Company** Product Description Indication Status (Date)
CANCER
Agouron AG3340 Small synthetic mole- Various advanced can- Presented data from 2
Pharmaceuticals cule designed to select- cers, including hormone- Phase I trials at 10th
Inc. ively inactivate matrix resistant advanced pro- European Organization
metalloproteases (also state cancer (combined for Research and Treat-
has anti-angiogenic with chemotherapy) ment of Cancer (EORTC)
activity) (oral dose) conference in Amsterdam
(6/17)
Avax M-Vax Therapeutic vaccine; Post-surgical treatment Announced that new
Technologies Inc. tumor cells removed of patients with stage dosing regimen in Phase
from patient, modified III melanoma II trial increased immuno-
with hapten (DNP; di- logical response (6/10)
nitrophenyl), then
injected back into
patient (along with
cyclophosphamide)
O-Vax Therapeutic vaccine; Advanced ovarian National Cancer Institute
tumor cells removed cancer (stage III) will conduct Phase I/II
from patient, modified trial (6/29)
with hapten (DNP; di-
nitrophenyl), then
injected back into
patient (along with
cyclophosphamide)
Coulter Bexxar Iodine I-131 tositumo- Retreatment of patients Initiated Phase II trial
Pharmaceutical mab; murine monoclo- with non-Hodgkin's B- (6/23)
Inc. nal antibody against cell lymphoma who have
CD20 antigen on B cells, relapsed following pre-
radiolabeled with I-131 vious Bexxar therapy
Human Genome MPIF-1 Human myeloid pro- Protection of hemato- Completed Phase I trial
Sciences Inc. genitor inhibitory poietic progenitor cells (6/2)
factor (genomics-deri- in human bone marrow
ved; member of chemo- from toxic effects of
kine/interleukin family) cancer chemotherapy
Immunex Corp. CD40 Soluble CD40 ligand Non-Hodgkin's B-cell Initiated Phase I trial
Ligand (binds to CD40 antigen lymphoma and solid (6/4)
expressed on surface of tumors for which stan-
B cells) dard therapies have failed
Introgen Ad5CMV-p53 p53 gene therapy via Newly diagnosed non- Initiated Phase II trial
Therapeutics Inc.* adenoviral vector; intra- small cell lung cancer (6/15)
and RPR Gencell tumoral injection in patients with nonres-
(division of Rhone- ectable tumors who have
Poulenc Rorer Inc.) not received chemother-
apy or radiation
Ligand Panretin Chemically synthesized Kaposi's sarcoma in Presented final results of
Pharmaceuticals Capsules version of 9-cis-retinoic AIDS patients (most open-label Phase II trial
Inc. acid (natural hormone of whom are taking as well as results of 2nd
derived from vitamin A) antiretroviral therapy) Phase II trial (sponsored
(oral dosage) by the National Cancer
Institute) at 12th World
AIDS Conference in
Geneva, Switzerland
(6/30)
Panretin Alitretinoin; 0.1% gel; Treatment of dermal Presented results of 2
Gel chemically synthesized lesions in AIDS- Phase III trials (in North
version of 9-cis-retinoic related Kaposi's America and internation-
acid (derived from sarcoma al) at AIDS conference
vitamin A) (6/30)
Neopharm Inc. LED Liposome-encapsulated Late-stage, hormone- Announced results of
doxorubicin resistant prostate Phase I trial (6/9)
cancer
NeoRx Corp. — Pre-targeting tech- Relapsed non-Hodg- Initiated Phase I trial
nology; multi-step kin's B-cell lymphoma (6/17)
process that involves
separate administration
of murine monoclonal
antibody and radio-
isotope, which are
then joined at the
tumor to kill it
— Radiopharmaceutical Multiple myeloma Initiated Phase I trial
Holmium-166 DOTMP (6/30)
(targets bone) combined
with chemotherapy and
stem cell transplantation
Progenics GMK Cancer vaccine; induces Malignant melanoma Reported results of Phase
Pharmaceuticals antibodies to GM2 gang- I/II trials at EORTC
Inc. and Bristol- lioside cancer antigen on conference (6/19)
Myers Squibb Co. melanoma cells
(NYSE:BMY)
Sugen Inc. SU5416 Angiogenesis inhibitor; Blockage of tumor Initiated Phase I trial
small molecule inhib- angiogenesis in (6/17)
itor of tyrosine kinase advanced malignancies,
Flk-1/KDR receptor (to including multiple
which vascular endo- myeloma
thelial growth factor
binds, thus activating
angiogenesis)
SunPharm Corp. and DENSPM Diethylnorspermine Solid tumor cancers Presented data from Phase
Warner-Lambert (polyamine analogue; that are refractory to I trial at EORTC confer-
Co. (NYSE:WLA) disrupts cancer cell conventional chemo- ence (6/18)
growth processes) therapy
Techniclone Corp. Oncolym LYM-1 murine mono- Intermediate- and high- Presented results from
clonal antibody to HLA- grade refractory or Phase II trial (radiation
DR10 protein (cell- relapsed non-Hodgkin's dosimetry study) at 45th
surface marker present B-cell lymphoma annual meeting of the
on 80% of lymphoma Society for Nuclear Med-
cells), labeled with I-131 icine in Toronto (6/15)
Vical Inc. Leuvectin Gene encoding inter- Prostate cancer Presented initial results
leukin-2 administered of Phase I/II trial at 93rd
by intratumoral injection annual meeting of the
(gene complexed with American Urological
lipid) Association (6/1)
CARDIOVASCULAR
Sparta RII Retinoid compound Myelodysplastic syn- Patient enrollment for
Pharmaceuticals Retinamide (derivative of vitamin A) dromes (failure to Phase I/II trial is complete
Inc. produce normal blood (6/1)
cells)
CENTRAL NERVOUS SYSTEM
CoCensys Inc. Ganaxolone Synthetic version of Migraine headaches Initiated Phase II trial
naturally occurring (6/23)
neuroactive steroids
(epalons) that bind to
gamma-amino-butyric
acid (GABA)-A
receptors in brain
(tablet formulation)
Cortex Ampalex Small molecule; mem- Schizophrenia Presented results on 1st
Pharmaceuticals (CX516) ber of ampakine family, (combination therapy 6 patients in physician-
Inc. which enhance the with clozapine) sponsored trial at annual
response of AMPA meeting of the American
receptors on neurons Psychiatric Association
in Toronto (6/2)
Sibia SIB-1553A Small molecule com- Cognitive deficits in Initiated Phase I trial
Neurosciences Inc. pound; subtype-selective various diseases, (6/23)
nicotinic acetylcholine initially Alzheimer's
receptor agonist; stimu- disease
lates release of acetyl-
choline in brain
DIABETES
Inhale Therapeutic — Dry powder formulation Types I and II Results of 2 Phase IIb
Systems and Pfizer of insulin; delivered via diabetes trials conducted by Pfizer
Inc. (NYSE:PFE) pulmonary delivery presented at 58th annual
system meeting of the American
Diabetes Association in
Chicago (6/16)
INFECTION
DuPont Sustiva Efavirenz; non-nucleo- Combination therapy Clinical trial results pre-
Pharmaceuticals side reverse trans- (with 1 protease inhibi- sented at AIDS confer-
Co. (formerly criptase inhibitor (once- tor and 2 nucleoside ence (6/30)
The DuPont Merck daily dosage) analogues) for treating
Pharmaceutical Co.) HIV infection and AIDS
Gilead Sciences Preveon Adefovir dipivoxil; Treatment of AIDS in Presented results of
Inc. reverse transcriptase patients with AZT- and Phase II/III trial at 2nd
inhibitor (oral dosage) 3TC-resistant virus International Workshop
on HIV Drug Resistance
and Treatment Strategies
in Lake Maggiore, Italy
(6/25)
Gilead Sciences Inc. GS4104 Neuraminidase inhibitor Treatment and preven- Reported preliminary
and F. Hoffmann- (oral formulation) tion of viral influenza results of 4 international
La Roche Ltd. (strains A and B) Phase II/III trials (con-
(Switzerland) ducted during 1997-1998
Northern Hemisphere
flu season) (6/30)
Glaxo Wellcome Abacavir Nucleoside analogue Combination therapy Presented results of com-
plc (NYSE:GLX; U.K.) reverse transcriptase with any 1 of 5 HIV bination trials at AIDS
inhibitor protease inhibitors for conference (6/29)
treating HIV infection
in treatment-naive
patients
Ziagen Abacavir; nucleoside Combination therapy Results from 1.5 year,
analogue reverse trans- with AZT and 3TC for small Phase II trial pre-
criptase inhibitor treating HIV infection sented at AIDS confer-
(tablet formulation) and AIDS in treatment- ence (6/29)
naive patients
Hoffmann-La Roche Fortovase Saquinivir (invirase); Combination therapy Results of comparison
Inc. (subsidiary of (FDA- HIV protease inhibitor with AZT and 3TC for trial with Crixivan pre-
F. Hoffmann-La Roche approved) in soft gelatin capsule treating HIV infection sented at AIDS confer-
AG; Switzerland) (new, more potent and AIDS ence (6/30)
formulation)
The Immune Remune Envelope-depleted HIV infection and Data Safety Monitoring
Response Corp. inactivated AIDS virus AIDS Board completed interim
(emulsified with analysis of Phase III
adjuvant) trial and recommended
continuance as currently
being conducted (6/9)
The Immune Remune Envelope-depleted HIV infection in Initiated clinical trial
Response Corp. inactivated AIDS virus patients treated with (6/17)
and Agouron (emulsified with highly active anti-
Pharmaceuticals adjuvant) retroviral therapy for
Inc. at least 6 months
Palatin LeuTech Radiolabeled, mono- In vivo detection and Completed Phase II trial
Technologies clonal antibody-based diagnosis of equivocal (6/29)
Inc. system for imaging appendicitis
infection (product binds
specifically to white
blood cells)
Progenics Pro 542 Fusion protein that HIV infection in adults Reported interim results
Pharmaceuticals incorporates HIV-bind- and children of Phase I/II trials (6/19)
Inc. ing region of human
cell surface receptor
into a human antibody
molecule
TheraTech Inc. Androderm Testosterone delivered Testosterone deficiency Presented results of trial
and SmithKline (FDA- by transdermal patch in HIV-infected men at Endocrine Society Con-
Beecham plc approved) and women ference in New Orleans
(NYSE:SBH; U.K.) (6/30)
— Testosterone delivered HIV-infected women Presented results of trial
by transdermal patch with AIDS wasting at Endocrine Society Con-
(different doses of syndrome ference in New Orleans
hormone) (6/30)
Trimeris Inc. T-20 Antiviral fusion- HIV infection in Initiated Phase II trial
inhibiting compound patients who have begun (6/25)
(delivered by contin- to fail triple combina-
uous subcutaneous tion therapy
infusion via pump)
VaxGen Inc.* AIDSVAX Bivalent vaccine com- Prevention of HIV FDA cleared protocol for
posed of recombinant infection in high-risk Phase III trial (6/3); init-
gp120 protein (envelope individuals iated Phase III trials in
protein) from 2 strains U.S. (6/23)
of HIV-1 that are pre-
valent in the Americas,
Western Europe and
Australia
Vertex Amprenavir Agenerase; 2nd genera- Combination therapy Results of trial conducted
Pharmaceuticals (formerly tion HIV protease with Abacavir for in Switzerland presented
Inc. and Glaxo VX-478 or inhibitor (oral) treating HIV infection at AIDS conference
Wellcome plc 141W94) in treatment-naive (6/30)
(NYSE:GLX; U.K.) patients
MISCELLANEOUS
Angiotech — Micellar paclitaxel; Rheumatoid arthritis FDA cleared protocol for
Pharmaceuticals yew tree-derived semi- Phase I trial (6/11)
Inc. (Canada) synthetic taxoid;
delivered into joints via
sustained release poly-
meric microspheres;
compound inhibits
angiogenesis
Bio-Technology OxSODrol Recombinant human Prevention of broncho- Data Safety and Monitor-
General Corp. superoxide dismutase pulmonary dysplasia in ing Committee recom-
premature neonates mended that trial be con-
tinued as a Phase II study
(instead of Phase III)
with revised endpoints of
reduction of asthmatic
complications and neuro-
developmental deficits
(6/29)
Celtrix SomatoKine IGF-BP3 complex; To restore muscle Reported preliminary
Pharmaceuticals recombinant version of tissue (attenuate protein results of ongoing Phase
Inc. complex formed by degradation) in patients II trial (6/15)
insulin-like growth with severe burns
factor-1 and its major
binding protein
Cypress Prosorba Disposable filter that Severe rheumatoid Presented results of Phase
Bioscience Inc. Column uses Protein A to arthritis III trial at 12th PanAmer-
(FDA- remove circulating ican Congress of Rheu-
approved) immune complexes matology (PANLAR) in
from patient's blood Montreal (6/23)
Discovery ST-630 Biologically active Postmenopausal Completed Phase Ib trial
Laboratories Inc. analogue of vitamin D osteoporosis (6/29)
in softgel capsules
GelTex Pharma- RenaGel Non-absorbed polymer- Control of elevated Reported preliminary
ceuticals Inc. and based compound that phosphorus levels in results from extended-use
Genzyme Corp. binds to and eliminates pre-dialysis chronic open-label trial at Crut-
target substances from kidney failure tenden Roth Healthcare
the intestinal tract Conference in New York
(6/29)
Immunex Corp. and Enbrel Recombinant, soluble Rheumatoid arthritis Long-term safety data
Wyeth-Ayerst Lab- p75 tumor necrosis (dosing up to 18 months)
oratories (division factor receptor (TNFr) presented at PANLAR
of American Home linked to the Fc portion conference (6/25)
Products Corp.; of human IgG1
NYSE:AHP)
Novavax Inc. Androsorb Micellar nanoparticles Testosterone replace- Completed dosing in
containing testosterone ment in hypogonadal pharmacokinetic trial
(topical cream) males (6/1)
Organogenesis Apligraf Living human skin Cosmetically important Initiated prospective
Inc. (a.k.a. equivalent, composed of wound treatment, clinical trial (6/26)
Graftskin; living human keratino- especially wounds due to
FDA- cytes and fibroblasts removal of skin cancer
approved) (epidermis and dermis,
isolated from infant
foreskins) cultured in
a 3-dimensional system
Reprogenesis Inc.* Natrolin-VR Minimally invasive Treatment of vesico- Initiated Phase III trial
tissue augmentation pro- ureteral reflux (pedia- (6/3)
duct; combines auto- tric urological dis-
logous cartilage cells order)
(chondrocytes) with
biodegradable hydro-
gel matrix that is
injected locally
(supports tissue gen-
eration in vivo)
Targeted Genetics tgAAV- Gene therapy; non- Cystic fibrosis Results of Phase I trial
Corp. CFTR replicating adeno- published in 6/6/98 issue
associated virus used to of The Lancet (6/8)
deliver cystic fibrosis
transmembrane con-
ductance regulator
gene into sinus via
catheter
TheraTech Inc. and — Transdermal estradiol/ Treatment of testos- Presented trial results at
The Procter & testosterone combina- terone deficiency in Endocrine Society Con-
Gamble Co. tion patch women who are surgi- ference in New Orleans
(NYSE:PG) cally menopausal (6/26)
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. 10-11.