Company* |
Product |
Description |
Indication |
Status (Date) |
| | ||||
AUTOIMMUNE | ||||
Barrier |
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 |
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 |
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 |
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 |
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 |
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 |
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. |
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. |
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 |
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 |
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 |
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 |
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 |
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 |
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. |
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 |
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 |
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 |
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 |
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. |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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. |
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 |
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 |
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. |
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 |
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 |
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 |
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 |
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* |
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 |
-- |
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 |
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 |
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- |
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 |
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 |
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 |
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 |
-- |
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. |
-- |
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 |
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 |
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 |
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 |
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 |
-- |
Recombinant subunit plague vaccine |
Plague infection |
Began Phase I trial to evaluate safety, tolerability and immuno-genicity in healthy volunteers (1/10) |
ID Biomedical |
Fluviral |
Influenza vaccine |
Influenza |
Began study in the U.S. to test safety and immunogenicity in 300 healthy adults (1/7) |
Idenix |
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 |
DB289 |
Oral, dicationic antiviral agent |
Infections |
Began Phase I trial to compare the current capsule formulation to two new formulations (1/24) |
Inhibitex |
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* |
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 |
-- |
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- |
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- |
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 |
Telavancin |
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 |
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 |
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. |
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 |
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 |
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 |
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 |
PYY3-36 Nasal Spray |
High-affinity Y2 receptor agonist |
Obesity |
Partner Merck & Co. Inc began a Phase I trial in obesity (1/26) |
Procyon |
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 |
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 |
TD-2749 |
Selective 5-HT4 agonist |
Gastrointestinal motility dysfunction |
Began Phase I trial to evaluate safety, tolerability and pharmacokinetics (1/3) |
Vela |
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. | ||||