Clinical Trials Update: November 2005
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) |
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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. |