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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.