Company* |
Product | Description | Indication |
Status |
AUTOIMMUNE | ||||
CombinatoRx |
CRx-140 |
Combination of low dose of cyclosporine and loratadine |
Psoriasis |
Phase II trial failed to demonstrate statistical significance on primary or secondary endpoints (2/22) |
Inotek |
IMS |
Analogue of inosine, an endogenous purine |
Inflammatory bowel disease |
Began Phase I trial to evaluate tolerability, safety and pharmaco-kinetics in healthy volunteers (2/22) |
NPS |
Teduglutide |
Analogue of the hormone glucagon-like peptide-2 |
Crohn's disease |
Phase IIa trial in 100 patients showed a consistent trend toward efficacy, and responses favoring the highest dose group (2/27) |
Rigel |
R788 |
Oral syk kinase inhibitor |
Rheumatoid arthritis |
Phase I trial with methotrexate showed tolerability and no significant adverse pharmacokinetic interactions (2/22) |
CANCER | ||||
Abeille |
AB-1001 |
Transdermal patch that delivers a commercially available 5HT3-antagonist |
Chemotherapy- induced nausea and vomiting |
Began Phase I trial to evaluate pharmacokinetics in healthy volunteers (2/1) |
Access |
AP5346 |
A DACH polymer platinate |
Head and neck cancer |
Began trial to compare platinum delivery to oxaliplatin(2/23) |
Aegera |
AEG35156 |
Agent targeting the X-linked inhibitor of apoptosis protein |
Advanced acute myeloid leukemia |
Began open-label Phase I trial to evaluate the agent in combination with ara-C and idarubicin (2/15) |
AEterna |
Neovastat |
Antiangiogenic agent |
Non-small-cell lung cancer |
Recruitment in Phase III trial was stopped due to slow enrollment; an interim efficacy analysis will be conducted after 320 events (2/17) |
Ariad |
AP23573 |
Agent designed to inhibit cell-signaling protein mTOR |
Advanced cancers |
Began Phase Ib trial to evaluate safety, tolerability and activity with doxorubicin in up to 60 patients (2/14) |
ArQule Inc. |
ARQ 197 |
Small-molecule inhibitor of the c-Met receptor tyrosine kinase |
Metastatic tumors |
Began Phase I trial to evaluate tolerability, safety, dosing and preliminary activity (2/1) |
BioVex Inc.* |
OncoVEX- GMCSF |
Oncolytic virus designed to selectively kill tumor cells |
Malignant melanoma |
Began Phase II trial to evaluate tumor response rates and other efficacy endpoints in 50 patients (2/14) |
Callisto |
Atiprimod |
Drug designed to inhibit VEGF and interleukin-6 |
Advanced solid tumors |
Phase I/IIa trial showed encouraging results in patients with carcinoid tumors (2/28) |
Cell Genesys |
GVAX |
Vaccine comprising non-patient- specific tumor cells modified to secrete GM-CSF |
Advanced prostate cancer |
Follow-up data from Phase II trial indicated that median survival had not yet been reached, and will be no less than 29.1 months (2/27) |
Cell |
Xyotax |
Paclitaxel linked to a biodegradable polyglutamate polymer |
Advanced non-small-cell lung cancer |
Updated data from PGT202 Phase II trial supported earlier observations on the beneficial effect of estrogen on Xyotax efficacy (2/15) |
Cel-Sci Corp.(AMEX:CVM) |
Multikine |
Mixture of human cytokines designed to stimulate an immune response |
Head and neck cancer |
Long-term follow-up data from Phase II trial showed substantially increased survival rates and a higher rate of two-year local regional control vs. historical controls (2/21) |
CuraGen Corp. |
PXD101 |
Small-molecule histone deacetylase inhibitor |
T-cell lymphomas |
Began Phase II trial to evaluate efficacy and safety; 25 patients will be enrolled initially, to be followed by 70 more if activity is shown (2/1) |
Cytogen |
Quadramet (FDA-approved) |
Samarium-153 bound to a small- molecule, bone-seeking phosphonate |
Bone metastases from prostate cancer |
Presented positive data from various studies of the agent both alone and with chemotherapy (2/27) |
Genentech |
Avastin (FDA-approved) |
Bevacizumab; antibody designed to inhibit vascular endothelial growth factor |
Colon cancer |
Enrollment in Phase III AVANT trial was suspended to allow monitors to review safety data; adverse events were higher in the Avastin arm of the study (2/13) |
Genitope |
MyVax |
Personalized immuno-therapy based on a patient's tumor |
Chronic lymphocytic leukemia |
Began Phase I/II trial to evaluate the product in 70 patients (2/27) |
Genta Inc. |
Genasense |
Oblimersen sodium; inhibits function of bcl-2 protein |
Advanced chronic lymphocytic leukemia |
Phase III trial met endpoint of showing benefit of improving remission rates when added to chemotherapy (2/15) |
GPC Biotech |
Satraplatin |
Oral platinum compound |
Advanced solid tumors |
Phase I trial in 17 patients showed drug appeared to be well tolerated, with no significant toxicitie observed (2/27) |
InterMune |
Actimmune (FDA-approved) |
Interferon gamma-1b |
Advanced ovarian cancer |
Stopped Phase II GRACES trial in combination with chemotherapy after an interim analysis did not show a survival benefit (2/2) |
Introgen |
INGN 225 |
Immunotherapy that uses an adenovector to deliver the p53 gene |
Advanced lung cancer |
Phase I/II trial showed 62% of patients had objective tumor responses following treatment with chemotherapy (2/21) |
Isis |
LY23275796 |
Second-generation antisense agent that targets eukaryotic initiation factor-4E |
Cancers |
Partner Eli Lilly and Co. began Phase I development of the product (2/1) |
Northwest |
DCVax-Brain |
Dendritic cell-based immunotherapy made from patients' cells |
Brain cancer |
Updated findings from Phase I trial in 10 patients showed increased survival vs. approved agents (2/22) |
Norwood |
Lupron Depot |
Leuprolide acetate for depot suspension |
Cancers |
Began Phase II trial to evaluateimmune recovery in 80 patients undergoing autologous bone marrow transplants (2/22) |
Onyx |
Nexavar (FDA-approved) |
Sorafenib; RAF kinase and VEGF inhibitor |
Non-small-cell lung cancer |
Began 900-patient Phase III trial to compare treatment with carboplatin and paclitaxel to those drugs alone (2/16) |
OxiGene |
CA4P |
Combretastatin A4P; vascular disrupting agent |
Advanced non-small- cell lung cancer |
Is starting a Phase II trial to evaluate the product in combination with chemoradiotherapy (2/3) |
Point |
Talabostat |
Small molecule designed to stimulate proliferation of hematopoietic progenitor cells |
Metastatic non-small- cell lung cancer |
Began Phase III trial to evaluate the drug with pemetrexed in up to 800 patients (2/8) |
Rexahn Corp.* |
RX-0201 |
Signal inhibitor that blocks the protein kinase Akt |
Cancers |
Phase I trial showed a limited side-effect profile (2/14) |
Telik Inc. |
Telintra tablets |
Glutathione analogue inhibitor of GST P1-1 |
Myelodysplastic syndrome |
Began Phase I/IIa trial to evaluate the tolerability and pharmcokinetics of tablet formulation (2/22) |
Ziopharm |
ZIO-201 |
Isophosphoramide mustard; alkylating agent |
Sarcoma |
Began a Phase I/II trial in the U.S. and UK (2/23) |
CARDIOVASCULAR | ||||
Aldagen Inc.* |
Aldesort |
Product designed to isolate a potent population of stem cells from patient's bone marrow |
Advanced heart failure |
Is starting a trial that initially will test safety in 10 patients, then in a 60-patient study (2/21) |
Avant Immuno- |
TP-10 |
Soluble complement inhibitor |
For use in cardiac surgery |
Phase IIb trial in women undergoing high-risk cardiac surgery using cardiopulmonary bypass did not meet primary efficacy endpoint (2/27) |
CV |
Ranexa (FDA-approved) |
Ranolazine; partial inhibitor of fatty- acid oxidation |
Acute coronary syndromes |
MERLIN TIMI-36 trial will continue as planned based on an interim efficacy analysis (2/9) |
DeCode |
DG041 |
Small-molecule antagonist of the EP3 receptor for prostaglandins E2 |
Peripheral artery disease |
Phase I trial demonstrated safety, tolerability and inhibition of platelet aggregation (2/21) |
Isis Pharmaceuticals |
ISIS 301012 |
Oral formulation of second- generation anti-sense inhibitor of ApoB-100 |
Cholesterol management |
Phase I trial in healthy volunteers demonstrated oral bioavailability and pharmacological activity (2/7); additional data from study that showed reductions in both apoB-100 and LDL-C, also showed reduced serum triglycerides (2/9) |
Isis |
ISIS 301012 |
Oral formulation of second- generation anti-sense inhibitor of ApoB-100 |
Familial hyper- cholesterolemia |
Began Phase II trial to evaluate safety and efficacy in FH patients who are not achieving cholesterol target levels on lipid-lowering therapy (2/6) |
Myogen Inc. |
Ambrisentan |
Oral endothelin receptor antagonist |
Pulmonary arterial hypertension |
Open-label study showed none of the 36 patients who discontinued other treatment due to liver function abnormalities had a recurrence of liver problems (2/13) |
Nuvelo Inc. |
Alfimeprase |
Modified fibrolase delivered via catheter; thrombolytic agent |
Central venous catheter occlusion |
Began SONOMA-3 pivotal Phase III trial, the second of two in the program; the trial will evaluate safety and efficacy in 800 patients (2/27) |
Renovis Inc. |
NXY-059/ Cerovive |
A neuroprotectant with free radical-trapping properties |
Acute ischemic stroke |
Phase III SAINT I trial showed a statistically significant reduction of stroke-related disability vs. placebo (2/8) |
CENTRAL NERVOUS SYSTEM | ||||
Axonyx |
Phenserine |
Selective inhibitor of acetylcholinesterase |
Alzheimer's disease |
Further analysis from Phase I trial in healthy volunteers showed a significant reduction in levels of beta-amyloid 1-42 (2/14) |
CytRx Corp. |
Arimoclomol |
Small molecule designed to provide cellular protection by activating molecular chaperone proteins |
Amyotrophic lateral sclerosis |
Began open-label extension in patients who have completed Phase IIa trial of the drug (2/13) |
DOV |
Bicifadine |
Serotonin and norepinephrine reuptake inhibitor |
Osteoarthritic pain |
Began Phase II trial to evaluate efficacy, tolerability and pharma-cokinetics of the drug alone and with ibuprofen (2/7) |
DOV |
Bicifadine |
Serotonin and norepinephrine reuptake inhibitor |
Diabetic peripheral neuropathy |
Began Phase II trial to evaluate efficacy and safety and interaactions with oxycodone in 50 patients (2/6) |
D-Pharm Ltd.* |
DP-VPA |
Lipid-modified formulation of valproic acid |
Epilepsy |
Phase II trial testing drug as add-on therapy showed a significant reduction in seizure frequency vs. placebo, with no significant adverse events (2/28) |
Halozyme |
Hylenex (FDA-approved) |
Formulation of recombinant human hyaluronidase |
Pain |
Began a trial testing subcutaneous administration of morphine with Hylenex in up to 18 patients (2/2) |
Javelin |
Rylomine |
Intranasal morphine |
Pain |
Phase IIb trial in 187 patients with post-surgical pain met primary and secondary endpoints related to pain relief (2/23) |
Jazz |
Xyrem (FDA-approved) |
Sodium oxybate oral solution |
Fibromyalgia syndrome |
Phase II trial in 188 patients demonstrated statistically significant pain relief vs. placebo (2/23) |
Neurobiological |
Xerecept |
Synthetic mimic of corticotropin- releasing factor |
Peritumoral brain edema |
Began second of two pivotal Phase III trials; Celtic Pharma has rights to the drug (2/6) |
Neurochem |
Alzhemed |
Small molecule designed to interfere with association between glycosamino-glycans and A-beta protein |
Alzheimer's disease |
Company is initiating an open-label extension study for ongoing North American Phase III trial (2/8) |
New River |
NRP290 |
Hydrocodone derivative |
Pain |
Phase I/II trial demonstrated positive bioavailability data (2/7) |
Penwest |
PW4142 |
Controlled-release formulation of nalbuphine hydrochloride |
Pain |
Phase IIa trial in 165 patients demonstrated reduced pain intensity in a dose-dependent manner (2/10) |
Prestwick |
Tetrabenazine |
Dopamine depletor that works by selectively blocking the VMAT2 transporter |
Chorea associated with Huntington's disease |
Pivotal Phase III trial demonstrated significantly improved clinical outcomes and reduced symptoms (2/14) |
TheraQuest |
TQ-1017 |
Extended-release formulation of tramadol |
Neuropathic pain |
Is starting pilot Phase I trial to evaluate pharmacokinetics vs. short-acting tramadol (2/6) |
TorreyPines |
NGX267 |
Selective muscarinic (M1) agonist |
Alzheimer's disease |
Began Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in 64 healthy elderly volunteers (2/27) |
DIABETES | ||||
Arena |
APD668 |
Orally active glucose-dependent insulinotropic receptor agonist |
Type II diabetes |
Partner Ortho-McNeil Inc. began a Phase I trial to evaluate safety, tolerability and pharmacokinetics in healthy volunteers (2/7) |
ConjuChem |
PC-DAC: Exendin-4 |
Modified exendin-4 analogue bonded to recombinant human albumin |
Type II diabetes |
Is starting a Phase I/II trial to evaluate safety, tolerability, dosing and pharmacokinetics in up to 68 patients (2/27) |
DiObex Inc.* |
DIO-902 |
Cortisol synthesis inhibitor; 2S,4R ketoconazole |
Type II diabetes |
Began Phase II trial that will evaluate safety and pharmacokinetics (2/22) |
Metabasis |
MB07803 |
Fructose 1,6 bisphosphatase inhibitor; from the same class as CS-917 |
Type II diabetes |
Began a Phase I trial of the agent (2/14) |
Metabasis |
CS-917 |
Fructose 1,6 bisphosphatase inhibitor |
Type II diabetes |
Partner Sankyo Co. Ltd. began a Phase IIb trial to evaluate safety and efficacy (2/1) |
OSI |
PSN357 |
Glycogen phosphorylase inhibitor |
Type II diabetes |
Began Phase IIa trial to evaluate safety and pharmacokinetics in up to 30 patients (2/21) |
OSI |
PSN010 |
Glucokinase activator |
Diabetes |
Began Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in up to 80 healthy volunteers (2/15) |
INFECTION | ||||
Acambis plc |
— |
Vaccine against Clostridium difficile |
C. difficle infections |
Phase I trial in 50 healthy volunteers demonstrated antibody responses and tolerability (2/15) |
Anadys |
ANA380 |
Oral prodrug of the nucleotide analogue ANA317 (LB80317) |
Hepatitis B |
Phase II trial in 59 patients with lamivudine-resistant HBV showed significant reductions in viral load and in levels of alanine amino-transferase (2/14) |
Arpida Ltd. |
Iclaprim |
Capsule formulation of broad- spectrum antibiotic |
Infections |
Phase I trial demonstrated the bioavailability of the oral formulation (2/13) |
Avant Immuno- |
Ty800 |
Vaccine against Salmonella typhi, the cause of typhoid fever |
Typhoid fever |
Began Phase I/II trial to evaluate safety and immunogenicity in 54 healthy volunteers (2/14) |
Coley |
Actilon (CPG 10101) |
Agent designed to target and stimulate Toll-like receptor 9 |
Hepatitis C |
Began Phase II trial in 90 patients who have failed previous therapy; drug will be given with pegylated interferon alpha and ribavirin (2/23) |
Incyte Corp. |
DFC |
Nucleoside analogue reverse transcriptase inhibitor |
HIV |
Began Phase II Study 204 that will compare drug to 3TC in 250 treatment-experienced patients (2/16) |
ISTA |
— |
Combination product containing tobramycin and prednisolone acetate |
Ocular conditions with a risk of bacterial infection |
Phase III trial achieved its primary endpoint of demonstrating bio- equivalence and achieved secondary endpoints (2/2) |
Nabi Bio- |
— |
S. epidermidis PS-1 vaccine and S. aureus Type 336 vaccine |
Infections |
Phase I trials in healthy volunteers showed the vaccines were well tolerated and produced significant increases in antibody levels (2/7) |
Optimer |
OPT-80/ |
Narrow-spectrum antibiotic agent |
Clostridium difficile- associated diarrhea |
Phase IIa trial showed clinical cures in 41 of 45 patients; the agent was well tolerated (2/7) |
Panacos |
PA-457 |
Small-molecule maturation inhibitor designed to block a step in processing of the HIV Gag protein |
HIV |
Drug-interaction trial showed drug had no detectable effect on atazanavir-induced hyperbiliru- binemia; another study showed bioavailability of tablet formulation (2/15) |
Peregrine |
Tarvacin Anti-Viral |
Anti-phosphotidylserine immunotherapeutic |
Hepatitis C |
Phase I trial in 24 patients demonstrated the agent was well tolerated; no serious adverse events were reported (2/27) |
The Immune |
— |
Whole-inactivated HIV-1 immunogen |
HIV |
Final data from Phase II trial in patients showed induction of HIV-specific immune responses (2/10) |
VaxGen Inc. |
LC16m8 |
Attenuated smallpox vaccine candidate |
Smallpox infection |
Phase II trial showed the vaccine was safe and well tolerated (2/15) |
Vertex |
VX-950 |
Oral hepatitis C virus protease inhibitor |
Hepatitis C |
Phase II trial in 12 treatment-naïve patients produced undetectable virus levels at 28 days in all patients (2/7) |
Vical Inc. |
— |
Ebola vaccine administered using Vical's DNA delivery technology |
Ebola virus |
Phase I trial in healthy volunteers demonstrated safety, tolerability and both antibody and T-cell Ebola-specific responses (2/21) |
Vical Inc. |
— |
DNA vaccine against cytomegalovirus |
Cytomegalovirus infection |
Began Phase II trial to evaluate the product in donors and patients undergoing stem cell transplants (2/1) |
MISCELLANEOUS | ||||
Acuity |
Cand5 |
Small interfering RNA therapeutic designed to shut down VEGF |
Diabetic macular edema |
Began a pilot Phase II trial to evaluate the product in patients (2/2) |
Adolor Corp. |
Entereg |
Alvimopan capsules; mu opioid antagonist |
Postoperative ileus |
Phase III trial in 654 patients showed statistically significant recovery of gastrointestinal function, as well as secondary end-points, vs. placebo (2/7) |
Advanced |
Ferumoxytol |
Intravenously administered bioavailable iron |
Iron replacement in anemic chronic kidney disease |
Monitors reviewing safety data from Phase III trial recommended the study continue (2/21) |
Alteon Inc. |
Alagebrium (ALT-711) |
Alagebrium chloride; A.G.E. crosslink breaker |
Erectile dysfunction |
Discontinued development in that indication after the FDA said more preclinical data were needed prior to a Phase IIa trial (2/1) |
Amgen Inc. |
Denosumab (AMG 162) |
Agent designed to target RANK Ligand, a protein implicated in promoting bone removal |
Bone loss |
Phase II trial in 412 healthy post-menopausal women demonstrated significantly increased bone mineral density vs. placebo (2/22) |
Amylin |
Pramlintide (FDA-approved) |
Synthetic analogue of human amylin |
Obesity |
Phase II trial in 408 obese subjects showed average weight losses of 8.4 to 13.4 pounds vs. 6.2 pounds for placebo (2/9) |
Antares |
Anturol |
Transdermal gel formulation of oxybutynin |
Overactive bladder |
Phase II trial in 48 healthy subjects demonstrated positive tolerability and pharmacokinetic data (2/22) |
Applied |
AGTC-0106 |
Gene therapy using an adeno- associated virus to deliver the AAT gene |
Alpha-1 antitrypsin deficiency |
Began a Phase I trial to evaluate safety and dosing in 12 patients (2/23) |
Bionovo Inc. |
MF101 |
Estrogen receptor beta selective modulator |
Menopausal symptoms |
Began a Phase II trial to evaluate the product (2/8) |
Corgentech |
Avrina |
NF-kB Decoy; inhibitor of the NF- B transcription factor |
Atopic dermatitis (eczema) |
Phase I/II trial in 75 patients showed the lowest dose to be most efficacious (2/6) |
Critical |
— |
Intravenous zileuton; 5-lipoxygenase inhibitor |
Asthma |
Began Phase I/II trial to evaluate the I.V. formulation's safety, tolerability, pharmacokinetics and preliminary efficacy in 60 patients (2/15) |
DUSA |
Levulan (FDA-approved) |
Aminolevulinic acid HCl; photodynamic therapy; used with light source |
Photodamaged skin |
Phase II trial in 80 patients demonstrated statistically significant improvements vs. vehicle and the same light source (2/24) |
GenVec Inc. |
AdPEDF |
Gene therapy using an adenovector to produce pigment epithelium- derived factor |
Wet age-related macular degeneration |
Phase I trial in 28 patients showed evidence of a halt in disease progression lasting six to 12 months; there were no serious adverse events (2/7) |
Halozyme |
Hylenex |
Formulation of recombinant human hyaluronidase |
For use in Sub-Q infusion |
INFUSE-LR trial showed use of drug preceding Sub-Q infusion accelerated the flow rate by four-fold vs. infusion with placebo (2/8) |
ISTA |
Ecabet sodium |
Eye drop formulation designed to increase production of mucin |
Dry eye syndrome |
Phase IIb trial demonstrated a a trend toward efficacy for the lower of two doses tested (2/21) |
Microbia Inc.* |
MD-1100 |
Peptide designed to act on guanylate cyclase-C, a receptor found on the surface of intestinal cells |
Chronic idiopathic constipation |
Began Phase II trial to evaluate the product in CIC (2/27) |
Nymox |
NX-1207 |
Investigational agent for BPH |
Benign prostatic hyperplasia |
Internal review of ongoing Phase II trial revealed no serious drug side effects (2/23) |
OSI |
Macugen (FDA-approved) |
Pegaptanib sodium injection; pegylated anti- VEGF-aptamer |
Age-related macular degeneration |
VISION trials showed systemic safety was maintained over two years of treatment; preliminary data also showed safety over three years (2/24) |
Palatin |
PT-141 |
Intranasally delivered melanocortin agonist |
Female sexual arousal disorder |
Began Phase IIb trial to evaluate safety and efficacy in 60 women (2/7) |
Progenics |
MNTX |
Methylnaltrexone; agent designed to block peripheral opioid receptors |
Opioid-induced constipation |
Second pivotal Phase III trial met all primary and secondary end- points with statistical significance (2/15) |
QLT Inc. |
Lemuteporfin |
Photodynamic therapy |
Benign prostatic hyperplasia |
Phase II trial failed to meet its primary endpoints at three months (2/16) |
QuatRx |
Fispemifene |
Oral, non-testosterone agent |
Andropause |
Began Phase II trial to evaluate drug in treating low testosterone in about 100 older men (2/16) |
QuatRx |
Ospemifene |
Small-molecule, selective estrogen receptor modulator |
Vaginal atrophy |
Began Phase III trial expected to enroll 800 post-menopausal women (2/16) |
Regeneron |
VEGF Trap |
Intravenous product designed to block vascular endothelial growth factor |
Wet age-related macular degeneration |
Data from 18 patients in ongoing Phase I trial showed rapid and prolonged reductions in retinal thickness (2/2) |
Zonagen Inc. |
Androxal |
Small-molecule agent designed to restore normal testosterone production in males |
Testosterone deficiency |
Open-label trial in 13 men produced positive results (2/3) |
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; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; PK = Pink Sheets; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange. | ||||
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