Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Barrier
Therapeutics
Inc.
(BTRX)

Rambazole

Oral retinoic acid metabolism-blocking agent

Psoriasis

Phase IIa trial in 10 patients showed PASI scores were reduced by an average of 50% (1/12)

ChemoCentryx
Inc.*

Traficet-EN (CCX282)

Oral anti-inflammatory agent that targets the CCR9 chemokine receptor

Inflammatory bowel disease

Began Phase II trial in 60 patients with Crohn's disease to evaluate safety, tolerability and certain indicators of clinical activity (1/6)

Serono SA
(Switzerland;
NYSE:SRA) and
IVAX Corp.

Mylinax

Oral formulation of cladribine; purine nucleoside analogue

Multiple sclerosis

They plan to begin a Phase III trial in 1,200 patients with relapsing forms of multiple sclerosis (1/11)

Trubion
Pharmaceuticals
Inc.*

TRU-015

Agent designed to deplete B lymphocytes

Rheumatoid arthritis

Began Phase I trial to evaluate the safety of increasing doses (1/11)

CANCER

Access
Pharmaceuticals
Inc.
(AMEX:AKC)

AP5346

A DACH polymer platinate

Cancers

Began a Phase I trial with fluorouracil and leucovorin to evaluate drug safety and establish dosing (1/28)

Adventrx
Pharmaceuticals
Inc.
(AMEX:ANX)

CoFactor

Form of folic acid designed to enhance the antitumor effects of 5-FU

Metastatic colorectal cancer

Phase II trial met primary endpoint for response rate and demonstrated safety in the first stage of two-stage trial (1/25)

Allos
Therapeutics
Inc.
(ALTH)

PDX

Pralatrexate; small-molecule inhibitor of dihydrofolate reductase

Advanced non- small-cell lung cancer

Began Phase I trial with vitamin B12 and folic acid supplementation in up to six patients with Stage IIIB-IV disease (1/20)

ArQule Inc.
(ARQL)

ARQ 501

Activated Checkpoint Therapy molecule designed to selectively kill cancer cells

Advanced cancers

Began Phase Ib/II trial with gemcitabine that initially will assess dose escalation (1/26)

Cytogen Corp.
(CYTO)

Quadramet (FDA-approved)

Samarium-153 bound to a small-molecule, bone-seeking phosphonate

Pain associated with metastatic bone disease

Began trial to test drug with bisphosphonates in patients with recurrent or refractory multiple myeloma (1/11)

Dendreon
Corp.
(DNDN)

Provenge

Immunotherapy that uses a recombinant form of the prostatic acid phosphatase antigen

Advanced prostate cancer

Phase III D9902A trial failed to demonstrate a statistically significant delay in time to disease progression in the overall group or in Gleason score subgroups (1/11)

EntreMed
Inc.
(ENMD)

Panzem

2-methoxyestradiol; naturally occurring metabolite of endogenous estrogen

Cancers

Began Phase Ib trial to evaluate pharmacokinetics and safety in advanced patients (1/5)

Gemin X
Biotechnologies
Inc.*
(Canada)

GX15-070

Small-molecule inhibitor of bcl-2 proteins

Chronic lymphocytic leukemia

Began Phase I/II trial to evaluate safety, tolerability and pharmacokinetics in CLL patients (1/6)

Genentech
Inc.
(NYSE:DNA)

Avastin (FDA- approved)

Bevacizumab; antibody designed to inhibit vascular endothelial growth factor

Metastatic colorectal cancer

Phase III study with FOLFOX4 regimen improved overall survival vs. the regimen alone (1/27)

Genentech
Inc.
(NYSE:DNA)
and ImClone
Systems Inc.
(IMCL)

Avastin and Erbitux (both FDA-approved)

VEGF inhibitor and EGFR inhibitor, respectively

Advanced colon cancer

Drugs plus irinotecan produced benefits vs. the drugs alone (1/26)

Genetronics
Biomedical
Corp.
(AMEX:GEB)

Medpulser DNA Delivery System

Electroporation-mediated method for delivering DNA-based therapies

Malignant melanoma

Began Phase I trial to measure the safety of delivering plasmid DNA encoding a cytokine directly to tumors (1/13)

GTx Inc.
(GTXI)

Acapodene

Toremifene citrate; small-molecule non-steroidal selective estrogen receptor modulator

Prostate cancer

Began pivotal Phase III trial that will evaluate the incidence of prostate cancer in patients with high-grade prostatic intraepithelial neoplasia (1/26)

ImClone
Systems Inc.
(IMCL)

IMC-1121B

Fully human antibody targeting the vascular endothelial growth factor receptor-2

Solid tumors

Began Phase I trial to evaluate safety and pharmacology in 33 patients (1/5)

Millennium
Pharmaceuticals
Inc.
(MLNM)

Velcade (FDA-approved)

Bortezomib; proteasome inhibitor

Multiple myeloma

Began Phase III VISTA trial with melphalan and prednisone vs. those drugs alone in patients with newly diagnosed MM who are not transplant candidates (1/10)

Northwest
Biotherapeutics
Inc.
(OTC BB:NWBT)

DCVax-Prostate

Cell-based dendritic-cell product

Hormone-independent prostate cancer

Started a Phase III trial that is expected to enroll about 600 patients (1/31)

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

Tarceva (FDA-approved)

Erlotinib HCl; small- molecule HER1/EGFR inhibitor

Advanced pancreatic cancer

Phase III trial with gemcitabine demonstrated a statistically significant 23.5% improvement in overall survival vs. gemcitabine plus placebo (1/27)

Peplin Ltd.
(Australia;
ASX:PEP)

PEP005 Topical

Molecular entity sourced from a plant

Actinic keratosis

Phase I trial demonstrated safety and tolerability, and also showed clearance of skin lesions (1/10)

Peregrine
Pharmaceuticals
Inc.
(PPHM)

Tarvacin

Chimeric monoclonal antibody that binds to the phospholipid phosphatidylserine

Advanced solid tumors

Starting a Phase I trial to test safety, tolerability and pharmaco-kinetics in up to 28 patients (1/27)

Peregrine
Pharmaceuticals
Inc.
(PPHM)

Cotara

Monoclonal antibody attached to iodine-131; product from Tumor Necrosis Therapy platform

Glioblastoma multiforme

Beginning a trial to evaluate safety, radiation exposure and efficacy at the first or second relapse (1/21)

Pro-Pharmaceuticals
Inc.
(AMEX:PRW)

Davanat

Carbohydrate compound designed for targeted delivery

Advanced solid tumors

Phase I data from 20 patients showed the drug with 5-FU was well tolerated (1/27)

Protein Design
Labs Inc.
(PDLI)

M200

Anti-alpha5beta1 integrin chimeric monoclonal antibody; anti-angiogenesis agent

Renal-cell carcinoma

Began Phase II open-label trial, the first of up to five Phase II trials in solid tumors (1/12)

Raven
Biotechnologies
Inc.*

RAV12

High-affinity IgG1 chimeric antibody

Colon, stomach and pancreatic cancers

Began Phase I/II trial to evaluate the safety and tolerability in 30 patients with advanced cancers (1/11)

Vertex
Pharmaceuticals
Inc.
(VRTX) and
Merck & Co. Inc.

VX-680

Small-molecule inhibitor of Aurora kinases

Solid tumors

Began Phase I trial to evaluate safety and tolerability in refractory patients (1/6)

CARDIOVASCULAR

Alexion
Pharmaceuticals
Inc.
(ALXN)

Eculizumab

Humanized monoclonal antibody designed to block complement protein C5

Paroxysmal nocturnal hemoglobinuria

Began treatment phase of Phase III SHEPERD trial under an FDA SPA; the trial will include 75 patients (1/10)

AtheroGenics
Inc.
(AGIX)

AGI-1067

Oral agent designed to inhibit the production of VCAM-1 and other molecules in the inflammatory process

Atherosclerosis

Company proposed increasing enrollment in Phase III ARISE trial, to 6,000 patients from 4,000, as well as other changes (1/3)

Dyax Corp.
(DYAX) and
Genzyme
Corp.
(GENZ)

DX-88

Recombinant small protein designed to inhibit human plasma kallikrein

Hereditary angioedema

Reported positive interim data from Phase II EDEMA2 trial based on 61 HAE attacks; Phase III trial is being planned (1/10)

Synthetic Blood
International
Inc.
(OTC BB:SYBD)

Oxycyte

Perfluorocarbon-based blood substitute and therapeutic oxygen carrier

Blood substitute

Began Phase II trial to test safety and efficacy in hip-surgery patients who lose blood during surgery (1/6)

TargeGen Inc.*

TG100-115

Selective PI3-kinase inhibitor

Acute myocardial infarction

Began a Phase I/II trial to test the agent in 100 patients (1/4)

CENTRAL NERVOUS SYSTEM

Allon
Therapeutics
Inc.
(Canada;
TSE:NPC)

AL-108

Vasoactive intestinal peptide agent, a neuroprotectant

Alzheimer's disease

Began Phase Ia trial in 30 healthy adults to evaluate safety and pharmacokinetics (1/25)

Amarin Corp.
plc
(UK; AMRN)

Miraxion (LAX-101c)

Compound that inhibits certain enzymes, including phospholipases and caspases

Depression

Phase IIa trials showed a significant benefit in a subgroup of patients with melancholic vegetative symptoms (1/12)

Catalyst
Pharmaceutical
Partners Inc.*

CPP-109

Designed to inhibit enzyme that normally breaks down gamma amino butyric acid

Cocaine addiction

Starting a Phase I trial to test the safety of the interaction of CPP-109 and cocaine (1/3)

Cortex
Pharmaceuticals
Inc.
(AMEX:COR)

CX717

Ampakine analogue

Cognitive dysfunction

Starting a pilot Phase II trial that will use PET imaging to determine response of patients with Alzheimer's disease and healthy elderly volunteers (1/31)

Memory
Pharmaceuticals
Corp.
(MEMY)

MEM 1003

Neuronal L-type calcium channel modulator

Alzheimer's disease

Began a two-phase trial that will include up to 32 patients in the dose-escalation and treatment phases, to test safety and tolerability (1/12)

Myriad
Genetics Inc.
(MYGN)

Flurizan (MPC-7869)

Modulator of gamma- secretase that selectively lowers levels of amyloid beta 42

Alzheimer's disease

Began a Phase III trial to evaluate changes in cognitive function and activities of daily living in 750 patients with mild to moderate AD (1/12)

Neuro3d*
(France)

ND7001

Agent that acts on a target that never has been associated with depression or anxiety

Depression and anxiety

Began Phase I trial to evaluate safety, tolerability and pharmaco-kinetics (1/25)

Somaxon
Pharmaceuticals
Inc.*

--

Low dose of the approved depression drug doxepin

Insomnia

Product demonstrated statistical significance in primary and secondary endpoints in a Phase II trial in 61 patients (1/6)

StemCells
Inc.
(STEM)

HuCNS-SC

Human neural stem cells

Batten disease

Filed IND with FDA; if approved it would be the first FDA-approved trial to use a purified composition of human neural stem cells as the therapeutic agent (1/4)

XenoPort
Inc.*

XP13512

Transported prodrug of gabapentin (Pfizer Inc.'s Neurontin)

Restless legs syndrome

Phase IIa trial in 38 patients demonstrated statistically significant benefits vs. placebo (1/6)

DIABETES

Keryx Bio-
pharmaceuticals
Inc.
(KERX)

KRX-101

Sulodexidel; oral heparinoid compound

Diabetic nephropathy

Monitors recommended moving into Phase III portion of Phase II/III trial after interim analysis of safety and efficacy data (1/5)

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

CS-917

Fructose 1-6 bisphosphatase inhibitor

Type II diabetes

Began Phase IIb trial to evaluate effectiveness in lowering blood glucose levels in patients (1/5)

INFECTION

Barrier
Therapeutics
Inc.
(BTRX)

Azoline

Broad-spectrum, oral antifungal agent

Superficial fungal infections

Phase IIa trial in 67 patients showed positive results in treating various fungal infections of the skin (1/12)

Biolex Inc.*

BLX-883

Form of alfa interferon manufactured using firm's LEX System

Infectious diseases

Plans to start Phase I trials in the U.S. and UK to evaluate safety and pharmacokinetics (1/6)

Coley
Pharmaceutical
Group Inc.*

Actilon (CPG 10101)

Synthetic Toll-like receptor-9 agonist

Hepatitis C

Phase Ia trial demonstrated tolerability in healthy volunteers; Phase Ib trial in relapsed HCV patients produced a 1.0 log or more reduction in HCV RNA in one-third of patients (1/6)

Corgentech
Inc.
(CGTK)

--

NF-kappaB decoy; inhibitor of the NF-kB transcription factor

Atopic dermatitis (eczema)

Beginning a Phase I/II trial to evaluate safety and feasibility of repeated applications in 75 people (1/12)

GenVec Inc.
(GNVC)

--

Vaccine developed using GenVec's adenovector technology and its 293- RF6 production cell line

HIV

The National Institute of Allergy and Infectious Diseases began the second Phase I trial of the vaccine in healthy volunteers (1/19)

Hemispherx
Biopharma
Inc.
(AMEX:HEB)

Ampligen

RNA drug with potential action as an immuno-modulator and antiviral

HIV

Partner Esteve Laboratories began a Phase II trial in patients with HIV who also may have hepatitis C (1/3)

Human Genome
Sciences Inc.
(HGSI)

CCR5 mAb

Fully human antibody that binds the chemokine receptor CCR5

HIV

Began Phase I trial to evaluate safety, tolerability and pharmacology in patients (1/10)

ID Biomedical
Corp.
(Canada;
IDBE)

StreptAvax

Subunit, protein-based vaccine against Group A streptococcal diseases

Group A streptococcal diseases

Phase II trial in 90 healthy adults showed a statistically significant increase in serum antibodies to all 26 M protein serotypes (1/26)

ID Biomedical
Corp.
(Canada;
IDBE)

FluINsure

Nonliving, subunit vaccine for intranasal administration

Influenza

Final analysis from 2003-04 field efficacy trial in 1,349 healthy subjects showed efficacy and other positive results (1/13)

ID Biomedical
Corp.
(Canada;
IDBE)

--

Recombinant subunit plague vaccine

Plague infection

Began Phase I trial to evaluate safety, tolerability and immuno-genicity in healthy volunteers (1/10)

ID Biomedical
Corp.
(Canada;
IDBE)

Fluviral

Influenza vaccine

Influenza

Began study in the U.S. to test safety and immunogenicity in 300 healthy adults (1/7)

Idenix
Pharmaceuticals
Inc.
(IDIX)

NM283

Valopicitabine; oral nucleoside analogue

Hepatitis C

Interim Phase IIa data showed a 99.94% reduction in viral load after 12 weeks in patients taking drug and pegylated interferon (1/10)

Immtech
International
Inc.
(AMEX:IMM)

DB289

Oral, dicationic antiviral agent

Infections

Began Phase I trial to compare the current capsule formulation to two new formulations (1/24)

Inhibitex
Inc.
(INHX)

Veronate

Antibody-based immune globulin

S. aureus infections in infants

Monitors recommended Phase III trial continue after reviewing safety and other data from the first 500 patients (1/7)

Intercell AG*
(Austria)

IC51

Purified, inactivated vaccine

Japanese encephalitis virus

Began Phase III program that includes a 800-person non-inferiority trial vs. JE-VAX and a safety study in 3,000 people (1/10)

MedImmune
Inc.
(MEDI)

--

Intranasal vaccine against respiratory syncytial virus and parainfluenza virus type-3

Pediatric respiratory diseases

Filed IND to begin Phase I trial to evaluate safety, tolerability and immunogenicity in healthy adults (1/20)

Nabi Bio-
pharmaceuticals
(NABI)

Altastaph

Staphylococcus aureus immune globulin

S. aureus infections

Phase IIa trial showed a 36% reduction in time to hospital discharge vs. placebo (9 days vs. 14 days) (1/10)

Nabi Bio-
pharmaceuticals
(NABI)

StaphVAX

Staphylococcus aureus polysaccharide conjugate vaccine

Infections

Began study in orthopedic surgery patients with implanted devices to evaluate safety and antibody levels (1/6)

Theravance
Inc.
(THRX)

Telavancin
(TD-6424)

Lipoglycopeptide antibiotic believed to have multiple mechanisms of action

Hospital-acquired pneumonia

Began Phase III trial to evaluate safety and efficacy vs. vancomycin in treating pneumonia caused by Gramositive organisms (1/26)

Vaxin Inc.*

--

Adenovirus-vectored nasal and epicutaneous influenza vaccines

Influenza

Phase I trial showed the product was immunogenic and well tolerated by volunteers (1/11)

MISCELLANEOUS

Advanced
Magnetics Inc.
(AMEX:AVM)

Ferumoxytol

Intravenously administered bioavailable iron

Iron replacement in anemic chronic kidney disease

Began a Phase III trial comparing the agent to placebo (1/13)

Alizyme plc
(UK; LSE:AZM)

ATL-962

Inhibitor of gastrointestinal lipases

Obesity

Starting a trial to evaluate fat levels, safety and tolerability in about 80 obese subjects (1/31)

Alteon Inc.
(AMEX:ALT)

Alagebrium chloride (ALT-711)

A.G.E. crosslink breaker

Erectile dysfunction

Began Phase II trial in 40 diabetic patients who achieve limited benefit from PDE5 drugs (1/18)

Enzon
Pharmaceuticals
Inc.
(ENZN)

ATG- Fresenius S

Polyclonal antibody preparation used for T-lymphocyte suppression

Preventing rejection in lung transplants

Began trial to compare drug and standard post-transplant triple immunosuppressive regimen to the regimen alone (1/6)

Discovery
Laboratories
Inc.
(DSCO)

Surfaxin

Engineered version of natural human lung surfactant

Respiratory disorders in premature infants

Began a Phase II trial to test the product for preventing broncho-pulmonary dysplasia, and began a Phase II pilot trial to evaluate an aerosolized formulation (1/6)

Genaera
Corp.
(GENR)

Squalamine

Anti-angiogenesis agent; vascular endothelial growth factor inhibitor

Age-related macular degeneration

Preliminary Phase II data showed preserved or improved vision at week three in all 12 eyes tested (1/10)

Nastech
Pharmaceutical
Co. Inc.
(NSTK)

PYY3-36 Nasal Spray

High-affinity Y2 receptor agonist

Obesity

Partner Merck & Co. Inc began a Phase I trial in obesity (1/26)

Procyon
Biopharma Inc.
(Canada; TSE:PBP)

Fibrostat

4 diaminobutane dihydrochloride; topical cream

Hypertrophic scarring

Phase IIb trial in 195 patients failed to demonstrate efficacy vs. placebo on excessive scar formation (1/18)

Progenics
Pharmaceuticals
Inc.
(PGNX)

Methylnaltrexone

Agent designed to block opioid receptors in the gastrointestinal tract

Post-operative bowel dysfunction

Phase II trial in 65 patients showed those who received drug following abdominal surgery had improved gastrointestinal recovery vs. placebo (1/20)

Savient Pharmaceuticals Inc. (SVNT)

Puricase

Polyethylene glycol conjugate of uricase

Gout

Phase II trial in 41 patients demonstrated reductions in plasma uric acid levels in most patients (1/10)

Theravance
Inc.
(THRX)

TD-2749

Selective 5-HT4 agonist

Gastrointestinal motility dysfunction

Began Phase I trial to evaluate safety, tolerability and pharmacokinetics (1/3)

Vela
Pharmaceuticals
Inc.*

Dextofisopam

R-enantiomer of racemic tofisopam, an agent used for multiple indications outside the U.S.

Irritable bowel syndrome

Phase II trial in 141 patients showed the agent was well tolerated and provided relief to patients (1/4)


Notes:

* Privately held.

BLA = Biologics license application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; SPA = Special protocol assessment.

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

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

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