Company**

Product

Description

Indication

Type Action (Date)


CANCER

Alfacell Corp.

Onconase

Cytotoxic ribonuclease; member of the superfamily of pancreatic ribo-nucleases

Treatment of unresectable mesothelioma

Presented results from Phase II trial at Malignant Pleura Mesothelioma Conference in Lignano Sabbiadoror, Italy (3/23)

AltaRex Corp. (Canada)

OvaRex MAb

Anti-idiotype induction therapy-based vaccine; consists of modified murine monoclonal antibody that binds to CA125 cancer antigen

To delay time to disease recurrence in advanced ovarian cancer

Data safety monitoring board conducted initial and interim reviews of 1st potentially pivotal Phase IIb study and recommended the study continue as designed (3/19)

BrevaRex MAb

Anti-idiotype induction therapy-based vaccine; consists of modified murine monoclonal antibody that binds to MUC1 cancer antigen

Cancer

Initiated Phase I trial (3/19)

Aronex Pharmaceuticals Inc.

Platar

Liposomal formulation of platinum product designed to overcome toxicity and drug resistance

Metastatic renal cell carcinoma

Initiated Phase II trial (3/31)

Bioject Medical Technologies Inc. and Vical Inc.

Vaxid

DNA-based vaccine using Biojector 2000 jet injector for delivery; vaccine contains a gene that encodes patient-specific idiotype (characteristic feature) of cancerous B cells

Treatment of low-grade non-Hodgkin's lymphoma

Initiated Phase I trials (3/16)

Celgene Corp.

Thalomid (FDA-approved)

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

Treatment of advanced non-small-cell lung cancer

Initiated pilot trial, in collaboration with the National Cancer Institute, under the sponsorship of the Cancer Therapy Evaluation Program (3/22)

Cell Pathways Inc.

(Prevatac)

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

Treatment for precancerous polyps in children with adenomatous polyposis coli

Initiated open Phase II efficacy study (3/17)

Genzyme Molecular Oncology

Melanoma vaccine

Vaccine utilizes dendritic cells and combines 2 melanoma tumor antigens, MelanA/MART1 and gp100

Therapeutic vaccine for Stage IV melanoma

Initiated Phase I/II trial (3/8)

MethylGene Inc.* (Canada)

MG98

2nd-generation antisense oligonucleotide that inhibits mRNA produced by the DNA methyltransferase gene

Solid tumors

Initiated international Phase I trials (3/17)

PharmaPrint Inc.

PPRT-321

Pharmaceutical derived from saw palmetto

Treatment of symptoms associated with enlarged prostate gland

Reported results of Phase I trial (3/11)

Techniclone Corp.

TNT

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

Malignant glioma

Results of Phase I trial accepted for presentation at the 35th annual meeting of the American Society of Clinical Oncology (5/99) in Atlanta (3/5)

Vion Pharmaceuticals

VNP20009

"Unarmed" Salmonella TAPET (Tumor Amplified Protein Expression Therapy) vector

Solid tumors

Initiated Phase I trial (3/18)


CARDIOVASCULAR

Centocor Inc. and Eli Lilly and Co. (NYSE:LLY)

ReoPro (FDA-approved)

Chimeric monoclonal antibody fragment to GPIIb/IIIa platelet receptor (abciximab)

Treatment of ischemic heart disease in combination with stents in diabetic patients

Presented new findings from EPISTENT and ADMIRAL study at the 48th Annual meeting of the American College of Cardiology in New Orleans (3/7)

Corvas International Inc.

rNAPc2

Recombinant nematode anticoagulant protein c2; subcutaneously delivered recombinant version of protein found in blood-feeding hookworms; inhibits Factor VIIa/Tissue Factor enzyme complex that initiates blood coagulation and clot formation

Prevention and treatment of disorders resulting from thrombosis

Presented data from Phase I trial in healthy male volunteers at the ACC meeting (3/8)

CytRx Corp.

Flocor

Purified poloxamer 188; intravenously delivered; surfactant molecule that alters the way cells and molecules interact with water

Sickle cell disease patients with Acute Chest Syndrome

Presented interim results of Phase I trial at National Sickle Cell Disease Program meeting in San Francisco (3/8)

GelTex Pharmaceuticals Inc.

Cholestagel

Cholesterol reducer; non-absorbed hydrogel that binds to and eliminates bile acids from intestinal tract

Reduction of low-density-lipoprotein cholesterol levels

Reported preliminary results of 2nd Phase III trial (3/15)

Genentech Inc. and Boehringer Ingelheim (Germany)

Tenecte-plase (TNK-tPA)

Single-bolus recombinant tissue plasminogen activator; 2nd generation product designed to replace Genentech's Activase

Acute myocardial infarction

Presented results from international Phase III trial comparing product to Genentech's marketed 1st generation product, Activase, at ACC meeting (3/9)

Immunex Corp and Wyeth Ayerst Laboratories (subsidiary of American Home Products; NYSE: AHP)

Enbrel (etanercept)

Recombinant, soluble p75 tumor necrosis factor (TNFr) linked to the Fc portion of human IgG1

Chronic heart failure

Presented Phase I data at ACC meeting; companies also announced start of Phase I/II trial (3/8)

Pharmacyclics Inc.

Antrin PA

Water-soluble photosensitizer that accumulates in atherosclerosis, is cleared rapidly from the blood and is activated by 732 nm light; drug is intravenously delivered

Photoangioplasty treatment of atherosclerotic peripheral arterial disease

Presented interim results from Phase I trial at the meeting of the Society of Cardiovascular Interventional Radiology in Orlando, Fla. (3/22)

Scios Inc. and Bayer AG (Germany)

Natrecor

Nesiritide; human B type natriuretic peptide (BNP; naturally occuring peptide in the heart)

Treatment of acutely de-compensated congestive heart failure

Presented trial data at the ACC meeting (3/8)


CENTRAL NERVOUS SYSTEM

Gliatech Inc.

GT2331

Small-molecule histamine (H3) receptor antagonist

Central nervous system disorders involving attention/learning or sleep disorders

Completed Phase I trial in healthy volunteers (3/1)

Merck & Co. Inc. (NYSE:MRK)

Vioxx

Rofecoxib; cyclooxygenase-2 specific inhibitor

Relief of pain

Presented results from 3 trials (2 of menstrual pain and 1 of dental pain) at the annual meeting of the American Society of Clinical Pharmacology and Therapeutics in San Antonio (3/18)

Synaptic Pharmaceutical Corp. and Eli Lilly and Co. (NYSE: LLY)

LY334370

Selective serotonin 1F receptor agonist

Treatment of migraine

Lilly discontinued development after delaying start of Phase II trials (3/19)

Teva Pharmaceutical Industries Ltd. (Israel)

Copaxone (FDA-approved)

Glatiramer acetate for injection

Primary progressive multiple sclerosis

Initiated 54-site North American trial (3/1)


DIABETES

Amylin Pharmaceuticals Inc.

AC2993

Synthetic exendin-4; 39-amino-acid peptide that exhibits antidiabetic activity similar to the mammalian hormone glucagon like peptide-1

Treatment of Type II diabetes

Initiated safety and tolerability study (3/3)

INSMED Pharmaceuticals Inc.

INS-1

D-chiron inositol; small, carbohydrate-based molecule (oral)

Treatment of Type II diabetes

Completed Phase II trial (3/16)

Regeneron Pharmaceuticals Inc. and The Procter & Gamble Co. (NYSE:PG)

Axokine

2nd generation ciliary neurotrophic factor

Treatment of obesity associated with Type II diabetes

Initiated Phase I trial in mildly to moderately obese healthy volunteers (3/30)


INFECTION

Cubist Pharmaceuticals Inc.

Daptomycin

Lipopeptide antibiotic; intravenous

Treatment of complicated skin and soft-tissue infections

Initiated 2 Phase III trials (3/1)

Daptomycin

Lipopeptide antibiotic; intravenous

Treatment of bloodstream infections, unassociated with endocarditis

Initiated open-label Phase II trial (3/1)

DuPont Pharmaceuticals Inc.

Sustiva (FDA-approved)

Efavirenz; non-nucleoside reverse transcriptase inhibitor; once-daily dosage

Treatment of HIV infection in combination with stavudine (Zerit, d4T) and lamivudine (Epivir, 3TC)

Presented trial data at the 9th European Conference of Clinical Microbiology and Infectious Diseases (CMID) in Berlin (3/22)

Sustiva (FDA-approved)

Efavirenz; non-nucleoside reverse transcriptase inhibitor; once-daily dosage

Treatment of HIV infection in women in combination with zidovudine (AZT) and lamivudine (Epivir, 3TC)

Presented trial data at the 9th European CMlD conference (3/22)

Gilead Sciences Inc.

Preveon

Adefovir dipivoxil; reverse transcriptase inhibitor (oral)

Treatment of HIV infection

Reported preliminary results from 2 monotherapy studies; data presented at the 12th International Conference on Antiviral Drugs in Jerusalem (3/19)

­

Adefovir dipivoxil; reverse transcriptase inhibitor (oral)

Treatment of chronic hepatitis B infection

Initiated multinational Phase III trial (3/17)

Immune Response Corp. and Agouron Pharmaceuticals Inc.

Remune

Envelope-depleted inactivated AIDS virus (emulsified with adjuvant)

Combination therapy with highly active anti-retroviral therapy (HAART) for HIV infection and AIDS

Data safety and monitoring board for Phase III trial met prior to scheduled interim analysis and decided, as a procedural matter, to postpone reviewing the clinical endpoint data until virological data was also available for review (3/26)

NeXstar Pharmaceuticals Inc. and Fujisawa Healthcare Inc. (subsidiary of Fujisawa Pharmaceutical Co. Ltd.; Japan)

AmBisome (FDA-approved)

Liposomal formulation of amphotericin B

Neutropenic patients with unresolved fever after 3 days of antibacterial drugs

Reported results of safety comparison study between AmBisome and Liposome Co.'s similar Abelcet product at the 9th annual Focus on Fungal Infections meeting in San Diego (3/23)

NeXstar Pharmaceuticals Inc. and Fujisawa Healthcare Inc. (subsidiary of Fujisawa Pharmaceutical Co. Ltd.; Japan)

AmBisome (FDA-approved)

Liposomal formulation of amphotericin B

Systemic fungal infections

Results of pivotal trial published in the New England Journal of Medicine (3/11)

NeXstar Pharmaceuticals Inc.

MiKasome

Liposomal formulation of amikacin

Complicated urinary tract infections

Presented data from Phase II trial at the European CMID conference (3/22)

Palatin Technologies Inc.

LeuTech

Radiolabeled, monoclonal antibody-based system for imaging infection (product binds specifically to white blood cells)

Difficult to diagnose appendicitis

Completed patient enrollment in Phase III trials (3/17)

Periodontix Inc.

HistaWash Mouthwash

Histatin-protein-based peptide called P-113

Prevention of gingivitis

Initiated Phase IIb trial based on results of 2 clinical studies presented at the International Association for Dental Research conference in Vancouver, B.C. (3/19)

PowderJect Pharmaceuticals plc

Hepatitis B DNA vaccine

Vaccine contains DNA that encodes the surface antigen of hepatitis B virus; delivered to the skin as a dry powder using needle-free injection system

Prophylactic vaccine for hepatitis B virus infection (to elicit protective immunity)

Presented Phase Ib trial data at the 2nd Annual Conference on Vaccine Research in Bethesda, Md. (3/30)

Steroidgenesis Inhibitors International (OTC BB:STGI)

Anticort

Anticortisol, immunomodulator

Treatment of HIV infection

Initiated trial to test different regimens in collaboration with AIDS Research Alliance (3/8)

Xoma Ltd.

Neuprex

Recombinant bactericidal/ permeability increasing protein (rBPI)

Treatment of meningococcemia

Data safety monitoring board recommended continued enrollment in Phase III trial in the U.S. and U.K. (3/9)


MISCELLANEOUS

British Biotech plc (U.K.)

Zacutex (formerly Lexipifant)

Platelet-activating factor antagonist (synthesized small-molecule drug)

Acute pancreatitis

Discontinued development following analysis of Phase III trial which showed the drug failed to reduce mortality (3/15)

Idec Pharmaceuticals

Idec-131

Humanized monoclonal antibody that targets GP39 molecules (a.k.a CD40 ligand) on helper T cells (to regulate antibody production)

Systemic lupus erythematosus

Initiated Phase II trial, following completion of Phase I testing (3/31)

Immunex Corp.

Nuvance

Recombinant, soluble interleukin-4 receptor

Long-term control of asthma

Reported results from Phase I/II multidose trial; announced plan to begin Phase II trial 2Q:99 (3/1)

InKine Pharmaceutical Corp.

Diacol (formerly INKP-100)

Sodium phosphate tablets

Purgative agent for adults undergoing colonoscopic evaluation

Completed enrollment of 1st of 2 pivotal Phase III trials (3/16)

Diacol (formerly INKP-100)

Sodium phosphate tablets

Purgative agent for adults undergoing colonoscopic evaluation

Completed enrollment of 2nd of 2 pivotal Phase III trials (3/23)

Ortec International Inc.

Composite Cultured Skin

Bioengineered bovine collagen matrix seeded with epidermal and dermal cells (biologically active wound dressing)

Treatment of burns

Presented data from trial comparing Composite Cultured Skin to Biobrane-L (Mylan Laboratories Inc.) at the American Burn Association meeting in Orlando, Fla. (3/30)

Composite Cultured Skin

Bioengineered bovine collagen matrix seeded with epidermal and dermal cells (biologically active wound dressing)

Treatment of chronic dermal ulcers in epidermolysis bullosa patients

Completed clinical trial and follow-up under investigator IDE at Rockefeller University (3/2)

Protein Design Labs Inc. and Hoffmann LaRoche Inc.

Zenapax (FDA-approved)

Daclizumab; humanized monoclonal antibody (SMART; AntiTAC) that binds to the interleukin-2 receptor on activated T cells

Treatment of acute graft vs. host disease

Presented Phase II results at Tandem Bone Marrow Transplant meeting in Keystone, Colo. (3/8)

Targeted Genetics Inc. 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

Treatment of chronic sinusitis in cystic fibrosis patients

Reported results from Phase I/II trial (3/30)

Vertex Pharmaceuticals Inc.

VX-745

Oral drug targeting p38 mitogen-activated protein kinase

Inflammatory diseases such as asthma, Crohn's disease and rheumatoid arthritis, and neurological diseases such as stroke

Initiated Phase I trial in healthy volunteers (3/9)


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.