Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Amgen
Inc.
(AMGN)

Enbrel (FDA-approved)

Etanercept; fully
human TNF
receptor

Rheumatoid arthritis; psoriatic arthritis and ankylosing spondylitis

Amgen presended data at ACR from the TEMPO trial showing 37% of RA patients taking Enbrel and methotrexate achieved clinical remission at one year, and 80% of patients had no progression of joint damage (10/24); other studies showed Psoriatic patients improved after one year, and that 57% of ankylosing spondylitis patients reported a 20% improvement at six months (10/24)

Aspreva Pharmaceuticals Corp.*

CellCept

Mycophenolate
mofetil; immunosuppressant
drug

Lupus nephritis

Lupus Foundation presented 24-week data at ACR from 140 patients showing it had equivalent efficacy to cyclophosphamide with potentially fewer side effects (10/27)

AtheroGenics Inc. (AGIX)

AGIX-4207

Modulator of TNF-alpha-induced inflammatory genes

Rheumatoid
arthritis

Company began a Phase II trial named OSCAR in which 220 patients will be given one of three doses or placebo (10/21)

Centocor Inc.
(unit of Johnson
& Johnson)

Remicade

Infliximab; antibody
that inhibits TNF-alpha

Ankylosing
spondylitis

Results of the ASSERT trial showed Remicade reduced signs and symptoms of the disease (10/25); another study showed the drug increased quality of life and decreased disease burden (10/28)

Biogen Inc. (BGEN)

Amevive (FDA-approved)

Alefacept; targets the CD45RO+ subset of T cells

Rheumatoid
arthritis

Study combining Amevive and methotrexate in 36 patients showed disease improvement (10/26)

Genentech Inc. (NYSE:DNA) and IDEC Pharmaceuticals
Inc.
(IDPH)

Rituxan

Rituximab; antibody
that targets B cells

Rheumatoid
arthritis

Follow-up results from the Phase II trial presented at ACR showed a short course of treatment improved symptoms at 48 weeks when compared to methotrexate alone (10/26)

Human Genome Sciences Inc. (HGSI)

LymphoStat-B

Human antibody to B-lymphocyte
stimulator

Systemic lupus erythematosus

Company said clinical and pre- clinical results to date support continued development (10/28)

Peptimmune Inc.*

PI-0824

Synthetic peptide

Pemphigus
vulgaris

Company began a Phase I trial to test safety (10/7)

NPS Pharmaceuticals
Inc.
(NPSP)

ALX-0600

Teduglutide; derivative of protein that regulates gastrointestinal processes

Crohn's
disease

NPS began a proof-of concept study examining dosing and efficacy in 100 patients (10/7)

Regeneron Pharmaceuticals
Inc.
(REGN)

IL-1 Trap

Designed to block interleukin-1

Rheumatoid
arthritis

Phase II trial in 200 patients missed primary endpoint of ACR-20 responses, though company said it demonstrated some evidence of efficacy (10/7)

CANCER

Antigenics Inc. (AGEN)

Oncophage (HSPPC-96)

Personalized cancer vaccine

Cancer

Immunological Phase II data published in The Journal Of Immunology showed a cancer-specific response (10/1)

Aton
Pharma
Inc.*

SAHA

Histone
deacetylase inhibitor

Multiple
myeloma

Enrollment began in Phase I trial that will assess safety and dosing, as well as anticancer effects and activity (10/13)

Bioenvision Inc. (AMEX:BIV)

Clofarabine

Purine nucleoside antimetabolite

Leukemia

Company said Phase I data published in Blood showed a 32% response rate in pediatric patients with advanced disease (10/29)

Bioenvision Inc. (AMEX:BIV)

Gossypol

Isoform of the cancer agent

Cancer

Company said it will begin Phase I testing to determine dosin (10/8)

Celgene Corp. (CELG)

CC-8490

Cancer compound
from the benzopyran class

Brain cancer

Celgene and the National Cancer Institute began clinical testing of the drug, which is being developed under a CRADA (10/31)

Celgene Corp. (CELG)

Actimid (CC-4047)

Immunomodulatory
drug

Prostate cancer

Initiated open-label Phase II trial in 19 patients to study safety and efficacy as a single agent for hormone-refractory disease (10/30)

Cell Therapeutics Inc. (CTIC)

Xyotax

Paclitaxel linked to biodegradable polyglutamate
polymer

Non-small-cell
lung cancer

Company is reducing the dose in its pivotal STELLAR 4 trial follow-recommendation from a data monitoring committee due to toxicities (10/20)

Cerus Corp. (CERS)

ACIT

Allogeneic cellular immune therapy

Use in stem cell tranplants

Product to improve transplant outcomes in patients with hema- tologic malignancies will be tested in Phase Ib trial involving three doses and up to 42 patients (10/23)

Endo Pharmaceuticals
Inc.
(subsidiary of Endo Pharmaceutical Holdings Inc.; ENDP)

EN3247

0.1% triclosan
oral rinse

Oral mucositis resulting from chemotherapy

The Phase III trial in 355 patients failed to demonstrate efficacy (10/24)

GlycoGenesys
Inc.
(GLGS)

GCS-100

Cancer compound

Advanced solid
tumors

Phase I results in 12 patients showed it was well tolerated with no dose-limiting toxicity; five patients achieved stable disease (10/22)

Hybridon Inc. (OTC BB: HYBN)

GEN231

Antisense
oligonucleotide targeted
to RI-alpha subunit of
kinase A

Cancer

Data from 14-patient safety study were published in Clinical Cancer Research; a dose was selected for Phase II study (10/2)

Genentech Inc. (NYSE:DNA) and OSI Pharmaceuticals Inc. (OSIP)

Tarceva

Erlotinib; small-molecule EGFR inhibitor

Metastatic non-small-cell
lung cancer

Data from two Phase III studies of Tarceva and standard chemotherapy showed drug did not meet primary endpoint of improving overall survival (10/1)

ILEX Oncology
Inc.
(ILXO)

ILX-651

Synthetic analogue of dolastatin; targets tubulin

Recurrent or
metastatic melanoma

ILEX began a Phase II study to measure efficacy and tolerability at 19 sites in the U.S. (10/7)

Millennium Pharmaceuticals
Inc.
(MLNM)

MLN2704

Targeted antibody delivering maytansinoid chemotherapeutic agent DM1

Metastatic androgen-
independent prostate cancer

Millennium began an escalating-dose Phase I/II study in about 46 patients (10/9)

Novuspharma SpA (Italy; Nuovo Mercato:NOV)

Pixantrone (BBR 2778)

Anthracycline agent

Aggressive non-Hodgkin's lymphom

Company began a Phase II trial, expected to include 75 patients, to test Pixantrone as part of a chemotherapy salvage regimen (10/22)

Onyx Pharmaceuticals
Inc.
(ONXX) and Bayer Corp.

BAY 43-9006

Signal transduction inhibitor designed to block the Ras/MEK/ERK pathway

Advanced
renal-cell
carcinoma

Companies initiated international Phase III trial in more than 800 patients who failed prior therapy; they also signed a special protocol agreement with the FDA (10/25)

OSI
Pharmaceuticals
Inc. (OSIP)

OSI-7904L

Liposomal thymidylate synthase inhibitor

Advanced gastric cancer

OSI began a Phase II study in 50 reviously untreated patients; the primary endpoint is response rate (10/24)

Progen Industries Ltd. (Australia; PGLAF)

PI-88

Anti-angiogenesis
drug

Advanced cancers

Progen presented early data from Phase I/II trial highlighting some encouraging results (10/8**)

Telik
Inc.
(TELK)

Telcyta (TLK286)

Small-molecule
prodrug

Refractory or resistant ovarian cancer

Telik reported positive interim results from Phase I/IIa trial of Telcyta in combination therapy (10/21)

Telik
Inc.
(TELK)

Telcyta (TLK286)

Small-molecule
prodrug

Non-small-cell
lung cancer

Telik reached agreement with FDA on special protocol assessment for Phase III trial of Telcyta; the ASSIST-2 study will include about 500 third-line patients (10/1)

CARDIOVASCULAR

AryX Therapeutics Inc.*

ATI-2042

Amiodarone
analogue

Atrial fibrillation

Company initiated first clinical study of drug, a Phase I trial to evaluate safety and pharmaco-kinetic profile (10/22)

Avant Immunotherapeutics Inc. (AVAN)

CETi-1

Vaccine for
management of cholesterol

Cholesterol maintenance

Results from 203-patient Phase II trial failed to demonstrate a statistically significant improvement over placebo in increasing HDL levels (10/22)

Corentech Inc.*

CGT003

EF2 decoy; oligonucleotide that inactivates E2F transcription factor

Graft failure following
peripheral
bypass graft
surgery

Company completed enrollment in second Phase III trial, this one in 1,400-patient PREVENT study (10/2)

CV Therapeutics Inc. (CVTX)

CVT-3146

Selective A2A-adenosine
receptor agonist

Stress agent in cardiac perfusion imaging studies

CV initiated a pivotal Phase III trial of drug, triggering $3M milestone from partner Fujisawa Healthcare Inc. (10/28)

Medicure Inc. (Canada; TSE:MPH)

MC-1

Cardioprotective
agent

For use in coronary artery bypass graft surgery

Company filed for approval in Canada and the U.S. to begin Phase II trial in up to 900 patients to assess effects in patients undergoing high-risk CABG (10/15)

United
Therapeutics
Corp.
(UTHR)

Remodulin (FDA-approved)

Treprostinil sodium injection

Pulmonary arterial hypertension

Sixteen-month data on 19 patients showed the drug was effective on a long-term basis (10/2)

XOMA Ltd. (XOMA)

Neuprex

Modified form of fragment of bactericidal/
permeability increasing protein

Pediatric patients with abnormalties requiring open-heart surgery associated with cardio-pulmonary bypass

XOMA said Children's Medical Center of Dallas started an open-label Phase I/II study (10/2)

XOMA Ltd. (XOMA) and Millennium Pharmaceuticals
Inc.
(MLNM)

MLN2201

Humanized
monocolonal antibody

Conditions related to inflammation of the heart and blood vessels

XOMA said it was discontinuing development following a Phase I trial that failed to meet predetermined criteria (10/10)

CENTRAL NERVOUS SYSTEM

Cortex Pharmaceuticals
Inc.
(AMEX:COR)

Ampakine CX516

Compound designed
to increase cerebral arousal

Excessive daytime sleepiness

Preiminary results of Phase I trial in 10 healthy men showed positive dose-related responses (10/21)

Cypress Bioscience Inc. (CYPB)

Milnacipran

Norepinephrine
serotonin reuptake inhibitor

Fibromylasia syndrome

Data presented at meeting from Phase II trial showed drug improved syndrome in multiple measures of clinical pain (10/28)

Cypress Bioscience Inc. (CYPB)

Milnacipran

Norepinephrine
serotonin reuptake inhibitor

Fibromylasia syndrome

Cypress began a Phase III program in the U.S. expected to take about two years (10/21)

Guilford Pharmaceuticals Inc. (GLFD)

GPI 1485

Neuroimmunophilin ligand

Parkinson's
disease

Company completed enrollment of 212 patients in Phase II trial (10/14)

Durect Corp. (DRRX)

Chronogesic pain product

Osmotic implant that delivers sufentanil

Chronic pain

Durect said data from a preclinical model indicated a potential problem with the delivery mechanism, a result expected to delay the restart of the Phase III program (10/16)

Ligand Pharmaceuticals
Inc.
(LGND)

Avinza (FDA-approved)

Extended-release morphine

Chronic back pain

Company said product provided stable analgesia for one year without an increase in dose or use of rescue medicines; data were from open-label extension study in 128 patients (10/14)

NeorogesX Inc.*

NGX-410

Capsaicin dermal delivery system

Neuropathic pain associated with HIV and AIDS

NeurogesX began a Phase II/III study comparing analgesic effect compared with low-dose capsaicinin in up to 300 patients (10/8)

Neurobiological Technologies Inc. (NTII) and Forest Laboratories Inc.

Namenda

Memantine; NMDA receptor antagonist

Neuropathic pain

Forest said it would continue to study the drug after analyzing Phase III results that did not demonstrate efficacy in treating nocturnal pain (10/22)

Pain Therapeutics Inc. (PTIE)

Oxytrex

Small-molecule
drug

Severe chronic pain

Company said Phase II results in osteoarthritic patients demonstrated statistically significant results in primary endpoint of prospectively defined reduction in pain scores at three weeks; study also met secondary endpoints (10/16)

Sepracor
Inc.
(SEPR)

Estorra

Eszopiclone; non-benzodiazepine agent

Chronic insomnia

Published Phase III data showed statistically significant improvement; drug is on file with FDA (10/21)

Targacept Inc.*

TC-1734

Neuronal nicotinic receptor agonist

Cognitive and memory disorders

Company said Phase I trial showed no safety concerns and a dose-specific effect on surrogate measures of disease (10/30)

DIABETES

AmCyte Inc.*

--

Replacement islets for transplantation

Diabetes

Company said a Phase I/II trial was initiated that will evaluate islet transplantion in three patients (10/30)

Generex Biotechnology
Corp.
(GNBT)

Oralin

Oral insulin spray formulation

Type II diabetes

Generex presented results from studies pointing to efficacy (10/7)

Keryx Biopharmaceuticals Inc. (KERX)

KRX-101

Sulodexidel; oral heparinoid compound

Diabetic nephropathy

Keryx began the Phase II portion of its Phase II/III program; this portion of the study will include about 135 patients with Type II diabetes (10/21)

INFECTION

Amarillo
BioSciences
Inc. (OTC BB:AMAR)

Interferon-alpha

Low-dose version formulated in lozenge

Oral warts in HIV patients

Amarillo filed an IND for a pivotal Phase III study in 90 patients (10/14)

AVI BioPharma
Inc.
(AVII)

AVI-420

Neugene
antisense drug

West Nile virus

AVI said it would being a second study in West Nile virus to allow expanded access of the drug (10/8)

Biosynexus Inc.*

BSYX-L210

Intranasal cream containing lysostaphin

Eradication of S. aureus nasal carriage

Company said Phase I/II trial met endpoints for safety and micro-biological activity, and data will be submitted for publication (10/14)

Chiron
Corp.
(CHIR)

Tifacogin

Recombinant form of tissue factor pathway inhibitor

Severe
community- acquired
pneumonia

Chiron said it was initiating plans for a Phase III trial; it also said it acquired all of Pfizer Inc.'s interest in the drug (10/29)

Genzyme Corp. (GENZ)

--

Tolevamer sodium

Clostridium difficile-associated diarrhea

Genzyme presented preliminary data from a Phase II trial in 289 patients showing non-inferiority to vancomysin in time to diarrhea resolution (10/20)

Gilead
Sciences
Inc.
(GILD)

Hespera (FDA-approved)

Adefovir dipivoxil; nucleoside analogue

Hepatitis B

Gilead presented data from open-label Study 460i showing drug was associated with sustained reduction of HBV through 144 weeks in lamivudine-resistant patients co-infected with HIV (10/28)

Gilead
Sciences
Inc.
(GILD)

Viread (FDA-approved)

Tenofovir disoproxil fumarate; nucleotide analogue reverse transcriptase inhibitor

HIV

One presentation from extension of pivotal study showed low incidence of adverse events for up to four years; another, from the1,350- patient RECOVER study, suggested drug in place of stavudine may improve dyslipidemia (10/28)

Human Genome Sciences Inc. (HGSI)

Albuferon

Long-acting form of interferon-alpha

Hepatitis C

Interim results from Phase I/II trial showed drug was well tolerated, had a prolonged half-life and was biologically active (10/28)

Idenix Pharmaceuticals Inc.*

Telbivudine (LdT)

Antiviral agent

Chronic hepatitis B

52-week data from Phase IIb trial in 104 patients showed better suppresion of HBV and normalization of ALT when compared to lamivudine monotherapy (10/28)

Idun Pharmaceuticals Inc.*

IDN-6556

Inhibitor of caspase enzymes that mediate apoptosis

Liver impairment caused by hepatitis C infection

Dose-ranging study showed the drug normalized liver enzymes after two weeks of treatment; data are based on results from 41 patients (10/27)

InterMune Inc. (ITMN)

Infergen

Interferon alfacon-1

Hepatitis C

Company said an investigator-sponsored study showed drug with ribavarin produced positive results (10/29)

MedImmune Inc. (MEDI)

Numax

Next-generation antibody

Respiratory syncytial virus

MedImmune submitted IND for first trial of Numax to assess safety and tolerability in healthy adult volunteers (10/1)

MedImmune Inc. (MEDI) and Wyeth

--

Intranasal, cold-adapted trivalent vaccine

Influenza

Companies presented encouraging data from five studies totaling 5,500 patients (10/13)

Samaritan Pharmaceuticals Inc. (OTC BB:SPHC)

--

Neuroimmuno-
modulator

HIV

Company submitted Phase II clinical report to FDA showing data demonstrating statistical significance for viral load and quality of life, and said it is developing a Phase III regimen (10/28)

SciClone Pharmaceuticals Inc. (SCLN)

Zadaxin

Synthetic thymosin alpha-1

Hepatitis C

Results from 23 patients in pilot trial showed triple therapy with ribavarin and pegylated interferon-alpha produced a 12-week early virologic response in 61% of non-responder patients (10/27)

Trimeris Inc. (TRMS) and F. Hoffmann La-Roche Ltd. (Switzerland)

Fuzeon (FDA-approved)

Enfuvirtide; HIV fusion inhibitor

HIV

New data presented at AIDS conference showed Fuzeon as part of combination therapy provided virologic and immunologic benefit through 48 weeks in patients with less-advanced HIV (10/27)

Vertex Pharmaceuticals
Inc.
(VRTX) and GlaxoSmithKline
plc
(UK)

Lexiva (FDA-approved)

Fosamprenavir
calcium; protease inhibitor

HIV infection

Data from Phase III study showed HIV patients taking drug boosted with ritonavir had increased levels of HDL cholesterol at 48 weeks (10/28)

Vertex Pharmaceuticals Inc. (VRTX)

VX-497

Merimepodib; small- molecule inhibitor of the enzyme inosine guanosine triphosphate

Hepatitis C

Vertex said the drug met its primary endpoint of safety and tolerability in an interim analysis from a Phase II study in 31 patients; it also showed clinical activity (10/17)

Vicuron Pharmaceuticals
Inc.
(MICU)

Dalbavancin

Semi-synthetic glycopeptide

Skin and
soft-tissue infections

Vicuron started a Phase III study comparing its drug to vancomycin in up to 150 patients (10/8)

MISCELLANEOUS

Adolor
Corp.
(ADLR)

Entereg

Alvimopan; mu opioid antagonist

Postoperative ileus

Top-line results from 519-patient Phase III study showed the drug generally was well tolerated; other Phase III trials are ongoing (10/22)

Altus Biologics Inc.*

TheraCLEC

Oral enzyme replacement therapy

Malabsorption resulting from pancreatic insufficiency

Altus said a Phase I trial demonstrated a favorable safety and clinical activity profile (10/22)

Avanir Pharmaceuticals Inc. (AMEX:AVN)

AVP 13358

Molecule designed to inhibit production of IgE

Allergy and asthma

Avanir said preliminary results show product was well tolerated at single rising doses in a Phase I trial (10/21)

AVI BioPharma Inc. (AVII)

AVI-4557

Neugene antisense drug

To affect drug metabolism

AVI initiated Phase I trial of oral drug (10/10)

BioSante Pharmaceuticals Inc. (AMEX:BPA)

LibiGel

Gel formulation of testosterone

Female sexual dysfunction

BioSante said interim analysis of Phase II trial showed statistically significant improvement in sexual desire and activity (10/21)

Corus Pharma Inc.*

Corus 1020

Aztreonam formulated for inhalation

Cystic fibrosis

Corus initiated Phase II trial to evaluate safety, tolerability and efficacy (10/15)

ICOS Corp. (ICOS) and Eli Lilly and Co.

Cialis

Talafidil; PDE 5 inhibitor dysfunction

Erectile Phase III data showing efficacy

Companies' joint venture reported of Cialis in men who have undergone a form of prostatectomy (10/10)

Genaera Corp. (GENR)

Lomucin

Talniflumate; an anti- inflammatory drug

Cystic fibrosis

Genaera and Cystic Fibrosis Foundation Therapeutics presented Phase II data showing safety and maintenance of existing lung function in CF patients (10/16)

Genaera Corp. (GENR)

Squalamine

Anti-angiogenic drug

Choroidal neo-vascularization related to age- related macular degeneration

Company said updated Phase II results in 40 patients were positive (10/7)

Idun Pharmaceuticals Inc.*

IDN-6556

Designed to protect liver cells from apoptosis

Liver damage in transplantation

Twelve transplant centers are expected to participate in the 100-patient Phase II study (10/8)

Indevus Pharmaceuticals Inc. (IDEV)

Trospium

Muscarinic receptor antagonist

Overactive bladder

Indevus presented data showing that early patient response was an accurate predictor of long-term therapeutic success (10/14)

Indevus Pharmaceuticals Inc. (IDEV)

Trospium

Muscarinic receptor antagonist

Urgency severity, a symptom of overactive bladder

Indevus presented data from controlled, 523-patient study showing reduced urgency severity (10/7)

Neurotech SA* (France)

NT-501

Intraocular polymer containing cells modified to secrete ciliary neurotrophic factor

Retinitis
pigmentosa

Company initiated Phase I trial in 10 patients with late-stage disease; trial will be conducted at U.S. National Eye Institute (10/8)

NexMed Inc.

Femprox

Alprostadil cream arousal disorder

Female sexual showed positive dose-related

Phase II data published in journal (NEXM) trends (10/7)

NPS Pharmaceuticals Inc. (NPSP)

Preos

Recombinant, full-length parathyroid hormone

Osteoporosis

NPS completed enrollment of 2,700 women in Phase III TOP trial (10/7)

Progenics Pharmaceuticals Inc. (PGNX)

Methylnaltrexone

Opioid-receptor antagonist

Opioid-induced urinary retention

Company said Phase II data showed drug relieved condition without reversing CNS effects of the opiod (10/10)

RegeneRx Biopharmaceuticals Inc. (OTC BB:RGRX)

Thymosin beta-4

Naturally occurring peptide

Wound healing

RegeneRx completed Phase I trial in 15 volunteers, showing it was well tolerated (10/8)

Theratechnologies Inc. (Canada; TSE:TH)

ThGRF

Growth hormone-releasing factor analogue

Chronic wasting

Preliminary results from Phase II study in patients with disease secondary to chronic obstructive pulmonary disease suggested improvement in condition (10/21)

Xenova Group plc (UK; XNVA)

TA-CD

Therapeutic vaccine designed to produce anti-cocaine antibodies

Cocaine addiction

Xenova initiated Phase IIb trial in up to 132 methadone-dependent addicts who will be given drug or placebo; trial is expected to last two years (10/24)

Xenova Group plc (UK; XNVA)

TA-NIC

Therapeutic vaccine

Smoking cessation

Xenova began a second Phase I trial to further establish safety and tolerability, and to determine dosing (10/8)


Notes:

* Privately held.

** Date item was published in BioWorld International.

ACR = American College of Rheumatology meeting

Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.

AMEX = American Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board;

TSE = Toronto Stock Exchange.