Company* (Symbol)

Product

Description

Indication

Status (Date)


CANCER

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)

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)

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)

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)

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)

Galenica Pharmaceuticals Inc.*

GPI-0100

Second-generation semisynthetic product derived by modification of certain natural saponins

Prostate cancer

Initiated Phase I trial (7/25)

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)

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)

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)

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)

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)

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)

CARDIOVASCULAR

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)

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)

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)

CENTRAL NERVOUS SYSTEM

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)

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)

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)

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)

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)

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)

DIABETES

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)

INFECTION

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

MISCELLANEOUS

Atrix Laboratories(ATRX)

Atrisone

Dapsone topical gel

Moderate to severe ache

Completed enrollment in Phase II trial (7/19)

Atrix Laboratories(ATRX)

Leuprogel

Leuprolide acetate

Advanced prostate cancer

Initiated enrollment of Phase III 90-day trial (7/19)

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)

Genzyme Tissue Repair(GZTR)

Carticel(FDA-approved)

Autologous cultured chondrocytes

Cartilage repair

Completed first of three postmarketing studies, the Registry Based Study (7/18)

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).

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)

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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