Company* (Country; Symbol)ProductDescriptionIndicationStatus (Date)
AUTOIMMUNE
Immunomedics Inc. (IMMU)EpratuzumabA humanized monoclonal antibody that targets the CD22 antigen found on B-cellsSystemic lupus erythematosusData showed it inhibits the activation of B-cells from patients with SLE but not from normal subjects (8/16)
CANCER
Allos Therapeutics Inc. (ALTH)PDXAntifolate; pralatrexate; a small-molecule agent designed to inhibit dihydrofolate reductaseRelapsed or refractory cutaneous T-cell lymphomaStarted patient enrollment in a Phase I trial of PDX with vitamin B12 and folic acid supplementation (8/15)
Antisoma plc (UK; LSE:ASM)AS1411Aptamer that binds to the protein nucleolin and has shown anticancer effects in animal modelsRelapsed or refractory acute myeloid leukemiaStarted a 70-patient Phase II trial (8/6)
Antisoma plc (UK; LSE:ASM)ASA404Small-molecule vascular disrupting agent designed to target blood vessels that nourish tumorsNon-small-cell lung cancerPhase II data showed one of the largest increases in median survival data reported in patients with the condition (8/22)
Ascenta Therapeutics Inc.*AT-101Oral, pan-Bcl-2 inhibitor; apoptotic agentHormone-refractory prostate cancerPhase I/II data indicate the compound has biological activity in combination with docetaxel and prednisone in men with HRPC (8/27)
Biomira Inc. (Canada; BIOM)PX-478A small molecule designed to inhibit the activity of hypoxia inducible factor-1 alphaAdvanced metastatic cancerEnrolled the first patient in a Phase I trial (8/28)
CuraGen Corp. (CRGN)BelinostatHistone deacetylase inhibitorMultiple myeloma; and acute myeloid leukemiaTwo of four MM patients enrolled in a Phase II study developed acute deterioration in already existing renal insufficiency in the first cycle of treatment; the company began a Phase I/II trial in Europe in up to 70 AML patients (8/7)
Cytokinetics Inc. (CYTK) and GlaxoSmithKline plc (UK)GSK-923295Small-molecule inhibitor of centromere-associated protein ESolid tumorsStarted a Phase I trial (8/15)
Dendreon Corp. (DNDN)NeuvengeAn active cellular immunotherapyHER2/neu-positive breast cancerPhase I data showed treatment was generally well tolerated and stimulated significant immune responses (8/20)
Genta Inc. (GNTA)GenasenseOblimersenAdvanced melanomaEnrolled the first patients in a Phase III trial of Genasense plus dacarbazine (8/21)
Genzyme Corp. (GENZ)Mozobil (AMD3100)Plerixafor; an antagonist of the SDF-1/CXCR4 complex; it acts to release stem cells from the bone marrow so they can circulateMultiple myelomaPhase III data showed 72% of patients treated with Mozobil and G-CSF achieved the target threshold for collection of at least 6M CD34+cells/kg from the peripheral blood with two days or fewer of apheresis sessions, compared with 34% of patients in the G-CSF/placebo group (8/2)
Hana Biosciences(HNAB)MarqiboVincristine sulfate injection, OptisomeRelapsed acute lymphoblastic leukemiaStarted a Phase II trial (8/3)
ImClone Systems Inc.(IMCL)IMC-1121BA monoclonal antibody targeted to the vascular endothelial growth factor receptor-2Metastatic renal-cell carcinomaOpened patient enrollment in the first of its Phase II trials (8/24)
ImClone Systems Inc. (IMCL)IMC-A12An anti-insulin-like growth factor-1 receptor monoclonal antibodyAdvanced prostate cancerBegan enrollment in a Phase II trial (8/29)
ImmunoCellular Therapeutics Ltd. (OTC BB: IMUC)A dendritic cell-based vaccineMalignant brain tumorsThe first three patients have been enrolled in a Phase I trial (8/3)
ImmunoGen Inc. (IMGN)huC242- DM4An antibody designed to bind to the CanAg antigen and deliver the company's DM4 cell-killing agentStomach cancerStarted a Phase II trial (8/1)
Kiadis Pharma BV* (the Netherlands)RevirocDeveloped to remove residual tumor cells from autologous transplantsNon-Hodgkin's lymphomaData from an open-label Phase II trial showed that Reviroc improved overall survival compared to historic controls (8/31)
Kosan Biosciences Inc. (KOSN)KOS-953Hsp90 inhibitor tanespimycinRelapsed/refractory multiple myelomaStarted a Phase II/III study (8/2)
Lorus Therapeutics Inc. (Canada; AMEX:LRP; TSX:LOR)GTI-2040Antisense agent that targets R2Acute myeloid leukemiaCompleted a proof-of-concept trial and started a Phase II trial (8/29)
Millennium Pharmaceuticals Inc. (MLNM)VelcadeBortezomibMultiple myelomaStarted a Phase II trial combining Velcade with lenalidomice/dexamethasone and cyclophosphamide in the front line setting (8/15)
Myriad Genetics Inc. (MYGN)AzixaMPC-6827; small molecule inhibitor of microtubule formationNon-small-cell lung cancerStarted a third Phase II trial in patients with NSCLC that has spread to the brain (8/16)
OncoGenex Technologies Inc.* (Canada)OGX-427Designed to block production of heat shock protein 27Breast, ovarian, bladder, prostate or lung cancerEnrolled the first patient in an open-label, dose-escalation, multicenter Phase I study (8/1)
Oxford BioMedica Ltd.(UK; LSE:OXB)TrovaxVaccine; modified vaccinia Ankara-encoding 5T4Colorectal cancerPhase II data showed Trovax shrank tumors in six of 17 patients with metastatic disease (8/2)
Pharmion Corp. (PHRM)Vidaza (FDA-approved)Azacitidne for injectionMyelodysplastic syndromePhase III data showed it extended overall survival by 74% (8/2)
Prolexys

Pharmaceuticals Inc.*

PRLX 93936A structural analogue

of a compound called erastin

Advanced

solid tumors

Began its first Phase I trial (8/29)
Proteolix Inc.*PR-171Carfilzomib; a selective proteasome inhibitorRelapsed or refractory multiple myelomaEnrolled the first patient in a Phase II trial (8/15)
Regeneron Pharmaceuticals Inc. (REGN) Aflibercept (VEGF Trap)Inhibits angiogenesis by targeting vascular endo-thelial growth factor; VEGF receptor fusion proteinProstate cancer and non-small-cell lung cancerStarted two Phase III trials (8/23)
Thallion Pharmaceuticals Inc. (Canada; TSX:TLN)ECO-4601A small molecule derived from a nonpathogenic microorganism; inhibits the Ras-MAPK pathwayAdvanced cancersCompleted the high-dose extension portion of its Phase I/II trial (8/23)
Vion Pharmaceuticals Inc. (VION)CloretazineVNP40101M; anticancer agentAcute myelogenous leukemiaAccrued 85 patients to the pivotal Phase II trial (8/15)
YM BioSciences Inc. (Canada; AMEX: YMI; TSX:YM) and Oncoscience AG* (Germany)NimotuzumabA humanized monoclonal antibody that targets the epidermal growth factor receptorDiffuse intrinsic pontine gliomaRecruited the 40th and final patient in a Phase III trial combining nimotuzumab with radiation to treat children and adolescents with the disease (8/15)
YM BioSciences Inc. (Canada; AMEX: YMI; TSX:YM) and Oncoscience AG* (Germany)NimotuzumabA humanized monoclonal antibody that targets the epidermal growth factor receptorGlioblastoma multiforme and advanced pancreatic cancerStarted a Phase III trial in glioblastoma multiforme and a Phase IIb/IIIa trial in chemo-therapy-naive patients with ad-vanced pancreatic cancer (8/21)
CARDIOVASCULAR
Biogen Idec Inc. (BIIB)AdentriOral; an A1 adenosine receptor antagonistStable heart failurePhase II showed Adentri for 10 days with standard heart failure therapy was well tolerated and resulted in clinically significant increases in sodium excretion while preserving renal function (8/14)
Cardium (AMEX:CXM)GenerxAlferminogene tadenovec; Ad5FGF-4Heart diseasePhase IIb and Phase III data Therapeutics showed significant improvements in multiple clinical measures of heart disease among women who received Generx compared with those who received placebo (8/28)
EPIX Pharmaceuticals Inc. (EPIX)PRX-08066A 5-HT2B antagonistPulmonary hypertension associated with chronic obstructive pulmonary diseasePhase IIa data demonstrated statistically significant reductions in systolic pulmonary artery pressure vs. placebo (8/7)
ImaRx Therapeutics Inc. (IMRX)SonoLysisCombines ImaRx's MRX-801 microbubbles with ultrasound to break up blood clots and restore blood flow to tissuesIschemic storkeA Data and Safety Monitoring Board granted the company permission to proceed to the second dose cohort in its Phase I/II trial combining SonoLysis with tPA (8/28)
Nuvelo Inc.AlfimepraseThrombolytic drug; recom-Central venousBegan enrollment in the prev-
(NUVO)binant enzyme that acts by directly degrading fibrincatheter occlusioniously discontinued SONOMA-3 Phase III trial (8/22)
Pharming Group NV (the Netherlands; Euronext:PHARM)RhucinA recombinant version of the human C1 inhibitor, which is produced in the milk of transgenic rabbitsHereditary angioedemaCompany stopped a placebo-controlled trial on ethical grounds after an interim analysis showed none of the treated patients experienced a relapse, and no adverse events were reported (8/22)**
CENTRAL NERVOUS SYSTEM
Accera Inc.*KetasynAC-1202; neuronal cell-targeting agentAge-associated memory impairmentPhase II data showed the drug had a positive and clinically meaningful effect on memory in older adults (8/29)
Anesiva Inc. (ANSV)Zingo (FDA-approved)Lidocaine hydrochloride monohydrate; powder intradermal injection systemTo reduce pain associated with peripheral venous access proceduresCompleted enrollment in a Phase III study (8/28)
Cephalon Inc. (CEPH)FentoraA fentanyl buccal tabletNoncancer breakthrough painData from a third Phase III trial showed statistically significant improvements in pain intensity vs. placebo (8/16)
DOV Pharmaceutical Inc. (OTC BB: DOVPW)DOV 21,947Lead triple reuptake inhibitorDepression and obesityPhase Ib data indicated that the drug was safe and well tolerated
Genaera Corp. (GENR)MSI-1436Trodusquemine; designed to inhibit the enzyme target protein tyrosine phosphatase 1BObesityPhase I data demonstrated safety and tolerability (8/8)
Memory Pharmaceuticals Corp. (MEMY)R4996/ MEM 63908A partial agonist of the nictotinic alpha-7 receptorAlzheimer's disease, schizophrenia and other nervous system disordersDosing was initiated for the first study participant in the Phase I program (8/30)
NeurAxon Inc.*NXN-188Small-molecule product that incorporates both 5-HT agonism and inhibition of neuronal nitric oxide synthaseAcute migrainePhase I data showed it was well tolerated with no drug-related adverse events (8/14)
Neurochem Inc. (NRMX)AlzhemedTramiprosateAlzheimer's diseaseFailed to meet its primary end-point in a Phase III trial (8/27)
Newron Pharmaceuticals (SWX:NWRN) and Merck Serono (Switzerland)SafinamideAn add-on treatment to dopamine agonist therapyEarly stage Parkinson's diseasePhase III data showed it did not reach statistical significance with the primary endpoint of time to intervention (8/22)
Obecure Ltd.* (Israel)HistaleanComprised of betahistine, an H1 receptor agonist and partial H3 receptor antagonistObesityPhase II data suggested strong gender and age effects, with greatest efficacy in women 50 or younger (8/30)
Orthogen AG* (Germany)OrthokineEndogenous protective proteins produced using the Orthokine procedureDisc-related back painOrthokine produced better results over six months than cortisone treatment (8/29)
Targacept Inc. (TRGT)AZD3480Acts selectively on neuronal nicotinic receptorsCognitive deficits in schizophreniaStarted a Phase IIb trial (8/23)
TorreyPines Therapeutics Inc. (TPTX)TezampanelAn AMPA/kainate receptor antagonist that selectively binds to certain AK receptors to potentially block the transmission of pain signalsMigraine headachesStarted a Phase I trial (8/27)
Transition Therapeutics Inc. (Canada; TTHI; TSX:TTH) and Elan Corp. plc (Ireland; NYSE:ELN)ELND-005/AZD-103Scyllo-cyclohexanehexol; oral agent that acts on beta amyloidAlzheimer's diseaseProduct was safe and well-tolerated at all doses and dosing regimens examined; there were no severe or serious adverse events observed in the Phase I studies (8/30)
Valeant Pharmaceuticals International(NYSE:VRX)RetigabineA first-in-class neuronal potassium channel openerEpilepsyCompleted enrollment in the first of two Phase III trials (8/28)
DIABETES
Alimera Sciences* and pSivida Ltd. (Australia; PSDV)MedidurA tiny insert, injected intravitreally to deliver a low dose of fluocinolone acetonide to the retina for up to three yearsDiabetic macular edemaBegan enrollment for the first human pharmacokinetic study (8/22)
AtheroGenics Inc. (AGIX)AGI-1067Oral anti-inflammatory antioxidant drugDiabetesPatient enrollment is under way in a Phase III trial (8/23)
CombinatoRx Inc. (CRXX)CRx-401Insulin sensitizer that combines a sustained-released dose of bezafibrate and a low dose of diflunisalType II diabetesDosed the first patient in a Phase IIa trial (8/15)
Elixir Pharmaceuticals Inc.*Mitiglinide (formerly Glufast)Mitiglinide calcium hydrateType II diabetesStarted a Phase III trial (8/20)
Generex Biotechnology Corp. (GNBT)Oral-lynOral insulin sprayType I diabetesClinical data showed regular insulin and Oral-lyn had similar glucodynamic effects in subjects with Type I diabetes receiving a twice-daily insulin analogue as baseline therapy (8/14)
MacroGenics Inc.*TeplizumabCD3 monoclonal antibodyType I diabetesStarted a pivotal Phase II/III trial (8/2)
Oramed Pharmaceuticals Inc. (Israel; OTC BB: ORMP)Oral insulin gel capsuleDiabetesCompleted a Phase Ia trial; no significant adverse events were noted in the drug group other than the expected insulin-related hypoglycemic side effects (8/14)
Rheoscience A/S* (Denmark) and Dr. Reddy's Laboratories (India)DRF2593-307Balaglitazone; an insulin sensitizer that acts as a partial PPAR gamma agonistDiabetesThe first patient has been dosed in a Phase III study (8/1)
INFECTION
Accentia Bio-pharmaceuticals Inc. (ABPI)SinuNaseIntranasal lavage of 0.01%amphotericin BRefractory chronic sinusitisInterim Phase III data showed improvement in polyposis by endoscopy in about 50% of patients and improvement in sinus inflammation by CT scan in about 50% of patients (8/15)
Artisan Pharma Inc.*ART-123A recombinant, soluble thrombomodulin agent designed to target both anticoagulant and systemic anti-inflammatory pathwaysDisseminated intravascular coagulation in sepsisLaunched a Phase IIb trial (8/21)
BioMarin Pharmaceutical Inc. (BMRN)KuvanSapropterin dihydrochloride; small moleculePhenylketo-nuria Phase III data suggested treatment results in significant reductions in blood Phe levels in some patients (8/13)
Cadence Pharmaceuticals Inc. (CADX)Intravenous acetaminophenAcute painCompleted patient enrollment in a pivotal Phase III study in acute pain following gynecologic surgery (8/30)
CuraGen Corp. (CRGN)Velafermin Growth factor that promotes both epithelial and mesenchymal cell proliferationTo prevent severe oral mucositisEnrollment has been completed in the Phase II study (8/7)
Human Genome Sciences Inc. (HGSI)AlbuferonAlbinterferon alfa-2bChronic hepatitis CCompleted enrollment of a target 1,331 patients in a Phase III trial (8/28)
Implicit Bioscience Pty. Ltd. (Australia)Intranasal oglufanide disodiumChronic hepatitis C viral infectionA Phase IIa trial is under way (8/27)
Intercell AG (Austria; Vienna: ICLL)IC41-202Vaccine that comprises five synthetic peptides harboring HCV and T-cell epitopes, as well as the adjuvant IC30, which consists of poly-L-arginineHepatitis C virusPhase II data indicated a 40% reduction in viral load, a statistically significant result (8/22)**
Iomai Corp. (IOMI)Patch-based vaccine for enterotoxigenic E. coli bacteriaTraveler's diarrheaPhase II data showed statistically significant protection from traveler's diarrhea vs. placebo (8/1); Phase I data showed that all patients who received the vaccine mounted a response (8/9)
MedImmune Inc. (LSE:MDI)Motavizumab (formerly Numax)Third-generation variant of the anti-RSV antibody SynagisRespiratory syncytial virus Phase III data showed the product reduced hospitalizations due to RSV by 83% vs. placebo (8/24)
Meridian Bioscience Inc. (VIVO)Parvovirus B19 vaccineParvovirusBegan a Phase I/II trial (8/28)
Pharmasset Inc. (VRUS)R7128A nucleoside polymerase inhibitorHepatitis C virusCompleted patient enrollment in its multiple ascending dose study of R7128 to treat HCV (8/2)
Romark Laboratories LC*AliniaNitazoxanide; a small-molecule compound from the thiazolides class that targets cell-signaling pathways used in viral replicationHepatitis C virusStarted a Phase II trial (8/15)
TaiGen Biotechnology Inc.* (Taiwan)NemonoxacinTG-873870; oral drug; quinolone antibioticCommunity-acquired pneumoniaCompleted enrollment of a target 265 patients in a Phase II trial (8/10)
ViroPharma Inc. (VPHM) and Wyeth PharmaceuticalsHCV-796An orally dosed non-nucleoside polymerase inhibitorHepatitis C virusCompanies discontinued dosing in a Phase II study after a safety board identified a potential association between HCV-796 and an elevation of the levels of serum transaminases (8/10)
MISCELLANEOUS
Altus Pharmaceuticals Inc. (ALTU)ALTU-237An orally delivered crystalline formulation of an oxalate-degrading enzymeHyperoxalurias and prevention of recurrent kidney stonesStarted a Phase I trial (8/14)
Akela Pharma Inc. (Canada; TSX:AKL)CGRPA 37 amino acid, natural neuropeptide produced in the lung in response to allergic stimuliAsthmaStarted a Phase IIb trial (8/27)
Ambrilia Biopharma Inc. (Canada; TSX:AMB)OctreotideProlonged-release formulation; octreotide acetate for injectable suspensionAcromegalyCompleted patient recruitment in a pivotal Phase III trial (8/28); data from the first clinical trial showed it normalizes the major marker for acromegaly, insulin-like growth factor-1, and suppresses high-growth hormone plasma levels (8/29)
Antares Pharma (AMEX:AIS)AnturolA transdermal oxybutynin ATD gelOveractive bladderStarted a pivotal trial of Anturol (8/23)
Ardana plc (UK; LSE:ARA)ARD-07Oral growth hormone secretagogueTo diagnose growth hormone deficiencyEnrolled the first patient in a Phase III trial (8/15)**
Biopartners Holdings AG* (Switzerland)ValtropinBiosimilar recombinant human growth hormoneGrowth hormone deficiency Phase III data showed it demonstrated equivalent safety and efficacy to the reference product (8/14)
Cobalis Corp. (OTC BB:CLSC)PreHistinCyanocobalamin; agent designed to modulate levels of IgE, reducing the over-production of histaminesModerate to moderately severe seasonal allergic rhinitisTop-line results from two Phase III trials showed very low symptom levels in both placebo and PreHistin-treated patient groups, leaving no room to demonstrate a meaningful effect (8/2); the trials did not achieve their primary endpoint (8/28)
CollaGenex Pharmaceuticals Inc. (CGPI)Col-118Topical formulation that incorporates a compound believes to reduce erythema by constricting enlarged blood vessels in facial tissueErythemaPhase II data demonstrated a highly statistically significant dose-response relationship in the reduction of erythema (8/28)
Kosan Biosciences Inc. (KOSN) and Pfizer Inc.PF-04548043Formerly KOS-2187; motilin receptor agonistGastroesopha-geal reflux diseaseStarted a Phase I trial (8/6)
Kiadis Pharma BV* (the Netherlands)RhitolA small-molecule drug designed to selectively accumulate in reactive immune cells and to eliminate those cells upon photo-activationSteroid-resistant or intolerant chronic graft-vs.-host diseaseEnrolled the last patient in its Phase I/II trial (8/29)**
Kythera Bio-pharmaceuticals Inc.*ATX-101Liposculpting agentTo reduce unwanted submental fatStarted a Phase II study (8/28)
MediciNova Inc. (MNOV)MN-221A selective beta2adrenergic receptor agonistPreterm laborA Phase Ib trial showed that target plasma concentrations were achieved with an intra-venous priming followed by maintenance infusion dosing paradigm (8/17)
MedImmune Inc. (LSE:MDI; unit of AstraZeneca plc; UK)MEDI-528Monoclonal antibody targeting interleukin-9Mild, persistent asthmaStarted a Phase IIa trial (8/1)
Opko Health Inc. (AMEX:OPK)BevasiranibsiRNA drugWet age-related macular degenerationFirst patient was dosed in a Phase III trial (8/30)
Palatin Technologies Inc. (AMEX:PTN)BremelanotideMelanocortin receptor agonistErectile dysfunctionThe FDA noted that the drug may raise blood pressure in certain patients, delaying the start of pivotal trials (8/30)
PDL BioPharma Inc. (PDLI)NuvionVisilizumab; humanized monoclonal antibodyUlcerative colitis Company discontinued development of the pivotal Phase III program due to insufficient efficacy and an inferior safety profile compared to intravenous steroids alone (8/29)
Pervasis Therapeutics Inc.*VascugelAn allogeneic cell therapy product that may restore natural repair and regeneration pathways in traumatized human vasculatureMaintenance of vascular patency arteriovenous access grafts and AV fistulae in dialysis patients with end-stage renal diseaseCompleted enrollment for its two Phase II trials (8/13)
Regeneron Pharmaceuticals Inc. (REGN) and Bayer HealthCare AG (Germany)VEGF Trap-EyeVEGF inhibitor that binds and blocks 1-to-2 orders of magnitudeWet age-related macular degenerationBegan a Phase III trial comparing it with Lucentis (8/3)
Unigene Laboratories Inc. (OTC BB:UGNE)CalcitoninOral calcitonin designed to deliver a more consistent dose while maintaining therapeutic blood levels of the peptide using Enteripep oral delivery technologyOsteoporosisStarted a study in the U.S. (8/2)
Urigen Pharmaceuticals Inc. (OTC BB:URGP)URG-101Intravesical lidocaine-heparin formulationPainful bladder syndrome/interstitial cystitisStarted a Phase II study (8/14)

Notes:
* Privately held.

BLA = Biologics license application; DMC = Data Monitoring Committee; 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; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; PK = Pink Sheets; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange.

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