Company**

Product

Description

Indication

Status (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)

Completed Phase II trial (12/15)

Aeterna Laboratories Inc. (TSE:AEL; Canada)

Neovastat (AE-941)

Shark cartilage extract with anti-angiogenic and anti-inflammatory properties

Advanced small-cell lung cancer (combined with chemotherapy)

Initiated Phase III trials in North America (12/9)

Ariad Pharmaceuticals Inc.

AP 1903

Small molecule dimerizer drug; used as component of ARGENT product (Ariad regulated gene expression technology); allows control of expression of modified cells used in gene and cell therapy; in this case, donor¿s T cells modified ex vivo to contain gene for inactive apoptosis protein

Graft-vs-host disease in patients undergoing allogeneic bone marrow or hematopoietic stem cell transplantation

Initiated Phase I trial (12/9)

Aronex Pharmaceuticals Inc.

Atragen

Liposomal formulation of all-trans retinoic acid; induces tumor cells to differentiate into mature normal cells (injection)

Acute promyelocytic leukemia

Presented preliminary results of Phase II trial at 40th annual meeting of the American Society of Hematology (ASH) in Miami Beach, Fla. (12/7)

AVI Biopharma Inc.

Avacine

Synthetic peptide conjugate vaccine designed to elicit immune responseto human chorionic gonadotropin (hCG, a cancer-associated oncofetal protein)

Metastatic pancreatic cancer

Announced results of Phase Ib/II trials (12/2)

AVI Biopharma Inc.

Avacine

Synthetic peptide conjugate vaccine designed to elicit immune response to human chorionic gonadotropin (hCG, a cancer-associated oncofetal protein)

Advanced colorectal cancer

Announced results of Phase II trials (12/10)

BioTransplant Inc.

AlloMune System

Process involves mixing bone marrow from patient and donor to create chimeric bone marrow; allows transplants of mis-matched organs without use of immunosuppressive drugs

Treatment of blood cell cancers that are unresponsive to standard therapies (following bone transplant)

Presented results of trial conducted at Massachusetts General Hospital at ASH marrow meeting (12/8)

Celgene Corp.

Thalomid (FDA-approved)

Thalidomide; thought to act by modulating levels of tumor necrosis factor-alpha

End-stage refractory multiple myeloma

Academic investigators presented trial results at the ASH meeting (12/7)

Cell Pathways Inc.

Prevatac

Exisulind; orally active drug designed to induce apoptosis in precancerous cells; inhibits a cyclic GMP phosphodiesterase

Barrett¿s esophagus (pre-cancerous condition)

Initiated Phase II trial (12/23)

Cell Therapeutics Inc.

Lisofylline

Compound designed to modulate selective stress-activated cell signaling pathways that respond to chemotherapy, radiation and trauma; reduces oxidative damage to tissues by inhibiting production of phosphatidic acid

Treatment of graft-vs-host disease resulting from bone marrow transplant from matched donor (HLA-identical)

Presented results of Phase III trial at ASH meeting (12/8)

Celltech Group plc (U.K.) and Wyeth-Ayerst Laboratories (division of American Home Products Corp.; NYSE:AHP)

CMA 676

Immunoconjugate consisting of an antibody linked to a cytotoxic agent

Acute myeloid leukemia in first-relapse patients

Wyeth-Ayerst presented interim results from pivotal clinical trial at the ASH meeting (12/7)

Coulter Pharmaceutical Inc.

Bexxar

Iodine I-131 tositumomab; murine monoclonal antibody against CD20 antigen on B cells, labeled with I-131

Non-Hodgkin¿s lymphoma in patients refractory to chemotherapy

Presented Phase III trial results (statistically significant) at ASH meeting (12/7)

Cytogen Corp.

ProstaScint

Monoclonal antibody that targets prostate-specific membrane antigen, conjugated with indium-111

In vivo imaging agent for prostate cancer that has recurred following therapy

Results presented at the annual meeting of the Radiologic Society of North America in Chicago (12/1)

Epic Therapeutics Inc.*

ProMaxx 100

Extended release version of an LH-RH (luteinizing hormone-releasing hormone) analogue (encapsulated in bio-degradable microspheres); suppresses testosterone levels

Prostate cancer

Initiated pivotal trial (12/15)

Genetix Pharmaceuticals Inc.*

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Retroviral-mediated transfer of human MDR1 gene (multiple drug resistance) by transducing patient¿s bone marrow ex vivo, then reinfusing into patient

To establish chemotherapy resistant bone marrow in patients with germ cell tumors; for long-term therapy

Academic investigators presented results of Phase I trial at ASH meeting (12/8)

Idec Pharmaceuticals Corp.

Rituxan (FDA-approved) and
IDEC-Y2B8

Rituxan is genetically engineered chimeric pan-B monoclonal antibody that targets CD20 antigen on B-cell surface; IDEC-Y2B8 is murine monoclonal antibody (that also targets CD20 antigen), conjugated to isotope yttrium-90

Low-grade or follicular non-Hodgkin¿s lymphoma

Presented further results of Phase I/II trial at ASH meeting (12/7)

Idec Pharmaceuticals Corp. and Genentech Inc.

Rituxan (FDA-approved)

Rituximab; genetically engineered chimeric pan-B monoclonal antibody that targets CD20 antigen on B-cell surface

Non-Hodgkin¿s lymphoma (relapsed or refractory, low-grade or follicular)

Presented results of long-term followup (up to 3 years after treatment) at ASH meeting; also presented results of Phase II retreatment study at ASH meeting (12/8)

The Liposome Co. Inc.

Evacet

Liposomal formulation of doxorubicin

Metastatic breast cancer (combination therapy with cyclophosphamide)

Presented results of Phase III trials at 21st annual Breast Cancer Symposium in San Antonio, Tex. (12/15)

Lorus Therapeutics Inc. (TSE: IMT; Canada)

Virulizin

Biological response modifier extracted from bovine reticuloendothelium; activates macrophages and stimulates release of tumor necrosis factor-alpha

Pancreatic cancer

Announced results of Phase I/II trial (12/8)

Maxia Pharmaceuticals Inc.*

MX6

Small molecule compound that incorporates retinoid-related molecules that trigger apoptosis in neoplastic cells

Women with intermediate-high grade cervial intra-epithelial neoplasia (pre-cancerous condition)

Initiated pivotal Phase III trial (12/1)

NeXstar Pharmaceuticals Inc.

DaunoXome

Liposomal formulation of daunorubicin

Life-threatening hematological malignancies, including adult and pediatric leukemias and multiple myeloma

Results of 13 Phase I and Phase II trials presented at ASH meeting (12/7)

Seattle Genetics Inc.*

SGN-10

Single chain immuno-toxin; genetically engineered fusion protein with tumor-specific antibody-binding site and toxin that blocks protein synthesis

Carcinoma

Initiated Phase I trial (12/10)

Techniclone Corp.

TNT

Tumor necrosis therapy; chimeric monoclonal antibody that targets DNA-associated histone antigens, labeled with I-131 (targets necrotic center of tumor)

Newly diagnosed and recurrent malignant glioma (interstitial delivery)

Initiated Phase II trial (12/7)

Vertex Pharmaceuticals Inc.

Incel (VX-710)

Biricodar dicitrate; small molecule drug that blocks 2 chemotherapy drug efflux pumps (MDR-1 and MRP) in chemotherapy-resistant

Resensitization of drug-resistant tumors to chemotherapy; treatment of advanced breast cancer refractory to paclitaxel tumor cells therapy

Reported preliminary results of Phase II trial at 21st annual Breast Cancer Symposium in San Antonio, Tex. (12/15)

CARDIOVASCULAR

Corvas International Inc.

rNAPc2

Recombinant NAPc2, an inhibitor of Factor VIIa/Tissue Factor enzyme complex that initiates blood coagulation and clot formation (subcutaneous)

Anticoagulant; prevention of deep vein thrombosis and other complications (including pulmonary embolism) following orthopedic surgery

Initiated Phase II trial in U.S., Canada, the Netherlands, and Italy (12/2)

Cypros Pharmaceutical Corp.

Cordox

Cardioprotective drug; small-molecule compound designed to reduce accumulation of lactate; facilitates anaerobic glycolysis

Sickle cell anemia crisis

Initiated Phase III trial (12/14)

Human Genome Sciences Inc. and Vascular Genetics Inc.*

VEGF-2 Gene Therapy

Gene for vascular endothelial growth factor-2 (VEGF-2) formulated as naked plasmid DNA and injected directly into muscle

Critical limb ischemia (peripheral artery disease)

FDA cleared protocol for Phase I/II trials (12/23)

The Medicines Co.*

Hirulog

Synthetic thrombin inhibitor based on hirudin (natural anti-coagulant secreted by leeches)

Anticoagulant for use in heart attack patients (acute myocardial infarction)

Initiated international Phase III trial (12/7)

Transkaryotic Therapies Inc.

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Non-viral gene therapy; patient¿s cells genetically engineered with Factor VIII gene, propagated and then reinfused into patient

Hemophilia A

Initiated Phase I trial (12/2)

CENTRAL NERVOUS SYSTEM

NPS Pharmaceuticals Inc.

NPS 1776

Orally active small molecule drug with anti-convulsant properties

Epilepsy

Completed Phase I trial (12/14)

DIABETES

Cygnus Inc.

GlucoWatch Biographer

Glucose monitoring device; uses reverse iontophoresis to non-invasively extract and measure glucose levels

To aid in controlling fluctuating glucose levels in diabetics

Initiated pivotal trials (12/11)

Myelos Neurosciences Corp.*

Prosaptide TX14

Small molecule drug; synthetic version of pharmacologically active peptide sequence within growth factor or cytokine; in models, relieves neuropathic pain

Relief of pain associated with diabetic neuropathy

Initiated Phase II trial (12/7)

INFECTION

Aviron

FluMist

Nasal spray formulation of influenza vaccine; attenuated, cold-adapted live virus vaccine

Vaccination of healthy working adults; also, pediatric challenge trial (against 3rd viral strain)

Presented preliminary trial results at International Symposium on Influenza and Other Respiratory Viruses in Kapalua, Hawaii (IORV symposium) (12/5)

Aviron

Croup vaccine

Intranasal vaccine against parainfluenza virus type 3 (PIV-3; adapted from bovine PIV-3)

Vaccine for prevention of parainfluenza virus infection (croup, bronchiolitis and pneumonia) in children

Presented results of Phase II trial at IORV symposium (12/5)

MedImmune Inc.

Synagis (FDA-approved)

Pavlivizumab; humanized monoclonal antibody to respiratory syncytial virus (RSV); binds to fusion protein on viral surface (intramuscular injection)

Prevention of serious RSV disease in certain high-risk infants and young children (causes pneumonia, bronchiolitis)

Published pediatric clinical data in 12/98 issue of the Journal of Infectious Diseases (12/22)

Micrologix Biotech Inc. (Canada)

MBI 226

Antimicrobial peptide; 12-amino acid analogue of mammalian derived host defense peptide

Prevention of bloodstream infections in patients undergoing central venous catheterization

Initiated Phase I trial (12/7)

Shaman Pharmaceuticals Inc. (OTC Bulletin Board: SHMN)

Provir

Oral formulation of compound SP-303, pivotal which is isolated from the croton plant; it is thought to act by inhibiting secretion of chloride from intestinal cells

AIDS-related diarrhea

Announced results from Phase III trial (12/22)

Trimeris Inc.

T-20

Antiviral fusion-inhibiting compound (delivered by continuous subcutaneous infusion via pump)

HIV infection (combination therapy with 3 other antiretroviraldrugs)

Presented preliminary results of Phase II trial at the International Conference on the Discovery and Clinical Development of Antiretroviral Therapies (12/14)

Visible Genetics Inc. (Canada)

OpenGene HIV Geno-typing System

Genotypic analysis of gag/pol region of HIV (patient-specific)

Detection of drug-resistant mutations in genes of HIV isolated from blood of AIDS patients (to optimize drug selection)

FDA cleared clinical trial protocol under Investigational Device Exemption (12/24)

MISCELLANEOUS

Allelix Biopharmaceuticals Inc. (Canada)

ALX1-11

Recombinant human parathyroid hormone

Postmenopausal osteoporosis

Reported results of Phase II North American trial at the American Society for Bone and Mineral Research (ASBMR) meeting in San Francisco (12/3)

Angiotech Pharmaceuticals Inc. (Canada)

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Topical paclitaxel gel (yew tree-derived semi-synthetic taxoid; inhibits abnormal skin cell growth, inflammatory cell response and angiogenesis)

Mild-to-moderate psoriasis

Initiated Phase I trial (12/1)

Axys Pharmaceuticals Inc.

APC-2059

Synthetic small molecule that inhibits tryptase (a serine protease involved in inflammation)

Inflammatory diseases, including inflammatory bowel disease

Initiated Phase I trial (12/1)

Celtrix Pharmaceuticals Inc.

SomatoKine

IGF-BP3 complex; recombinant version of complex formed by insulin-like growth factor-1 and its major binding protein (intra-venous administration)

To reduce protein wasting in severely burned adults and children

Presented Phase II trial results at the Southern Surgical Association meeting in Palm Beach, Fla. (12/10)

Idec Pharmaceuticals Corp.and SmithKline Beecham plc (NYSE:SBH; U.K.)

IDEC-151/ SB-217969

2nd-generation primatized anti-CD4 monoclonal antibody

Moderate-to-severe rheumatoid arthritis

SmithKline delayed initiation of Phase IIb trial; also, further dosing in ongoing open-label extension trial has been suspended pending analysis of data; SmithKline is reconsidering product development strategy (12/23)

The Immune Response Corp.

TCR Vaccine

T cell receptor peptide vaccine (combines 3 T cell receptor peptides with an adjuvant)

Rheumatoid arthritis

Announced results of Phase IIb trial (12/21)

Medarex Inc.

MDX-RA

Monoclonal antibody inked to plant toxin ricin; binds to and destroys lens epithelial cells

Prevention of secondary lcataracts in patients undergoing primary cataract surgery

Suspended enrollment of patients in Phase III trial due to unexplained sight-limiting adverse events occurring almost equally in patients taking drug or placebo (12/14)

MedImmune Inc. and BioTransplant Inc.

MEDI-507

Humanized monoclonal antibody that binds to CD2 antigen receptor found on T cells and natural killer cells

Acute graft-vs-host disease in steroid-naive adults and children (all recipients of bone marrow or stem cell transplants)

Initiated 2 Phase I/II trials (12/14)

Targeted Genetics Corp. and Medeva plc (NYSE:MDV; U.K.)

tgAAV-CF

Gene therapy; use of adeno-associated virus to deliver normal CFTR (cystic fibrosis transmembrane regulator) gene into nasal passage

Cystic fibrosis

Initiated Phase I trial (12/8)

Transkaryotic Therapies Inc.

Alpha-Gal A

Alpha-galactosidase A

Protein replacement for Fabry¿s disease (lysosomal storage disease)

Initiated Phase II trial at the National Institutes of Health (12/14)

U.S. Bioscience Inc.

Ethyol (FDA-approved)

Amifostine; selective cytoprotective agent

To improve peripheral blood counts in patients with myelodysplastic syndromes (bone marrow disorders)

Presented results of Phase II trial at the ASH meeting (12/8)


NOTES:

TSE = Toronto Stock Exchange

* 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.