Company Product Name Description Indication Status/Date
CANCER
Aastrom Bio- Aastrom Ex vivo stem cell Production of ex vivo stem Announced initial results
sciences Inc. Cell Produc- culturing device with cells from umbilical cord of pilot clinical trial; also
tion System disposable casettes blood for children with expanded trial to include
leukemia and patients with more patients (5/13)
diseases of the blood
Agouron AG3340 Small synthetic mole- Advanced lung or prostate Initiated Phase II/III
Pharmaceuticals cule designed to select- cancer; advanced non-small trials in North America
Inc. ively inactivate matrix cell lung cancer (combination (5/5)
metalloproteases (also therapy with Taxol and
has anti-angiogenic carboplatin); and advanced
activity) (oral dose) hormone-refractory prostate
cancer (combination therapy
with mitoxantrone and
prednisone)
Avax M-Vax Therapeutic vaccine; tumor Stage IV malignant Presented results of small
Technologies cells removed from patient, melanoma that has clinical study at 34th
Inc. modified with hapten metastasized to the lung annual meeting of the
(dinitrophenyl; DNP), then American Society of Clin-
injected back into patients ical Oncology (ASCO) in
(along with cyclophos- Los Angeles (5/18)
phamide)
Cell Genesys Gene T cell cancer gene therapy; Advanced metastatic Presented preliminary
Inc. therapy patient's own T cells are colon cancer results of Phase I/II trial
genetically modified with at ASCO meeting (5/18)
the CC49-zeta gene (which
targets cancer cells
expressing TAG-72 surface
protein); cells then expanded
in number and infused back
into patient
Cell Genesys GVAX Cancer vaccine; 1st generation Prostate cancer Presented results of Phase
Inc. product is patient-specific I trial (with 1st generation
(autologous), in which product) and preliminary
patient's cells are genetically results of Phase I/II trial
modified ex vivo with gene (with 2nd generation pro-
for granulocyte macrophage- duct) at ASCO meeting
colony stimulating factor (5/19)
(GM-CSF), then infused back
into patient; 2nd-generation
product is non-patient-specific
(allogeneic), in which vaccine
consists of irradiated,
genetically modified GM-CSF-
secreting tumor cell lines
Cell CT-2584 Small-molecule anti- Chemotherapy-resistant Presented data from Phase
Therapeutics angiogenic drug that cancers I trial at ASCO meeting
Inc. affects tumor-cell phos- (5/18)
pholipids (intravenous)
Corixa Corp. HER2/neu Peptide vaccine com- Breast cancer, ovarian Presented results of Phase
vaccine posed of multiple short cancer and non-small I trial at ASCO meeting
peptides from the natural cell lung cancer (5/18)
sequence of HER2/neu,
mixed with granulo-
cyte macrophage-colony
stimulating factor
Coulter Pharma- Bexxar Iodine I-131 tositumo- Low-grade and trans- Presented meta-analysis
ceutical Inc. mab; murine monoclo- formed low-grade non- of 4 clinical trials at the
nal antibody against Hodgkin's B-cell ASCO meeting (5/19)
CD20 antigen on B cells; lymphoma
radiolabeled with I-131
Coulter Pharma- Bexxar Iodine I-131 tositumo- Retreatment therapy in Presented clinical trial
ceutical Inc. mab; murine monoclo- non-Hodgkin's lymph- results at ASCO meeting
nal antibody against oma patients who had (5/19)
CD20 antigen on B cells; relapsed after initial
radiolabeled with I-131 Bexxar treatment
Coulter Pharma- Bexxar Iodine I-131 tositumo- Patients with newly Presented preliminary
ceutical Inc. mab; murine monoclo- diagnosed, advanced results of Phase II trial at
nal antibody against low-grade non-Hodg- ASCO meeting (5/18)
CD20 antigen on B cells; kin's lymphoma
radiolabeled with I-131
Coulter Pharma- Bexxar Iodine I-131 tositumo- High-dose Bexxar in Presented preliminary
ceutical Inc. mab; murine monoclo- combination with results of Phase I/II trial
nal antibody against chemotherapy and stem at ASCO meeting (5/18)
CD20 antigen on B cells; cell transplantation for
radiolabeled with I-131 treating non-Hodgkin's
lymphoma
Coulter Pharma- Bexxar Iodine I-131 tositumo- Patients with non- Announced interim data
ceutical Inc. mab; murine monoclo- Hodgkin's lymphoma from Phase III trial; also,
nal antibody against who are refractory to patient enrollment for
CD20 antigen on B cells; chemotherapy this trial is complete
radiolabeled with I-131 (5/12)
Diatide Inc. P829 Synthetic, somatostatin- In vivo imaging agent Phase III trial results did
(techtide) type receptor-binding for detecting and local- not support precise reg-
peptide P829, designed izing cancer in the lung ional localization of
to attach to targeted dis- tumor mass; company
ease molecules and will no longer use product
labeled with technetium- to localize lung cancer
99m but rather as general tool
for differentiating be-
tween benign and malig-
nant masses in lung (5/11)
GeneMedicine IL-2 Plasmid encoding the Head and neck cancer Reported results of Phase
Inc. and Gene human interleukin-2 I trials (in U.S. and Ger-
Boehringer Medicine gene and a cationic many) at the 1st annual
Mannheim GmbH lipid gene-delivery meeting of the American
(Germany) system that enhances Society of Gene Therapy
uptake of gene into (ASGT) in Seattle (5/29)
target cells after direct
intra-tumoral injection
Genentech Inc. Herceptin Trastuzumab; human- Treatment of HER2- Presented results of Phase
ized monoclonal anti- overexpressing meta- III trial at ASCO meeting
body to HER2 growth static breast cancer (5/18)
factor receptor (in combination with
standard chemotherapy)
Idec Pharma- Rituxan Rituximab; genetically Combination therapy Presented results of small
ceuticals (FDA- engineered chimeric pan- with standard CHOP Phase II study at ASCO
Corp. and approved) B monoclonal antibody chemotherapy in treat- meeting (5/18)
Genentech Inc. that targets CD20 anti- ing previously untreated
gen on B cell surface intermediate- and high-
grade non-Hodgkin's
B-cell lymphoma
ImClone Systems BEC2 Anti-idiotypic mono- Small cell lung cancer Initiated international
Inc. and Merck clonal antibody that Phase III trials (5/19)
KGaA (Germany) mimics GD3 glycolipid
(structural tumor antigen)
that is overexpressed on
various cancers
ImClone Systems C225 Chimerized monoclonal Combination therapy Presented results of Phase
Inc. antibody to epidermal with radiation for treat- Ib/II trial at ASCO meet-
growth factor receptor ing advanced squamous ing (5/18)
cell head and neck cancer
Immunomedics CEA-Scan Fragment of murine In vivo imaging of non- Reported data from clini-
Inc. monoclonal antibody to palpable breast lesions cal study at ASCO meet-
tumor marker carcino- that are abnormal by ing (5/18)
embryonic antigen mammography
(CEA), labeled with
technetium-99m
Immunomedics LymphoCide Humanized lymphoma Advanced, chemo- Reported data from clini-
Inc. antibody consisting of therapy-resistant non- cal study at ASCO meet-
murine binding sites Hodgkin's lymphoma ing (5/18)
linked to human immuno-
globulin backbone;
labeled with I-131
Introgen Thera- INGN 201 p53 gene therapy via Advanced non-small Presented results of Phase
peutics Inc.* and adenoviral vector; intra- cell lung cancer in I/II trial at ASCO meeting
RPR Gencell tumoral injection patients who had not (5/18)
(division of Rhone- responded to conven-
Poulenc Rorer tional therapy
Inc.)
Introgen Thera- INGN 201 p53 gene therapy via Advanced head and Reported results of Phase
peutics Inc.* and adenoviral vector; intra- neck cancer and non- I trials at ASGT meeting
RPR Gencell tumoral injection small cell lung cancer (5/30)
(division of (use as single agent or
Rhone-Poulenc as adjuvant to standard
Rorer Inc.) therapy)
Isis Pharma- ISIS3521/ 20-base antisense DNA Solid tumors Presented results of Phase
ceuticals Inc. and CGP64128A sequence that hybridizes I trial at ASCO meeting
Novartis Pharma to and inhibits protein (5/19)
AG (Switzerland) kinase C-alpha expression
(infusion)
Isis Pharma- ISIS5132/ Antisense inhibitor of Various cancers, Presented results of Phase
ceuticals Inc. and CGP69846A C-raf kinase (thought to including colon cancer I trial at ASCO meeting
Novartis Pharma play role in signal trans- (5/19)
AG (Switzerland) duction processes that
regulate cell proliferation)
(infusion)
Ixsys Inc.* Vitaxin Monoclonal antibody Various cancers Presented results of com-
that inhibits angiogene- pleted Phase I trial at
sis by binding to alpha ASCO meeting (5/18)
(V)-beta (3) receptor
that is expressed on
newly sprouting blood
vessels (derived from
murine monoclonal
antibody; modified via
molecular design)
Jenner Bio- OncoVax-P Cancer vaccine; incor- Prostate cancer Presented results of pilot
therapies Inc.* porates recombinant trial at ASCO meeting
prostate-specific antigen (5/18)
plus adjuvant in lipo-
somal formulation
Ligand Pharma- LGD 1550 Retinoic acid receptor- Advanced cancers Reported results of 2
ceuticals Inc. selective retinoid (oral) Phase I/II trials at ASCO
meeting (5/18)
Ligand Pharma- Panretin Chemically synthesized Kaposi's sarcoma in Presented final results of
ceuticals Inc. Capsules version of 9-cis-retinoic AIDS patients Phase II trial (sponsored
acid (natural hormone by the National Cancer
derived from vitamin A) Institute) at ASCO meet-
(oral dosage) ing (5/18)
The Liposome Evacet Liposomal formulation Advanced-stage Presented interim results
Co. Inc. of doxorubicin breast cancer of Phase III trial at ASCO
meeting (5/20)
Megabios Corp. Gene therapy Combination of 2 genes Melanoma FDA approved protocol
(interleukin-2 and a for Phase I/II trial (5/28)
superantigen gene)
injected directly into
tumor (non-viral
delivery)
NeoRx Corp. and Avicidin Multi-step process that Various advanced Presented data from
Janssen Pharma- involves separate ad- cancers that are resistant Phase I trial at ASCO
ceutica NV (Bel- ministration of murine to standard therapies meeting (5/19)
gium; subsidiary of monoclonal antibody
Johnson & Johnson; (linked to strepavidin)
NYSE:JNJ) and yttrium-90 (linked
to biotin); products
join at and kill tumor
NeuroVir Inc.* G 207 Genetically engineered Malignant brain tumors, Initiated Phase I trial
(Canada) herpes simplex virus; including recurrent (5/13)
variant that replicates glioblastoma
selectively in and kills
tumor cells
Onyx Pharma- ONYX-015 Genetically engineered Head and neck cancer Presented results of 2
ceuticals Inc. adenovirus that repli- in patients with recurrent Phase II trials at ASCO
cates in and kills tumor disease or end-stage meeting (5/18)
cells deficient in p53 treatment-resistant disease
tumor suppressor gene (combination with 5-FU
product and cisplatin)
Onyx Pharma- ONYX-015 Genetically engineered Pancreatic cancer Presented results of 2
ceuticals Inc. adenovirus that repli- and gastrointestinal Phase I trials at ASCO
cates in and kills tumor cancer that has metas- meeting (5/19)
cells deficient in p53 tasized to the liver
tumor suppressor gene
product
Sugen Inc. SU 101 Small-molecule signal Recurrent malignant Presented results of 2
transduction inhibitor; glioma and prostate separate Phase II trials at
specifically inhibits cancer ASCO meeting (5/18)
platelet-derived growth
factor receptor signaling
Sugen Inc. SU 5416 Small-molecule angio- Blockage of tumor Presented interim results
genesis inhibitor target- angiogenesis in advan- of ongoing Phase I trial
ing Flk-1/KDR receptor ced malignancies at ASCO meeting (5/18)
(to which vascular endo-
thelial growth factor
binds, thus activating
angiogenesis)
SunPharm Corp. DENSPM Diethylnorspermine Late-stage lung cancer Presented data from
and Warner- (polyamine analogue; in patients refractory to Phase I trial at ASCO
Lambert Co. disrupts cancer cell all conventional chemo- meeting (5/19)
growth processes) therapy
SuperGen Inc. RFS 2000 2nd generation topo- Pancreatic cancer Announced interim
isomerase I inhibitor results of Phase II trial
(causes single-stranded at ASCO meeting (5/18)
breaks in DNA); semi-
synthetic derivative of
naturally occurring
plant alkaloid (oral)
Targeted E1A Gene E1A tumor suppressor Breast cancer and head Reported additional re-
Genetics Inc. Therapy gene product; consists of and neck cancer sults of Phase I trial at
(tgDCC-E1A) E1A gene formulated in ASCO meeting (5/18)
lipid-based gene delivery
system; intratumoral
injection
Targeted E1A Gene E1A tumor suppressor Advanced breast and Reported additional re-
Genetics Inc. Therapy gene product; consists of ovarian cancers sults of Phase I trial at
(tgDCC-E1A) E1A gene formulated in ASGT meeting (5/30)
lipid-based gene delivery
system; intratumoral
injection
Titan Pharma- TriAb Anti-idiotypic mono- Early-stage post- Presented preliminary
ceuticals Inc. clonal antibody-based surgical breast cancer; results of Phase I/II trial
vaccine; mimics epitope also metastatic breast at ASCO meeting (5/19)
on breast cancer cell- cancer
associated antigen HMFG
Titan Pharma- CeaVac Anti-idiotypic mono- Resected colon cancer Presented preliminary
ceuticals Inc. clonal antibody-based (stages II, III and IV) results of Phase I/II trial
vaccine; mimics CEA at ASCO meeting (5/19)
antigen present on many
types of cancer cells
Titan Pharma- TriGem Anti-idiotypic mono- Metastatic melanoma Presented preliminary
ceuticals Inc. clonal antibody-based results of Phase I/II trial
vaccine; mimics GD2 at ASCO meeting (5/19)
antigen present on many
types of cancer cells
Vical Inc. Allovectin-7 Gene encoding HLA-B7 Metastatic, refractory Initiated expanded, open-
(human leukocyte anti- Stage III or IV mela- label Phase II trial in North
gen) complexed with noma that has not yet America and Phase III trial
lipid and administered spread to multiple (product combined with
by intratumoral internal organs chemotherapy) (5/18)
injection
Vical Inc. Leuvectin Gene encoding inter- Advanced metastatic Initiated Phase II trial
leukin-2 administered renal cell carcinoma (5/18)
by intratumoral injection
(naked DNA gene therapy)
CARDIOVASCULAR
Collateral Thera- Gene therapy Intra-arterial delivery Patients suffering from Berlex initiated Phase I/II
peutics Inc. (IPO of growth factor gene stable exertional angina trial (5/12)
pending) and FGF-4 (which promotes due to atherosclerosis
Berlex angiogenesis) via adeno- (coronary artery disease)
Laboratories viral vector
Inc. (subsidiary of
Schering AG;
Germany)
Corvas Inter- rNAPc2 Recombinant NAPc2, Anticoagulant; prevent- Initiated Phase I trial
national Inc. an inhibitor of Factor ion and treatment of (5/13)
VIIa/Tissue Factor disorders resulting from
enzyme complex that thrombosis, especially
initiates blood coagu- deep vein thrombosis
lation and clot forma-
tion (subcutaneous)
CV Therapeutics CVT-124 Selective adenosine Treatment of edema Reported results of Phase
Inc. and Biogen A(1) receptor antagonist associated with congest- II trial (5/29)
Inc. (intravenous) ive heart failure
Emisphere Tech- -- Oral formulation of Prevention of deep vein Initiated Phase II trial in
nologies Inc. and heparin (anticoagulant) thrombosis in patients U.S. and Canada (5/27)
Elan Corp. plc undergoing surgery for
(Ireland) hip replacement
Genzyme Trans- rhATIII Recombinant human To improve anticoag- Initiated 3 Phase III trials
genics Corp. and antithrombin III, pro- ulation response to (2 in heparin-resistant
Genzyme Corp. duced in milk of trans- heparin in patients patients; one comparing
genic goats (regulates undergoing coronary rhATIII with plasma-
blood clotting) artery bypass graft derived product; trials to
surgery be conducted in U.S. and
Europe) (5/13)
Hemosol Inc. Hemolink Highly purified hemo- Treatment of anemia FDA cleared protocol for
(TSE:HML; Canada) globin extracted from secondary to kidney Phase II trial (5/1)
outdated human donor failure
blood, then cross-linked
to form stable hemo-
globin molecule (red
blood cell substitute)
Ibex Technologies Neutralase Heparinase I, a heparin Heparin neutralization Presented results of Phase
Inc. (TSE:IBX; degrading enzyme in patients undergoing II trial at 20th annual
Canada) (bolus injection) coronary artery bypass meeting of the Society of
graft surgery Cardiovascular Anesthes-
iologists in Seattle (5/4)
Scios Inc. and Fiblast Trafermin; recombinant Acute stroke Enrollment in Phase II/III
Wyeth-Ayerst human basic fibroblast North American trial was
(division of American growth factor temporarily suspended;
Home Products Data Safety and Monitor-
Corp.; NYSE:AHP) ing Committee wants to
review data from all
patients (5/18)
CENTRAL NERVOUS SYSTEM
NeoTherapeutics AIT-082 Small molecule com- Mild-to-moderate Initiated Phase II trial
Inc. pound designed to cross Alzheimer's disease (5/11)
blood-brain barrier and
enhance nerve cell func-
tion by increasing levels
of neurotrophic factors
Sibia Neuro- SIB-1508Y Small molecule com- Parkinson's disease Modified dosing regimen
sciences Inc. pound that is selective for newly enrolled trial
for certain nicotinic subjects in ongoing Phase
acetylcholine receptor II trial (5/15)
(NAChR) subtypes in
the brain; the receptors
regulate the release of
dopamine and acetyl-
choline
INFECTION
Antex Biologics Campylobac- Oral, inactivated whole- Prevention of Campylo- Announced preliminary
Inc. (OTC Bulletin ter vaccine cell vaccine, combined bacter infection and its results of Phase II trial
Board: ANTX) and with adjuvant related gastroenteritis (being conducted by the
SmithKline and diarrhea U.S. Army and U.S.
Beecham plc Navy) (5/5)
(NYSE:SBH; U.K.)
Aronex Pharma- Nyotran Liposomal formulation Systemic fungal Reported clinical trial
ceuticals Inc. of the antifungal agent infections (2nd-line data at annual meeting of
Nystatin therapy) the American Society for
Microbiology in Atlanta
(5/21)
Aviron FluMist Attenuated, cold-adapted Prevention of influenza Results of Phase III trial
live virus vaccine infection in children (sponsored by National
(nasal spray formulation) 15 months to 6 years Institutes of Health) pub-
lished in 5/14/98 issue of
The New England Journal
of Medicine (5/13)
BioChem Pharma BCH-10652 Nucleoside analogue; HIV infection and Initiated Phase I trial
Inc. (Canada) blocks replication of AIDS (5/6)
HIV, including strains
resistant to 3TC and AZT
Cel-Sci Corp. Multikine Natural mixture of HIV infection and Completed patient enrol-
human cytokines, AIDS lment in Phase I trial
including interleukin-2 (conducted at AIDS Re-
SEARCH Alliance in
West Hollywood) (5/5)
Schering-Plough Rebetron Combination of Combination therapy Schering-Plough reported
Corp. (NYSE:SGP) Intron A (recombi- for treating chronic results of 2 pivotal Phase
and ICN Pharma- nant human interferon hepatitis C virus III trials (5/18)
ceuticals Inc. alfa-2b; injection) and infection in patients
(NYSE:ICN) Rebotol (ribavirin; with compensated liver
synthetic nucleoside disease who have not
with antiviral activity; received previous alpha-
oral) (each product interferon therapy
separately approved (treatment-naive)
by FDA for other uses)
SunPharm Corp. DEHOP Diethyl-homospermine AIDS-related Presented data from Phase
(polyamine analogue) diarrhea II trial at the American
Gastroenterology Assoc-
iation's annual Digestive
Disease Week conference
in Chicago (5/18)
MISCELLANEOUS
AtheroGenics AGI 1067 Composite vascular Onset and progression FDA cleared protocol for
Inc.* protectant; oral small of coronary artery Phase I trial (5/15)
molecule compound disease (lowers LDL
that targets regulatory cholesterol levels)
signals for genes in-
volved in inflammatory
and proliferative diseases
AutoImmune Inc. Colloral Liquid oral formulation Rheumatoid arthritis Initiated Phase III trial
of a Type II collagen (5/5)
BioTransplant MEDI-507 Humanized monoclonal To prevent or reduce Presented preliminary
Inc. and antibody that binds to incidence of kidney results of Phase I trial at
MedImmune Inc. CD2 antigen receptor transplant rejection annual meeting of the
found on T cells and American Society for
natural killer cells Transplant Surgeons
(ASTS) in Chicago (5/14)
Celtrix Pharma- SomatoKine IGF-BP3 complex; Treatment of severe Presented preliminary
ceuticals Inc. recombinant version of burns in children results of Phase II trial at
complex formed by the Surgical Infection
insulin-like growth Society conference in
factor-1 and its major New York (5/4)
binding protein
CytoMed Inc.* CMI-977 Orally active small Asthma Initiated Phase I trial
molecule product that (5/12)
inhibits 5-lipoxygenase
cellular inflammation
pathway (blocks gen-
eration of leukotrienes)
GeneMedicine AAT Gene Alpha-1 antitrypsin AAT deficiency (a Rsearchers from Vander-
Inc. Medicine (AAT) gene delivered pulmonary deficiency bilt University conducted
intranasally via cationic that can lead to emphy- Phase I trial (using AAT
lipid gene delivery sema) Gene Medicine); results
system (DOTMA) presented at American
Lung Association and
American Thoracic Soc-
iety international confer-
ence (5/12)
Nexell Isolex 300i Stem cell selection Chronic granulomatous Initiated Phase I/II trial
Therapeutics Inc. (gene therapy) system; device that disease (genetic) (as part of CRADA with
(majority-owned separates CD34+ stem National Institutes of
subsidiary cells from peripheral Health) (5/4)
of VIMRx Pharma- blood; the gp91 gene
ceuticals Inc.) is transferred via
retroviral vector into
cells isolated from
patient; cells then
infused back into patient
OSI Pharma- TGF-Beta 3 Recombinant trans- Wound healing; also Novartis, which conduct-
ceuticals Inc. and forming growth factor- prevention of oral ed Phase II trials, said
Novartis Pharma beta mucositis in cancer that product showed no
AG (Switzerland) patients undergoing statistically significant
chemotherapy benefit over placebo for
either indication; the com-
panies will drop develop-
ment in oral mucositis
but Novartis is evaluating
other approaches for
using the product in
wound healing (5/18)
Protein Design Zenapax Daclizumab; human- Immunosuppression in Presented interim data
Labs Inc. (FDA- ized monoclonal anti- kidney transplantation from international Phase
and Hoffmann- approved) body (SMART Anti- (combination therapy II trial at ASTP/ASTS
La Roche Inc. TAC) that binds to the with CellCept and cor- meeting (5/13)
interleuklin-2 receptor ticosteroids but without
on activated T cells cyclosporine)
Protein Design Zenapax Daclizumab; human- Immunosuppression in Presented preliminary
Labs Inc. and (FDA- ized monoclonal anti- kidney transplantation results of Phase I/II
Hoffmann- approved) body (SMART Anti- in children (combina- trial at ASTP meeting
La Roche Inc. TAC) that binds to the tion therapy with stan- (5/11)
interleuklin-2 receptor dard immunosuppres-
on activated T cells sive drugs)
SangStat Medical Thymo- Rabbit anti-human Prevention of acute Results of long-term
Corp. globulin thymocyte polyclonal graft rejection in kidney follow-up of U.S. trial
antibody transplant patients comparing Thymoglobu-
lin with Atgam (horse
anti-thymocyte globulin;
standard of care) presen-
ted at annual meeting of
the American Society of
Transplant Physicians
(ASTP) in Chicago (5/12)
Transcend Thera- Procysteine Product that delivers Acute respiratory Phase III trial, which was
peutics Inc. and I.V. cysteine into cells to distress syndrome suspended on 3/20/98,
Boehringer Ingel- neutralize tissue-damag- has now been discontin-
heim International ing reactive oxygen ued to allow companies
GmbH (Germany) species by boosting to unblind study and con-
cellular production of duct full analysis of safe-
glutathione ty and efficacy data (5/8)
Unimed Pharma- Androgel Gel-based product for Testosterone deficiency Completed patient enrol-
ceuticals Inc. transdermal administra- in males (hypogo- lment in pivotal Phase
tion of testosterone nadism) III trial (5/28)
NOTES:
TSE = Toronto Stock Exchange
* Private companies are indicated with an asterisk.