Company** | Product | Description | Indication | Status (Date) |
CANCER | ||||
Amgen Inc. | MGDF | Recombinant human | Various cancers | Some patients in trial devel- |
megakaryocyte growth | oped neutralizing antibodies; | |||
and development | so did some in separate platelet | |||
factor | donor trial; company discon- | |||
tinued MGDF program (9/11) | ||||
Biomira Inc. | Theratope | Synthetic, carbohydrate- | Metastatic breast cancer | Bridging study on improved |
(Canada) and | vaccine | based vaccine (mimic of | following chemotherapy | formulation of vaccine is |
Chiron Corp. | cancer antigen sialyl-Tn | fully enrolled (9/18) | ||
plus carrier molecule KLH) | ||||
Celgene Corp. | Thalomid | Thalidomide; thought to | End-stage, refractory | Results of trial conducted by |
(FDA- | act by modulating levels | multiple myeloma | researchers at Arkansas Can- | |
approved) | of tumor necrosis factor- | cer Research Center present- | ||
alpha | ed at Leukemia Society of | |||
America meeting in Wash- | ||||
ington (9/28) | ||||
Cell Genesys Inc. | GVAX | Cancer vaccine; 2nd-gen- | Prostate cancer | Reported preliminary results |
eration product that is non- | of ongoing Phase I/II trial at | |||
patient-specific (allogeneic); | 5th Annual CaP Cure Sci- | |||
consists of irradiated, gen- | entific Retreat at Lake Tahoe, | |||
etically modified prostate | Nevada (9/14) | |||
cancer cells that secrete | ||||
granulocyte macrophage- | ||||
colony stimulating factor; | ||||
intradermal injection | ||||
Enzon Inc. and | PEG- | Long-acting dosage form | Malignant melanoma | Schering-Plough initiated |
Schering-Plough | Intron A | of Intron A (recombinant | Phase III trial (9/21) | |
Corp. (NYSE:SGP) | interferon alfa-2b) conju- | |||
gated to polyethylene | ||||
glycol | ||||
The Immune | — | Vaccine consisting of | Recurrent refractory | Initiated Phase Ib trial (9/16) |
Response Corp. | combination of 3 colon | colon cancer | ||
tumor cell lines plus a | ||||
fibroblast cell line that | ||||
secretes interleukin-2 | ||||
NeoPharm Inc. | LEP | Liposomal encapsulated | Various cancers | Initiated Phase I trial (9/22) |
paclitaxel | ||||
Onyx | ONYX-015 | Genetically engineered | Pancreatic cancer (as both | Initiated Phase I/II trial (9/29) |
Pharmaceuticals | adenovirus that repli- | single agent and in combi- | ||
Inc. | cates in and kills tumor | nation with gemcitabine | ||
cells deficient in p53 | intravenous) | |||
tumor suppressor gene | ||||
product | ||||
Osiris | Stromagen | Infused, autologous | Metastatic breast cancer | Initiated Phase I/II trial (9/30) |
Therapeutics | human mesenchymal | patients receiving high- | ||
Inc.* | stem cell product, | dose chemotherapy and | ||
expanded ex vivo | hematopoietic stem cell | |||
transplants | ||||
Sugen Inc. | SU 101 | Small-molecule signal | Non-small cell lung cancer | Initiated Phase II trial (9/18) |
transduction inhibitor; | (administered prior to sur- | |||
specifically inhibits | gery or radiation and | |||
platelet-derived growth | chemotherapy) | |||
factor receptor signaling | ||||
CARDIOVASCULAR | ||||
CV Therapeutics | CVT-510 | Selective adenosine A(1) | Atrial arrhythmia | Initiated Phase I trial (9/30) |
Inc. | agonist | |||
Transkaryotic | GA-EPO | Gene-activated erythro- | Treatment of anemia in | Hoechst Marion Roussel |
Therapies Inc. and | poietin (EPO); gene in | patients with renal failure | initiated Phase III trial (9/29) | |
Hoechst Marion | human cells is activated | who are receiving dialysis; | ||
Roussel Inc. | in situ to produce EPO | also treatment in pre- | ||
dialysis patients | ||||
CENTRAL NERVOUS SYSTEM | ||||
CoCensys Inc. | Ganaxolone | Synthetic version of | Moderate to severe | Completed Phase II trial (9/10) |
naturally occurring | migraine headaches | |||
neuroactive steroids | ||||
(epalons) that bind to | ||||
gamma amino butyric | ||||
acid (GABA)-A | ||||
receptors in brain | ||||
(tablet formulation) | ||||
Immunex Corp. | Novantrone | Mitoxantrone for injection | To reduce incidence of | Reported preliminary results |
(FDA- | (intravenous) | relapse and disease | of Phase III trial at 14th Con- | |
approved) | progression in multiple | gress of the European Com- | ||
sclerosis | mittee for Treatment and Re- | |||
search in Multiple Sclerosis | ||||
in Stockholm (9/10) | ||||
DIABETES | ||||
Chrysalis | Chrysalin | Synthetic peptide that | Mild to moderate | FDA cleared protocol for |
Biotechnology | accelerates healing of | chronic diabetic ulcers | Phase I/II trial (9/24) | |
Inc.* | wounds and broken | |||
bones; topical | ||||
Ergo Science | Ergoset | Low-dose, oral formu- | Type II diabetes (mono- | Presented clinical data at |
Corp. | Tablets | lation of bromocriptine | therapy as adjunct to | SG Cowen Securities Corp. |
(ergot alkaloid; generic | diet to improve glycem- | 13th Annual Life Sciences | ||
dopamine agonist) | ic control in diabetics) | Conference (Cowen confer- | ||
ence) in San Francisco (9/24) | ||||
Inhale | — | Dry powder formulation | To improve glycemic | Reported preliminary results |
Therapeutics Inc. | of insulin; delivered via | control in Types I and II | of Phase IIb trial at European | |
and Pfizer Inc. | pulmonary delivery system | diabetes | Association for the Study of | |
(NYSE:PFE) | Diabetes meeting in Barce- | |||
lona, Spain (9/9) | ||||
INFECTION | ||||
Aronex | Nyotran | Liposomal formulation of | Severe systemic fungal | Presented data from Phase II |
Pharmaceuticals | antifungal agent Nystatin | infections | trial at 38th Interscience Con- | |
Inc. | ference on Antimicrobial | |||
Agents and Chemotherapy | ||||
(ICAAC) in San Diego (9/28) | ||||
Aviron | FluMist | Nasal spray formulation | Prevention of influenza | Presented new data from 2nd |
of influenza vaccine; | infection in children | year of Phase III trial at | ||
attenuated, cold-adapted | ICAAC (9/27) | |||
live virus vaccine | ||||
Cell Genesys Inc. | Gene | Procedure by which | Combination therapy | Completed patient enroll- |
therapy | patient's own T cells are | with antiretroviral drugs | ment in Phase II trial; also | |
collected, genetically | for HIV infection and | presented results of 1st | ||
modified to recognize and | AIDS | Phase II trial at ICAAC | ||
destroy HIV-infected cells, | (9/28) | |||
then returned to patient | ||||
Gilead Sciences | PMPA | Oral prodrug of nucleo- | Combination therapy | Initiated Phase II trial (9/4) |
Inc. | tide analogue known to | with antiretroviral drugs | ||
inhibit reverse transcrip- | for treating HIV infection | |||
tase | in treatment-experienced | |||
patients | ||||
Preveon | Adefovir dipivoxil; | HIV infection and AIDS | Completed patient enroll- | |
reverse transcriptase | ment in 3 clinical trials | |||
inhibitor (oral dosage) | (Phases II and II/III) and | |||
concluded 4th trial (Phase | ||||
III) (9/23) | ||||
Gilead Sciences | GS4104 | Neuraminidase inhibitor | Treatment and preven- | Presented results of U.S. and |
Inc. and F. Hoff- | (oral formulation) | tion of viral influenza | international Phase III trials | |
mann-La Roche | (strains A and B) | at ICAAC (9/25) | ||
Ltd. (Switzerland) | ||||
ImmuCell Corp. | TravelGAM | Bovine anti-Escherichia | Traveler's diarrhea | Preliminary results of Phase |
coli immunoglobulins | II trial were negative; company | |||
will not pursue this clinical | ||||
indication (9/22) | ||||
Lidak | Lidakol | N-docosanol 10% cream; | Recurrent outbreaks of | Presented results of pivotal |
Pharmaceuticals | long-chain fatty acid that | oral herpes (cold sores | Phase III trials at ICAAC | |
interferes with viral entry | or fever blisters caused | (9/26) | ||
into cells | by herpes simplex virus) | |||
MedImmune Inc. | MEDI-501 | Virus-like particle-based | Genital warts; cervical | Presented new data from |
vaccine for human papil- | cancer | Phase I trial at ICAAC (9/28) | ||
loma virus (HPV) Type 11 | ||||
MedImmune Inc. | Synagis | Palivizumab; humanized | Treatment and prevention | Results from pivotal Phase III |
(FDA- | monoclonal antibody to | of serious RSV disease in | trial published in 9/98 issue | |
approved) | respiratory syncytial virus | certain high-risk infants | of Pediatrics (9/3) | |
(RSV); binds to fusion pro- | and children (causes pneu- | |||
tein on viral surface | monia, bronchitis) | |||
Synagis | Palivizumab; humanized | Treatment and prevention | Presented new data from | |
(FDA- | monoclonal antibody to | of RSV infection in adult | Phase I trial at ICAAC (9/28) | |
approved) | respiratory syncytial virus | recipients of hematopoi- | ||
(RSV); binds to fusion pro- | etic stem cell transplants | |||
tein on viral surface | ||||
NeXstar Pharma- | MiKasome | Liposomal formulation of | HIV infection and AIDS | Presented results from 2nd |
ceuticals Inc. | antibiotic amikacin | Phase I trial at ICAAC (9/28) | ||
Sarawak Medi- | Canolide A | Non-nucleoside reverse | HIV infection and AIDS in | Initiated Phase Ib trial (9/30) |
Chem Pharmaceu- | transcriptase inhibitor | treatment-naive patients | ||
ticals Inc.* (joint | (originally isolated from | |||
venture between | tree found in Sarawak | |||
MediChem Research | rain forest) | |||
Inc. and the state of | ||||
Sarawak, Malaysia) | ||||
Trimeris Inc. | T-20 | Antiviral fusion- | HIV infection and AIDS | Initiated dosing in Phase II |
inhibiting compound | trial (9/16) | |||
(delivered by continuous | ||||
or intermittent subcut- | ||||
aneous infusion pump) | ||||
U.S. Bioscience | FddA | Lodenosine; acid-stable, | Combination therapy | FDA cleared protocol for |
Inc. | purine-based reverse | with Zerit and Crixivan for | Phase II trial (9/10) | |
transcriptase inhibitor | treating HIV infection in | |||
treatment-naive patients | ||||
Vertex | VX-497 | Small molecule drug | Hepatitis C virus infection | Initiated Phase II trial (9/21) |
Pharmaceuticals | designed to inhibit inosine | in patients unresponsive | ||
Inc. | monophosphate dehydro- | to alpha interferon therapy | ||
genase (essential for pro- | ||||
duction of nucleotides) | ||||
Vertex Pharma- | Agenerase | Amprenavir; 2nd-generation | Combination therapy with | Presented interim results of |
ceuticals Inc. and | HIV protease inhibitor; | Retrovir and Epivir in HIV | Phase III trial at ICAAC | |
Glaxo Wellcome | twice-daily dosage | infection and AIDS | (9/27) | |
plc (NYSE:GLX; U.K.) | ||||
Xoma Corp. | Neuprex | Recombinant bactericidal/ | Complicated intra-abdom- | Presented Phase II results at |
permeability-increasing | inal infections | ICAAC (9/24) | ||
protein (rBPI) | ||||
MISCELLANEOUS | ||||
Agouron | AG 3340 | Small synthetic mole- | Age-related macular | Initiated Phase II trial (9/15) |
Pharmaceuticals | cule designed to select- | degeneration | ||
Inc. | ively inactivate matrix | |||
metalloproteases (also has | ||||
anti-angiogenic activity) | ||||
(oral dosage) | ||||
Amgen Inc. | OPG | Osteoprotegerin; recombi- | Bone protection in osteo- | Initiated Phase I trial (9/9) |
nant version of naturally | porosis and cancer-related | |||
occurring protein that | bone metastasis | |||
regulates bone mass | ||||
Axys | APC-366 | 1st-generation tryptase | Asthma | In Phase I trials, some individ- |
Pharmaceuticals | inhibitor; dry powder | uals exhibited signs of bron- | ||
Inc. and Bayer AG | inhaler drug formulation | chospasm; clinical studies | ||
(Germany) | will be discontinued (9/29) | |||
Gliatech Inc. | Adcon-P | Anti-adhesion barrier | To inhibit scarring and ad- | Presented results of pilot |
solution (semisynthetic | hesions following pelvic | trial at Cowen conference | ||
carbohydrate polymer) | and abdominal surgery | (9/25) | ||
The Immune | TCR | T cell receptor peptide | Moderate to severe | Presented results of explora- |
Response Corp. | Vaccine | vaccine (combines 3 | psoriasis | tory Phase II trial at 5th Euro- |
T cell receptor peptides | pean Congress on Psoriasis/ | |||
with an adjuvant) | 7th International Psoriasis | |||
Symposium in Milan, Italy | ||||
(9/5) | ||||
Immunex Corp. | Enbrel | Recombinant, soluble | Juvenile rheumatoid | Reported results from 2nd |
p75 tumor necrosis factor | arthritis | segment of trial (9/3) | ||
receptor (TNFr) linked | ||||
to the Fc portion of | ||||
human IgG1 | ||||
InSite Vision Inc. | ISV-205 | Product that inhibits pro- | Glaucoma | Initiated Phase II trial (9/11) |
tein product of TIGR gene | ||||
SciClone | CPX | Oral drug that appears to | Cystic fibrosis | Initiated Phase II trial (9/17) |
Pharmaceuticals | bind to defective CFTR | |||
Inc. | protein (cystic fibrosis trans- | |||
membrane regulator) and | ||||
permit transport of | ||||
chloride ions | ||||
Texas | TBC 1269 | Small molecule compound | Mild to moderate | Announced preliminary |
Biotechnology | that inhibits selectin (anti- | asthma | results of Phase II trial (9/9) | |
Corp. | inflammatory) | |||
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. 14-15. |
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