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Company** | Product | Description | Indication | Status/Date | ||||
Name | ||||||||
CANCER | ||||||||
Avax Tech- | O-Vax | Therapeutic vaccine; | Advanced ovarian | Completed Phase I/II | ||||
nologies Inc. | tumor cells removed | cancer (stage III) | pilot study (8/24) | |||||
from patient, modified | ||||||||
with hapten (DNP, di- | ||||||||
nitrophenyl), then | ||||||||
injected back into | ||||||||
patient (along with | ||||||||
cyclophosphamide) | ||||||||
Idec Pharma- | Rituxan | Rituximab; genetically | Relapsed or refractory | Study results on project- | ||||
ceuticals Corp. | (FDA- | engineered chimeric | low-grade or follicular | ed median time to dis- | ||||
and Genentech | approved) | pan-B monoclonal anti- | non-Hodgkin's | ease progression pub- | ||||
Inc. | body that targets CD20 | lymphoma | lished in 8/98 issue of | |||||
antigen on B-cell surface | Journal of Clinical On- | |||||||
cology (8/17) | ||||||||
Ilex Oncology Inc. | Campath-1H | Humanized monoclonal | Chronic lymphocytic | Completed patient en- | ||||
and LeukoSite Inc. | antibody that specific- | leukemia in patients | rollment in internation- | |||||
ally targets and binds to | who have failed con- | al pivotal trial (8/12) | ||||||
CD52 cell surface anti- | ventional therapies | |||||||
gen on lymphocytes | ||||||||
Imutec | Virulizin | Biological response | Advanced-stage pancre- | Announced results of | ||||
Pharma Inc. | modifier extracted from | atic cancer in patients | Phase I/II trial (8/26) | |||||
(TSE:IMT; Canada) | bovine reticuloendo- | who have failed prior | ||||||
thelium; activates | therapies | |||||||
macrophages | ||||||||
IntraBiotics | IB-367 | Synthetic analogue of | Oral mucositis in cancer | Announced results of | ||||
Pharmaceuticals | protegrin family of | patients receiving myelo- | Phase I trial (8/27) | |||||
Inc.* and Pharma- | mammalian antimicro- | ablative chemotherapy | ||||||
cia & Upjohn | bial peptides | |||||||
(NYSE:PNU; U.K.) | ||||||||
Techniclone Corp. | TNT | Tumor necrosis therapy; | Malignant glioma | Announced interim | ||||
chimeric monoclonal | (interstitial delivery) | results from dosimetry | ||||||
antibody that targets | portion of Phase I trial | |||||||
DNA-associated histone | (8/28) | |||||||
antigens, labeled with | ||||||||
I-131 (targets necrotic | ||||||||
center of tumor) | ||||||||
CARDIOVASCULAR | ||||||||
Amgen Inc. | MGDF | Recombinant human | To improve yield and | Discontinued trials after | ||||
megakaryocyte growth | efficiency of platelet | some patients developed | ||||||
and development | collections from blood | thrombocytopenia and | ||||||
factor | donors | neutralizing antibodies | ||||||
(8/18) | ||||||||
Centocor Inc. | ReoPro | Chimeric monoclonal | Use with stents in | Results of 6-month fol- | ||||
and Eli Lilly & Co. | (FDA- | antibody fragment to | patients undergoing | low up of EPISTENT trial | ||||
(NYSE:LLY) | approved) | GPIIb/IIIa platelet | coronary intervention | reported at 20th Con- | ||||
receptor (abciximab) | gress of the European | |||||||
Society of Cardiology in | ||||||||
Vienna, Austria (8/22) | ||||||||
Cor Therapeutics | Integrilin | Eptifibatide; small | Adjunct to broad spec- | Results of international | ||||
Inc. and Schering- | (FDA- | molecule synthetic com- | trum of patient man- | PURSUIT trial published | ||||
Plough Corp. | approved) | pound (derived from | agement strategies to | in 8/13/98 issue of The | ||||
(NYSE:SGP) | rattlesnake venom) that | reduce death, heart | New England Journal of | |||||
inhibits GPIIb/IIIa | attack and other com- | Medicine (8/12) | ||||||
receptor that mediates | plications in acute coro- | |||||||
platelet aggregation | nary syndromes | |||||||
Hemosol Inc. | Hemolink | Highly purified hemo- | Blood substitute in | FDA cleared protocol for | ||||
(TSE:HML; Canada) | globin extracted from | patients undergoing | Phase II trials (8/24) | |||||
outdated human donor | coronary artery bypass | |||||||
blood, then cross-linked | graft surgery | |||||||
to form stable hemo- | ||||||||
globin molecule | ||||||||
Northfield Labor- | PolyHeme | Chemically modified | Blood substitute; direct | FDA asked company to | ||||
atories Inc. | hemoglobin derived | replacement of blood in | expand to at least 600 | |||||
from outdated donor | elective surgery | the number of patients | ||||||
blood | in Phase III trials (based | |||||||
on public concerns over | ||||||||
failures of competing | ||||||||
products in late-stage | ||||||||
trials) (8/12) | ||||||||
Northfield Labor- | PolyHeme | Chemically modified | Blood substitute; direct | FDA cleared protocol to | ||||
atories Inc. | hemoglobin derived | replacement of blood in | infuse up to 20 units of | |||||
from outdated donor | large volumes (20 units) | product in Phase II trials | ||||||
blood | in trauma patients | (8/12) | ||||||
CENTRAL NERVOUS SYSTEM | ||||||||
Interneuron | Pagoclone | Compound that poten- | Treatment of patients | Announced results of | ||||
Pharmaceuticals | tiates action of the | with panic disorder | Phase II/III trial (8/17) | |||||
Inc. | neurotransmitter gamma | |||||||
amino butyric acid | ||||||||
(partial agonist) | ||||||||
Neurogen Corp. | NGD 91-2 | Small molecule drug | Situational anxiety | Pfizer initiated Phase Ib | ||||
and Pfizer Inc. | that acts on specific | trial (8/19) | ||||||
(NYSE:PFE) | receptor subtypes of the | |||||||
neurotransmitter gamma | ||||||||
amino butyric acid | ||||||||
Titan Pharma- | Iloperidone | Small molecule drug | Schizophrenia | Novartis initiated | ||||
ceuticals Inc. and | that blocks serotonin | international Phase III | ||||||
Novartis AG | and dopamine | trial (8/18) | ||||||
(Switzerland) | ||||||||
INFECTION | ||||||||
Aviron | FluMist | Nasal spray formu- | Prevention of influ- | Announced preliminary | ||||
lation of influenza | enza infection in | analysis of data from 2nd | ||||||
vaccine; attenuated, | children | year of 2-year study | ||||||
cold-adapted live | (1997-1998 flu season) | |||||||
virus vaccine | (8/3) | |||||||
Aviron | FluMist | Nasal spray formu- | Prevention of influ- | Initiated 3-year clinical | ||||
lation of influenza | enza infection in | trial to assess commu- | ||||||
vaccine; attenuated, | pre-school and school- | nity wide vaccination in | ||||||
cold-adapted live | age children | children; non-random- | ||||||
virus vaccine | ized, open-label trial to | |||||||
be conducted by Baylor | ||||||||
College of Medicine and | ||||||||
others (8/6) | ||||||||
Virus Research | Rotavirus | Oral vaccine consisting | Prevention of rotavirus | Announced results of | ||||
Institute Inc. and | vaccine | of live, weakened rota- | disease (gastroenteritis) | Phase II trial (8/13) | ||||
SmithKline Beech- | virus | in infants | ||||||
am Biologicals | ||||||||
(Belgium; unit of | ||||||||
SmithKlineBeech- | ||||||||
am plc; NYSE: | ||||||||
SBH; U.K.) | ||||||||
MISCELLANEOUS | ||||||||
Cellegy Pharma- | Glylorin | Monolaurin | Ichthyosis vulgaris | Announced results of | ||||
ceuticals Inc. and | (severe dry skin | Phase II trial (8/13) | ||||||
Glaxo Wellcome | disorder) | |||||||
plc (NYSE:GLX; U.K.) | ||||||||
Hemispherx Bio- | Ampligen | Double-stranded syn- | Chronic fatigue | Initiated Phase III con- | ||||
Pharma Inc. | thetic RNA compound | syndrome/myalgic | firmatory trial (8/3) | |||||
(AMEX:HEB) | poly I:poly C12U | encephalomyelitis | ||||||
Human Genome | KGF-2 | Keratinocyte growth | Various wound- | Completed Phase I trial | ||||
Sciences Inc. | factor-2 (genomics- | healing applications | (8/25) | |||||
derived; member of | (topical) | |||||||
fibroblast growth | ||||||||
factor family) | ||||||||
The Immune | IR 501 | Therapeutic vaccine; | Rheumatoid arthritis | Initiated open-label, | ||||
Response Corp. | combination of 3 T-cell | long-term follow-up trial | ||||||
receptor peptides plus | (8/18) | |||||||
adjuvant; intramuscular | ||||||||
injection | ||||||||
NeXstar Pharma- | NX 1838 | Small molecule inhib- | Age-related macular | FDA cleared protocol for | ||||
ceuticals Inc. | itor of vascular endo- | degeneration | Phase I trial (8/27) | |||||
thelial growth factor, | ||||||||
developed via NeXstar's | ||||||||
SELEX combinatorial | ||||||||
chemistry process | ||||||||
Novavax Inc. | Androsorb | Topical cream formu- | Testosterone defic- | Initiated 2nd phase of | ||||
lation containing nano- | iency in men | pharmacokinetic study | ||||||
some encapsulated | (8/17) | |||||||
testosterone | ||||||||
Novavax Inc. | Estrasorb | Topical cream formu- | Symptomatic meno- | Completed subject dos- | ||||
lation containing nano- | pausal women | ing in pharmacokinetic | ||||||
some-encapsulated | study (8/13) | |||||||
17 beta estradiol | ||||||||
Ortec Inter- | Composite | Bioengineered bovine | Donor site wounds | Initiated patient enrol- | ||||
national Inc. | Cultured Skin | collagen matrix seeded | lment in pilot trial (8/5) | |||||
with epidermal and | ||||||||
dermal cells (biologi- | ||||||||
cally active wound | ||||||||
dressing) | ||||||||
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. 11-12. |