Company* (Symbol) | Product | Description | Indication | Status (Date) |
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Cell Pathways Inc. (CLPA) | Aptosyn | Exisulind; orally active drug designed to induce apoptosis in precancerous cells; inhibits a cyclic GMP phosphodiesterase | Advanced nonsmallcell lung cancer | Cell Pathways and Glaxo Wellcome will cooperate in supporting a clinical trial to study the combination of Aptosyn and Navelbine as a first-line treatment for elderly patients with advance non-small-cell lung cancer (7/19) |
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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 | Intermediategrade non Hodgkin's lymphoma | Initiated Phase II trial of Bexxar as first-line therapy in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy (7/26) |
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Cytran Inc.* | IM862 | Anti-angiogenic, 2-amino-acid peptide delivered via nose spray | Kaposi's sarcoma | Participants sought to participate in a multi-national Phase III trial (7/21) |
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EntreMed Inc. (ENMD) | Angiostatin | Recombinant human antiangiogenic protein | Cancer | Commenced Phase I trial of Angiostatin combined with radiation therapy in patients with advanced cancer (7/6) |
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EntreMed Inc. (ENMD) | Endostatin | Recombinant human antiangiogenic protein | Refractory solid tumors | Company announced that an additional 12 patients will be enrolled in the final stage of a Phase I trial (7/10) |
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Galenica Pharmaceuticals Inc.* | GPI-0100 | Second-generation semisynthetic product derived by modification of certain natural saponins | Prostate cancer | Initiated Phase I trial (7/25) |
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Genta Inc.(GNTA) | Genasense | Antisense compound;synthetic DNA strands that bind to mRNA for the bcl2 gene (proto-oncogene) | Advanced prostate cancer | Launched two additional clinical studies (7/11) |
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IntraBiotics Pharmaceuticals Inc. (IBPI) | Protegrin IB-367 | Synthetically derived analogue of naturally occurring protegrins | Oral mucositis associated with chemotherapy | Initiated enrollment for the second of two Phase III trials (7/27) |
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Matrix Pharmaceuticals Inc. (MATX) | IntraDose Injectable Gel | Biodegradable gel containing cisplatin and epinephrine (intratumoral injection) | Head and neck cancer | Presented additional data from two pivotal, placebocontrolled Phase III trials at the 5th International Conference on Head and Neck Cancer in SanFrancisco (7/31) |
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Pharmacyclics Inc. (PCYC) | Xcytrin | Motexafin gadolinium; intravenously delivered radiation-sensitizer | Brain metastases | Reported progress of randomized controlled Phase III trial; enrollment expected to be complete by year end (7/27) |
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Tularik Inc.(TLRK) | T67 | Acts on tubulin, the proteins that make up the microtubule cytoskeleton and control cell division;remains active against tumors that are multiple drug resistant and can cross the blood-brain barrier | Hepatocellular carcinoma | Initiated Phase I/II trial (7/27) |
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Tularik Inc.(TLRK) | T64 | Anticancer compound,lometrexol; in class of drugs called antifolates | Cancer | Initiated Phase II efficacy and Phase I combination trials (7/17) |
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CARDIOVASCULAR |
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Biopure Corp.(BPUR) | Hemopure | Hemoglobin glutamer-250 (bovine); each unit of product contains approximately 30 grams of purified, chemically cross-linked hemoglobin in 250 ml of a balanced salt solution | Alternative to red blood cell transfusion in orthopedic surgery | Completed enrollment in pivotal Phase III trial in the U.S., Europe,Canada and South Africa (7/14) |
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Scios Inc. (SCIO) | Natrecor (Nesiritide) | A recombinant form of B-type natriuretic peptide, a naturally occurring hormone that aids healthy functioning of the heart | Vasodilation in the management of acute congestive heart failure | Reported positive results from two Phase III studies in The New England Journal of Medicine;Natrecor is currently being tested in a larger ongoing Phase III trial (7/27) |
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V.I. Technologies Inc. (VITX) | Inactine | Small-molecule, electrophilic compounds that selectively and irreversibly modify nucleic acids, preventing viral replication | Eradication of viral and bacterial pathogens in blood products | Presented new data on progress of red blood cell program at the International Society of Blood Transfusion meeting in Vienna (7/10) |
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CENTRAL NERVOUS SYSTEM |
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Boston Life Sciences Inc.(BLSI) | Altropane | Radioimaging probe for dopamine neurons | Parkinson's disease | Reported positive results of Phase III trial; results confirmed Altropane's ability to differentiate Parkinson's movement disorders from other movement disorders (7/27) |
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Centaur Pharmaceuticals Inc. | CPI-1189 | Small-molecule agent that modifies cellular response to stress | Parkinson's disease | Completed enrollment in Phase IIa trial (7/18) |
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Cephalon Inc.(CEPH) | Provigil (FDA- | Modafinil; oral formulation of synthetic compound that approved) | Attention deficit hyperactivity is thought to affect alphadisorder in adults adrenergic receptors in the brain | Provigil failed to beat placeboin trial (7/31) |
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NeoTherapeutics Inc. (NEOT) | Neotrofin (AIT-02) | Leteprinim potassium; smallmolecule compound debarrier and enhance nervecell function by increasing levels of neurotrophic factor | Alzheimer's disease signed to cross blood-brain | Presented preliminary results from global Phase IIb trial at the World Alzheimer's Congress 2000 Conference in Washington.(7/13) |
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Neurobiological Technologies Inc.(OTC BB:NTII) and Merz + Co. GmbH(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 | Alzheimer's disease | Merz reported data from doubleblind, placebo-controlled trial (7/14) |
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Neurocrine Biosciences(NBIX) and Janssen Pharmaceutica NV (Belgium) | NB30775(R121919) | Corticotropin-releasing factor receptor antagonist | Depression | Reported results from open label Phase IIa trial in the Journal of Psychiatric Research (7/20) |
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DIABETES |
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DepoMed Inc.(AMEX:DMI) | Metformin GR | Extended-release dosage formulation of metformin | Diabetes | Reported results from second Phase I trial (6/19) | |
Advanced Tissue Sciences Inc. (ATIS) and Smith &Nephew plc(NYSE:SNN) | Dermagraft | Human tissue engineered replacement for dermal layer of skin (viable human dermal fibroblasts, derived from foreskins, cultured on bioresorbable scaffold) | Diabetic foot ulcers | Completed enrollment in pivotal clinical trial (7/26) |
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INFECTION |
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Abbott Laboratories(NYSE:ABT) | ABT-378/r | Lopinavir/ritonavir; HIV protease inhibitor- | Treatment-naive and protease inhibitor experienced HIV patients | Reported data from two ongoing 72-week Phase II trials at the 13th International AIDS Conference in Durban, South Africa (World AIDS Conference) (7/11) |
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Abbott Laboratories(NYSE:ABT) | ABT-378 | Lopinavir/ritonavir; HIV protease inhibitor in combination with the nonnucleoside reverse transcriptase inhibitor (NNRT) efavirenz and nucleoside reverse transcriptase inhibitors (NRTIs) | Multiple protease inhibitor experienced HIV patients | Reported data from Phase II trial at the World AIDS Conference (7/11) |
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Agouron Pharmaceuticals Inc.(unit of Pfizer Inc.[NYSE:PFE]) | Viracept (FDA-approved) | Nelfinavir mesylate; HIV protease inhibitor | HIV infection | Reported positive results from several studies at the World AIDS Conference (7/13) |
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Antex Biologics(OTC BB:ANTX) | Helivax | Oral vaccine produced using NST (Nutriment Signal Transduction) technology; this technology regulates bacterial growth by reproducing environmental signals in the laboratory; NS-grown microbes are antigenically enhanced and result in more potent, clinically relevant inactivated whole-cell vaccines | Helicobacter pylori infection | Initiated Phase Ib/II trial (7/26) |
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Aquila Biopharmaceuticals Inc. (AQLA) | QS-21 | Vaccine adjuvant | HIV infection | Reported data from clinical trial of VaxGen Inc.'s AIDSVAX that incorporated the adjuvant (7/12) |
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Chiron Corp.(CHIR) | IL-2 | Immune-based therapy; laboratory-engineered product modeled after a substance the body makes that promotes T-cell growth | HIV infection | Reported new data on NIAID trials in the Journal of American Medical Association (7/8) |
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Chiron Corp.(CHIR) | rhIL-2 | Aldesleukin; recombinant form of T-cell growth factor (interleukin-2) | HIV infection | Reported positive data from Phase II trial in JAMA and at the American Medical Association Media Briefing for the World AIDS Conference (7/8) |
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Micrologix Biotech Inc. (Canada; TSE:MBI) | MBI 853NL | Intranasally delivered antibiotic | Prevention and treatment of Staphylococcusaureus infection,including methicillinresistant S. aureus | Completed Phase I trial (7/22) |
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Synsorb Biotech Inc. (Canada; SYBB) | Synsorb Pk | Orally delivered carbohydrate attached to inert, insoluble support; binds to toxins secreted by bacteria in the gastrointestinal tract | Prevention of hemolytic uremic syndrome associated with E. colinfections | Product demonstrated a trend toward efficacy, but did not meet defined protocol objectives in an interim analysis of Phase III results (7/12) |
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Trimeris Inc. (TRMS)and Hoffmann La Roche Inc.(Switzerland) | T-20 | Antiviral fusion inhibiting compound (twice-daily subcutaneous injection) | HIV infection | Reported positive data from single-arm, open-label rollover Phase II trial at the World AIDS Conference (7/10) |
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VaxGen Inc.(VXGN) | AIDSVAX | Bivalent vaccine composed of recombinant gp 120 (envelope protein) from two strains of HIV-1 that are prevalent in North America | Prevention of HIV infection and AIDS | Described initiation of North American Phase III trial and social harm monitoring at the World AIDS Conference (7/10) |
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Vertex Pharmaceuticals Inc. (VRTX) and Glaxo Wellcome plc (NYSE:GLX) | Agenerase | Amprenavir, 2nd-generation HIV protease inhibitor; twice-daily dosage | Treatment naive AIDS/HIV patients | Presented preliminary study results of combination therapy with the protease inhibitor ritonavir at the World AIDS Conference (7/11) |
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Vertex Pharmaceuticals Inc. (VRTX) | VX-497 | Inhibitor of inosine monophosphate dehydrongenase in combination with interfer on alpha | Hepatitis C | Initiated patient dosing in Phase II trial (7/3) | |
ViroLogic Inc.(VLGC) | PhenoSense HIV | Phenotypic test designed to measure resistance or susceptibility of a patient's HIV to antiviral drugs | HIV infection | Presented four studies that used PhenoSense HIV test at the World AIDS Conference (7/10) |
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MISCELLANEOUS | |||||
Atrix Laboratories(ATRX) | Atrisone | Dapsone topical gel | Moderate to severe ache | Completed enrollment in Phase II trial (7/19) |
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Atrix Laboratories(ATRX) | Leuprogel | Leuprolide acetate | Advanced prostate cancer | Initiated enrollment of Phase III 90-day trial (7/19) |
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Chiron Corp.(CHIR) | rhIGF-I | Recombinant insulin-like growth factor-1; directly injected into cartilage | Osteoarthritis | Announced Chiron will not proceed with further clinical development based on results of two Phase IIa proof-of-concept trials (7/25) |
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Genzyme Tissue Repair(GZTR) | Carticel(FDA-approved) | Autologous cultured chondrocytes | Cartilage repair | Completed first of three postmarketing studies, the Registry Based Study (7/18) |
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MacroChem Corp. (MCHM) | Topiglan | 1% alprostadil and 5% Sepatopical formulation | Erectile dysfunction | Initiated double-blind, randomized placebo-controlled Phase III trial (7/10); published paper on double-blind randomized Phase II trial in Urology (7/12). |
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PathoGenesis Corp. (PGNS)and AeroGen Inc.* | Tobi and AeroDose | Tobramycin solution for inhalation in combination with AeroDose (hand-held battery powered inhaler) | Cystic fibrosis | Initiated enrollment of Phase I trial (7/11) |
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Regeneron Pharmaceuticals Inc. (REGN) | Axokine | Second-generation ciliary neurotrophic factor | Obesity | Completed enrollment in Phase II dose-ranging trial (7/10) |
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