Company **




Type Action (Date)


Abgenix Inc.


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)



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.


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.


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.*


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


Initiated Phase II trial (2/4)

The Liposome Co. Inc.


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.


Liposomal form of the investigational anticancer drug lurtotecan, a topoisomerase I inhibitor

Advanced-stage solid tumors

Initiated Phase I trials (2/3)

Ontogen Corp.*


Small-molecule P-glycoprotein inhibitor

Reversal of effects of multidrug resistance in patients undergoing cancer chemotherapy

Completed Phase I study (2/3)



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. *


Small-molecule inhibitor of ubiquitin-proteasome pathway that regulates many important cellular proteins


Initiated second Phase I trial (2/11)


Cypros Pharmaceutical Corp.


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.


Recombinant human vascular endothelial growth factor

Coronary artery disease

Failed to meet primary end-point in Phase II trial (2/18)

Intercardia Inc.


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)


Abbott Laboratories (NYSE:ABT)


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


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)


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)


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.


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.


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.


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.)


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)


Abgenix Inc.


Fully human monoclonal antibody that binds to interleukin-8 (produced via Xeno-Mouse technology)


Phase I trial results presented at the Hawaii Dermatology Seminar meeting in Maui (2/16)

AutoImmune Inc.


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)


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.


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.


Recombinant human relaxin-H2

Treatment of sclero-derma

Initiated Phase II/III pivotal trial

Discovery Laboratories Inc.


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.


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)


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)


* 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.