Company** Product Description Indication Status (Date)
CANCER
Alfacell Corp. Onconase Cytotoxic ribonuclease; Pancreatic cancer Preliminary analysis of
(NASDAQ:ACEL) member of the super- Phase III trials did not
family of pancreatic demonstrate survival
ribonucleases benefit over standard
therapies; company has
stopped trial and will not
file NDA for this indi-
cation (7/15)
Aronex Atragen Liposomal formulation Relapsed or refractory Initiated Phase I trial in
Pharmaceuticals of all-trans retinoic acid; non-Hodgkin's B cell NHL; completed patient
Inc. induces tumor cells to lymphoma (NHL); also enrollment in Phase II
differentiate into mature acute promyelocytic trial in PML (7/21)
normal cells leukemia (PML)
Avax Technologies M-Vax Therapeutic vaccine; Postsurgical treatment Restarted Phase III trial
Inc. tumor cells removed of patients with stage (which had been halted
from patient, modified III melanoma in 10/97 to file paperwork
with hapten (DNP; di- with FDA on manufactur-
nitrophenyl), then ing data) (7/27)
injected back into
patient (along with
cyclophosphamide)
Cell Pathways Inc.* FGN-1 Exisulind; orally active Adenomatous poly- Initiated open-label safety
drug designed to induce posis coli in children study (7/28)
apoptosis in precan- (precancerous colonic
cerous cells polyps)
Genta Inc. G3139 Anticode (antisense) Hormone-resistant Initiated new Phase I/IIa
compound; synthetic metastatic prostate trial (7/14)
DNA strands that bind cancer (combination
to mRNA for bcl2 gene therapy with an andro-
(proto-oncogene) gen receptor-blocking
agent)
Jenner OncoVax-P Cancer vaccine; incor- Hormone-refractory Initiated Phase II trial
Biotherapies Inc.* porates recombinant prostate cancer (7/23)
prostate-specific antigen
plus adjuvant in lipo-
somal formulation
Medarex Inc. MDX-220 Bispecific antibody TAG-72-positive can- Initiated Phase I/II trial
composed of trigger cers, including colon (7/16)
antibody and 2nd, and prostate cancer
humanized antibody (pretreatment with
that targets TAG-72 granulocyte colony-
antigen present on stimulating factor)
many cancers
NaPro Paclitaxel Compound extracted Various cancers Initiated clinical trial
BioTherapeutics from needles and limb (7/9)
Inc. stock of ornamental
yew trees; administered
via NaPro's Q4D
administration (which
includes 60-180 minute
infusion)
Sugen Inc. SU 101 Small-molecule signal Malignant glioma Initiated Phase III trial
transduction inhibitor; (7/1)
specifically inhibits
platelet-derived growth
factor receptor signaling
SU 101 Small-molecule signal Recurrent ovarian Initiated Phase II trial
transduction inhibitor; cancer in patients who (7/14)
specifically inhibits have failed standard
platelet-derived growth therapy
factor receptor signaling
Techniclone Corp. Oncolym LYM-1 murine mono- Intermediate- and high- FDA allowed amendment
clonal antibody to HLA- grade refractory or to current Phase II/III
DR10 protein (cell- relapsed non-Hodgkin's trial protocol to include
surface marker present B cell lymphoma NHL patients who have
on 80% of lymphoma (NHL) failed or relapsed follow-
cells), labeled with I-131 ing treatment with other
monoclonal antibodies
(7/23)
TNT Tumor necrosis therapy; Malignant glioma Completed patient enroll-
chimeric monoclonal (interstitial delivery) ment in radiation dosi-
antibody that targets metry (imaging) portion
DNA-associated histone of Phase I trial (7/21)
antigens, labeled with
I-131 (targets necrotic
center of tumor)
Titan CeaVac Anti-idiotypic mono- Stage IV colorectal Initiated Phase II trials
Pharmaceuticals clonal antibody-based cancer in U.S. and U.K. (7/16)
Inc. vaccine; mimics CEA
antigen present on many
types of cancer cells
Pivanex Small-molecule ana- Refractory Stage III Initiated Phase II trial
logue of butyric acid and IV non-small cell (7/22)
(naturally occurring lung cancer
substance that regulates
cell growth)
TriAb Anti-idiotypic mono- Metastatic breast cancer Initiated Phase II trial
clonal antibody-based in patients who have (7/16)
vaccine; mimics epitope responded to standard
on breast cancer cell- therapy
associated antigen HMFG
Vertex Incel Small synthetic molecule Advanced hormone- Initiated Phase II trial
Pharmaceuticals (VX-710) designed to block both refractory prostate can- (7/27)
Inc. the MDR1 and MRP cer (combination ther-
drug-resistance mecha- apy with prednisone
nisms in chemotherapy- and Novantrone)
resistant tumor cells
Vical Inc. — DNA vaccine; contains Metastatic melanoma Initiated Phase I/II trial
gene sequence for modi- (sponsored by National
fied melanoma antigen Cancer Institute) (7/9)
gp100 peptides (intra-
muscular or intra-
dermal administration)
CARDIOVASCULAR
Centocor Inc. and ReoPro Chimeric monoclonal Heart patients under- Results of EPISTENT clini-
Eli Lilly and Co. (FDA- antibody fragment to going stenting and cal trials (conducted in U.S.
(NYSE:LLY) approved) GPIIb/IIIa platelet balloon angioplasty and Canada) published
receptor (abciximab) in 7/11/98 The Lancet (7/9)
Corvas NIF Neutrophil inhibitory Ischemic stroke Pfizer completed Phase
International Inc. factor (anti-inflammatory) Ia trial (7/6)
and Pfizer Inc.
(NYSE:PFE)
Genentech Inc. Activase Alteplase; recombinant Acute ischemic stroke Data safety monitoring
(FDA- tissue plasminogen (administered 3-5 hours board recommended
approved) activator from symptom onset) termination of ATLANTIS
trial; interim analysis
showed lack of clinical
benefit in patients treated
after 3 hours (7/20)
GenVec Inc.* and Gene Direct injection of VEGF Peripheral vascular Initiated Phase I/II trial
the Parke-Davis therapy gene (vascular endothel- disease at New York Hospital/
Research division of ial growth factor; in adeno- Cornell Medical Center
Warner-Lambert Co.; viral vector) into heart (7/6)
(NYSE:WLA) muscle during cardiac
bypass surgery; to induce
revascularization of
heart tissue
Interneuron CerAxon Citicholine sodium; Reduction of infarct Initiated new Phase III
Pharmaceuticals organic molecule that size and improvement trial with increased dos-
Inc. consists of cytidine and in neurological function age and larger patient
choline (components in patients with ischemic numbers than in previous
of brain cell membranes) stroke failed trial (7/7)
Scios Inc. and Fiblast Trafermin; recombinant Acute stroke Terminated North Amer-
Wyeth-Ayerst Lab- human basic fibroblast ican Phase II/III trial due
oratories (division growth factor to unfavorable risk-to-
of American Home benefit ratio of drug vs.
Products Corp.; placebo (7/21)
NYSE:AHP)
Texas TBC 11251 Small-molecule drug; Moderate-to-severe Announced preliminary
Biotechnology endothelin-A receptor congestive heart failure results of Phase IIa trial
Corp. antagonist (intravenous) (7/21)
CENTRAL NERVOUS SYSTEM
Icos Corp. Hu23F2G Humanized monoclonal Acute exacerbations Initiated multidose
antibody that blocks in multiple sclerosis Phase II trial (7/17)
CD11/CD18-mediated cell
adhesion (inhibits move-
ment of neutrophils
from blood into tissue)
NPS NPS 1506 Small molecule; inter- Neuroprotection in Initiated Phase Ib trial
Pharmaceuticals acts with N-methyl-D- stroke (administered (7/1)
Inc. aspartate (NMDA) recep- within 48 hours)
tor to block flow of
calcium into brain cells
DIABETES
Amylin Pramlintide Synthetic analogue of To improve glucose Completed patient enroll-
Pharmaceuticals human pancreatic control in patients with ment in 2 one-year
Inc. hormone amylin Type I diabetes and in Phase III trials (7/10)
insulin-using patients
with Type II diabetes
Celtrix SomatoKine IGF-BP3 complex; To improve glycemic Initiated Phase II trial
Pharmaceuticals recombinant version control and lower require- (7/15)
Inc. of complex formed by ment for exogenous
insulin-like growth insulin in patients with
factor-1 and its major Type I diabetes
binding protein
INFECTION
Cell Genesys Inc. Gene Procedure by which HIV infection and Reported interim results
therapy patient's own T cells are AIDS (in combination from Phase II trial at 2nd
collected, genetically with antiretroviral International Workshop
modified to recognize drugs) on HIV Drug Resistance
and destroy HIV-infected and Treatment Strategies
cells, then returned in Lake Maggiore, Italy,
to same patient and at 12th International
AIDS Conference in Geneva,
Switzerland (7/1)
Enzo Therapeutics HGTV 43 Genetic antisense To stop viral pro- Initiated Phase I trial
Inc. (subsidiary of medicine; insertion of gression in HIV- (7/13)
Enzo Biochem Inc.) gene that synthesizes infected patients
antisense molecule to
HIV-1 directly into
blood cells (patient's
stem cells treated ex
vivo to render them
HIV-resistant, then
reinfused into patient)
Gilead Sciences Preveon Adefovir dipivoxil; HIV infection and Presented results of
Inc. reverse transcriptase AIDS (combination Phase II/III trial at AIDS
inhibitor (oral dosage) therapy with anti- conference (7/1)
retroviral drugs)
Interferon Alferon N Highly purified, multi- Hepatitis C virus (HCV) Completed Phase III
Sciences Inc. Injection species, natural-source infection in previously trial (7/23)
(FDA- human alpha interferon untreated patients
approved)
Alferon N Highly purified, multi- HIV infection and Completed treatment
Injection species, natural-source AIDS (combination phase of open-label con-
(FDA- human alpha interferon therapy with anti- tinuation study of Phase
approved) retroviral drugs) III trial (7/23)
Alferon N Highly purified, multi- HIV/HCV co-infection Company will add more
Injection species, natural-source clinical centers to Phase
(FDA- human alpha interferon II trial (7/23)
approved)
NeXstar MiKasome Liposomal formulation Treatment of compli- Initiated patient enroll-
Pharmaceuticals of antibiotic amikacin cated urinary tract ment for 2nd arm of on-
Inc. infections going Phase II trial (7/8)
MiKasome Liposomal formulation Treatment of nosoco- Initiated 3rd Phase II
of antibiotic amikacin mial (hospital-acqui- trial (7/13)
red) infections
SmithKline LYMErix Recombinant OspA Prevention of Lyme Clinical trial results pub-
Beecham plc vaccine (outer surface disease (both definitive lished in 7/23/98 issue of
(NYSE:SBH; U.K.) protein A; antigen disease and asympto- The New England
from tick-borne bac- matic infection) Journal of Medicine
terium Borrelia burg- (7/23)
dorferi, which causes
the infection)
Triangle FTC Nucleoside reverse HIV infection and Reported data from Phase
Pharmaceuticals transcriptase inhibitor AIDS I/II monotherapy trial at
Inc. AIDS conference (7/1)
U.S. Bioscience Inc. Lodenosine FddA; acid-stable HIV infection and Presented data from Phase
purine-based reverse AIDS I trial (sponsored by
transcriptase inhibitor National Cancer Institute)
at AIDS conference (7/2)
MISCELLANEOUS
Alexion 5G1.1 C5 complement inhib- Rheumatoid arthritis Initiated Phase I/II trial
Pharmaceuticals itor; humanized mono- (7/7)
Inc. clonal antibody designed
to inhibit complement
activation and reduce
inflammation over pro-
longed period of time
Alexion 5G1.1 C5 complement inhib- Systemic lupus Initiated Phase I/II trial
Pharmaceuticals itor; humanized mono- erythematosus (7/23)
Inc. clonal antibody designed
to inhibit complement
activation and reduce
inflammation over pro-
longed period of time
Amarillo — Low-dose oral alpha Fibromyalgia syndrome Initiated Phase II trial
Biosciences Inc. interferon (natural) (7/9)
Anergen Inc. and AnergiX Peptide vaccine; com- Established rheumatoid Initiated Phase I trial
Organon NV bines peptide derived arthritis in patients who (7/7)
(the Netherlands) from human cartilage- are taking methotrexate
derived glycoprotein
(HCgp39) with AnergiX
technology (selectively
inactivates T cells that
cause inflammation)
BioTransplant Inc. AlloMune Process involves mixing Kidney transplantation FDA cleared protocol for
System bone marrow from Phase I/II trial (7/13)
patient and donor to
create chimeric bone
marrow; allows trans-
plants of mismatched
kidneys without use of
immunosuppressive
drugs
BioTransplant Inc. BTI-322 Murine monoclonal Treatment of acute Reported results of Phase
and MedImmune Inc. antibody that binds to graft-vs.-host disease in II trial at 17th annual
CD2 antigen receptor allogeneic bone marrow World Congress Meeting
on T cells and natural transplant patients of the Transplantation
killer cells unresponsive to steroid Society in Montreal
therapy (7/15)
Celgene Corp. Thalidomid Thalidomide; thought AIDS-associated Results from ongoing,
(FDA- to act by modulating weight loss (cachexia) open-label study present-
approved) levels of tumor necrosis ed at AIDS conference
factor-alpha (7/27)
Circe Biomedical HepatAssist Extra-corporeal bio- To provide temporary FDA cleared protocol for
Inc. (wholly owned artificial liver system essential liver functions Phase II/III trial (in U.S.
subsidiary of W.R. consisting of membranes in patients suffering and Europe) (7/23)
Grace; NYSE:GRA) and porcine liver cells from acute liver failure
Connetics Corp. Clobetasol Foam formulation of Severe, corticosteroid- Initiated Phase III trial
ViaFoam 0.05% clobetasol responsive dermatoses (7/8)
proprionate of the scalp, including
psoriasis
Discovery Surfaxin Sinapultide; lung sur- Acute respiratory Initiated pivotal Phase II/
Laboratories Inc. factant containing the distress syndrome III trial (7/14)
peptide KL4 (a 21- from direct causes
amino-acid peptide (i.e., non-sepsis
modeled after the SP-B causes such as
protein in the human pneumonia)
surfactant system)
Ergo Science Corp. Ergoset Oral formulation of Clinical obesity Completed patient enroll-
Tablets bromocriptine (ergot ment in Phase II trial
alkaloid; generic (7/21)
dopamine agonist)
Synsorb Biotech Synsorb Cd Product that binds to Treatment for recurring FDA cleared protocol for
Inc. (Canada) toxins secreted by or relapsing antibiotic- Phase II trial (7/22)
bacteria in the gastro- associated diarrhea
intestinal tract
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.