Clinical Trial Update: October 1998
Company** Product Description Indication Status (Date)
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
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
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
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)
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)
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
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)
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
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.
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
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)
* 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.