Company* |
Product | Description | Indication | Status |
AUTOIMMUNE | ||||
Androclus |
AT-001 (dnaJP1) |
Short synthetic peptide derived from heat-shock protein dnaJ; immunomodulatory agent |
Rheumatoid arthritis |
Phase II trial in 60 patients demonstrated safety and tolerability; agent improved symptoms vs. placebo, but the ACR20 endpoint did not reach statistical significance (11/2) |
Biogen Idec |
Amevive (FDA-approved) |
Alefacept; targets the CD45RO+ subset of T cells |
Psoriatic arthritis |
Phase II trial showed significant improvement in disease and less progression of disease (11/15) |
Genentech |
Rituxan (FDA-approved) |
Rituximab; antibody that targets and selectively depletes CD20-positive B cells |
Rheumatoid arthritis |
520-patient REFLEX trial showed significantly greater responses with drug and methotrexate vs. placebo and methotrexate (11/16) |
Human Genome |
LymphoStat-B |
Belimumab; human monoclonal antibody that inhibits activity of B- lymphocyte stimulator |
Rheumatoid arthritis |
Phase II trial in 283 patients met primary efficacy and safety endpoints, reducing RA activity at a level of statistical significance (11/17) |
Immunomedics |
Epratuzumab |
Humanized anti-CD22 antibody labeled with yttrium-90 |
Sjogren's syndrome |
Updated Phase I/II trial data showed patients retained clinical benefits six months following treatment (11/15) |
Vitae |
VTP- 201227 |
Selective inhibitor of two enzymes active in the skin; topical agent |
Psoriasis |
Began Phase II trial designed to test the agent on 28 patients (11/29) |
CANCER | ||||
Adherex |
Eniluracil |
Oral dihydropyrimidine dehydrogenase inhibitor |
Colorectal cancer |
Starting a trial in 20 patients; drug will be evaluated for its effect on enzymes involved in the activation and breakdown of 5-FU (11/28) |
Agensys Inc.* |
AGS-PSCA |
Fully human monoclonal antibody directed to prostate stem cell antigen |
Prostate cancer |
Began Phase I trial to evaluate safety and pharmacokinetics in up to 24 patients with hormone- refractory disease (11/1) |
Allos |
RH1 |
Small-molecule agent bioactivated by the enzyme DT-diaphorase |
Cancers |
Interim data from 15 patients in Phase I trial did not show objective tumor responses, but did show DNA cross- linking (11/17) |
American |
Abraxane (FDA-approved) |
Paclitaxel protein-bound particles for injection; albumin-bound |
Various cancers |
Presented data from several trials showing high response rates (11/3) |
American |
Abraxane (FDA-approved) |
Paclitaxel protein-bound particles for injection; albumin-bound |
Advanced cancers |
Phase I trial in 39 patients helped establish dosing for future trials (11/1) |
Amgen Inc. |
Panitumumab |
Fully human monoclonal antibody directed against the epidermal growth factor receptor |
Metastatic colorectal cancer |
Pivotal Phase III trial in 463 patients met the primary end- point of improving progression-free survival (11/3) |
AmpliMed |
Amplimexon |
Imexon injection; a cyanoaziridine compound believed to disrupt mitochondria |
Advanced solid tumors |
Phase I trial in 48 patients demonstrated tolerability and preliminary evidence of antitumor activity (11/16) |
Antigenics |
Oncophage |
Personalized cancer vaccine based on heat-shock protein technology |
Recurrent glioma |
Began Phase I/II trial designed to enroll 60 patients with primary or recurrent high- grade glioma (11/21) |
Ariad |
AP23573 |
Oral form of agent designed to inhibit cell- signaling protein mTOR |
Advanced soft- issue and bone sarcomas; solid tumors |
Interim data from Phase II trial showed 27% of 188 patients had sustained tumor regression and/ or disease stabilization (11/16); Phase Ib trial in solid tumors showed positive safety and biovailability vs. intravenous form of drug (11/17) |
BioCryst |
Fodosine |
Forodesine hydrochloride; transition-state purine nucleoside phosphorylase inhibitor |
Leukemias and lymphomas |
Data from trials showed activity, with minimal toxicity in T-cell malignancies (11/17) |
Biomira Inc. |
BLP25 (L-BLP25) |
Liposomal vaccine encapsulating a sequence of the MUC1 cancer mucin |
Non-small-cell lung cancer |
Interim Phase II data showed new formulation was not different from previous formulation in terms of safety (11/17) |
Celgene |
Thalomid (FDA-approved) |
Thalidomide |
Recurrent epithelial ovarian cancer |
Phase II trial showed use of drug with topotecan may slow the growth of ovarian cancer (11/3) |
Cell |
GVAX |
Vaccine comprising non-patient-specific tumor cells modified to secrete GM-CSF |
Pancreatic cancer |
Phase II trial in 60 patients who received vaccine after resection and radiation, and chemotherapy, had one-year survival of 88% and two-year survival of 76% (11/15) |
Cell |
Pixantrone |
Anthracycline agent designed to have improved properties |
Indolent non- Hodgkin's lymphoma |
Trial in 38 advanced patients showed drug plus Rituxan impro- ved time to disease progression and progession-free survival vs. Rituxan alone(11/9) |
Celsion Corp. |
ThermoDox |
Liposome-encapsulated formulation of doxorubicin |
Advanced breast cancer |
Duke University began Phase I trial to evaluate safety and pharmacokinetics (11/8) |
Coley |
PF-3512676 (CPG 7909, ProMune) |
Toll-like receptor 9 agonist |
Non-small-cell lung cancer |
Pfizer began two Phase III trials as first-line treatment that will evaluate survival in a total of 800 patients (11/28) |
CuraGen Corp. |
PXD101 |
Small-molecule histone deacetylase inhibitor |
Advanced solid tumors |
Updated Phase I data on 42 patients suggested the agent was well tolerated and may have anti-tumor activity (11/18) |
Cytogen |
Quadramet (FDA-approved) |
Samarium-153 bound to a small-molecule, bone- seeking phosphonate |
Multiple myeloma |
Began Phase I trial with Velcade to evaluate safety and preliminary efficacy of the combination in up to 36 patients (11/28) |
Cytokinetics |
Ispinesib (SB-715992) |
Small-molecule inhibitor of kinesin spindle protein |
Advanced solid tumors |
Phase I trials demonstrated tolerability of the agent when used with standard chemotherapeutics (11/17) |
EntreMed |
Panzem |
2-methoxyestradiol; naturally occurring metabolite of endogenous estrogen |
Advanced cancers |
Pharmacokinetic endpoints were met in each of two Phase Ib trials, providing dosing information for Phase II trials (11/16) |
Exelixis Inc. |
XL647 |
Oral compound targeting multiple receptor tyrosine kinases |
Advanced solid tumors |
Phase I data from 31 patients showed agent generally was well tolerated and had clinical and biologic activity (11/15) |
Exelixis Inc. |
XL880 |
Small-molecule spectrum- selective kinase inhibitor; inhibits Met and VEGFR2 |
Advanced solid tumors |
Interim Phase I data demonstrated tolerability and evidence of biologic and clinical activity (11/15) |
Exelixis Inc. |
XL999 |
Spectrum-selective kinase inhibitor; targets multiple receptor tyrosine kinases |
Advanced solid tumors |
Phase I trial established a maximum tolerated dose and demonstrated preliminary evidence of clinical activity (11/17) |
Favrille Inc. |
Favid |
Patient-specific vaccine designed to stimulate immune responses |
Follicular B-cell non- Hodgkin's lymphoma |
Long-term data from Phase II trial of drug following Rituxan treatment showed improved responses vs. Rituxan alone (11/15) |
GlycoGenesys |
GCS-100 |
Complex carbohydrate agent |
Advanced multiple myeloma |
Began Phase I/II trial to evaluate safety, dosing and efficacy (11/17) |
GPC Biotech |
Satraplatin |
Oral platinum compound |
Metastatic breast cancer |
Began Phase II trial to evaluate response rates in 80 patients (11/2) |
Hana |
Talotrexin (PT-523) |
Non-classical antifolate; analogue of aminopterin |
Advanced non- small-cell lung cancer |
Interim data from 15 patients in Phase I trial showed acceptable tolerability with encouraging activity (11/14) |
Human Genome |
HGS-ETR1 to TRAIL receptor 1 |
Mapatumumab; agonistic human monoclonal antibody |
Advanced solid tumors and safe; partial responses were |
Phase Ib trials showed drug with chemotherapy was well tolerated (HGSI) seen in several patients (11/17) |
ImClone |
Erbitux (FDA-approved) |
Cetuximab; antibody that blocks the epidermal growth factor receptor |
Head and neck cancer |
Phase III trial with radiation in 424 patients showed statistically significant improvements in loco-regional control and survival vs. radiation alone (11/16) |
ImmunoGen |
huN901-DM1 |
Antibody designed to deliver DM1 to CD56-expressing cancer cells |
Advanced solid tumors |
Phase I trial in 21 patients showed one complete remission and five cases of stable disease (11/16) |
Lorus |
GTI-2040 |
Antisense oligonucleotide complementary to the R2 component of ribonucleotide reductase |
Hormone- refractory prostate cancer |
Interim data from trial with docetaxel and prednisone showed seven PSA responses, seven disease stabilizations and one disease progression (11/15) |
Marshall |
Phenoxodiol |
Agent designed to induce apoptosis by removing intracellular proteins XIAP and c-FLIP |
Recurrent ovarian cancer |
Is starting Phase Ib/IIa trial with docetaxel that will evaluate tumor responses and disease- free survival in 60 patients (11/28) |
MethylGene |
MGCD0103 |
Small-molecule inhibitor of histone deacetylases |
Advanced hematological malignancies |
Data from first 26 patients in Phase I trial showed prolonged disease stabilization in three patients (11/15) |
MethylGene |
MGCD0103 |
Small-molecule inhibitor of histone deacetylases |
Solid tumors |
Began Phase I/II trials to evaluate drug with standard Vidaza treatment in up to 50 patients (11/14) |
Millennium |
MLN8054 |
Selective Aurora kinase inhibitor |
Advanced malignancies |
Began Phase I trial in 30 advanced patients to evaluate dosing, pharmacokinetics and preliminary activity (11/30) |
NeoPharm Inc. |
LErafAON- ETU |
Liposomal formulation of c- raf antisense oligonucleotide |
Advanced cancers |
Preliminary Phase I trial data showed agent generally was well tolerated (11/15) |
Novacea Inc.* |
DN-101 |
Agent containing calcitriol, the biologically active form of vitamin D |
Prostate cancer |
Data from ASCENT trial showed drug and Taxotere produced a survival advantage vs. Taxotere and placebo, and fewer adverse events (11/2) |
OxiGene Inc. |
Combrestatin A4 Prodrug |
Vascular-targeting agent designed to block the flow of blood to a tumor |
Advanced ovarian cancer |
Updated data from combination therapy trial showed a 67% response rate among a subpopulation of evaluable patients (11/15) |
Point |
Talabostat |
Small molecule designed to stimulate proliferation of hematopoietic progenitor cells |
Advanced non- small-cell lung cancer |
Data from 42 patients in Phase II trial showed five responses, including two complete responses (11/16) |
Point |
Talabostat |
Small molecule designed to stimulate proliferation of hematopoietic progenitor cells |
Metastatic melanoma |
Data from 31 Stage IV patients in single-agent Phase II trial showed two responses, including one complete response (11/11) |
Santaris |
SPC2996 |
Locked nucleic acid-based RNA antagonist designed to reduce levels of the Bcl-2 protein |
Chronic lymphocytic leukemia |
Got OK from FDA for Phase I/II trial to evaluate safety and efficacy in 42 relapsed or refractory patients (11/8) |
Seattle |
SGN-33 |
Lintuzumab; humanized anti- D33 monoclonal antibody |
Leukemias and myelodysplastic syndromes |
Began Phase I trial to evaluate safety, pharmacokinetics and antitumor activity in up to 60 patients (11/17) |
Seattle |
SGN-40 |
Humanized monoclonal antibody that targets the CD40 antigen |
Chronic lymphocytic leukemia |
Began single-agent Phase I/II trial to evaluate tolerability, pharmacokinetics and antitumor activity in advanced patients (11/29) |
Sunesis |
SNS-595 |
Small-molecule cell-cycle modulator designed to induce apoptosis |
Advanced solid tumors |
Phase I trial in 41 patients showed one partial response and 12 who achieved stable disease for more than 12 weeks (11/17) |
Sunesis |
SNS-595 |
Small-molecule cell-cycle modulator designed to induce apoptosis |
Refractory acute leukemias |
Began Phase I trial to evaluate safety, tolerability and pharmacokinetics in patients (11/15) |
ZioPharm |
ZIO-101 |
An organic arsenic agent |
Cancers |
Data from 11 patients in Phase I trial demonstrated safety at doses 25 times higher than the approved arsenic trioxide dose (11/16) |
ZymoGenetics |
IL-21 |
Interleukin-21 |
Advanced cancers |
First part of Phase I trial produced positive results; another 24 patients now will be tested (11/14) |
CARDIOVASCULAR | ||||
Alexion |
Pexelizumab |
Monoclonal antibody fragment; terminal complement inhibitor |
Heart attack |
Phase III PRIMO-CABG2 trial showed benefit but not statistical significance in reducing myocardial infarction or death through 30 days following coronary artery bypass graft surgery (11/23) |
Alteon Inc. |
Alagebrium (ALT-711) |
Alagebrium chloride; A.G.E. crosslink breaker |
Heart failure |
Phase IIa PEDESTAL trial demonstrated improved diastolic function; second Phase IIa trial showed improved endothelial function (11/15) |
CV |
Ranexa (ranolazine) |
Partial inhibitor of fatty-acid oxidation |
Chronic angina |
ERICA trial in 565 patients demonstrated a statistically significant reduction of weekly angina frequency vs. placebo (11/16) |
Dyax Corp. |
DX-88 |
Recombinant small protein designed to inhibit human plasma kallikrein |
Hereditary angioedema |
Final data from Phase I trial showed subcutaneous delivery of drug was safe and well tolerated in healthy volunteers (11/7) |
FibroGen |
FG-2216 |
Small-molecule inhibitor of hypoxia-inducible factor-prolyl hydroxylase |
Anemia in chronic kidney disease |
Presented positive data from ongoing dose-escalation studies (11/14) |
Forbes |
FM-VP4 |
Amphipathic analogue of phytostanols; a cholesterol absorption inhibitor |
Cholesterol control |
Began Phase II trial to evaluate the effect on LDL cholesterol and other measures in 150 patients (11/2) |
Isis |
ISIS 301012 |
Capsule formulation of second-generation anti- sense inhibitor of ApoB-100 |
Cholesterol management |
Began Phase II trial to evaluate safety and efficacy with the statin simvastatin in those not achieving cholesterol targets (11/7) |
Lev |
C1-INH |
C1-esterase inhibitor |
Hereditary angioedema |
Began second part of Phase III trial, to evaluate the drug in preventing the onset of HAE attacks (11/1) |
Millennium |
Integrilin (FDA-approved) |
Eptifibide; glycoprotein IIb/IIIa inhibitor |
Use in coronary procedures |
Drug showed benefit when used in early intervention for myocardial infarction, and when used with clopidogrel in stenting procedures (11/14) |
Neurobiological |
Viprinex (ancrod) |
Thrombin-like enzyme specific to fibrinogen; derived from venom of the Malayan pit viper |
Acute ischemic stroke |
Began first of two Phase III trials, each of which will enroll 650 patients; endpoints relate to survival and patient independence (11/22) |
Northfield |
PolyHeme |
Oxygen-carrying blood substitute derived from human blood |
Blood loss |
Monitors recommended Phase III trial in treating hemorrhagic shock following traumatic injury continue, after fourth interim analysis involving 500 patients (11/15) |
Nuvelo Inc. |
rNAPc2 |
Recombinant nematode anticoagulant protein c2; originally isolated from hookworms |
Acute coronary syndrome |
Final data from Phase IIa ANTHEM trial showed an acceptable safety profile and that agent was well tolerated (11/14) |
Osiris |
Provacel |
Formulation of adult mesenchymal stem cells |
For use in cardiac patients |
Phase I trial cleared its first safety milestone and was cleared by monitors to proceed to a higher dose (11/4) |
Predix |
PRX-08066 |
Small-molecule 5-HT2B antagonist |
Pulmonary arterial hypertension |
Began Phase Ib trial to evaluate the agent in 12 conditioned athletic adults with transient PAH induced by a low-oxygen environment (11/30) |
Surface |
SLx-2101 |
Selective, long-acting, oral PDE-5 inhibitor |
Endothelial dysfunction |
Began Phase IIa trial to evaluate safety, tolerability and efficacy in patients with erectile dysfunction who are known to respond to PDE5 inhibitors (11/30) |
CENTRAL NERVOUS SYSTEM | ||||
Acadia |
ACP-104 |
N-desmethylclozapine;M1 muscarinic agonist, 5-HT2A inverse agonist and dopamine D2 and D3 partial agonist |
Schizophrenia |
Initial data from 10 patients in a trial showed the agent was safe and well tolerated (11/10) |
Aeolus Pharmaceuticals Inc. (OTC BB:AOLS) |
AEOL 10150 |
Small-molecule catalytic antioxidant |
Amyotrophic lateral sclerosis |
Data from first cohort of patients in Phase I trial showed no serious adverse events; testing in second cohort began (11/30) |
AlgoRx |
ALGRX 3268 |
Anesthetic administered into the skin by Powderject system |
Pain |
Phase III trial in 535 pediatric patients getting venipunctures and intravenous line placements demonstrated statistically significant pain relief vs. placebo (11/8) |
Axonyx |
Phenserine |
Inhibitor of acetylcholin- esterase and beta-amyloid precursor protein |
Alzheimer's disease |
Company ended development of drug following further review of failed Phase III trials (11/7); subgroup analysis from trials showed statistically significant benefit vs. placebo in those taking higher dose (11/29) |
BioDelivery |
BEMA |
Oral adhesive disc formulation of fentanyl |
Cancer pain |
Crossover trial in 12 subjects showed favorable results vs. Actiq (11/1) |
DOV |
Bicifadine |
Serotonin and norepinephrine reuptake inhibitor |
Chronic low-back pain |
Data from open-label trial indicate drug is at least equivalent to standard of care for efficacy and behavioral functioning (11/3) |
Endo |
Lidoderm |
Lidocaine patch 5% |
Chronic low-back pain |
Analysis of trial that was stopped early showed 50% of patients vs. 42% of Celebrex patients experienced improved pain intensity of at least 30% (11/16) |
Helicon Thera- |
HT-0712 (IPL455,903) |
Oral inhibitor of phosphodiesterase-4 |
Learning and memory disorders |
Phase Ib trial in young and elderly volunteers showed drug was safe and well tolerated (11/23) |
Memory |
MEM 1003 |
Neuronal L-type calcium channel modulator |
Alzheimer's disease |
Began Phase IIa trial to evaluate safety and efficacy in 180 patients with mild to moderate AD (11/4) |
Myriad |
Flurizan |
Selective amyloid beta 42 lowering agent |
Alzheimer's disease |
Phase II follow-on study showed participants improved as a group, regaining cognitive ability from months 12 through 18. (11/15) |
Orphan |
Xyrem (FDA-approved) |
Sodium oxybate oral solution |
Fibromyalgia syndrome |
Phase II trial in 188 patients demonstrated significant pain relief and improved functioning (11/17) |
Pain |
Oxytrex |
Oral agent combining naltrexone (an opioid antagonist) with oxyco- done (an opioid agonist) |
Osteoarthritic pain |
Phase III trial in 775 patients failed to show reductions in physical dependency vs. oxycocodone due to high dropout rates in all study arms (11/22) |
Predix |
PRX-03140 |
Selective serotonin 4 (5-HT4) receptor agonist |
Alzheimer's disease |
Agent showed desired alterations in brain wave activity in patients and was well tolerated in 14-day Phase Ib trial (11/14) |
Santhera |
SNT-MC17 |
Idebenone |
Friedreich's ataxia |
The National Institutes of Neurological Disorders and Stroke is starting a Phase II trial to evaluate safety and efficacy in 48 patients (11/3) |
Sepracor |
Lunesta (FDA-approved) |
Eszopiclone tablets; a non-enzodiazepine agent |
Insomnia |
Phase IIIb/IV trial in 153 rheumatoid arthritis patients showed statistically significant improvements in sleep measures (11/15) |
DIABETES | ||||
Amylin |
Byetta (FDA-approved) |
Exenatide; incretin mimetic |
Type II diabetes |
Trial of drug with thiazolidine-diones in 233 patients showed improved glucose control vs. placebo (11/15) |
INFECTION | ||||
Acambis plc |
-- |
Vaccine against Clostridium difficile |
C. difficile infection |
Began Phase I trial in healthy elderly subjects to evaluate safety, tolerability and immunogenicity (11/28) |
Advancis |
Amoxicillin Pulsys |
Amoxicillin formulation delivered with once-daily pulsatile Pulsys technology |
Pharyngitis/tonsillitis |
Began pivotal Phase III trial that will evaluate non-inferiority vs. penicillin in 600 patients (11/3) |
AnorMED Inc. |
AMD070 |
Agent targeting CXCR4 chemokine receptor to prevent HIV from entering healthy cells |
HIV |
Began open-label XACT trial to evaluate safety and antiviral activity in up to 48 patients (11/29) |
Coley |
Actilon (CPG 10101) |
Agent designed to target and stimulate Toll-like receptor 9 |
Hepatitis C |
Phase Ib trial in 60 patients demonstrated a dose-dependent decrease in HCV viral levels; Phase Ia trial demonstrated safety (11/14) |
Dynavax |
Heplisav |
Immunostimulatory sequence- ased vaccine targeting Toll-like receptor 9 |
Hepatitis B |
Began Phase I trial to evaluate safety and efficacy vs. Engerix-B in 96 patients with end-stage renal failure (11/1) |
Gilead |
Hepsera (FDA-approved) |
Adefovir dipivoxil; a nucleotide analogue |
Hepatitis B |
Five-year extension data from Study 438 showed regression of liver fibrosis in 75% of patients taking drug (11/14) |
Gilead |
Truvada (FDA-approved) |
Combination of the approved drugs Emtriva and Viread in one tablet |
HIV |
Phase IV COMET trial suggested decreased viral load vs. Combivir when both were used with efaviren (11/17) |
Human Genome |
Albuferon |
Long-acting form of interferon alpha that uses albumin fusion technology |
Hepatitis C |
Phase II trial with ribavirin in non-responding patients demonstrated safety, tolerability and antiviral activity (11/15) |
Idenix Pharmaceuticals |
Valopicitabine |
HCV polymerase inhibitor |
Hepatitis C |
Phase IIb trial with pegylated interferon in refractory patients showed significantly greater viral suppression at 12 weeks vs. ribavirin and pegylated interferon (11/11) |
InSite Vision |
AzaSite |
Topical solution of azithromycin formulated with DuraSite delivery vehicle |
Bacterial |
Pivotal Phase III trial in 746 patients showed clinical resolution equivalent to tobramycin, the primary efficacy endpoint (11/30) |
Intarcia |
Omega interferon |
Recombinant, glycosylated human type-1 interferon |
Hepatitis C |
Phase II trial with ribavirin demonstrated tolerability and early viral response rate of 84% (11/15) |
InterMune |
Infergen (FDA-approved) |
Interferon alfacon-1 |
Hepatitis C |
Investigator studies showed positive results when Infergen replaced pegylated interferon in use with ribavirin in nonresponders (11/14) |
Nabi Bio- |
StaphVAX |
Staphylococcus aureus polysaccharide conjugate vaccine |
To prevent S. aureus infections |
Confirmatory Phase III trial in 3,600 patients on hemodialysis failed to reduce S. aureus infections vs. placebo (11/1) |
Oxxon |
PrimeBoost |
Immunotherapeutic vaccine |
Hepatitis B |
Phase IIa trial in 54-patients demonstrated safety and tolerability, and positive viral effects vs. lamivudine (11/11) |
Vertex |
VX-950 |
Oral HCV protease inhibitor |
Hepatitis C |
Patients in all dose groups in a Phase Ib trial demonstrated substantial antiviral effects (11/11) |
ViroPharma |
HCV-796 |
Oral viral polymerase inhibitor |
Hepatitis C |
Phase Ib trial in adult patients showed antiviral effects; drug generally was well tolerated, with no dose-limiting toxicities (11/10) |
XTL Bio- |
Ab68 |
Fully human monoclonal antibody against the HCV E2 envelope protein |
Hepatitis C |
Pilot Phase I/II trial showed increased reductions in viral load vs. placebo in the two highestdose groups(11/16) |
MISCELLANEOUS | ||||
Aastrom |
Tissue Repair Cells |
Autologous bone marrow-derived adult stem and progenitor cells |
Bone formation |
Began Phase I/II trial to evaluate safety and bone formation in the spine in patients undergoing lumbar spinal fusion surgery (11/30) |
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 (11/1) |
Amgen Inc. |
Denosumab (AMG 162) |
Agent designed to target RANK Ligand, a protein implicated in promoting bone removal |
Bone loss |
Phase II trial in 337 women showed twice-yearly injections increased bone mineral density vs. placebo at 24 months (11/13) |
Critical |
Zyflo (FDA-approved) |
Zileuton tablets; 5-lipoxy genaseinhibitor |
Severe asthma |
Retrospective data showed the drug significantly improved lung function, while reducing the need for rescue medications and oral corticosteroids (11/2); study showed a steroid-sparing effect (11/7) |
CuraGen |
CR002 |
Fully human monoclonal antibody that targets platelet-derived growth factor-D |
Kidney inflammation |
Phase I trial in 40 healthy volunteers demonstrated safety and tolerability (11/14) |
Dynavax |
Tolamba |
Immunostimulatory sequence molecule linked to the purified major allergen of ragweed |
Ragweed allergy |
Phase I trial in 24 children with mild to moderate allergy demonstrated safety (11/7) |
Genentech |
Lucentis |
Ranibizumab; humanized antibody fragment designed to bind and inhibit VEGF-A |
Wet age- related macular degeneration |
Phase III trial met its primary end- point of maintaining vision in patients with wet AMD; it showed benefit vs. Visudyne (11/7) |
Othera |
OT-551 |
Eye-drop formulation of a catalytic antioxidant |
Cataracts |
Began Phase II trial to assess the drug in preventing or arresting the progression of cataracts in patients who have undergone vitrectomy surgery (11/7) |
RenaMed |
Renal Bio- Replacement Therapy |
Human renal epithelial cells incorporated in a cartridge that's administered outside the body |
Acute renal failure |
Phase II trial in 58 patients showed a 72% increase in the survival rate at 28 days (11/12) |
Savient |
Puricase |
Polyethylene glycol conjugate of uricase |
Gout |
Phase II trial showed substantial and sustained reduction in urate levels in disease-resistant patients with high levels (11/14) |
Sepracor |
Xopenex HFA (FDA-approved) |
Levalbuterol tartrate inhalation solution |
Bronchospasm associated with asthma |
Trial in patients 4 to 11 years old demonstrated a statistically significant greater change in FEV(1) vs. placebo (11/7) |
Vivus Inc. |
Avanafil |
Oral phosphodiesterase type-5 inhibitor |
Erectile dysfunction |
Phase II trial in 280 patients showed dose-related, significant increases in various aspects of penile function (11/17) |
Y's |
YSPSL |
Molecule resulting from fusion of P- electin glyco- protein ligand and human IgG1 |
Delayed graft function |
Began Phase II trial to evaluate safety and efficacy for preventing DGF in up to 84 patients under- going cadaveric kidney transplantation (11/29) |
| | ||||
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; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange. | ||||
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