Company** | Product | Description | Indication | Status/Date |
Name | ||||
CANCER | ||||
Avax Technologies | O-Vax | Therapeutic vaccine; | Advanced ovarian | Presented results of small |
Inc. | tumor cells removed | cancer | clinical study at the Soc- | |
from patient, modified | iety of Gynecologic On- | |||
with hapten (DNP; di- | cologists meeting in Or- | |||
nitrophenyl), then | lando (2/18) | |||
reinjected into patient | ||||
(along with cyclophos- | ||||
phamide) to stimulate | ||||
patient's immune system | ||||
CellPro Inc. | Ceprate B- | Device intended to | To be used with the | FDA granted company an |
Cell Depletion | reduce number of B | Ceprate SC Stem Cell | investigational device | |
System | cells in peripheral blood | Collection System to | exemption to initiate | |
stem cell graft | purge lymphoma cells | clinical trial (2/19) | ||
from blood used for | ||||
autologous hematopo- | ||||
ietic transplantation in | ||||
patients with relapsed | ||||
non-Hodgkin's lymphoma | ||||
Human Genome | MPF-1 | Human myeloid pro- | Protection of hemato- | Initiated Phase I trial |
Sciences Inc. | genitor inhibitory factor | poietic progenitor cells | (12/18)# | |
(genomics-derived; | in human bone marrow | |||
member of chemokine/ | from toxic effects of | |||
interleukin family) | chemotherapy | |||
Idec | Rituxan | Rituxan is genetically | Relpased or refractory | Initiated Phase III pivotal |
Pharmaceuticals | (FDA- | engineered chimeric | B cell non-Hodgkin's | trial (2/24) |
Corp. | approved) | pan-B monoclonal anti- | lymphoma | |
and | body that targets CD20 | |||
IDEC-Y2B8 | antigen on B cell sur- | |||
face; IDEC-Y2B8 is | ||||
murine monoclonal | ||||
antibody (that also | ||||
targets CD20 antigen), | ||||
conjugated to radio- | ||||
isotope yttrium-90 | ||||
Ilex Oncology Inc. | Aminopterin | Anti-folate; inhibits | Persistent or recur- | Initiated Phase II trial |
cancer cell replication | rent endometrial | (2/24) | ||
cancer in patients who | ||||
have failed prior | ||||
therapy | ||||
Ligand | Panretin | Chemically synthesized | Kaposi's sarcoma in | Analyses of 2 open-label |
Pharmaceuticals | Capsules | version of 9-cis-retinoic | AIDS patients (oral) | Phase II trials showed |
Inc. | acid (natural hormone | patient response rates of | ||
derived from vitamin A) | 38% and 37% (2/10) | |||
Maxim | Maxamine | H2 receptor agonist that | Combination therapy | Initiated international |
Pharmaceuticals | blocks phagocyte signal | with interleukin-2 for | Phase III trial (U.S., | |
Inc | that leads to death of | improving relapse- | Europe and Australia) | |
natural killer T cells | remission in acute | (2/19) | ||
myelogenous leukemia | ||||
SunPharm Corp. | DEHOP | Diethyl-homospermine | Non-Hodgkin's lymph- | FDA cleared protocol |
(polyamine analogue) | oma in AIDS patients | for Phase I trial (2/2) | ||
CARDIOVASCULAR | ||||
Icos Corp. | Hu23F2G | Humanized monoclonal | Hemorrhagic shock | Initiated Phase II trial |
antibody that blocks | (2/17) | |||
CD11/CD18-mediated | ||||
cell adhesion (inhibits | ||||
movement of neutro- | ||||
phils from blood into | ||||
tissue) | ||||
Texas Biotech- | TBC 11251 | Small molecule drug; | Congestive heart | Terminated Phase IIa |
nology Corp. | endothelin-A receptor | failure | trial ahead of schedule | |
antagonist (oral dosage) | due to achievement of | |||
statistical significance | ||||
after enrolling 24 patients | ||||
(2/11) | ||||
CENTRAL NERVOUS SYSTEM | ||||
CoCensys Inc. | Ganaxolone | Synthetic version of | Acute treatment of | Reported results of Phase |
naturally occurring | migraine headaches | II trial at conference | ||
neuroactive steroids | sponsored by the Dia- | |||
(epalons) that bind to | mond Headache Clinic | |||
GABA-A receptors in | Research and Educational | |||
brain | Foundation (2/19) | |||
Discovery Thera- | N-0923 | Transdermal patch | Mild-to-severe Park- | Reported preliminary re- |
peutics Inc.* | Patch | formulated with dopa- | inson's disease | sults of North American |
mine D2 agonist N-0923 | Phase IIb trial (2/11) | |||
NeoTherapeutics | AIT-082 | Small molecule com- | Neurodegenerative | Initiated Phase I trial in |
Inc. | pound designed to cross | diseases (i.e., Alz- | elderly volunteers (2/25) | |
blood-brain barrier and | heimer's disease) | |||
enhance nerve cell func- | ||||
tion by increasing levels | ||||
of neurotrophic factors | ||||
PowderJect Pharma- | Lidocaine | Use of dermal Powder- | Management of pain | FDA cleared clinical |
ceuticals plc and | Ject needleless drug | trial protocol (2/10) | ||
Chiroscience Group | delivery system with | |||
plc (both U.K.) | local anesthetic lidocaine | |||
INFECTION | ||||
Agouron Pharma- | Viracept | Nelfinavir mesylate; | HIV infection and AIDS; | Results of combination |
ceuticals Inc. | (FDA- | HIV protease inhibitor | (in combination with | trials presented at 5th |
approved) | (synthetic small | other protease inhibitors | Conference on Retro- | |
molecule) | and other HIV drugs) | viruses and Opportunistic | ||
Infections (ROI) in Chi- | ||||
cago (2/3) | ||||
Aviron | Nasal spray | Attenuated, cold-adapted | Prevention of influenza | Announced positive re- |
formulation | live virus vaccine con- | infection in young | sults of trial intended to | |
of influenza | taining strains likely to | children | demonstrate manufactur- | |
vaccine | be circulating during | ing consistency of vac- | ||
the current flu season | cine (2/24) | |||
Cell Genesys Inc. | Gene therapy | Procedure by which | HIV infection and AIDS | Reported interim results |
patient's own T cells are | (in combination with | of ongoing Phase II | ||
collected, genetically | antiretroviral drugs) | trials at ROI conference | ||
modified to recognize | (2/5) | |||
and destroy HIV-infect- | ||||
ed cells, then returned | ||||
to same patient | ||||
Chiron Corp. | HCV | Vaccine consisting of | HCV infection | Completed enrollment in |
Vaccine | recombinant hepatitis | Phase I trial (2/16) | ||
C virus (HCV) antigen | ||||
combined with MF 59 | ||||
adjuvant | ||||
Gilead Sciences Inc. | PMPA | Oral prodrug of nuc- | Monotherapy for HIV | Results of Phase I/II trial |
leotide analogue known | infection and AIDS | presented at ROI confer- | ||
to inhibit reverse | ence (2/5) | |||
transcriptase | ||||
The Immune | Remune | Envelope-depleted, | HIV infection and AIDS | Clinical study (showing |
Response Corp. | inactivated AIDS virus | treatment decreased levels | ||
(emulsified with | of tumor necrosis factor | |||
adjuvant) | alpha) published in 2/2/98 | |||
issue of Journal of | ||||
Human Virology (2/10) | ||||
Interferon Sciences | Alferon N | Highly purified, multi- | HIV infection and AIDS | Completed preliminary |
Inc. | Injection | species, natural-source | analysis of data from | |
(FDA- | human alpha interferon | Phase III trial (2/24) | ||
approved) | ||||
Isis Pharmaceuticals | Fomivirsen | Antisense inhibitor of | CMV retinitis in AIDS | Reported results of inter- |
Inc. and Ciba Vision | (ISIS 2922) | cytomegalovirus (CMV) | patients (intravitreal | national Phase III trial |
Corp. (unit of Novartis | replication | injection) | at ROI conference; pro- | |
AG; Switzerland) | duct demonstrated statis- | |||
tical significance in delay- | ||||
ing disease progression | ||||
(2/5) | ||||
Pharmacia & Upjohn | Rescriptor | Delavirdine mesylate; | HIV infection and AIDS | Terminated North Ameri- |
Inc. (NYSE:PNU) | Tablets | non-nucleoside analogue | (combination therapy | can trial ahead of sched- |
reverse transcriptase | with ZDV and 3TC) | ule (interim analysis | ||
inhibitor | showed statistical signi- | |||
ficance over double ther- | ||||
apy) (2/2); also, presented | ||||
preliminary analysis of data | ||||
at ROI conference (2/4) | ||||
Sarawak MediChem | Canolide A | Non-nucleoside reverse | HIV infection and AIDS | Reported results of |
Pharmaceuticals Inc.* | transcriptase inhibitor | Phase Ia trial at ROI con- | ||
(joint venture between | (originally isolated from | ference (2/5) | ||
MediChem Research | tree found in Sarawak | |||
Inc. and the state of | rain forest) | |||
Sarawak, Malaysia) | ||||
U.S. Bioscience Inc. | Lodenosine | FddA; acid-stable | HIV infection and AIDS | Presented results of |
purine-based reverse | Phase I trial at ROI con- | |||
transcriptase inhibitor | ference (2/5) | |||
Vertex Pharma- | Amprenavir | HIV protease inhibitor | HIV infection and AIDS; | Presented preliminary |
ceuticals Inc. and | (formerly | (2nd generation; oral | combination therapy | results of 2 open-label |
Glaxo Wellcome plc | VX-478 or | dosage) | with various other pro- | Phase II trials at ROI |
(NYSE:GLX; U.K.) | 141W94) | tease inhibitors as well | conference (2/2) | |
as with Glaxo's exper- | ||||
imental nucleoside | ||||
analogue reverse trans- | ||||
scriptase inhibitor abacavir | ||||
(formerly 1592) | ||||
MISCELLANEOUS | ||||
Acute Therapeutics | Surfaxin | Sinapultide; lung surf- | Acute respiratory | Announced results of |
Inc. (majority-owned | actant containing the | distress syndrome in | Phase Ib trial (2/9) | |
subsidiary of Discov- | peptide KL4 (a 21- | adults | ||
ery Laboratories Inc.) | amino acid peptide | |||
modeled after the SP-B | ||||
protein in the human | ||||
surfactant system) | ||||
Bio-Technology | OxSODrol | Recombinant human | Prevention of broncho- | Data Safety and Monitor- |
General Corp. | superoxide dismutase | pulmonary dysplasia in | ing Committee requested | |
premature neonates | additional data for inter- | |||
im analysis; further enrol- | ||||
ment of patients tempor- | ||||
arily stopped (2/18) | ||||
Cell Therapeutics | Lisofylline | Compound designed to | Acute lung injury in | Initiated pivotal trial (in |
Inc. | inhibit production of | patients requiring | collaboration with Nat- | |
phosphatidic acid and | mechanical venti- | ional Institutes of Health) | ||
reduce oxidative damage | lation | (2/18) | ||
(protects epithelial | ||||
cells from damage by | ||||
free radicals) | ||||
Human Genome | KGF-2 | Keratinocyte growth | Two wound-healing | Initiated 2 separate Phase |
Sciences Inc. | (HGO3400) | factor-2 (genomics- | indications (not dis- | I trials (2/10) |
derived; member of | closed); both topical | |||
fibroblast growth | and systemic admin- | |||
factor family) | istration | |||
Icos Corp. | rPAF-AH | Human recombinant | Acute respiratory | Completed patient enrol- |
platelet-activating | distress syndrome; | lment in 2 separate Phase | ||
factor (PAF) acetyl- | also asthma | II trials (2/17) | ||
hydrolase; regulates | ||||
levels of PAF by con- | ||||
verting it to inactive | ||||
form | ||||
Idec Pharma- | IDEC-131 | Humanized mono- | Systemic lupus | Initiated Phase I trial |
ceuticals Corp. | clonal antibody that | erythematosus | (2/10) | |
targets GP39 mole- | ||||
cules (a.k.a. CD40 | ||||
ligand) on helper | ||||
T cells (to regulate | ||||
antibody production) | ||||
LifeCell Corp. | Alloderm | Acellular dermal | Repair of nasal | Clinical results published |
graft derived from | septal perforation | in 2/98 issue of Archives | ||
human dermis | of Otolaryngology, Head | |||
and Neck Surgery (2/5) | ||||
Protein Design | Zenapax | Daclizumab; human- | Combination therapy | Preliminary results of |
Labs Inc. and | (FDA- | ized monoclonal anti- | with other anti-rejection | this 'cyclosporine elim- |
Hoffmann-La Roche | approved) | body (SMART Anti- | drugs (CellCept and | ination trial' were presen- |
Inc. | TAC) that binds to the | prednisone, but not | ted at New Dimensions | |
interleukin-2 receptor | cyclosporine) for reduc- | in Transplantation Con- | ||
on activated T cells | ing acute rejection epi- | ference in Florence, | ||
sodes in kidney trans- | Italy (2/18) | |||
plantation | ||||
Protein Design | Zenapax | Daclizumab; human- | Autoimmune uveitis | Results of Phase I/II trial |
Labs Inc. and | (FDA- | ized monoclonal anti- | (sight-threatening | reported at 3rd Internat- |
Hoffmann-La Roche | approved) | body (SMART Anti- | disease of eye) | ional Conference on New |
Inc. | TAC) that binds to the | Trends in Clinical and | ||
interleukin-2 receptor | Experimental Immuno- | |||
on activated T cells | suppression in Geneva, | |||
Switzerland (2/17) | ||||
NOTES: | ||||
# Human Genomes Sciences Inc. announced simultaneously that it had filed an IND and initiated a Phase I trial on MPF-1 in 12/97. | ||||
* 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. 14-15. |