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. |