Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Active Biotech
AB
(Sweden; SSE: ACTI)

SAIK-MS

Laquinimod

Multiple sclerosis

Phase II data showed that the trial met its primary endpoint, a statistically significant reduction in disease activity in patients treated with the oral compound during a six-month period (9/16)

Biogen Inc.
(BGEN)

Avonex (FDA-approved)

Interferon beta-1a

Multiple sclerosis

Clinical data showed that Avonex could alter the long-term course of MS in patients who began treatment immediately after their initial MS attack, compared to initiation of treatment more than two years after onset of symptoms (9/22)

Human Genome
Sciences Inc.
(HGSI)

LymphoStat-B

Human antibody to B-lymphocyte stimulator

Lupus

Company initiated a Phase II trial designed to evaluate safety, dosing and preliminary efficacy in 300 patients (9/25)

Isis
Pharmaceuticals
Inc.
(ISIS)

ISIS 104838

TNF-alpha inhibitor

Rheumatoid rthritis

Phase IIa data showed that ISIS 104838 reduced TNF-alpha mRNA levels in synovial tissue and stabilized levels of TNF-alpha in blood in rheumatoid arthritis patients who received 300 mg of the drug (9/18)

MedImmune
Inc.
(MEDI)

Vitaxin

Monoclonal antibody that targets alpha-v-beta-3 integrin

Rheumatoid arthritis

Company began a Phase II trial (9/9)

SkyePharma plc
(UK; LSE:SKP) and
Astralis Ltd
(OTC BB:ASTR)

Psoraxine

Injectable treatment

Psoriasis

Astralis initiated a Phase I trial in the U.S. (9/15)

ZymoGentics Inc.
(ZGEN) and Serono
SA
(Switzerland;
NYSE:SRA)

TACI-Ig

Soluble-receptor protein

Autoimmune disease

Companies initiated a Phase I trial to assess safety and pharmacokinetics; effects on B lymphocytes also will be measured (9/29)

CANCER

AEterna
Laboratories Inc.
(Canada; AELA)

Neovastat

Anti-angiogenic drug

Renal-cell carcinoma

Drug failed to hit primary endpoint in 305-patient Phase III trial, but company said subgroup benefited (9/24)

Antigenics Inc.
(AGEN)

Oncophage

Cancer vaccine

Nonmetastatic pancreatic cancer

Phase I data showed a median overall survival of 2.5 years, with one patient still alive and disease free after more than five years (9/22)

Antisense
Pharma GmbH*
(Germany)

AP 12009

Combines precise selection of cancer target molecules and DNA-based phosphorothioate oligonucleotides

High-grade glioma

Phase I/II data were positive (9/4)

Aptamera Inc.*

AGRO100

G-rich oligonucleotide that binds to nucleoin

Cancer

Company started Phase I trial testing safety and pharmacokinetics (9/24)

ArQule Inc.
(ARQL)

CO-501

Small-molecule drug that acts on cellular checkpoints

Solid tumors

Company started first trial, a dose-escalation safety study in cancer patients (9/30)

Bioenvision
Inc.
(AMEX:BIV)

Modrenal

Trilostane

Breast cancer

Company presented meta-analysis data from 700 postmenopausal patient with resistance showing clinical benefit rate of 55% (9/30)

Callisto
Pharmaceuticals
Inc.
(OTC BB:CLSP)

Atiprimod

Small-molecule drug with antiproliferative and anti- angiogenic activity

Refractory or relapsed multiple myeloma

Company filed IND for Phase I/IIa open-label safety and efficacy trial (9/24)

Celgene Corp.
(CELG)

Thalomid (FDA-approved)

Thalidomide

Metastatic melanoma

Clinical data showed an overall objective response rate of 32% when Thalomid was combined with temozolomide as an oral regimen (9/8)

Celgene Corp.
(CELG)

Thalomid (FDA-approved)

Thalidomide

Androgen- independent prostat carcinoma

Phase I/II data from 18 of 33 evaluable patients showed a 50%-79% decrease in PSA levels following combination therapy (9/25)

Cell Genesys
Inc.
(CEGE)

GVAX

Vaccine modified to secrete GM-CSF

Melanoma

Phase I data showed that 10 of 35 patients remained alive, with a minimum follow-up of 36 months, including four patients without evidence of recurrent disease following surgical resection of their tumor; the treatment was safe and well tolerated (9/2)

Corixa Corp.
(CRXA)

--

Vaccine containing a recombinant plasmid DNA and an adenovirus

Non-small-cell lung cancer

Company began a Phase I trial (9/18)

Corixa Corp.
(CRXA)

Bexxar (FDA-approved)

Tositumomab and I-131 tositumomab

Non-Hodgkin's lymphoma

Phase II data showed that therapy with Bexxar following chemotherapy produced a high rate of response in patients with advanced follicular non-Hodgkin's lymphoma (9/22)

Dendreon
Corp.
(DNDN)

Provenge

Immunotherapy

Prostate cancer

Phase III data showed Provenge did not achieve the pre-specified endpoint (9/18)

Exelixis Inc.
(ELEX)

XL119

Small-molecule cancer compound

Bile duct tumors and non-small-cell lung cancer

Phase II data showed encouraging results relative to overall survival and progression-free survival in both indications (9/15)

Eximias
Pharmaceutical
Corp.*

Thymitaq

Nolatrexed dihydrochloride

Advanced solid tumors

Company began a Phase I/II trial (9/16)

Genmab A/S
(Denmark; CSE:GEN)

HuMax-EGFr

Human antibody

Head and neck cancer

Company began Phase I/II trial in up to 36 patients; the trial will test six doses (9/24)

Kosan Biosciences Inc. (KOSN)

KOS-862

Epothilone D

Cancer

Company reported Phase I results in 10 patients with advanced solid tumors showing it was well tolerated and had preliminary activity (9/23)

Ligand
Pharmaceuticals
Inc.
(LGND)

Targretin

Bexarotene capsules

Advanced non-small-cell lung cancer

Company exceeded its 600-patient enrollment goal in the second of two pivotal Phase III studies of Targretin capsules in front-line combination therapy (9/19)

Medarex
Inc.
(MDRX)

MDX-010

A fully human anti-CTLA-4 antibody

Metastatic breast cancer

Company began a Phase II trial (9/8)

MedImmune
Inc.
(MEDI)

Vitaxin

Monoclonal antibody that targets alpha-v-beta-3 integrin

Metastatic melanoma

Company began a Phase II trial (9/9)

Metabasis
Therapeutics Inc.*

MB7133

Prodrug of cytarabine

Inoperable primary liver cancer

Company began clinical testing in trial to test safety and tolerability in patients (9/23)

Oxigene Inc.
(OXGN)

Combrestatin A4 Prodrug

Vascular-targeting agent; combined with radio-
immunotherapy in the trial

Advanced colorectal cancer

Company began Phase I/II trial of drug in combination with an iodine-labeled antibody (9/30)

Pharmacyclics
Inc.
(PCYC)

Xcytrin

Motexafin gadolinium injection

Advanced solid tumors

Company opened two new Phase I trials (9/4)

Salmedix Inc.*

Bendamustine
(SDX-105)

Alkylating agent

Relapsed non-Hodgkin's lymphoma

Company began Phase II/III trials as part of registrational program of drug that's been on market in Germany for decades (9/30)

Spectrum Pharmaceuticals Inc. (SPPI) and GPC Biotech Inc. (Germany; FSE:GPC)

Satraplatin

Orally available platinum compound

Prostate cancer

Companies initiated Phase III trial of drug in combination with prednisone vs. prednisone alone as second-line treatment (9/2)

Therion
Biologics Corp.*

--

Prototype vaccine administered in combination with interleukin-2

Metastatic melanoma

Clinical data showed objective tumor response in six of 12 treated patients (9/15)

Transgene SA
(France; TRGNY)

MVA-FCU1

A virus-directed enzyme prodrug therapy

Tumors

Company began clinical development (9/18)

Xcyte Therapies
Inc.*

Xcellerate

Activated T cells and low doses of IL-2

Metastatic kidney cancer

Some therapeutic effect was seen in Phase I trial in 25 patients; no adverse events reported (9/25)

CARDIOVASCULAR

Agenix Ltd.
(Australia; ASX:AGX)

ThromboView

Blood-clot detection technology

Deep-vein thrombosis

Company completed the first dose level in a group of six patients as part of a Phase Ib trial (9/16)

Alexion
Pharmaceuticals
Inc.
(ALXN)

Pexelizumab

Antibody fragment

Acute myocardial infarction

Phase II data showed pexelizumab did not significantly reduce infarct size, the primary endpoint, but it significantly reduced all-cause mortality at 90 days by 70% (9/2)

Alteon Inc.
(AMEX: ALT)

ALT-711

A.G.E. crosslink breaker

Heart failure

Phase IIa data showed a statistically significant reduction in left ventricular mass and a marked improvement in left ventricular diastolic filling, as well as statistically significant improvements in multiple quality-of-life measurements (9/3)

Avant
Immunotherapeutics
Inc.
(AVAN)

TP10

Complement inhibitor

Women undergoing cardiopulmonary surgery

Company reinstated development with plans for Phase II trial in 200 patients by year's end (9/23)

AVI BioPharma
Inc.
(AVII)

Resten-NG

Antisense drug

Restenosis

Phase II data showed that use of Resten-NG resulted in a statistically significant, 75% reduction in the rate of restenosis (9/18)

BioMarin
Pharmaceutical
Inc.
(BMRN)

Neutralase

Carbohydrate-modifying enzyme that cleaves heparin

Coronary artery bypass graft surgery

Company stopped its Phase IIIa study and terminated further development after a Data Safety Monitoring Board recommended stopping enrollment due to an increasing frequency of adverse events (9/22)

Cardiome Pharma
Corp.
(Canada;
TSE:COM)

Oxypurinol

Designed to improve oxygen-use efficiency

Heart disease

Clinical data showed it met its primary endpoint (9/22)

Corgentech Inc.*

CGT003

Oligonucleotide that binds and blocks E2F

To prevent graft failure following coronary artery bypass graft surgery

Company completed patient enrollment in a pivotal Phase III trial (9/18)

Icagen Inc.*

ICA-17043

Ion channel
blocker

Sickle-cell anemia

Company completed enrollment of 90 patients in a Phase II trial (9/3)

Medicure Inc.
(Canada; TSE:MPH)

MC-1

Oral therapeutic

Heart damage

Phase II MEND-1 trial showed reduced damage to heart caused by ischemia in 60 high-risk cardiovascular patients undergoing angioplasty (9/26)

NicOx SA
(France; NICXF)

NCX 4016

Cardiovascular
protective agent

Peripheral arterial obstructive disease

Clinical data showed NCX 4016 showed greater activity in the inhibition of inflammatory markers compared to aspirin (9/9)

Octagen Corp.*
and Ipsen Group
(France)

OBI-1

Recombinant porcine coagulation Factor VIII

Hemophilia A

Companies began a Phase I trial (9/3)

Pharmacyclics
Inc.
(PCYC)

Antrin Injection

Motexafin lutetium; water-soluble photoactive agent that accumulates in vascular plaque and is cleared from the rest of the body

Atherosclerotic plaque

Clinical data showed no deleterious effects on treated arterial segments and no significant systemic toxicities (9/19)

Scios Inc.
(unit of Johnson &
Johnson)

Natrecor (FDA-approved)

Nesiritide; recombinant B- type natriuretic peptide

Advanced chronic congestive heart failure

Company reported positive results from pilot study named FUSION I (9/23)

CENTRAL NERVOUS SYSTEM

Aradigm
Corp.
(ARDM)

AERx Pain Management System

Delivers morphine via inhalation

Pain

Clinical data showed it was safe, well tolerated and produced comparable pain relief to intravenous morphine (9/8)

Axonyx Inc.
(AXYX)

Phenserine

Acetylcholinesterase beta amyloid precursor protein inhibitor

Alzheimer's disease

Company is providing Phenserine treatment to Alzheimer's disease patients in an ongoing Phase IIb and Phase III trial through a formal six-month extension study (9/18)

DOV
Pharmaceuticals
Inc.
(DOVP)

Bicifadine

Non-narcotic analgesic

Post-surgical dental pain

Phase III data showed bicifadine was an effective analgesic, compared to placebo, with efficacy at least equivalent to tramadol (9/10)

Labopharm
Inc.
(Canada; TSE:DDS)

Tramadol

Analgesic

Pain

Company completed the treatment stage for two pivotal Phase III trials (9/15)

Neurocrine
Biosciences
Inc.
(NBIX)

Indiplon

Modified-release formulation of indiplon

Insomnia

Preliminary top-line results from first Phase III study showed statistically significant improvements (9/24)

Pozen Inc.
(POZN)

MT 100

Tablet formulation

Migraine

Phase III data showed MT100 was more effective in providing pain relief at two hours than a single tablet of Imitrex 50 mg in migraine patients with severe pain or nausea at baseline (9/16); Phase IIIb data showed superior pain relief compared to placebo (9/24)

Proneuron Biotechnologies Inc.*

ProCord

Autologous activated macrophage therapy

Spinal cord injury

Company began enrollment in 61-patient, controlled Phase II trial (9/23)

DIABETES

Isis
Pharmaceuticals
Inc.
(ISIS)

ISIS 113715

Transports glucose into cells; an antisense inhibitor of protein tyrosine phosphatase

Type II diabetes

Clinical data showed increased insulin sensitivity; less insulin was required to normalize glucose, without causing hypoglycemia (9/16)

Metabasis Therapeutics Inc.* and Sankyo Co. Ltd. (Japan)

--

Oral gluconeogenesis inhibitor

Type II diabetes

Companies completed a Phase IIa trial; results showed class of drug demonstrated potential in reducing glucose levels (9/26)

INFECTION

Agouron Pharmaceuticals Inc. (unit of Pfizer Inc.)

Viracept (FDA-approved)

Nelfinavir mesylate

HIV and hepatitis C virus

Clinical results were positive, showing CD4 cell-count changes and viral load changes (9/15)

AnorMED Inc. (Canada; TSE:AOM)

AMD070

CXCR4 inhibitor

HIV

Company began enrolling healthy volunteers in a Phase I trial to evaluate the safety of AMD070 (9/3)

Avant Immunotherapeutics
Inc.
(AVAN)

CholeraGarde

Oral vaccine candidate

Cholera

Clinical data showed the vaccine's ability to elicit vibriocidal antibodies without an increased incidence of adverse effects compared to placebo in healthy volunteers who took part in the study (9/16)

AVI BioPharma Inc. (AVII)

AVI-4020

Neugene antisense drug

West Nile virus

Company began dosing patients in a Phase Ib trial (9/10)

Biosyn Inc.*

UC-781

Microbicide; a non-nucleo- side reverse transcriptase inhibitor

HIV

Company initiated enrollment in a Phase I trial (9/4)

Depomed Inc. (AMEX:DMI)

Ciprofloxacin GR

Formulation using Gastric Retention technology

Urinary tract infections

Phase III data showed that the once-daily Ciprofloxacin GR product was as effective as Cipro, which is given twice daily (9/4)

ID Biomedical Corp. (Canada; IDBE)

FluINsure

Vaccine

Influenza

Clinical data showed significant reductions in clinical illness across all vaccine regimens tested when compared with placebo (9/18)

Inhibitex Inc.*

Aurexis

Humanized monoclonal antibody

Staphylococcus aureus infections

Company completed a Phase I study showing all dose levels were well tolerated (9/8)

InterMune Inc. (ITMN)

Oritavancin

Intravenous antibiotic

Skin/skin- structure infections

Phase III data showed oritavancin achieved its primary efficacy endpoint, demonstrating that the drug was as effective as the comparator regimen of vancomycin followed by cephalexin (9/16)

IntraBiotics Pharmaceuticals Inc. (IBPI)

Iseganan hydrochloride

Oral rinse product

To prevent ventilator- associated pneumonia

Company will begin two pivotal trials enrolling 900 patients each (9/19)

Nabi Biopharmaceuticals Inc. (NABI)

StaphVAX

S. aureus polysaccharide conjugate vaccine

To prevent S. aureus infections in end-stage renal disease

Company started second Phase III study that will include 3,000 pat-ients on hemodialysis (9/29)

SciClone Pharmaceuticals Inc. (SCLN)

Zadaxin

Synthetic thymosin alpha-1

Hepatitis C

Company completed enrollment of 500 patients in first of two Phase III trials (9/24)

Stressgen Biotechnologies Corp. (Canada; TSE:SSB)

HspE7

Heat-shock protein

Recurrent respiratory papillomatosis

Phase II data showed HspE7 hit its primary endpoint (9/16)

The Immune Response Corp. (IMNR)

Remune

Immune-based therapeutic vaccine

HIV

Company began Phase II trial of Remune in drug-naïve patients (9-29)

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

433908

HIV protease inhibitor

HIV

Clinical data showed the compound can be co-administered with the antacids Maalox TC or Zantac as well as the cholesterol-lowering Lipitor (9/16)

MISCELLANEOUS

Adolor Corp.
(ADLR)

Entereg (alvimopan)

Muopiod antagonist

Postoperative ileus

Phase II study showed statistically significant improvement in time to recovery of gastrointestinal function (9/23)

Auxilium Pharmaceuticals
Inc.*

Testim

Testosterone gel

Hypogonadism

Clinical data showed treatment with Testim can significantly increase bone mineral density and improve body composition in aging hypogonadal men (9/22)

Cerus Corp. (CERS) and Baxter Healthcare Corp.

Intercept Blood System

Pathogen-inactivation system for red blood cells that uses the compound S-303

Blood transfusions

Companies stopped a Phase III trial after two study patients developed antibodies to red blood cells treated with S-303 (9/4)

Helix BioMedix Inc. (OTC BB:HXBM)

HB64

Peptides

Acne

Clinical data showed 75% of patients had clinical improvement, while 85% reported the gel helped their complexion (9/8)

Human Genome Sciences Inc. (HGSI)

Repifermin

Keratinocyte growth factor-2

Chronic venous ulcers

Company ended development in that indication following failed Phase II trial, which measured wound closure (9/25)

Nobex Corp.*

Apaza

Combines marketed drugs 5-ASA and 4-APAA

Inflammatory bowel disease

Completed Phase I trial exploring tolerance, safety and pharmacokinetics (9/30)

NPS
Pharmaceuticals
Inc.
(NPSP)

PTH

Parathyroid hormone

Osteoporosis

Clinical data suggest that PTH might be more effective than the combination of PTH and alendronate, and alendronate alone, in promoting bone formation in postmenopausal osteoporotic women (9/22)

Regeneron Pharmaceuticals Inc. (REGN)

Axokine

A modified form of ciliary neutrophic factor

Obesity

Company began a confirmatory Phase III trial (9/10)

Rigel Pharmaceuticals Inc. (RIGL)

R112

Interrupts IgE receptor signal

Allergic rhinitis

Company initiated a trial of R112 (9/11)

Sucampo Pharmaceuticals Inc.*

SPI-0211

Chloride channel activator

Constipation

Company completed enrollment for the second of two Phase III studies (9/8)

Titan Pharmaceuticals Inc. (AMEX:TTP)

--

Oral gallium maltolate

Paget's disease

Clinical data showed serum gallium concentrations increased in a linear fashion with increasing doses (9/22)

Titan Pharmaceuticals Inc. (AMEX:TTP)

Probuphine

Incorporates buprenorphine in Titan's delivery system

Opiate addiction

Company reported positive preliminary results from first cohort in a pilot safety and efficacy study (9/26)

Transkaryotic Therapies Inc.
(TKTX)

Iduronate-2- sulfatase

Enzyme replacement therapy

Hunter syndrome

Phase I/II data demonstrated the ability of the enzyme replacement therapy in treating Hunter syndrome (9/4); company began dosing in a Phase III pivotal trial (9/19)

XOMA
Ltd.
(XOMA)

XMP.629

Topical synthetic peptide derived from human host- defense protein

Acne

Company began Phase I safety study in healthy volunteers (9/29)


Notes:

* Privately held

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

AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; TSE = Toronto Stock Exchange.

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