Company** |
Product |
Description |
Indication |
Status (Date) |
CANCER | ||||
Aronex Pharmaceuticals Inc. |
Atragen |
Liposomal formulation of all-trans retinoic acid; induces tumor cells to differentiate into mature normal cells (injection) |
Advanced renal cell carcinoma (combination therapy with alpha interferon) |
Initiated Phase I/II trial (1/7) |
Diatide Inc. |
NeoTect |
Small molecule synthetic peptide labeled with technetium-99m; peptide designed to adhere to somatostatin receptor |
In vivo imaging agent for suspected malignant tumors of the lung |
Report of clinical study published in 1/14/99 issue of Chest (1/14) |
Ilex Oncology Inc. and Symphar SA (Switzerland) |
SR-45023A |
Orally active bisphosphonate ester derivative; binds to nuclear receptor FXR and selectively induces apoptosis in malignant cells (but not normal ones) |
Advanced metastatic cancer |
Initiated Phase I trial (1/5) |
Onyx Pharmaceuticals Inc. |
ONYX-015 |
Genetically engineered adenovirus that replicates in and kills tumor cells deficient in p53 tumor suppressor gene product (administration via hepatic artery) |
Colorectal cancer that has metastasized to the liver (as monotherapy; also in combination with 5-FU and leucovorin) |
Initiated new Phase I/II trial (1/14) |
CARDIOVASCULAR | ||||
Alexion Pharmaceuticals Inc. |
5G1.1-SC |
Humanized single-chain antibody designed to intervene in complement cascade (complement inhibitor) |
Patients undergoing cardiopulmonary bypass during coronary artery bypass graft surgery |
Initiated Phase IIb trial (1/13) |
CytRx Corp. |
Flocor |
Purified poloxamer 188; surfactant molecule that alters the way cells and molecules interact with water |
Vascular occlusive crisis in sickle cell disease |
After review of Phase III trial results on 1st 50 patients, Safety and Data Monitoring Review Board recommended that company proceed with trial (1/12) |
Emisphere Technologies Inc. and Elan Corp. (Ireland) |
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Oral formulation of heparin (anticoagulant) |
Prevention of deep vein thrombosis in patients plc undergoing surgery for hip replacement |
Announced preliminary results of Phase II trial (1/11) |
Icos Corp. |
LeukArrest (formerly Hu23F2G) |
Humanized monoclonal antibody that blocks CD11/CD18-mediated cell adhesion (inhibits movement of neutrophils from blood into tissue) |
Acute iscehmic stroke |
Initiated Phase III trial in North America (1/25) |
CENTRAL NERVOUS SYSTEM | ||||
Boston Life Sciences Inc. |
Altropane |
Radioimaging probe for dopamine neurons |
Photon emission computed tomography imaging agent for early diagnosis of Parkinson¿s disease |
Announced interim results of Phase II trial (1/26) |
NeoTherapeutics Inc. |
Neotrofin (AIT-082) |
Small molecule compound designed to cross blood-brain barrier and enhance nerve cell function by increasing levels of neurotrophic factors |
Mild-to-moderate Alzheimer¿s disease |
Announced results of Phase Ib trial (1/11); announced results of Phase IIa trial (1/27) |
Sibia NeuroSciences Inc. |
SIB-1508Y |
Small molecule compound that is selective for certain nicotinic acetylcholine receptor (NAChR) subtypes in the brain; the receptors regulate the release of dopamine and acetylcholine |
Patients with mid-to-late stage Parkinson¿s disease (combination therapy with L-dopa at half of the usual dosage) |
Initiated 2nd Phase II trial (1/4) |
Sibia Neurosciences Inc. |
SIB-1553A |
Small molecule compound; subtype-selective nicotinic acetylcholine receptor agonist; stimulates release of acetylcholine in brain |
Alzheimer¿s disease |
Completed multi-dose Phase I trial and initiated Phase II trial (1/7) |
DIABETES | ||||
Amylin Pharmaceuticals Inc. |
Pramlintide |
Synthetic analogue of human pancreatic hormone amylin |
To improve glucose control in patients with Type I diabetes and in insulin-using patients with type II diabetes label |
Reported new clinical data from 4 completed Phase III trials (1/11); announced preliminary results from open long-term studies (1/25) |
INFECTION | ||||
Alpha-Beta Technology Inc. |
Betafectin PGG-Glucan |
Complex carbohydrate-based product |
Prevention of serious infections in patients undergoing upper gastrointestinal surgery |
Discontinued Phase III trial; interim analysis of data showed insufficient evidence of clinical benefit to warrant continuation of trial; company is liquidating its assets (1/22) |
AntexBiologics Inc. (OTC Bulletin Board:ANTX) |
Helicobacter vaccine |
Oral, whole-cell vaccine; consists of inactivated Helicobacter pylori plus mucosal adjuvant |
Gastric ulcers |
Announced results of Phase I trial (1/27) |
IntraBiotics Pharmaceuticals Inc.* |
Protegrin IB-367 |
Synthetic analogue of protegrin family of mammalian antimicrobial peptides (liquid formulation delivered via nebulizer) |
Respiratory infections in cystic fibrosis patients |
Initiated Phase I trial (1/20) |
IntraBiotics Pharmaceuticals Inc.* |
Ramoplanin Ointment |
Naturally occurring antibiotic that kills Gram-positive bacteria (administered intranasally) |
Prevention of nosocomial infections due to Staphylococcus aureus, including methicillinresistant strains |
Initiated Phase II trial (1/13) |
Maxim Pharmaceuticals Inc. |
MaxDerm |
Topical gel or solution; active ingredient is H2 receptor agonist (same as in cancer drug Maxamine) |
Herpes labialis (cold sores) |
Announced preliminary results of clinical study (1/11) |
Shaman Pharmaceuticals Inc. (OTC Bulletin Board: SHMN) |
Provir |
Oral formulation of compound SP-303, which is isolated from the croton plant; it is thought to act by inhibiting secretion of chloride from intestinal cells |
AIDS-related diarrhea |
Initiated open-label study (1/12) |
Targeted Genetics Corp. |
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Adoptive immunotherapy; HIV-positive (gag-specific) cytotoxic T lymphocyrtes isolated from patient, expanded in culture, then infused back |
HIV infection and AIDS |
Results of Phase I trial published in 1/99 issue of Nature Medicine (1/4) |
ViroPharma Inc. |
Pleconaril |
Oral liquid formulation of a small molecule inhibitor of several RNA viruses (blocks replication) |
Severe meningococcemia (viral meningitis) in adults |
Announced results of 2nd of 4 Phase III trials; product did achieve statistical significance in primary endpoint (1/6) |
MISCELLANEOUS | ||||
Abgenix Inc. |
ABX-IL8 |
Fully human monoclonal antibody that binds to interleukin-8 (produced via XenoMouse technology) |
Moderate-to-severe rheumatoid arthritis |
Initiated Phase I trial (1/28) |
Axys Pharmaceuticals Inc. |
APC 2059 |
Topical cream formulation of tryptase inhibitor (tryptase involved in mast cell-mediated inflammation) |
Psoriasis |
Initiated Phase I trial (1/5) |
GelTex Pharmaceuticals Inc. |
CholestaGel |
Cholesterol reducer; non-absorbed hydrogel that binds to and eliminates bile acids from intestinal tract |
Reduction of LDL (low-density lipid) cholesterol in treatmentof hyper-cholesterolemia |
Presented results of Phase III trial at 17th annual Hambrecht & Quist Healthcare Conference in San Francisco (H&Q conference) (1/11) |
Gliatech Inc. |
Adcon-P |
Adhesion control barrier; resorbable carbohydrate polymer liquid |
To inhibit scarring and adhesions in the peritoneal cavity in patients under-going laparoscopic gynecological surgery |
Initiated pivotal trial (1/28) |
Icos Corp. |
ICM3 |
Monoclonal antibody designed to block activity of adhesion molecule ICAM-3 |
Psoriasis |
Initiated Phase I/II trial (1/14) |
Icos Corp. and Eli Lilly and Co. |
IC 351 |
Selective phosphodiesterase 5 inhibitor (thought to reinforce normal physiological signals to increase blood flow) |
Erectile dysfunction |
Presented results of 2 Phase II trials (in U.S. and Europe) at H&Q conference (1/14) |
Medarex Inc. and Centeon LLC |
MDX-33 |
Humanized bispecific antibody; modulates activity of immune system killer cells that can destroy platelets |
Idiopathic thrombocytopenic purpura |
Initiated Phase II trial (1/13) |
Medarex Inc. and Eisai Co. Ltd. (Japan) |
MDX-CD4 |
Fully human monoclonal antibody (created via HuMAb-Mouse technology) to CD4 |
Rheumatoid arthritis |
Initiated Phase I trial (1/28) |
Oxis Therapeutics Inc. (subsidiary of Oxis International Inc.) |
BXT-51072 |
Small molecule compound that mimics action of natural antioxidant enzyme glutathione peroxidase (blocks activity of free radicals) |
Mild-to-moderate ulcerative colitis (2nd-line therapy) |
Announced preliminary results of Phase IIa trial (1/5) |
Vertex Pharmaceuticals Inc. |
VX-497 |
Inosine monophosphate dehydrogenase (IMPDH) inhibitor (blocks DNA synthesis) |
Severe, chronic plaque-type psoriasis |
Initiated Phase II trial (1/21) |
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. x-y. |