Company* (Country)

Product

Description

Indication

Type Action (Date)

CANCER

Alfacell Corp.

Onconase

Cytotoxic ribonuclease; member of the superfamily of pancreatic ribonucleases

Inoperable malignant mesothelioma

Completed patient accrual in Phase III trial (4/26)

Alkermes Inc.

Cereport (in combination with carbo-platin)

9-amino-acid peptide based on bradykinin; synthetic analog that increases transiently the permeability of the blood-brain barrier by triggering brief relaxation of tight cellular junctions

Newly diagnosed brain tumors

Phase III study discontinued because "elements of the study design are no longer appropriate . . . and the probability of successful completion is low" (4/7)

AltaRex Corp. (Canada)

OvaRex MAb

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

Ovarian cancer

Company reported that 221 of 280 patients have been enrolled in North American Phase IIb trial; 6 of 102 have been enrolled in U.S. Phase IIb; also protocol change submitted for Phase II trial to examine cellular response (4/1)

BrevaRex MAb

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

Patients with elevated MUC1 levels; multiple myeloma

Company reported that 4 of 15 patients have been enrolled in Phase I trial (4/1)

Aronex Pharmaceuticals Inc.

Annamycin

Liposomal anthracycline

Refractory or relapsed leukemia

Initiated Phase I/II trial (4/26)

Atragen

Injectable formulation of all-trans-retinoic acid

Bladder cancer

Initiated Phase I/II trial (4/5)

Avax Technologies Inc.

M-Vax

Therapeutic vaccine; tumor cells removed from patient, modified with hapten (DNP; dinitrophenyl), then injected back into patient (along with cyclophos-phamide)

Melanoma that has metastasized to 2 nodal sites

Presented results from
Phase II trial at 90th annual meeting of the American Association For Cancer Research (AACR) (4/14)

Cell Genesys Inc.

GVAX cancer vaccine for prostate cancer

Cancer vaccine comprised of irradiated prostate cancer cells that have been genetically modified to produce granulocyte-macrophage colony stimulating factor

Hormone refractory prostate cancer

Initiated 2nd Phase I/II trial (4/5)

Cell Genesys Inc.

GVAX cancer vaccine for prostate cancer

Cancer vaccine comprised of irradiated prostate cancer cells that have been genetically modified to produce granulocyte-macrophage colony stimulating factor

Hormone refractory prostate cancer

Released additional data from Phase I/II trial (4/13)

GVAX cancer vaccine for lung cancer

Cancer vaccine comprised of tumor cells that have been irradiated to secrete granulocyte-macrophage colony stimulating factor

Advanced non-small-cell lung cancer

Released data from Phase I/II trial (4/12)

DiagnoCure Inc. (Canada)

DiagnoGene

Test consisting of 3 kits: extraction kit for preparation of RNA from a biological sample, a kit for the amplification of RNA in vitro (NASBA technology), and a detection kit in ELISA format for the amplified products

Early detection of circulating tumor cells from which metastases develop in cases of prostate cancer

Experimental stage test made available to cancer research centers to assess its clinical value (4/8)

Immunocyt

Test for bladder cancer that uses 3 monoclonal antibodies to detect specific cell markers

Early diagnosis of bladder cancer

Data from an independent study published in The Journal of Urology (4/20)

Encore Pharmaceuticals Inc.*

E-7869

Component of flurbiprofen, a marketed non-steroidal anti-inflammatory drug; appears to modulate expression of cyclooxygenase-2

Advanced or hormone refractory prostate cancer

Initiated Phase IIa trial (4/15)

Sugen Inc.

SU6668

Orally delivered angiogenesis inhibitor; specifically, product is tyrosine kinase inhibitor that targets receptors for vascular endothelial growth factor, platelet-derived growth factor and fibroblast growth factor

Advanced cancers that have failed other treatment options

Initiated Phase I dose-escalating trial (4/14)

CARDIOVASCULAR

American Biogenetic Sciences Inc.

Thrombus Precursor Protein test

Enzyme test that uses monoclonal antibodies to measure soluble fibrin polymers in blood to indicate active thrombosis

Point-of-care detection of blood clot formation in patients with myocardial infarction, deep vein thrombosis and pulmonary embolism

Initiated clinical testing (4/6)

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

ReoPro (FDA-approved)

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

Acute ischemic stroke

Presented results from Phase II study at the 8th Annual European Stroke Meeting in Venice, Italy (4/10)

GelTex Pharmaceuticals Inc.

Cholestagel

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

Reduction of low-density lipoprotein levels

Reported findings from 2 Phase II trials (4/15)

Pharmacyclics Inc.

Antrin

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 for patients with atherosclerotic peripheral arterial disease

Completed enrollment in Phase I trial (4/27)

CENTRAL NERVOUS SYSTEM

Alkermes Inc. and Janssen Pharmaceutica (unit of Johnson & Johnson; NYSE: JNJ)

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Injectable, sustained-released formulation of Risperdal (risperidone), using Alkermes' Medisorb technology, which encapsulates small molecules into microspheres made of common medical polymers

Antipsychotic

Janssen opted to proceed with Phase III trials (4/22)

Boston Life Sciences Inc.

Altropane

Radioimaging probe for dopamine neurons

Photo emission computed tomography imaging agent for early diagnosis of Parkinson's disease

Reported results of Phase II trial (4/9)

CoCensys Inc.

Ganaxolone

Synthetic version of naturally occurring neuroactive steroids (epalons) that bind to gamma amino butyric acid (GABA)-A receptors in brain (tablet formulation)

Catamenial epilepsy

Initiated Phase II open-label probe study (4/21)

Cortex Pharmaceuticals Inc. and NV Organon (unit of Akzo Nobel; the Netherlands)

CX516 (Ampalex)

Small molecule; member of the Ampakine family, which enhance the response of AMPA receptors

Treatment of schizophrenia in combination with clozapine

Reported results from safety trial (4/19)

Trega Biosciences Inc.

HP 228

Small molecule that acts at melanocortin receptors to modulate cytokine levels; intravenous formulation

Management of pain following hip surgery

Reported results of Phase II trial (4/7)

DIABETES

Genentech Inc.

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Recombinant human nerve growth factor

Diabetic peripheral neuropathy

Company said Phase III trial did not meet its objectives (4/8)

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

Diabetic foot ulcers

Presented 1st results from pivotal trial at The Symposium on Advanced Wound Care meeting in Anaheim, Calif. (4/26)

INFECTION

BioChem Pharma Inc. and Glaxo Wellcome plc (NYSE:GLX; U.K.)

Zeffix (lamivudine; FDA-approved)

Nucleoside analogue (oral dosage)

Chronic hepatitis B infection

Presented data from 3 clinical studies at the 34th annual meeting of the European Association for the Study of the Liver (EASOL) in Naples, Italy (4/11)

Gilead Sciences Inc.

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Adefovir dipivoxil; reverse transcriptase inhibitor (oral)

Chronic, lamivudine-resistant hepatitis B infection

Presented preliminary clinical data at the EASOL meeting (4/9)

Immunomedics Inc.

LeukoScan (sulesomab)

Monoclonal antibody fragment labeled with technetium-99 that binds to white blood cells

Imaging agent for diagnosis of acute atypical appendicitis

Phase III pivotal trial results published in Surgery (4/6)

Micrologix Biotech Inc. (Canada)

MBI 226

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

Prevention of blood-stream infections in patients undergoing central venous catheterization

Completed 2-part Phase I trial (4/28)

Nabi

Nabi-Altastaph

Highly purified 5% hyper-immune globulin that contains high levels of functional opsonic antibody to Staphylococcus aureus

Patients who do not have time to, or are immune- compromised and cannot respond to, a vaccine and who need immediate protection from S. aureus infections

Released preliminary analysis of data from Phase I/II trial (4/26)

Palatin Technologies Inc.

LeuTech

Antibody-based infection imaging agent

Diagnosis of appendicitis

Reported results of Phase III trial (4/26)

ViroPharma Inc.

Pleconaril

Oral liquid formulation of a small-molecule inhibitor of several RNA viruses (blocks replication)

Viral meningitis

Presented additional data from study in adults and adolescents at the annual meeting of the American College of Physicians in New Orleans (4/23)

MISCELLANEOUS

Alexion Pharmaceuticals Inc.

5G1.1

Humanized single-chain antibody designed to intervene in complement cascade (complement inhibitor)

Rheumatoid arthritis

Completed preliminary analysis of Phase I/II trial (4/21)

Alteon Inc.

Pimagedine

Compound designed to block abnormal glucose/protein complexes (advanced glycosylation end products)

End-stage renal disease

Closed Phase III trial, but may use data as a pilot study for new Phase III if the company decides to continue development in the indication (4/8)

Amarillo Biosciences Inc.

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Low-dose oral interferon alpha

Treatment of dry mouth in Sjogren's syndrome patients

Opened enrollment for final Phase III trial (4/6)

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Low-dose oral interferon alpha

Treatment of fibromyalgia syndrome in conjunction with amitriptyline

Initiated enrollment at 3 additional Phase II trial sites (4/28)

Cell Therapeutics Inc.

LSF (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

Acute lung injury and acute respiratory distress syndrome

Completed initial enrollment and required follow-up period for the first planned interim analysis of Phase II/III pivotal study (4/27)

Cephalon Inc.

Provigil tablets (FDA-approved)

Modafinil; oral formulation of synthetic compound that is thought to affect alpha-adrenergic receptors in the brain

Excessive daytime sleepiness associated with sleep apnea

Initiated clinical trials in the U.S. and U.K. (4/28)

InKine Pharmaceutical Co. Inc.

Diacol (formerly INKP-100)

Sodium phosphate tablets

Purgative agent for colonic cleansing prior to colonoscopy

Reported data from 2 Phase III trials comparing Diacol with NuLYTELY liquid (4/29)

INSMED Pharmaceuticals Inc.

INS-1

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

Polycystic ovary syndrome

Safety/efficacy trial results published in 4/29 issue of New England Journal of Medicine (4/28)

Isis Pharmaceuticals Inc. and CIBA Vision Corp. (unit of Novartis AG; Switzerland)

Vitravene

Fomivirsen; antisense inhibitor of cytomegalovirus replication (intravitreal injection)

Cytomegalovirus retinitis in patients with AIDS

Committee for Proprietary Medicinal Products of the European Medicines Evaluation Agency recommended approval of Marketing Authorization Application (4/28)

Novavax Inc.

Estrasorb

Topical cream formulation containing nanosome- encapsulated 17 beta estradiol

Symptomatic menopausal women

Completed dosing in Phase II trial, with plans to submit proposed Phase III protocol (4/16)

* Privately held company.
** Unless otherwise noted, the stock symbols for public companies are listed on pp. 10-11.