Clinical Trial Update: April 2000
Company* (Symbol) | Product | Description | Indication | Status (Date) |
CANCER | ||||
Aphton Corp. (APHT) | | Anti-gastrin therapeutic vaccine; neutralizes hormone G17 and Gly-extended G17 | Metastatic gastric cancer | Initiated pivotal trial (4/28) |
Antigenics Inc. (AGEN) | Oncophage | Cancer vaccine consisting of purified, patient-specific heat shock protein-peptide complexes | Melanoma | Presented Phase I/II data at the 91st annual meeting of the American Association for Cancer Research in San Francisco (AACR) (4/5) |
Avax Technologies Inc. (AVXT) | M-Vax | Therapeutic vaccine; tumor cells removed from patient, modified with hapten (DNP; dinitrophenyl), then injected back into patient (along with cyclophosphamide) | Metastatic melanoma | Presented T cell response data at AACR (5/4) |
BioTransplant Inc. (BTRN) | AlloMune Cancer System | Mixed chimerism approach whereby patients are prepared for a bone-marrow or stem-cell transplant with a combination of low-dose chemotherapy and antibodies against T cells | Refractory Hodgkin's and non-Hodgkin's lymphoma | Initiated Phase I/II trial (4/6) |
Coley Pharmaceutical Group Inc.* | CpG 7909 | DNA-based immune stimulant | Relapsed or refractory non-Hodgkin's lymphoma | Initiated Phase I/II trial (4/17) |
CollaGenex Pharmaceuticals Inc. (CGPI) | Metastat | Orally administered inhibitor of matrix metalloproteinases | HIV-associated Kaposi's sarcoma | Released initial findings from Phase I trial (4/4) |
Coulter Pharmaceutical (CLTR) and SmithKline Beecham plc (NYSE:SBH) | Bexxar | Tositumomab iodine I-131; radioimmunotherapy involving an antibody conjugated to iodine-131 that attaches to a protein found on the surface of B cells | Previously untreated low-grade non-Hodgkin's lymphoma | Initiated Phase II trial of combination therapy using cyclophosphamide, vincristine and prednisone (4/26) |
EntreMed Inc. (ENMD) | Angiostatin | Recombinant human anti-angiogenic protein | Cancer | Initiated Phase I trial (4/11) |
Genta Inc. (GNTA) | Genasense (G3139) | Antisense compound; synthetic DNA strands that bind to mRNA for the bcl2 gene (proto-oncogene) | Advanced malignant melanoma | Updated results of Phase I/IIa trial at AACR (4/4) |
Hoffmann-La Roche Inc. (U.S. prescrip-drug unit of the Roche Group; Switzerland) | Xeloda | Capecitabine; oral anticancer agent | Metastatic colorectal cancer | Phase II trial results published in the 4/00 issue of the Journal of Clinical Oncology (4/19) |
MGI Pharma Inc. (MOGN) | Irofulven (MGI 114) | Hydroxymethylacyfulvene; lead compound from acylfulvene family | Ovarian cancer | Presented interim Phase II trial data at AACR (4/6) |
OXiGENE Inc. (OXGN) | Combreta-statin A4 Prodrug (CA4P) | Angiogenesis inhibitor | Advanced cancer | Presented preliminary Phase I trial results at AACR (4/5) |
Novelos Therapeutics Inc.* | BAM-002 | Formulation that stabilizes a natural human peptide in its oxidized form; peptide has antitumor and chemoprotective effects, and stimulates hematopoiesis and the immune system | Late-stage non-small-cell lung cancer | Initiated Phase I/II trial (4/19) |
SafeScience Inc. (SAFS) | GBC-590 | Carbohydrate lectin inhibitor that competitively binds to unique lectins on cancer cells and disrupts the metastatic process | Pancreatic carcinoma | Initiated dosing in Phase II trial at Beth Israel Deaconess Medical Center (4/11) and the University of Chicago Medical Center (4/19) |
SciClone Pharmaceuticals (SCLN) | Zadaxin | Thymosin alpha 1; synthetic version of naturally occurring peptide hormone thymosin (immunomodulator) | Metastatic malignant melanoma | Data from open-label Phase II trial of Zadaxin combined with chemotherapy published in 4/00 issue of Melanoma Research (4/6) |
CARDIOVASCULAR | ||||
Alteon Inc. (OTC BB: ALTN) | ALT-711 | AGE cross-link breaker; orally active compound that breaks cross-linked advanced glycosylation end products | Cardiovascular disease due to aging or diabetes | Initiated Phase IIa trial (4/6) |
CytRx Corp. (CYTR) | Flocor | Purified poloxamer 188; surfactant molecule that alters the way cells and molecules interact with water | Sickle cell disease | Presented data from four studies at the 24th annual meeting of the National Sickle Cell Disease Program in Philadelphia (4/17) |
Discovery Therapeutics Inc.* and Fujisawa Healthcare Inc. (Japan) | DTI-0009 | Orally active molecule that acts at the A1 and A2 receptor subtypes | Cardiac arrhythmias characterized by chaotic or abnormally rapid heartbeats | Initiated Phase II trial (4/24) |
GenVec Inc.* | Biobypass | Angiogenic gene therapy that delivers vascular endothelial growth factor 121 | Coronary artery disease and peripheral vascular disease | Initiated Phase II trial (4/26) |
Icos Corp. (ICOS) | LeukArrest | Humanized monoclonal antibody that blocks CD11/CD18-mediated cell adhesion (inhibits movement of neutrophils from blood into tissue) | Ischemic stroke | Failed to achieve efficacy endpoint in interim analysis (4/20) |
Neurobiological Technologies Inc. (OTC BB:NTII) and Merz + Co. GmbH & Co. (Germany) | Memantine | Orally available neuroprotective agent that appears to restore damaged nerve cells and block excitatory signals by modulating the N-methyl D-aspartate (NMDA) receptor on cell membranes | Mild to moderate vascular dementia | Reported positive results in two Phase III trials at the Sixth International Stockholm/Springfield Symposium on Advances in Alzheimer's Therapy (4/10) |
V.I. Technologies Inc. (VITX) | Universal PLAS+SD | Plasma transfusion product that inactivates lipid-enveloped viruses including HIV, hepatitis B and hepatitis C, and is depleted of antibodies that cause plasma to be blood-type specific | Transfusions | Initiated Phase III pivotal trial (4/4) |
CENTRAL NERVOUS SYSTEM | ||||
Boston Life Sciences Inc. (BLSI) | Altropane | Radioimaging probe for dopamine neurons | Diagnosis of attention deficit hyperactivity disorder | Initiated Phase II trial (4/6); reported results of Phase II evaluation of scans by outside specialists (4/25) |
Centaur Pharmaceuticals Inc.* | CPI-1189 | Small-molecule agent that modifies cellular response to stress | AIDS dementia complex | Completed enrollment in Phase II trial (4/25) |
Diacrin Inc. (DCRN) | | Porcine neural cells for transplantation in stroke patients | Stroke | Phase I trial put on hold while company investigates the cause of two adverse events; the FDA is expected to work with investigators to evaluate the events; Diacrin will not restart the study without the FDA's concurrence (4/17) |
Inhale Therapeutic Systems Inc. (INHL) and Biogen Inc. (BGEN) | Avonex (inhalable) | Powder formulation of Avonex (interferon beta-1a) for inhalation | Multiple sclerosis | Initiated dosing in Phase I trials (4/18) |
MacroChem Corp. (MCHM) | Benefen | Topical treatment combining ibuprofen and drug-absorption enhancement agent called SEPA (soft enhancement of percutaneous absorption) | Localized pain | Completed analysis of trial (4/7) |
Nastech Pharmaceutical Co. (NSTK) | | Intranasal formulation of morphine | Third-molar dental extraction | Reported data from pilot efficacy trial (4/4) |
Nastech Pharmaceutical Co. (NSTK) | | Intranasal formulation of apomorphine | Erectile dysfunction | Completed pilot studies (4/11) |
NeoTherapeutics Inc. (NEOT) | Neotrofin (AIT-082) | Leteprinim potassium; small-molecule compound designed to cross blood-brain barrier and enhance nerve cell function by increasing levels of neurotrophic factor | Alzheimer's disease | Completed enrollment in Phase IIb trial (4/5); initiated open-label extension of trial (4/6) |
Neurocrine Biosciences Inc. (NBIX) | NBI 5788 | Altered peptide ligand targeting T cells that bind to myelin sheath | Relapsing remitting multiple sclerosis | Reported results of Phase II trial (4/4) |
Neurocrine Biosciences Inc. (NBIX) | NBI-3001 | Interleukin-4 Pseudomonas toxin fusion protein; chimeric protein linking interleukin-4 (which binds to cancer cells because they express elevated levels of the IL-4 receptor) and Pseudomonas exotoxin (a cytotoxin) | Advanced malignant glioma | Reported results of Phase I/II trial (4/27) |
Teva Pharmaceutical Industries (Israel;TEVA) and H. Lundbeck A/S (CSE:LUN.CO) | Rasagiline | Selective irreversible MAO-B inhibitor | Parkinson's disease | Reported positive Phase III results (4/7) |
DIABETES | ||||
DepoMed Inc. (AMEX:DMI) | Metformin GR | Extended-release dosage formulation of metformin | Diabetes | Presented results from Phase I trial at the Millennial World Congress of Pharmaceutical Sciences in San Francisco (4/18) |
INFECTION | ||||
Enzon Inc. (ENZN) and Schering-Plough Corp. (NYSE:SGP) | PEG-Intron | Long-acting dosage form of Schering's Intron A (recombinant interferon alfa-2b) conjugated to polyethylene glycol | Hepatitis C | Reported positive results in Phase III trial comparing product to Intron A (interferon alfa-2b, recombinant; marketed by Schering-Plough); data to be presented at the European Association for the Study of the Liver annual meeting on 5/1 (4/18) |
Gilead Sciences Inc. (GILD) | | Tenofovir disopoxil fumarate; reverse transcriptase inhibitor | Treatment-experienced HIV infection | Reported preliminary results of Phase II trial (4/16); presented data at the International Conference for Antiviral Research in Baltimore (4/17) |
Gilead Sciences Inc. (GILD) | | Adefovir dipivoxil; reverse transcriptase inhibitor | Chronic hepatitis B infection resistant to lamivudine | Presented data from open-label trial at the 10th International Symposium on Viral Hepatitis and Liver Disease in Atlanta (4/11) |
The Immune Response Corp. (IMNR) and Agouron Pharmaceuticals (subsidiary of Warner-Lambert Co. [NYSE:WLA]) | Remune | Envelope-depleted, inactivated AIDS virus (emulsified with adjuvant) | HIV infection | Immune response data published in AIDS Research and Human Retroviruses (4/13) |
Maxim Pharmaceuticals (MAXM) | Maxamine | Histamine dihydrochloride; H2 receptor agonist | Hepatitis C infection | Presented 24-week results from Phase II combination trial with interferon-alpha at the 10th International Symposium on Viral Hepatitis and Liver Disease in Atlanta (4/12) |
Periodontix Inc.* | | Silver ions delivered locally via a bioresorbable wafer | Periodontitis | Presented results of Phase I trial at the International Association for Dental Research conference in Washington (4/10) |
Synsorb Biotech Inc. (Canada; SYBB) | Synsorb Cd | Product that binds to toxins secreted by bacteria in the gastrointestinal tract | Prevention of recurrent Clostridium difficile antibiotic-associated infection | Initiated Phase III trials (4/3) |
Triangle Pharmaceuticals Inc. (VIRS) | Coviracil | Emtricitabine; antiviral nucleoside analogue | HIV infection | South African Medicines Control Agency said Study FTC-302 should be terminated (4/6) |
ViroPharma Inc. (VPHM) | Pleconaril | Oral liquid formulation of a small-molecule inhibitor of several RNA viruses (blocks replication) | Viral respiratory infection in adults | Phase III did not achieve statistical significance in primary endpoint of time to resolution of illness (4/11) |
ViroPharma Inc. (VPHM) | Pleconaril | Oral liquid formulation of a small-molecule inhibitor of several RNA viruses (blocks replication) | Viral meningitis in adults and children | Reported data from two Phase III trials, one in adults and one in children; product did not achieve primary endpoint of reduction in time to complete resolution of headache (4/11) |
MISCELLANEOUS | ||||
Abgenix Inc. (ABGX) | ABX-IL8 | Fully human monoclonal antibody that targets interleukin-8 | Moderate to severe psoriasis | Initiated first Phase II trial (4/3) |
Amarillo Biosciences Inc. (OTC BB: AMAR) | | Oral interferon alpha | Primary Sjogren's syndrome | Completed first 24-week Phase III trial (4/7) |
Corixa Corp. (CRXA) and NV Organon (The Netherlands) | AnergiX.RA | A complex of solubilized HLA with a specific peptide from the human cartilage glycoprotein HCgp39 | Rheumatoid arthritis | Completed Phase I/II trial (4/17) |
Entropin Inc. (ETOP) | Esterom Solution | Topical liquid solution containing three cocaine derivatives benzoylecgonin, ecgonine and ecgonidine | Range of motion difficulties due to shoulder dysfunction and back strain | Reported enrollment of almost 100 patients in Phase IIIa trial; enrollment expected to be complete by 6/00 (4/6) |
Icos Corp. (ICOS) | Pafase (formerly rhPAF-AH) | Recombinant platelet-activating factor acetylhydrolase; degrades PAF and thereby lessening inflammatory response | Patients with severe sepsis or severe traumatic injuries at risk for development of acute respiratory distress syndrome | Reported data from Phase II trial (4/20) |
Inflazyme Pharmaceuticals Ltd. (TSE:IZP) and Aventis Pharma (France; NYSE:AVE) | IPL576,092 | Oral compound based on a molecule originally isolated from a sea sponge; inflammation mediator | Asthma | Announced results of Phase I trials and plans to initiate Phase IIa trials mid-year (4/6) |
La Jolla Pharmaceutical Co. (LJPC) | LJP 394 | Molecule (toleragen) that binds to surface of B cells and shuts off production of antibodies to double-stranded DNA | Lupus | Presented methods and results of a blood test used in analyzing data from lupus trials at Keystone Symposia 2000 in Steamboat Springs, Colo. (4/4) |
Ortec International Inc. | Composite Cultured Skin | Tissue-engineered dressing consisting of two layers of human-derived skin cells (dermal and epidermal) supported with a porous collagen matrix | Venous ulcers | Presented preliminary trial data at the 13th Annual Symposium on Advanced Wound Care and Medical Research Forum in Dallas (4/7) |
PPL Therapeutics (UK; LSE:PTH) | Bile Salt Stimulated Lipase Product (BSSL) | Transgenically produced recombinant human protein | Pancreatic insufficiency | Reported Phase II results (4/4) |
Unigene Laboratories Inc. (OTC BB: UGNE) and Warner-Lambert Co. (NYSE:WLA) | | Oral formulation of calcitonin | Osteoporosis | Initiated Phase I/II trial (4/12) |
Notes: | ||||
* Privately held. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SBI=Stockholm Borsinformation; SSE = Swedish Stock Exchange; TSE = Toronto Stock Exchange | ||||
ND = Not disclosed. | ||||
AACR = 91st annual meeting of the American Association for Cancer Research in San Francisco. | ||||