| Company ** |
Product |
Description |
Indication |
Type Action (Date) |
CANCER | ||||
| Abgenix Inc. |
ABX-CBL |
Monoclonal antibody that targets CBL antigen (selectively expressed on activated immune cells) |
Severe graft-vs.-host disease (complication of bone marrow transplant in leukemia patients) |
Reported Phase II trial data (2/4) |
| BIOSTAR Inc.* |
Norelin |
Therapeutic vaccine that stimulates immune response to gonadotropin-releasing hormone |
Prostate cancer |
Initiated Phase I/II trial in U.S. and Canada (2/16) |
| Cel-Sci Corp. |
Multikine |
Natural mixture of human cytokines, including interleukin-2 |
Pretreatment before prostatectomy |
Received FDA clearance to start second prostate cancer study (2/9) |
| CollaGenex Pharmaceuticals Inc. |
Metastat |
Orally administered inhibitor of matrix metalloproteinases |
Metastatic cancer unresponsive to other therapeutic strategies |
Reported preliminary findings from ongoing Phase I study at the 1st International Symposium on Antiangiogenic Agents in Irving, Texas (2/11) |
| Corixa Corp. |
-- |
Micro-encapsulated Her-2/neu vaccine; biodegradable microspheres composed of poly-lactic-poly-glocolic acid; designed to improve immune response to protein fragments and peptides |
Breast, ovarian and lung cancer |
Initiated Phase I trial (2/22) |
| ILEX Oncology Inc. |
Eflornithine (DFMO) |
Orally delivered difluoro-methylornithine; selective irreversible inhibitor of ornithine decarboxylase, an enzyme which controls formation of certain poly-amines required by dividing cells |
Prevention of recurrence of superficial bladder cancer |
Initiated pivotal Phase III trial (2/23) |
| Ixsys Inc.* |
Vitaxin |
Monoclonal antibody (derived from murine monoclonal, then modified via molecular design) that inhibits angiogenesis by binding to alpha (V)-beta (3) receptor that is expressed on newly sprouting blood vessels |
Leiomyosarcoma |
Initiated Phase II trial (2/4) |
| The Liposome Co. Inc. |
TLC ELL-12 |
Liposomal ether lipid |
Solid tumors, including non-small-cell lung, prostate and melanoma |
Initiated Phase I trial (2/18) |
| Maxim Pharmaceuticals Inc. |
Maxamine Therapy |
H2 receptor agonist; combination therapy with low-dose interleukin-2 |
Advanced-stage malignant melanoma |
Completed enrollment in Phase III trial (2/8) |
| NeXstar Pharmaceuticals Inc. |
NX211 |
Liposomal form of the investigational anticancer drug lurtotecan, a topoisomerase I inhibitor |
Advanced-stage solid tumors |
Initiated Phase I trials (2/3) |
| Ontogen Corp.* |
OC144-093 |
Small-molecule P-glycoprotein inhibitor |
Reversal of effects of multidrug resistance in patients undergoing cancer chemotherapy |
Completed Phase I study (2/3) |
| OXiGENE Inc. |
Neu- |
Radiation-sensitizer from a class of N-substituted benzamides that inhibit a DNA repair enzyme |
Non-small-cell lung cancer and glioblastoma (in combination with radiation) |
Discontinued development due to excessive side effects in Phase III trials (2/16) |
| ProScript Inc. * |
PS-341 |
Small-molecule inhibitor of ubiquitin-proteasome pathway that regulates many important cellular proteins |
Cancer |
Initiated second Phase I trial (2/11) |
CARDIOVASCULAR | ||||
| Cypros Pharmaceutical Corp. |
Ceresine |
Small molecule; acts during and after ischemia by maintaining cellular ATP levels or accelerating their restoration |
Adult ischemic stroke |
Reported data on study measuring drug's effect on accumulation of brain lactic acid (2/18) |
| Genentech Inc. |
rhVEGF165 |
Recombinant human vascular endothelial growth factor |
Coronary artery disease |
Failed to meet primary end-point in Phase II trial (2/18) |
| Intercardia Inc. |
Bextra |
Bucindolol HCl; non-selective beta blocker with vasodilating properties |
Moderate-to-severe congestive heart failure |
Data Safety and Monitoring Board reviewed interim data from Phase III BEST trial (Beta-blocker Evaluation of Survival Trial) and recommended continuation (2/25) |
CENTRAL NERVOUS SYSTEM | ||||
| Abbott Laboratories (NYSE:ABT) |
r-ProUK |
Recombinant pro-urokinase; clot-dissolving agent |
Lessening of neurological disability associated with stroke |
Data from PROACT II trial, aimed at supporting NDA, presented at 24th American Heart Association International Conference on Stroke and Cerebral Circulation in Nashville (2/4) |
| Neurogen Corp. and Pfizer Inc. (NYSE:PFE) |
NGD 96-1 |
Small molecule that modulates specific gamma amino butyric acid (GABA) neuro-transmitter subtypes |
Insomnia |
Initiated Phase I trials (2/1) |
| Pepgen Corp. (affiliate of Calypte Biomedical Corp.) |
Interferon Tau |
Oral interferon |
Multiple sclerosis |
Initiated Phase I trials (2/25) |
DIABETES | ||||
| Ergo Science Corp. |
Ergoset Tablets |
Low-dose, oral formulation of bromocriptine (ergot alkaloid; generic dopamine agonist) |
Type II diabetes (in patients taking insulin who are also obese) |
Reported results from study (2/5) |
INFECTION | ||||
| Agouron Pharmaceuticals Inc. |
Viracept (nelfinavir mesylate; FDA- |
Synthetic small molecule designed to inhibit HIV protease |
HIV infection; in combination with nucleoside analogues or alone |
Study evaluated patients who had failed Viracept combination therapy and were then switched to combination of ritonavir, saquanivir and Epivir; results presented at the 6th Conference on Retro-viruses and Opportunistic Infections (CROI) meeting in Chicago (2/2) |
| Agouron Pharmaceuticals Inc. |
Viracept (nelfinavir mesylate; FDA- approved) |
Synthetic small molecule designed to inhibit HIV protease |
HIV infection |
Presented data from ongoing study in women at the CROI meeting (2/3) |
| Enzon Inc. and Schering-Plough Corp. (NYSE:SGP) |
PEG-Intron A and Rebetol (ribavirin) |
Long-acting dosage form of Intron A (recombinant interferon alfa-2b) conjugated to polyethylene glycol; combination therapy with Rebetol (ribavirin; synthetic nucleo-side with antiviral activity; oral) |
Treatment of hepatitis C viral infection |
Schering-Plough initiated Phase III trial (2/1) |
| Merck & Co. Inc. (NYSE:MRK) |
Crixivan (indinavir sulfate; FDA- approved) |
Protease inhibitor |
HIV infection; combination therapy with AZT (zidovudine) and 3TC (lamivudine) |
Presented data from ongoing 035 study at CROI meeting (2/5) |
| NeXstar Pharmaceuticals Inc. |
MiKasome |
Liposomal formulation of antibiotic amikacin |
Urinary tract infection |
New Phase II data to be presented 3/22 at the 9th European Congress of Clinical Microbiology and Infectious Diseases in Berlin (2/25) |
| Palatin Technologies Inc. |
LeuTech |
Radiolabeled, monoclonal antibody-based system for imaging infection (product binds specifically to white blood cells) |
Diagnosis and imaging of osteomyelitis (bone infections) |
Initiated Phase II studies (2/4) |
| Pharmos Corp. and Bausch & Lomb (NYSE:BOL) |
-- |
Combination of loteprednol (steroid) and antibiotic |
Treatment of patients with steroid-responsive inflammatory ocular conditions where superficial bacterial ocular infection or a risk of bacterial infection exists |
Completed patient enrollment in pivotal study (2/9) |
| Progenics Pharmaceuticals Inc. |
PRO 542 |
Fusion protein that incorporates the HIV-binding region of of the human cell surface receptor (CD4) into a human antibody molecule; designed to bind to the HIV surface glycoprotein (gp120) and prevent attachment to host cells |
HIV infection |
Reported Phase I/II results at CROI meeting (2/3) |
| Trimeris Inc. |
T-20 |
Antiviral fusion-inhibiting compound (delivered by continuous subcutaneous infusion via pump) |
HIV infection (combination therapy with 3 other antiretroviral drugs) |
Presented preliminary results at CROI meeting (1/25) |
| Vertex Pharmaceuticals Inc. and Glaxo Wellcome plc (NYSE:GLX; U.K.) |
Agenerase |
Amprenavir; 2nd-generation HIV protease inhibitor; twice-daily dosage |
Combination therapy with Retrovir (AZT) and Epivir (3TC) for HIV infection and AIDS adults and children |
Data from several studies presented at CROI meeting: Phase III pediatric trial, semen analysis in study, and safety analysis (2/2) |
MISCELLANEOUS | ||||
| Abgenix Inc. |
ABX-IL8 |
Fully human monoclonal antibody that binds to interleukin-8 (produced via Xeno-Mouse technology) |
Psoriasis |
Phase I trial results presented at the Hawaii Dermatology Seminar meeting in Maui (2/16) |
| AutoImmune Inc. |
Colloral |
Liquid oral formulation of a Type II collagen |
Rheumatoid arthritis |
Completed enrollment in Phase III pivotal trial (2/18) |
| Axys Pharmaceuticals Inc. |
APC 2059 |
Topical cream formulation of tryptase inhibitor (tryptase involved in mast cell-mediated inflammation) |
Psoriasis |
Initiated Phase Ib trial (2/11) |
| Axys Pharmaceuticals Inc. |
APC 2059 |
Injectable formulation of tryptase inhibitor (tryptase involved in mast cell-mediated inflammation) |
Acute inflammatory bowel disease |
Initiated Phase Ib trial (2/11) |
| Biomatrix Inc. and Wyeth-Ayerst Laboratories (subsidiary of American Home Products; NYSE:AHP) |
Synvisc (FDA- approved) |
Elastoviscous hylan biopolymer; chemically modified version of natural hyaluronan |
Delay or avoidance of knee-replacement surgery, in patients with osteoarthritis of the knee |
Presented study results at annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) in Anaheim, Calif. (2/4) |
| Cell Pathways Inc. |
Prevatac |
Exisulind; orally active drug designed to induce apoptosis in precancerous cells; inhibits a cyclic GMP phosphodiesterase |
Adenomatous polyposis coli |
Preliminary evaluation of un-blinded Phase III data suggests the study did not achieve a statistically significant clinical response when compared to placebo; NDA filing expected to be delayed (2/1) |
| Cellegy Pharmaceuticals Inc. |
-- |
Transdermal testosterone gel |
Male hypogonadism |
Commenced clinical trials (2/11) |
| Connetics Corp. |
ConXn |
Recombinant human relaxin-H2 |
Treatment of sclero-derma |
Initiated Phase II/III pivotal trial |
| Discovery Laboratories Inc. |
Surfaxin |
Sinapultide; lung surfactant containing the peptide KL4 (a 21-amino-acid peptide modeled after the SP-B protein in the human surfactant system) |
Full-term infants with Meconium Aspiration Syndrome |
Completed Phase II trial (2/4) |
| Genzyme Tissue Repair (division of Genzyme Corp.) |
Carticel (FDA- approved) |
Autologous cultured chondrocytes |
Repair of damaged cartilage on the thigh-bone part of the knee |
Reported long-term study data from the company's Cartilage Repair Registry (2/3) |
| Gliatech Inc. |
ADCON-L (FDA- approved) |
Anti-adhesion barrier gel (semisynthetic carbohydrate polymer) |
Reduction of peridural scar associated with lumbar diskectomy surgery |
Presented data at AAOS meeting (2/4) |
| Human Genome Sciences Inc. |
KGF-2 |
Keratinocyte growth factor-2; genomics-derived |
Topical wound healing treatment for venous ulcers |
Initiated Phase II studies (2/10) |
| Organogenesis Inc. |
Apligraf (FDA- approved) |
Living human skin equivalent, composed of living human keratinocytes and fibroblasts (epidermis and dermis, isolated from infant foreskins) cultured in a 3-dimensional system |
Severe burns |
Data presented at John A. Boswick, M.D., Burn & Wound Care Symposium in Maui, Hawaii (2/25) |
| SangStat Medical Corp. |
SangCya (formerly Sang-35; FDA- approved) |
Cyclosporine (oral formulation; bioequivalent to Neoral oral solution) |
Prevention of rejection in solid organ transplant recipients |
Reported results of SangCya Oral Solution vs. Neoral cyclosporine capsule bioequivalence trial (Neoral is marketed by Novartis AG [Switzerland]) 2/5 |
| StressGen Biotechnologies Corp. (Canada) |
HspE7 |
Recombinant fusion product composed of heat shock protein 65 (Hsp65) from M. bovis BCG and protein E7; E7 is derived from the human papillomavirus and is involved in malignant transformation of cervical epithelial cells; E7 is a tumor-specific antigen |
Non-surgical treatment of cervical dysplasia |
Initiated Phase 1 trial (2/2) |
| VitaGen Inc. |
ELAD Artificial Liver |
Extracorporeal liver assist device that incorporates a living functional human liver cell line to provide external liver support to bridge the patient to transplant or to allow the patient's native liver to recover |
Temporary hepatic replacement therapy for patients with fulminant hepatic failure |
Initiated second clinical trial to evaluate safety (2/12) |
|
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. 16-17. | ||||
