CF meeting | ||
normal CFTR gene into | (10/16) | |||
nasal passage | ||||
Vertex Pharma- | HMR 3480/ | Orally administered small | Rheumatoid arthritis | Initiated Phase I trial (10/29) |
ceuticals Inc. and | VX-740 | molecule inhibitor of | ||
Hoechst Marion | interleukin-1 (IL-1) beta | |||
Roussel Inc. | converting enzyme (ICE; | |||
regulates production of IL-1 | ||||
and gamma interferon) | ||||
Vimrx Pharma- | VM 301 | Semisynthetic derivative | Wound healing in partial- | Completed Phase I trial |
ceuticals Inc. | of compound isolated | and full-thickness wounds | (10/13) | |
from the sea whip (a | ||||
marine organism; topical) | ||||
NOTES: | ||||
* 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. 13-14. |