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Company** Product Description Indication Status (Date)
CANCER
Aronex Atragen Liposomal formulation To induce remission Reported preliminary
Pharmaceuticals of all-trans retinoic acid and prevent relapse in results of Phase II trial at
Inc. patients with acute pro- 39th annual meeting of
myelocytic leukemia the American Society of
whose cancer has Hematology (ASH), in
recurred San Diego (12/8)
Cangene Corp. Leucotropin Granulocyte macro- Mobilization of peri- FDA cleared protocol for
(TSE:CNJ; Canada) phage-colony stimu- pheral blood stem cells Phase III trial (12/9)
lating factor (GM-CSF) in breast cancer patients
Coulter Bexxar Murine monoclonal Relapsed and refractory, Reported results of Phase
Pharmaceutical antibody against CD20 low-grade and transform- II trials at the ASH meet-
Inc. antigen on B cells; ed low-grade non-Hodg- ing (12/8)
radiolabeled with I-131 kin's lymphoma
Diatide Inc. Techtide Synthetic, somatostatin- In vivo imaging agent Completed patient enroll-
(P829) type receptor-binding for non-small cell lung ment in pivotal Phase
peptide P829, designed cancer III trials (12/29)
to attach to targeted
disease molecules and
labeled with technetium-
99m
Genentech Inc. Herceptin Trastuzumab; human- Treatment of HER2- Announced preliminary
ized monoclonal anti- overexpressing meta- results of Phase III trial;
body to HER2 growth static breast cancer (both product slowed cancer's
factor receptors as single agent therapy progress and shrank
and in combination with tumor size (12/19)
chemotherapy)
Genta Inc. G 3139 Anticode (antisense) Androgen-independent Initiated Phase I/IIa trial
compound; synthetic advanced prostate cancer (12/3)
DNA strands that bind
to mRNA for bcl2 gene
(proto-oncogene)
Genzyme Idiotypic cancer vaccine; Combination therapy Reported results of Phase
Transgenics Corp. contains antigen derived with granulocyte macro- I/II trial (being conducted
from patient's own phage colony stimu- at the National Cancer
cancer cells; intended lating factor for treating Institute) at the ASH
to activate cellular low-grade follicular meeting (12/8)
immune response B cell lymphoma
Idec Rituxan Rituxan is genetically Relapsed or refractory Interim results of Phase
Pharmaceuticals (FDA- engineered chimeric B cell non-Hodgkin's I/II trial reported at the
Corp. approved) pan-B monoclonal anti- lymphoma ASH meeting; also, FDA
and body that targets CD20 accepted protocol design
IDEC-Y2B8 antigen on B cell surface; for Phase III trial (12/9)
IDEC-Y2B8 is murine
monoclonal antibody
(that also targets CD20
antigen), conjugated to
radioisotope yttrium-90
ImClone Systems C225 Chimeric monoclonal Metastatic renal cell Initiated open-label Phase
Inc. antibody to epidermal carcinoma II trial (12/4)
growth factor receptor
Introgen INGN 201 p53 gene therapy, Prostate cancer Initiated Phase I trial
Therapeutics Inc.* using adenoviral vector (12/16)
(gene delivered directly
into prostate gland)
Ligand Panretin Chemically synthesized Kaposi's sarcoma in Announced positive
Pharmaceuticals Topical Gel version of 9-cis-retinoic AIDS patients results from North Amer-
Inc. acid (natural hormone ican pivotal Phase III
derived from vitamin A) trial (12/10)
(topical gel formulation)
Magainin Squalamine Angiogenesis inhibitor; Solid tumors Initiated Phase I trial
Pharmaceuticals product, an aminosterol, (12/16)
Inc. is isolated from body
tissues of dogfish shark
Neoprobe Corp. RIGS/ACT RIGS technology Colorectal cancer, both FDA cleared protocols
(radioimmunoguided operable and inoperable for Phase I/II trial
surgery) used to identify (operable cancers) and
lymph nodes that Phase II trial (inoperable
contain tumor-reactive cancers) (12/4)
helper T cells; cells
removed from patient,
activated and expanded
in vitro (ACT or activated
cell therapy), then
reinfused into patient
Protein Design SMART Humanized monoclonal Combination with Presented results from
Labs Inc. M 195 antibody standard therapy for ongoing Phase II trial at
treating acute promyelo- ASH meeting (12/9)
cytic leukemia
SMART Humanized monoclonal Combination with Reported preliminary
M 195 antibody radioisotope bismuth- results from Phase I
213 for treating relapsed trial at ASH meeting
or refractory myeloid (12/9)
leukemia
Seragen Inc. DAB389IL-2 Denileukin diftitox; Cutaneous T cell lymph- Reported preliminary
(OTC Bulletin Board: interleukin-2 (IL-2) oma that recurs or per- results of pivotal Phase
SRGN) fusion protein consist- sists after prior therapy III trial at the ASH meet-
ing of diphtheria toxin (i.e., as 2nd-line therapy) ing (12/9)
fragment A-fragment B
genetically fused to
human IL-2 (targets high-
affinity IL-2 receptors
on activated T cells)
Sugen Inc. SU 101 Small-molecule signal Hormone-refractory Initiated Phase II trial
transduction inhibitor; prostate cancer patients (12/3)
specifically inhibits with metastatic disease
platelet-derived growth
factor receptor signaling
SunPharm Corp. DENSPM Analogue of naturally Patients with cancer (of Completed Phase I trial
and the Parke-Davis (CI-1006) occurring polyamine various types) that is (12/4)
Pharmaceutical spermine (disrupts refractory to all conven-
Research division of growth process of tional chemotherapy
Warner-Lambert Co. cancer cells)
(NYSE:WLA)
SuperGen Inc. Nipent Pentostatin for injection; Hairy cell leukemia Data from long-term
(FDA- chemotherapeutic drug (1st-line therapy) follow-up of patients
approved) that inhibits adenosine treated in Phase III trial
deaminase (blocks DNA presented at the ASH
synthesis) meeting (12/11)
CARDIOVASCULAR
Cambridge Cerestat Small molecule, N- Stroke Companies will not
NeuroScience Inc. Methyl-D-Aspartate resume accrual of patients
and Boehringer (NMDA) ion channel into Phase III trial; after
Ingelheim GmbH blocker 2nd interim analysis of
(Germany) data, companies decided
that continuation of trial
is not justified (12/16)
Cytel Corp. Cylexin Cell adhesion blocker; Prevention of reper- Initiated clinical registra-
carbohydrate-based fusion injury in infants tion trials in U.S. and
small molecule that undergoing hypothermic Canada (12/18)
binds both E- and P- cardiopulmonary bypass
selectins during surgical repair
of congenital heart defects
GelTex CholestaGel Cholesterol reducer; Reduction of LDL (low- Initiated 1st of 2 Phase
Pharmaceuticals non-absorbed hydrogel density lipid) cholesterol III trials (12/18)
Inc. that binds to and elimi- in treatment of hyper-
nates target substances cholesterolemia
from the intestinal tract
Genzyme rhATIII Recombinant human To improve response Results of Phase II trial
Transgenics Corp. antithrombin III, pro- to heparin in patients presented at ASH meeting
and Genzyme Corp. duced in milk of trans- undergoing coronary (12/8)
genic goats (regulates artery bypass graft
blood clotting) surgery
Texas TBC 11251 Small molecule drug; Congestive heart Completed Phase I trial
Biotechnology endothelin-A receptor failure (12/11)
Corp. antagonist (oral dosage)
Transkaryotic GA-EPO Gene-activated erythro- Treatment of anemia Hoechst Marion Roussel
Therapies Inc. and poietin (EPO); gene in in patients with renal initiated Phase II trial
Hoechst Marion human cells is activated failure who are receiving (12/4)
Roussel Inc. in situ to produce EPO dialysis
CENTRAL NERVOUS SYSTEM
DepoTech Inc. DepoMorphine Sustained release, Acute post-surgical pain Initiated Phase II trials
encapsulated morphine (broad range of surgeries) (12/9)
sulfate (uses Depo-
Foam, lipid-based drug
delivery)
Neurocrine NBI-30775 Corticotropin-releasing Anxiety and depression Janssen initiated Phase I
Biosciences Inc. (R121919) factor receptor antag- trial (12/2)
and Janssen onist
Pharmaceutica NV
(Belgium)
Sibia SIB-1508Y Small molecule com- Parkinson's disease Reported results from
Neurosciences Inc. pound that is selective Phase I trial (12/8)
for certain nicotinic
acetylcholine receptor
(NAChR) subtypes in
the brain; the receptors
regulate the release of
dopamine and acetyl-
choline
INFECTION
Gilead Sciences GS 4104 Neuraminidase inhibitor Treatment and preven- Initiated international
Inc. and Hoffmann- (oral formulation) tion of viral influenza Phase II/III trials (12/16)
La Roche Inc. (strains A and B)
The Immune Remune Envelope-depleted, HIV infection Data Safety Monitoring
Response Corp. inactivated AIDS virus Board recommended that
(emulsified with the Phase III trial be
adjuvant) continued (12/4)
Interferon Alferon N Highly purified, multi- HIV infection Completed Phase III
Sciences Inc. Injection species, natural-source trial (12/8)
(FDA- human alpha interferon
approved)
Alferon N Highly purified, multi- Treatment of patients Initiated Phase II trial
Injection species, natural-source co-infected with HIV (12/19)
(FDA- human alpha interferon and hepatitis C virus
approved)
SciClone Zadaxin Thymosin alpha 1; Combination therapy Meta-analyisis of 3 clin-
Pharmaceuticals synthetic version of with alpha-interferon ical trials (done on intent-
Inc. naturally occurring for hepatitis C virus to-treat basis) presented
peptide hormone infection at 2nd annual conference
thymosin on Therapies for Viral
(immunomodulator) Hepatitis, in Hawaii (12/23)
SunPharm Corp. DEHOP Diethylhomo- AIDS-related diarrhea Reported statistically
spermine; analogue in patients previously significant results of
of naturally occurring unresponsive to conven- Phase II trial (12/9)
essential intracellular tional therapy
polyamine compound
Triangle DMP-450 HIV-1 protease inhib- HIV infection FDA removed clinical
Pharmaceuticals itor (a cyclic urea) hold; Phase I trials will
Inc. be reinitiated in 1/98 (12/22)
MISCELLANEOUS
Acute Therapeutics Surfaxin Peptide-containing lung Acute respiratory Completed patient enroll-
Inc. (unit of Discovery surfactant (protein-lipid distress syndrome ment in Phase Ib trial
Laboratories Inc.) complex that coats airsacs (12/12)
of lungs and facilitates
oxygen exchange)
Alliance LiquiVent Perflubron; oxygen- Adult patients with Initiated Phase II trial
Pharmaceuticals carrying liquid that is acute respiratory (12/22)
Corp. used in partial liquid distress syndrome
ventilation method
Amarillo Low-dose oral alpha Primary Sjogren's syn- Reported positive data
Biosciences Inc. interferon (natural) drome (salivary gland from Phase II trial (12/1)
hypofunction)
Discovery ST-630 Vitamin D-based Post-menopausal Initiated Phase I trial
Laboratories Inc. analogue osteoporosis (12/5)
Idec Pharma- IDEC-151/ 2nd generation prima- Moderate-to-severe Reported results of Phase
ceuticals Corp. and SB-217969 tized anti-CD4 mono- rheumatoid arthritis I part of Phase I/II trial
SmithKline Beecham clonal antibody at 10th meeting of the
plc (NYSE:SBH; U.K.) European League Against
Rheumatism, in Vienna,
Austria (12/2)
The Immune TCR Vaccine T cell receptor peptide Rheumatoid arthritis Initiated Phase IIb trial
Response Corp. vaccine (combines 3 (12/2)
T cell receptor peptides
with an adjuvant)
ImmuLogic Cocaine Vaccine containing Treatment of cocaine FDA cleared protocol for
Pharmaceutical Vaccine cocaine-protein con- addiction Phase I trial (12/3)
Corp. jugate; expected to
induce anti-cocaine
antibody response
InSite Vision Inc. ISV-208 DuraSite-based form- Once-daily treatment Initiated trials (12/3)
and Bausch & Lomb ulation of ophthalmic of elevated intraocular
Inc. (NYSE:BOL) beta-blocker (eyedrop- pressure associated with
based delivery system) glaucoma and ocular
hypertension
Life Medical Repel Bioresorbable adhesion Prevention and Announced successful
Sciences Inc. barrier film reduction of post- results from pilot clinical
(NASDAQ:CHAI) operative adhesions in trial (12/4)
gynecologic surgery
Lifecore Intergel Hyaluronate gel Prevention of adhesion Preliminary analysis of
Biomedical Inc. formation following data from international
female abdominal pivotal trials indicates
surgery results are statistically
significant (12/15)
Medarex Inc. MDX-RA Monoclonal antibody Prevention of second- Initiated Phase III trial
linked to plant toxin ary cataracts in patients (12/17)
ricin; binds to and undergoing primary
destroys lens epithelial cataract surgery
cells
Neurogen Corp. NGD 95-1 Orally active small Obesity Reported preliminary
and Pfizer Inc. molecule; antagonist of results of Phase I trial;
(NYSE:PFE) neuropeptide Y receptors some patients experienced
significant elevation of
certain liver enzymes; trial
was stopped to evaluate
data (12/8)
Ortec Composite Bioengineered bovine Treatment of donor- FDA cleared protocol for
International Inc. Cultured Skin collagen matrix seeded site wounds (created pilot trial (12/19)
with epidermal and during autografting)
dermal cells
NOTES:
TSE = Toronto Stock Exchange
* 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. 16-17.