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. |