Company | Product Name | Description | Indication | Status/Date |
CANCER | ||||
Aastrom Bio- | Aastrom | Ex vivo stem cell | Production of ex vivo stem | Announced initial results |
sciences Inc. | Cell Produc- | culturing device with | cells from umbilical cord | of pilot clinical trial; also |
tion System | disposable casettes | blood for children with | expanded trial to include | |
leukemia and patients with | more patients (5/13) | |||
diseases of the blood | ||||
Agouron | AG3340 | Small synthetic mole- | Advanced lung or prostate | Initiated Phase II/III |
Pharmaceuticals | cule designed to select- | cancer; advanced non-small | trials in North America | |
Inc. | ively inactivate matrix | cell lung cancer (combination | (5/5) | |
metalloproteases (also | therapy with Taxol and | |||
has anti-angiogenic | carboplatin); and advanced | |||
activity) (oral dose) | hormone-refractory prostate | |||
cancer (combination therapy | ||||
with mitoxantrone and | ||||
prednisone) | ||||
Avax | M-Vax | Therapeutic vaccine; tumor | Stage IV malignant | Presented results of small |
Technologies | cells removed from patient, | melanoma that has | clinical study at 34th | |
Inc. | modified with hapten | metastasized to the lung | annual meeting of the | |
(dinitrophenyl; DNP), then | American Society of Clin- | |||
injected back into patients | ical Oncology (ASCO) in | |||
(along with cyclophos- | Los Angeles (5/18) | |||
phamide) | ||||
Cell Genesys | Gene | T cell cancer gene therapy; | Advanced metastatic | Presented preliminary |
Inc. | therapy | patient's own T cells are | colon cancer | results of Phase I/II trial |
genetically modified with | at ASCO meeting (5/18) | |||
the CC49-zeta gene (which | ||||
targets cancer cells | ||||
expressing TAG-72 surface | ||||
protein); cells then expanded | ||||
in number and infused back | ||||
into patient | ||||
Cell Genesys | GVAX | Cancer vaccine; 1st generation | Prostate cancer | Presented results of Phase |
Inc. | product is patient-specific | I trial (with 1st generation | ||
(autologous), in which | product) and preliminary | |||
patient's cells are genetically | results of Phase I/II trial | |||
modified ex vivo with gene | (with 2nd generation pro- | |||
for granulocyte macrophage- | duct) at ASCO meeting | |||
colony stimulating factor | (5/19) | |||
(GM-CSF), then infused back | ||||
into patient; 2nd-generation | ||||
product is non-patient-specific | ||||
(allogeneic), in which vaccine | ||||
consists of irradiated, | ||||
genetically modified GM-CSF- | ||||
secreting tumor cell lines | ||||
Cell | CT-2584 | Small-molecule anti- | Chemotherapy-resistant | Presented data from Phase |
Therapeutics | angiogenic drug that | cancers | I trial at ASCO meeting | |
Inc. | affects tumor-cell phos- | (5/18) | ||
pholipids (intravenous) | ||||
Corixa Corp. | HER2/neu | Peptide vaccine com- | Breast cancer, ovarian | Presented results of Phase |
vaccine | posed of multiple short | cancer and non-small | I trial at ASCO meeting | |
peptides from the natural | cell lung cancer | (5/18) | ||
sequence of HER2/neu, | ||||
mixed with granulo- | ||||
cyte macrophage-colony | ||||
stimulating factor | ||||
Coulter Pharma- | Bexxar | Iodine I-131 tositumo- | Low-grade and trans- | Presented meta-analysis |
ceutical Inc. | mab; murine monoclo- | formed low-grade non- | of 4 clinical trials at the | |
nal antibody against | Hodgkin's B-cell | ASCO meeting (5/19) | ||
CD20 antigen on B cells; | lymphoma | |||
radiolabeled with I-131 | ||||
Coulter Pharma- | Bexxar | Iodine I-131 tositumo- | Retreatment therapy in | Presented clinical trial |
ceutical Inc. | mab; murine monoclo- | non-Hodgkin's lymph- | results at ASCO meeting | |
nal antibody against | oma patients who had | (5/19) | ||
CD20 antigen on B cells; | relapsed after initial | |||
radiolabeled with I-131 | Bexxar treatment | |||
Coulter Pharma- | Bexxar | Iodine I-131 tositumo- | Patients with newly | Presented preliminary |
ceutical Inc. | mab; murine monoclo- | diagnosed, advanced | results of Phase II trial at | |
nal antibody against | low-grade non-Hodg- | ASCO meeting (5/18) | ||
CD20 antigen on B cells; | kin's lymphoma | |||
radiolabeled with I-131 | ||||
Coulter Pharma- | Bexxar | Iodine I-131 tositumo- | High-dose Bexxar in | Presented preliminary |
ceutical Inc. | mab; murine monoclo- | combination with | results of Phase I/II trial | |
nal antibody against | chemotherapy and stem | at ASCO meeting (5/18) | ||
CD20 antigen on B cells; | cell transplantation for | |||
radiolabeled with I-131 | treating non-Hodgkin's | |||
lymphoma | ||||
Coulter Pharma- | Bexxar | Iodine I-131 tositumo- | Patients with non- | Announced interim data |
ceutical Inc. | mab; murine monoclo- | Hodgkin's lymphoma | from Phase III trial; also, | |
nal antibody against | who are refractory to | patient enrollment for | ||
CD20 antigen on B cells; | chemotherapy | this trial is complete | ||
radiolabeled with I-131 | (5/12) | |||
Diatide Inc. | P829 | Synthetic, somatostatin- | In vivo imaging agent | Phase III trial results did |
(techtide) | type receptor-binding | for detecting and local- | not support precise reg- | |
peptide P829, designed | izing cancer in the lung | ional localization of | ||
to attach to targeted dis- | tumor mass; company | |||
ease molecules and | will no longer use product | |||
labeled with technetium- | to localize lung cancer | |||
99m | but rather as general tool | |||
for differentiating be- | ||||
tween benign and malig- | ||||
nant masses in lung (5/11) | ||||
GeneMedicine | IL-2 | Plasmid encoding the | Head and neck cancer | Reported results of Phase |
Inc. and | Gene | human interleukin-2 | I trials (in U.S. and Ger- | |
Boehringer | Medicine | gene and a cationic | many) at the 1st annual | |
Mannheim GmbH | lipid gene-delivery | meeting of the American | ||
(Germany) | system that enhances | Society of Gene Therapy | ||
uptake of gene into | (ASGT) in Seattle (5/29) | |||
target cells after direct | ||||
intra-tumoral injection | ||||
Genentech Inc. | Herceptin | Trastuzumab; human- | Treatment of HER2- | Presented results of Phase |
ized monoclonal anti- | overexpressing meta- | III trial at ASCO meeting | ||
body to HER2 growth | static breast cancer | (5/18) | ||
factor receptor | (in combination with | |||
standard chemotherapy) | ||||
Idec Pharma- | Rituxan | Rituximab; genetically | Combination therapy | Presented results of small |
ceuticals | (FDA- | engineered chimeric pan- | with standard CHOP | Phase II study at ASCO |
Corp. and | approved) | B monoclonal antibody | chemotherapy in treat- | meeting (5/18) |
Genentech Inc. | that targets CD20 anti- | ing previously untreated | ||
gen on B cell surface | intermediate- and high- | |||
grade non-Hodgkin's | ||||
B-cell lymphoma | ||||
ImClone Systems | BEC2 | Anti-idiotypic mono- | Small cell lung cancer | Initiated international |
Inc. and Merck | clonal antibody that | Phase III trials (5/19) | ||
KGaA (Germany) | mimics GD3 glycolipid | |||
(structural tumor antigen) | ||||
that is overexpressed on | ||||
various cancers | ||||
ImClone Systems | C225 | Chimerized monoclonal | Combination therapy | Presented results of Phase |
Inc. | antibody to epidermal | with radiation for treat- | Ib/II trial at ASCO meet- | |
growth factor receptor | ing advanced squamous | ing (5/18) | ||
cell head and neck cancer | ||||
Immunomedics | CEA-Scan | Fragment of murine | In vivo imaging of non- | Reported data from clini- |
Inc. | monoclonal antibody to | palpable breast lesions | cal study at ASCO meet- | |
tumor marker carcino- | that are abnormal by | ing (5/18) | ||
embryonic antigen | mammography | |||
(CEA), labeled with | ||||
technetium-99m | ||||
Immunomedics | LymphoCide | Humanized lymphoma | Advanced, chemo- | Reported data from clini- |
Inc. | antibody consisting of | therapy-resistant non- | cal study at ASCO meet- | |
murine binding sites | Hodgkin's lymphoma | ing (5/18) | ||
linked to human immuno- | ||||
globulin backbone; | ||||
labeled with I-131 | ||||
Introgen Thera- | INGN 201 | p53 gene therapy via | Advanced non-small | Presented results of Phase |
peutics Inc.* and | adenoviral vector; intra- | cell lung cancer in | I/II trial at ASCO meeting | |
RPR Gencell | tumoral injection | patients who had not | (5/18) | |
(division of Rhone- | responded to conven- | |||
Poulenc Rorer | tional therapy | |||
Inc.) | ||||
Introgen Thera- | INGN 201 | p53 gene therapy via | Advanced head and | Reported results of Phase |
peutics Inc.* and | adenoviral vector; intra- | neck cancer and non- | I trials at ASGT meeting | |
RPR Gencell | tumoral injection | small cell lung cancer | (5/30) | |
(division of | (use as single agent or | |||
Rhone-Poulenc | as adjuvant to standard | |||
Rorer Inc.) | therapy) | |||
Isis Pharma- | ISIS3521/ | 20-base antisense DNA | Solid tumors | Presented results of Phase |
ceuticals Inc. and | CGP64128A | sequence that hybridizes | I trial at ASCO meeting | |
Novartis Pharma | to and inhibits protein | (5/19) | ||
AG (Switzerland) | kinase C-alpha expression | |||
(infusion) | ||||
Isis Pharma- | ISIS5132/ | Antisense inhibitor of | Various cancers, | Presented results of Phase |
ceuticals Inc. and | CGP69846A | C-raf kinase (thought to | including colon cancer | I trial at ASCO meeting |
Novartis Pharma | play role in signal trans- | (5/19) | ||
AG (Switzerland) | duction processes that | |||
regulate cell proliferation) | ||||
(infusion) | ||||
Ixsys Inc.* | Vitaxin | Monoclonal antibody | Various cancers | Presented results of com- |
that inhibits angiogene- | pleted Phase I trial at | |||
sis by binding to alpha | ASCO meeting (5/18) | |||
(V)-beta (3) receptor | ||||
that is expressed on | ||||
newly sprouting blood | ||||
vessels (derived from | ||||
murine monoclonal | ||||
antibody; modified via | ||||
molecular design) | ||||
Jenner Bio- | OncoVax-P | Cancer vaccine; incor- | Prostate cancer | Presented results of pilot |
therapies Inc.* | porates recombinant | trial at ASCO meeting | ||
prostate-specific antigen | (5/18) | |||
plus adjuvant in lipo- | ||||
somal formulation | ||||
Ligand Pharma- | LGD 1550 | Retinoic acid receptor- | Advanced cancers | Reported results of 2 |
ceuticals Inc. | selective retinoid (oral) | Phase I/II trials at ASCO | ||
meeting (5/18) | ||||
Ligand Pharma- | Panretin | Chemically synthesized | Kaposi's sarcoma in | Presented final results of |
ceuticals Inc. | Capsules | version of 9-cis-retinoic | AIDS patients | Phase II trial (sponsored |
acid (natural hormone | by the National Cancer | |||
derived from vitamin A) | Institute) at ASCO meet- | |||
(oral dosage) | ing (5/18) | |||
The Liposome | Evacet | Liposomal formulation | Advanced-stage | Presented interim results |
Co. Inc. | of doxorubicin | breast cancer | of Phase III trial at ASCO | |
meeting (5/20) | ||||
Megabios Corp. | Gene therapy | Combination of 2 genes | Melanoma | FDA approved protocol |
(interleukin-2 and a | for Phase I/II trial (5/28) | |||
superantigen gene) | ||||
injected directly into | ||||
tumor (non-viral | ||||
delivery) | ||||
NeoRx Corp. and | Avicidin | Multi-step process that | Various advanced | Presented data from |
Janssen Pharma- | involves separate ad- | cancers that are resistant | Phase I trial at ASCO | |
ceutica NV (Bel- | ministration of murine | to standard therapies | meeting (5/19) | |
gium; subsidiary of | monoclonal antibody | |||
Johnson & Johnson; | (linked to strepavidin) | |||
NYSE:JNJ) | and yttrium-90 (linked | |||
to biotin); products | ||||
join at and kill tumor | ||||
NeuroVir Inc.* | G 207 | Genetically engineered | Malignant brain tumors, | Initiated Phase I trial |
(Canada) | herpes simplex virus; | including recurrent | (5/13) | |
variant that replicates | glioblastoma | |||
selectively in and kills | ||||
tumor cells | ||||
Onyx Pharma- | ONYX-015 | Genetically engineered | Head and neck cancer | Presented results of 2 |
ceuticals Inc. | adenovirus that repli- | in patients with recurrent | Phase II trials at ASCO | |
cates in and kills tumor | disease or end-stage | meeting (5/18) | ||
cells deficient in p53 | treatment-resistant disease | |||
tumor suppressor gene | (combination with 5-FU | |||
product | and cisplatin) | |||
Onyx Pharma- | ONYX-015 | Genetically engineered | Pancreatic cancer | Presented results of 2 |
ceuticals Inc. | adenovirus that repli- | and gastrointestinal | Phase I trials at ASCO | |
cates in and kills tumor | cancer that has metas- | meeting (5/19) | ||
cells deficient in p53 | tasized to the liver | |||
tumor suppressor gene | ||||
product | ||||
Sugen Inc. | SU 101 | Small-molecule signal | Recurrent malignant | Presented results of 2 |
transduction inhibitor; | glioma and prostate | separate Phase II trials at | ||
specifically inhibits | cancer | ASCO meeting (5/18) | ||
platelet-derived growth | ||||
factor receptor signaling | ||||
Sugen Inc. | SU 5416 | Small-molecule angio- | Blockage of tumor | Presented interim results |
genesis inhibitor target- | angiogenesis in advan- | of ongoing Phase I trial | ||
ing Flk-1/KDR receptor | ced malignancies | at ASCO meeting (5/18) | ||
(to which vascular endo- | ||||
thelial growth factor | ||||
binds, thus activating | ||||
angiogenesis) | ||||
SunPharm Corp. | DENSPM | Diethylnorspermine | Late-stage lung cancer | Presented data from |
and Warner- | (polyamine analogue; | in patients refractory to | Phase I trial at ASCO | |
Lambert Co. | disrupts cancer cell | all conventional chemo- | meeting (5/19) | |
growth processes) | therapy | |||
SuperGen Inc. | RFS 2000 | 2nd generation topo- | Pancreatic cancer | Announced interim |
isomerase I inhibitor | results of Phase II trial | |||
(causes single-stranded | at ASCO meeting (5/18) | |||
breaks in DNA); semi- | ||||
synthetic derivative of | ||||
naturally occurring | ||||
plant alkaloid (oral) | ||||
Targeted | E1A Gene | E1A tumor suppressor | Breast cancer and head | Reported additional re- |
Genetics Inc. | Therapy | gene product; consists of | and neck cancer | sults of Phase I trial at |
(tgDCC-E1A) | E1A gene formulated in | ASCO meeting (5/18) | ||
lipid-based gene delivery | ||||
system; intratumoral | ||||
injection | ||||
Targeted | E1A Gene | E1A tumor suppressor | Advanced breast and | Reported additional re- |
Genetics Inc. | Therapy | gene product; consists of | ovarian cancers | sults of Phase I trial at |
(tgDCC-E1A) | E1A gene formulated in | ASGT meeting (5/30) | ||
lipid-based gene delivery | ||||
system; intratumoral | ||||
injection | ||||
Titan Pharma- | TriAb | Anti-idiotypic mono- | Early-stage post- | Presented preliminary |
ceuticals Inc. | clonal antibody-based | surgical breast cancer; | results of Phase I/II trial | |
vaccine; mimics epitope | also metastatic breast | at ASCO meeting (5/19) | ||
on breast cancer cell- | cancer | |||
associated antigen HMFG | ||||
Titan Pharma- | CeaVac | Anti-idiotypic mono- | Resected colon cancer | Presented preliminary |
ceuticals Inc. | clonal antibody-based | (stages II, III and IV) | results of Phase I/II trial | |
vaccine; mimics CEA | at ASCO meeting (5/19) | |||
antigen present on many | ||||
types of cancer cells | ||||
Titan Pharma- | TriGem | Anti-idiotypic mono- | Metastatic melanoma | Presented preliminary |
ceuticals Inc. | clonal antibody-based | results of Phase I/II trial | ||
vaccine; mimics GD2 | at ASCO meeting (5/19) | |||
antigen present on many | ||||
types of cancer cells | ||||
Vical Inc. | Allovectin-7 | Gene encoding HLA-B7 | Metastatic, refractory | Initiated expanded, open- |
(human leukocyte anti- | Stage III or IV mela- | label Phase II trial in North | ||
gen) complexed with | noma that has not yet | America and Phase III trial | ||
lipid and administered | spread to multiple | (product combined with | ||
by intratumoral | internal organs | chemotherapy) (5/18) | ||
injection | ||||
Vical Inc. | Leuvectin | Gene encoding inter- | Advanced metastatic | Initiated Phase II trial |
leukin-2 administered | renal cell carcinoma | (5/18) | ||
by intratumoral injection | ||||
(naked DNA gene therapy) | ||||
CARDIOVASCULAR | ||||
Collateral Thera- | Gene therapy | Intra-arterial delivery | Patients suffering from | Berlex initiated Phase I/II |
peutics Inc. (IPO | of growth factor gene | stable exertional angina | trial (5/12) | |
pending) and | FGF-4 (which promotes | due to atherosclerosis | ||
Berlex | angiogenesis) via adeno- | (coronary artery disease) | ||
Laboratories | viral vector | |||
Inc. (subsidiary of | ||||
Schering AG; | ||||
Germany) | ||||
Corvas Inter- | rNAPc2 | Recombinant NAPc2, | Anticoagulant; prevent- | Initiated Phase I trial |
national Inc. | an inhibitor of Factor | ion and treatment of | (5/13) | |
VIIa/Tissue Factor | disorders resulting from | |||
enzyme complex that | thrombosis, especially | |||
initiates blood coagu- | deep vein thrombosis | |||
lation and clot forma- | ||||
tion (subcutaneous) | ||||
CV Therapeutics | CVT-124 | Selective adenosine | Treatment of edema | Reported results of Phase |
Inc. and Biogen | A(1) receptor antagonist | associated with congest- | II trial (5/29) | |
Inc. | (intravenous) | ive heart failure | ||
Emisphere Tech- | -- | Oral formulation of | Prevention of deep vein | Initiated Phase II trial in |
nologies Inc. and | heparin (anticoagulant) | thrombosis in patients | U.S. and Canada (5/27) | |
Elan Corp. plc | undergoing surgery for | |||
(Ireland) | hip replacement | |||
Genzyme Trans- | rhATIII | Recombinant human | To improve anticoag- | Initiated 3 Phase III trials |
genics Corp. and | antithrombin III, pro- | ulation response to | (2 in heparin-resistant | |
Genzyme Corp. | duced in milk of trans- | heparin in patients | patients; one comparing | |
genic goats (regulates | undergoing coronary | rhATIII with plasma- | ||
blood clotting) | artery bypass graft | derived product; trials to | ||
surgery | be conducted in U.S. and | |||
Europe) (5/13) | ||||
Hemosol Inc. | Hemolink | Highly purified hemo- | Treatment of anemia | FDA cleared protocol for |
(TSE:HML; Canada) | globin extracted from | secondary to kidney | Phase II trial (5/1) | |
outdated human donor | failure | |||
blood, then cross-linked | ||||
to form stable hemo- | ||||
globin molecule (red | ||||
blood cell substitute) | ||||
Ibex Technologies | Neutralase | Heparinase I, a heparin | Heparin neutralization | Presented results of Phase |
Inc. (TSE:IBX; | degrading enzyme | in patients undergoing | II trial at 20th annual | |
Canada) | (bolus injection) | coronary artery bypass | meeting of the Society of | |
graft surgery | Cardiovascular Anesthes- | |||
iologists in Seattle (5/4) | ||||
Scios Inc. and | Fiblast | Trafermin; recombinant | Acute stroke | Enrollment in Phase II/III |
Wyeth-Ayerst | human basic fibroblast | North American trial was | ||
(division of American | growth factor | temporarily suspended; | ||
Home Products | Data Safety and Monitor- | |||
Corp.; NYSE:AHP) | ing Committee wants to | |||
review data from all | ||||
patients (5/18) | ||||
CENTRAL NERVOUS SYSTEM | ||||
NeoTherapeutics | AIT-082 | Small molecule com- | Mild-to-moderate | Initiated Phase II trial |
Inc. | pound designed to cross | Alzheimer's disease | (5/11) | |
blood-brain barrier and | ||||
enhance nerve cell func- | ||||
tion by increasing levels | ||||
of neurotrophic factors | ||||
Sibia Neuro- | SIB-1508Y | Small molecule com- | Parkinson's disease | Modified dosing regimen |
sciences Inc. | pound that is selective | for newly enrolled trial | ||
for certain nicotinic | subjects in ongoing Phase | |||
acetylcholine receptor | II trial (5/15) | |||
(NAChR) subtypes in | ||||
the brain; the receptors | ||||
regulate the release of | ||||
dopamine and acetyl- | ||||
choline | ||||
INFECTION | ||||
Antex Biologics | Campylobac- | Oral, inactivated whole- | Prevention of Campylo- | Announced preliminary |
Inc. (OTC Bulletin | ter vaccine | cell vaccine, combined | bacter infection and its | results of Phase II trial |
Board: ANTX) and | with adjuvant | related gastroenteritis | (being conducted by the | |
SmithKline | and diarrhea | U.S. Army and U.S. | ||
Beecham plc | Navy) (5/5) | |||
(NYSE:SBH; U.K.) | ||||
Aronex Pharma- | Nyotran | Liposomal formulation | Systemic fungal | Reported clinical trial |
ceuticals Inc. | of the antifungal agent | infections (2nd-line | data at annual meeting of | |
Nystatin | therapy) | the American Society for | ||
Microbiology in Atlanta | ||||
(5/21) | ||||
Aviron | FluMist | Attenuated, cold-adapted | Prevention of influenza | Results of Phase III trial |
live virus vaccine | infection in children | (sponsored by National | ||
(nasal spray formulation) | 15 months to 6 years | Institutes of Health) pub- | ||
lished in 5/14/98 issue of | ||||
The New England Journal | ||||
of Medicine (5/13) | ||||
BioChem Pharma | BCH-10652 | Nucleoside analogue; | HIV infection and | Initiated Phase I trial |
Inc. (Canada) | blocks replication of | AIDS | (5/6) | |
HIV, including strains | ||||
resistant to 3TC and AZT | ||||
Cel-Sci Corp. | Multikine | Natural mixture of | HIV infection and | Completed patient enrol- |
human cytokines, | AIDS | lment in Phase I trial | ||
including interleukin-2 | (conducted at AIDS Re- | |||
SEARCH Alliance in | ||||
West Hollywood) (5/5) | ||||
Schering-Plough | Rebetron | Combination of | Combination therapy | Schering-Plough reported |
Corp. (NYSE:SGP) | Intron A (recombi- | for treating chronic | results of 2 pivotal Phase | |
and ICN Pharma- | nant human interferon | hepatitis C virus | III trials (5/18) | |
ceuticals Inc. | alfa-2b; injection) and | infection in patients | ||
(NYSE:ICN) | Rebotol (ribavirin; | with compensated liver | ||
synthetic nucleoside | disease who have not | |||
with antiviral activity; | received previous alpha- | |||
oral) (each product | interferon therapy | |||
separately approved | (treatment-naive) | |||
by FDA for other uses) | ||||
SunPharm Corp. | DEHOP | Diethyl-homospermine | AIDS-related | Presented data from Phase |
(polyamine analogue) | diarrhea | II trial at the American | ||
Gastroenterology Assoc- | ||||
iation's annual Digestive | ||||
Disease Week conference | ||||
in Chicago (5/18) | ||||
MISCELLANEOUS | ||||
AtheroGenics | AGI 1067 | Composite vascular | Onset and progression | FDA cleared protocol for |
Inc.* | protectant; oral small | of coronary artery | Phase I trial (5/15) | |
molecule compound | disease (lowers LDL | |||
that targets regulatory | cholesterol levels) | |||
signals for genes in- | ||||
volved in inflammatory | ||||
and proliferative diseases | ||||
AutoImmune Inc. | Colloral | Liquid oral formulation | Rheumatoid arthritis | Initiated Phase III trial |
of a Type II collagen | (5/5) | |||
BioTransplant | MEDI-507 | Humanized monoclonal | To prevent or reduce | Presented preliminary |
Inc. and | antibody that binds to | incidence of kidney | results of Phase I trial at | |
MedImmune Inc. | CD2 antigen receptor | transplant rejection | annual meeting of the | |
found on T cells and | American Society for | |||
natural killer cells | Transplant Surgeons | |||
(ASTS) in Chicago (5/14) | ||||
Celtrix Pharma- | SomatoKine | IGF-BP3 complex; | Treatment of severe | Presented preliminary |
ceuticals Inc. | recombinant version of | burns in children | results of Phase II trial at | |
complex formed by | the Surgical Infection | |||
insulin-like growth | Society conference in | |||
factor-1 and its major | New York (5/4) | |||
binding protein | ||||
CytoMed Inc.* | CMI-977 | Orally active small | Asthma | Initiated Phase I trial |
molecule product that | (5/12) | |||
inhibits 5-lipoxygenase | ||||
cellular inflammation | ||||
pathway (blocks gen- | ||||
eration of leukotrienes) | ||||
GeneMedicine | AAT Gene | Alpha-1 antitrypsin | AAT deficiency (a | Rsearchers from Vander- |
Inc. | Medicine | (AAT) gene delivered | pulmonary deficiency | bilt University conducted |
intranasally via cationic | that can lead to emphy- | Phase I trial (using AAT | ||
lipid gene delivery | sema) | Gene Medicine); results | ||
system (DOTMA) | presented at American | |||
Lung Association and | ||||
American Thoracic Soc- | ||||
iety international confer- | ||||
ence (5/12) | ||||
Nexell | Isolex 300i | Stem cell selection | Chronic granulomatous | Initiated Phase I/II trial |
Therapeutics Inc. | (gene therapy) | system; device that | disease (genetic) | (as part of CRADA with |
(majority-owned | separates CD34+ stem | National Institutes of | ||
subsidiary | cells from peripheral | Health) (5/4) | ||
of VIMRx Pharma- | blood; the gp91 gene | |||
ceuticals Inc.) | is transferred via | |||
retroviral vector into | ||||
cells isolated from | ||||
patient; cells then | ||||
infused back into patient | ||||
OSI Pharma- | TGF-Beta 3 | Recombinant trans- | Wound healing; also | Novartis, which conduct- |
ceuticals Inc. and | forming growth factor- | prevention of oral | ed Phase II trials, said | |
Novartis Pharma | beta | mucositis in cancer | that product showed no | |
AG (Switzerland) | patients undergoing | statistically significant | ||
chemotherapy | benefit over placebo for | |||
either indication; the com- | ||||
panies will drop develop- | ||||
ment in oral mucositis | ||||
but Novartis is evaluating | ||||
other approaches for | ||||
using the product in | ||||
wound healing (5/18) | ||||
Protein Design | Zenapax | Daclizumab; human- | Immunosuppression in | Presented interim data |
Labs Inc. | (FDA- | ized monoclonal anti- | kidney transplantation | from international Phase |
and Hoffmann- | approved) | body (SMART Anti- | (combination therapy | II trial at ASTP/ASTS |
La Roche Inc. | TAC) that binds to the | with CellCept and cor- | meeting (5/13) | |
interleuklin-2 receptor | ticosteroids but without | |||
on activated T cells | cyclosporine) | |||
Protein Design | Zenapax | Daclizumab; human- | Immunosuppression in | Presented preliminary |
Labs Inc. and | (FDA- | ized monoclonal anti- | kidney transplantation | results of Phase I/II |
Hoffmann- | approved) | body (SMART Anti- | in children (combina- | trial at ASTP meeting |
La Roche Inc. | TAC) that binds to the | tion therapy with stan- | (5/11) | |
interleuklin-2 receptor | dard immunosuppres- | |||
on activated T cells | sive drugs) | |||
SangStat Medical | Thymo- | Rabbit anti-human | Prevention of acute | Results of long-term |
Corp. | globulin | thymocyte polyclonal | graft rejection in kidney | follow-up of U.S. trial |
antibody | transplant patients | comparing Thymoglobu- | ||
lin with Atgam (horse | ||||
anti-thymocyte globulin; | ||||
standard of care) presen- | ||||
ted at annual meeting of | ||||
the American Society of | ||||
Transplant Physicians | ||||
(ASTP) in Chicago (5/12) | ||||
Transcend Thera- | Procysteine | Product that delivers | Acute respiratory | Phase III trial, which was |
peutics Inc. and | I.V. | cysteine into cells to | distress syndrome | suspended on 3/20/98, |
Boehringer Ingel- | neutralize tissue-damag- | has now been discontin- | ||
heim International | ing reactive oxygen | ued to allow companies | ||
GmbH (Germany) | species by boosting | to unblind study and con- | ||
cellular production of | duct full analysis of safe- | |||
glutathione | ty and efficacy data (5/8) | |||
Unimed Pharma- | Androgel | Gel-based product for | Testosterone deficiency | Completed patient enrol- |
ceuticals Inc. | transdermal administra- | in males (hypogo- | lment in pivotal Phase | |
tion of testosterone | nadism) | III trial (5/28) | ||
NOTES: | ||||
TSE = Toronto Stock Exchange | ||||
* Private companies are indicated with an asterisk. |