| Company* (Country; Symbol) |
Product | Description | Indication | Status (Date) |
| AUTOIMMUNE | ||||
| NicOx SA (France; FSE:NXO) | Naproxcinod | COX-inhibiting nitric oxide-donating agent | Osteoarthritis | Completed enrollment of 1,020 patients in its pivotal Phase III study (12/14) |
| Rigel Pharmaceuticals Inc. (RIGL) | R788 | Tamatinib fosdium; an oral syk kinase inhibitor | Rheumatoid arthritis | Phase II data showed it achieved higher ACR criteria specified response rates than the placebo group when dosed at 100 mg and 150 mg orally twice daily (12/13) |
| ZymoGenetics Inc. (ZGEN) and Merck Serono (division of Merck KGaA; Germany) | Atacicept | Antagonist protein that binds to the TNF cytokines BLyS and APRIL | Lupus nephritis | Started a Phase II/III trial (12/13) |
| CANCER | ||||
| Adventrx Pharmaceuticals Inc. (AMEX:ANX) | ANX-510 | CoFactor; the active metabolite of leucovorin | Breast cancer | Completed enrollment of a targeted 32 patients in a Phase II trial of ANX-510 plus 5-fluorour-acil (12/5) |
| Allos Therapeutics Inc. (ALTH) | PDX | Pralatrexate | Peripheral T-cell lymphoma | An independent data monitoring committee completed the 65-patient safety review and recommended the trial continue (12/27) |
| Altor BioScience Corp.* | ALT-801 | A tumor-targeted immunotherapeutic | Metastatic cancer | Finished treating the first cohort of patients in a Phase I/IIa trial (12/20) |
| Amgen Inc. (AMGN) | Aranesp (FDA-approved) | Darbepoetin alfa | Breast cancer | Phase III data showed hemoglobin levels were above the range already specified on the Aranesp label; interim results seemed to affirm safety concerns (12/3) |
| Amgen Inc. (AMGN) | Denosumab | Human monoclonal antibody | Non-metastatic breast cancer | The first Phase III pivotal study showed a positive effect on bone mineral density across the skeleton in women (12/17) |
| Array BioPharma Inc. (ARRY) and AstraZeneca plc (UK) | AZD6244 (ARRY-886) | A MEK kinase inhibitor | Melanoma | Phase II data showed it failed to meet the primary endpoints (12/20) |
| AVAX Technologies Inc. (OTC BB: AVXT) | MVax | Autologous vaccine | Melanoma | Completed its Phase I/II dose-ranging trial (12/11) |
| BioCryst Pharmaceuticals Inc. (BCRX) | Fodosine | Forodesine HCl | T-cell acute lymphoblastic leukemia/lymphoma | Company is voluntarily discontinuing its Phase IIb study; it was placed on hold in March following a stability issue (12/6) |
| Chroma Therapeutics Ltd.* (UK) | CHR-2797 | Oral, once-daily experimental cancer therapy | Acute myeloid leukemia, myelo-dysplastic syndromes and multiple myeloma | Phase I data showed three of 13 AML patients had a complete response and one of two MM patients remained in stable disease; the drug was well tolerated (12/13) |
| Cougar Biotechnology Inc. (CGRB) | CB3304 | Noscapine; an oral inhibitor of microtubule dynamics | Relapsed or refractory multiple myeloma | Enrolled the first patient in a Phase I trial (12/21) |
| CuraGen Corp. (CRGN) and TopoTarget AS (Denmark; CSE:TOPO) | Belinostat | A small-molecule histone deacetylase inhibitor | Thymoma and Thymic carcinoma | Started dosing in a Phase II trial (12/19) |
| Cytokinetics Inc. (CYTK) | Ispinesib | Kinesin spindle protein inhibitor | Locally advanced or metastatic breast cancer | Started a Phase I/II trial (12/31) |
| Endo Pharmaceuticals Inc. (ENDP) | Rapinyl | Oral, fast-dissolving fentanyl formulation | Breakthrough cancer pain | Phase III data showed it met its primary endpoint of decreasing pain intensity within 30 minutes (12/17) |
| EntreMed Inc. (ENMD) | MKC-1 | A cell-cycle inhibitor | Advanced pancreatic cancer | Started a Phase II trial (12/4) |
| Ferring Pharmaceuticals* | Degarelix | Part of the GnRH-blocker class | Prostate cancer | Completed the pivotal Phase III study; it met its primary objective (12/3) |
| F. Hoffmann-La Roche Inc. | Xeloda | Capecitabine | HER2-positive breast cancer | Interim Phase II results suggested that the combination of Xeloda and Taxotere, with the addition of Herceptin, may be an active and well tolerated presurgical treatment option for women with invasive breast cancer (12/17) |
| Genentech Inc. (NYSE:DNA) and F. Hoffmann-La Roche Ltd.(Switzerland) | Avastin (FDA-approved) | Bevacizumab | Breast cancer | Phase II data suggested Avastin may have the potential to be used as a curative treatment following breast cancer surgery (12/10) |
| Genitope Corp. (GTOP) | MyVax | Recombinant product manufactured in mammalian cells | Follicular B-cell non-Hodgkin's lymphoma | It missed its primary endpoint in a pivotal Phase III trial, failing to improve progression-free survival compared to control (12/21) |
| Genmab A/S (Denmark; CSE:GEN) | HuMax-CD38 | Fully human IgG1 antibody that targets the CD38 molecule | Multiple myeloma | Started a Phase I/II study (12/7) |
| Genmab A/S (Denmark; CSE:GEN) | HuMax-CD20 | Ofatumumab | Diffuse large B-cell lymphoma | Initiated enrollment in a Phase II study (12/13) |
| Genmab A/S (Denmark; CSE: DEN) and F. Hoffmann-La Roche Ltd. (Switzerland) | R1507 | Monoclonal antibody | Recurrent or refractory sarcoma | Initiated a Phase II trial (12/20) |
| Genzyme Corp. (GENZ) | Clolar | Clofarabine | Acute myelogenous leukemia | Completed enrollment of a targeted 109 patients in a Phase II trial (12/5) |
| GlaxoSmithKline plc (UK) | Tykerb | Oral small-molecule HER2 (ErbB2) kinase inhibitor; lapatinib | HER2-positive breast cancer | In a study of 49 patients, the combination of Tykerb plus capecitabine showed a reduction in HER2-positive breast cancer that had spread to the brain and had progressed on Tykerb alone (12/17) |
| Idera Pharmaceuticals IDRA) | IMO-2055 | A novel agonist of Toll-like Receptor 9 | Non-small-cell lung cancer | First patient was dosed in a Phase Ib trial (12/13) |
| ImClone Systems Inc. (IMCL) | IMC-1121B | A fully human IgG1 vascular endothelial growth factor receptor-2 monoclonal antibody | Advanced malignant melanoma | Enrolled the first patient in a Phase II trial (12/13) |
| Medarex Inc. (MEDX) | MDX-010 | Ipilimumab; an antibody that binds to CTLA-4 | Advanced melanoma | Company plans to file a BLA next year despite missed primary end-points in three pivotal trials, including one conducted under an SPA with the FDA (12/11) |
| Metastatix Inc.* | MSX-122 | CXCR4 inhibitor | Advanced solid tumors | Started a Phase I trial (12/5) |
| Northwest Bio-therapeutics Inc. (OTC BB: NWBO) | DCVax-L | A personalized immuno-therapy for cancer that is made from a patient's own dendritic cells and antigens from the patient's own tumor tissue | Recurrent ovarian cancer | The first patients have been enrolled and have undergone initial treatment steps in a Phase I/II trial of DCVax-L (12/27) |
| Oncolytics Biotech Inc. (Canada; TSX:ONC; ONCY) | Reolysin | Formulation of the human reovirus | Advanced cancer | Completed patient enrollment in its Phase Ia/Ib trial (12/21) |
| OxiGene Inc. (OXGN) | Zybrestat | Combretastatin-A4 phosphate | Ovarian cancer | Achieved the pre-specified primary efficacy endpoint for the first stage of an ongoing Phase II ovarian cancer trial testing the drug in combination with carbo-platin and paclitaxel (12/31) |
| Peplin Inc. (ASX:PLI) | PEP005-007 | Topical agent designed to kill cancer cells and stimulate an immune response | Actinic keratosis | Phase IIa data established the maximum tolerated dose at 0.025% applied daily for two consecutive day dosing regimes (12/12) |
| Seattle Genetics Inc. (SGEN) | SGN-40 | A humanized monoclonal antibody that targets the CD40 antigen | Relapsed or refractory diffuse large B-cell lymphoma | Started a Phase IIb trial (12/7) |
| Serenex Inc.* | SNX-5422 | Heat shock protein 90 inhibitor | Hematologic malignancies | Began a second Phase I trial (12/4) |
| SuperGen Inc. (SUPG) | MP470 | Inhibits mutant forms of the kinases c-KIT, PDGFR and FLT3 | Cancer | Started a Phase Ib trial (12/17) |
| SymBio Pharmaceuticals* (Japan) | Bendamustine HCl | Anticancer drug | Non-Hodgkin's lymphoma | Began a Phase II study (12/7) |
| Trubion Pharmaceuticals Inc. (TRBN) and Wyeth Pharmaceuticals | TRU-015 | Small moedular immuno pharmaceutical drug candidate | Non-Hodgkin's lymphoma | Started a Phase I/II trial (12/11) |
| United Therapeutics Corp. (UTHR) | OvaRex MAb-B43.13 | Oregovomab | Ovarian cancer | Company ceased development after two pivotal trials failed to meet their endpoints (12/5) |
| Vion Pharmaceuticals Inc. (VION) | VNP40101M | Cloretazine | Hematolic malignancies | Started a Phase I trial in combination with hematopoietic cell transplant (12/4) |
| ZymoGeneticsInc. (ZGEN) | IL-21 | Interleukin 21 | Metastatic melanoma | Started treating patients in a Phase II study (12/18) |
| CARDIOVASCULAR | ||||
| Ablynx NV (Belgium; BR:ABLX) | ALX-0081 | An anti-thrombotic therapeutic | Thrombosis in patients with acute coronary syndrome | Phase I data showed it was safe and well tolerated (12/17) |
| Alexion Pharmaceuticals Inc. (ALXN) | Soliris | Eculizumab | Paroxysmal nocturnal hemoglobinuria | Phase III data showed the therapy reduced hemolysis and improved fatigue, overall quality of life and anemia (12/4) |
| Lipid Sciences Inc. (LIPD) | PDS-2 | Lipid's Selective Delipidation System | Acute coronary syndrome | Concluded patient enrollment in its first HDL therapy trial (12/19) |
| Pharmacopeia Inc. (PCOP) | PS433540 | A dual-acting angiotensin and endothelin receptor antagonist | Hypertension | Phase I data showed the drug produced statistically significant, dose-dependent increases in plasma-renin activity levels, as well as reductions in systolic and diastolic blood pressure (12/3) |
| Portola Pharmaceuticals Inc.* | PRT060128 | An antiplatelet compound that is the only reversible I.V. and oral ADP receptor antagonist in development | ST-segment elevation myocardial infarction | Began a Phase II trial (12/4) |
| The Medicines Co. Inc. (MDCO) | Angiomax | Bivalirudin | Acute coronary syndrome | One-year results of its ACUITY trialshowed that acute coronary syndrome patients treated with Angiomax alone had similar rates of ischemic clinical outcomes compared with a more complicated treatment regimen of heparin plus a glycoprotein IIb/IIIa inhibitor (12/5) |
| Theravance Inc. (THRX) and GlaxoSmithKline plc (UK) | GSK1160724 | An inhaled, long-acting muscarinic antagonist | Chronic obstructive pulmonary disease | Initiated subject screening in a Phase I study (12/13) |
| YM BioSciences Inc. (Canada; AMEX:YMI) | Nimotuzumab | A monoclonal antibody targeting the epidermal growth factor receptor | Colorectal cancer | Completed accrual in the first 50-patient cohort of its Phase II trial of nimotuzumab in combination with irinotecan (12/20) |
| CENTRAL NERVOUS SYSTEM | ||||
| Acadia Pharmaceuticals Inc. (ACAD) | ACP-104 | N-desmethylclozapine | Schizophrenia | Completed enrollment of its Phase IIb trial (12/14) |
| Alexza PharmaceuticalsInc. (ALXA) | AZ-104 | Staccato loxapine | Migraine headache | Completed its target patient enrollment in a Phase IIa trial (12/18) |
| Allon Therapeutics Inc. (Canada; TSX:NPC) | AL-108 | Amnestic mild cognitive impairment
|
Completed patient dosing for its Phase II trial (12/18) | |
| Alseres Pharmaceuticals Inc. (ALSE) | Altropane | A diagnostic molecular imaging agent | To differentiate Parkinsonian syndromes from non-Parkinsonian tremor | Enrolled the first subject in the initial stage of its POET-2 study (12/18) |
| Arena Pharmaceuticals Inc. (ARNA) | Lorcaserin hydrochloride | Obesity | Began patient screening in the second and third Phase III trials (12/13) | |
| Avicena Group Inc. | AL-08 | A second-generation drug | Amyotrophic lateral sclerosis | Phase II data showed that those taking the AL-08/celecoxib (OTC BB:AVGO) showed a smaller mean decline in ALS-Functional Score compared to those taking the AL08/mino-cycline combination (12/3) |
| BioMS Medical Corp. (Canada; TSX:MS) | MBP8298 | A synthetic peptide | Secondary progressive multiple sclerosis | Independent data safety monitoring board has reviewed data from the ongoing U.S. pivotal Phase III trial and recommended it continue (12/12) |
| Catalyst Pharmaceutical Partners Inc.(CPRX) | CPP-109 | A bioequivalent to vigabatrin | Cocaine addiction | Phase II data showed it was effective (12/7) |
| Ceregene Inc.* | CERE-120 | A gene therapy product consisting of an adeno-associated virus vector carrying the gene for neurturin | Parkinson's disease | Phase I data suggest sustained reduction in symptoms at 18 months and 24 months post-treatment (12/12) |
| Clinical Data Inc. (CLDA) | Vilazodone | Acts as a selective serotonin reuptake inhibitor and a 5-HTIA partial agonist | Depression | Started a long-term safety study (12/17) |
| Collegium Pharmaceuticals Inc.* | COL-003 | Abuse-deterrent, sustained-release, oral oxycodone formulation | Pain | Reported positive study results from its proof-of-concept trial (12/20) |
| CytRx Corp. (CYTR) | Arimoclomol | Small molecule designed to protect cells by activating molecular chaperone proteins | Amyotrophic lateral sclerosis | Started screening volunteers for its Phase IIb trial (12/20) |
| Durect Corp. (DRRX) | Eladur | A bupivacaine transdermal pain patch | Pain | Phase IIa data showed improved pain control vs. placebo during three days of continuous treatment (12/18) |
| Dynogen Pharmaceuticals Inc.* | DDP225 | An oral noradrenaline reuptake inhibitor and a weak 5HT3 receptor antagonist | To relieve pain or discomfort in patients with irritable bowel syndrome with diarrhea | Achieved a 71% response rate compared with a 25% response rate for placebo in a Phase II trial (12/17) |
| Elan Corp. (Ireland; NYSE:ELN) and Wyeth Pharmaceuticals | AAB-001 | Bapineuzumab | Mild to moderate Alzheimer's disease | Dosed the first patient in a global Phase III program (12/26) |
| EpiCept Corp. (EPCT) | EpiCept NP-1 cream | A topical formulation of two FDA-approved drugs, 4% amitriptyline and 2% ketamine | Pain | Completed patient enrollment in its Phase IIb trial (12/3) |
| EPIX Pharmaceuticals Inc. (EPIX) | PRX-03140 | 5-HT4 agonist | Alzheimer's disease | Phase IIa data showed it helped improve cognitive function and memory after only two weeks of use (12/18) |
| Intra-Cellular Therapies Inc.* | ITI-722 | Acts predominantly as a selective 5-HT2A receptor antagonist | Insomnia | Started a sleep maintenance insomnia Phase II trial (12/20) |
| Javelin Pharmaceuticals Inc. (AMEX:JAV) | PMI-150 | Intranasal ketamine | Acute post-operative pain associated with molar extraction | Phase II data showed the drug demonstrated a rapid onset of pain relief, generally mild and transient adverse events and had no changes in vital signs, oxygen saturation or the nasal mucosa and no significant dis-associative psychological effects (12/19) |
| Kalypsys Inc.* | KD7040 | Topical gel, an inducible nitric oxide synthase inhibitor | Postherpetic neuralgia | Started a Phase IIa trial (12/18) |
| Knopp Neurosciences Inc.* (Canada) | KNS-760704 | An oral, small molecule | Amyotrophic lateral sclerosis | Phase I data showed the drug was safe and well tolerated in single oral doses up to 300 mg (12/3) |
| Memory Pharmaceuticals Corp. (MEMY) | MEM 3454 | A nicotinic alpha-7 receptor partial agonist | Cognitive impairment associated with schizophrenia | Dosed the first subject in a Phase IIa trial (12/21) |
| Neuro-Hitech Inc. (NHPI) | Huperzine A | A naturally occurring alkaloid compound derived from the club moss Huperzia serrata; it is designed as a reverse inhibitor of acetylcholinesterase | Mild to moderate Alzheimer's disease | Company completed the double-blind part of its Phase II trial (12/14) |
| Orexigen Therapeutics Inc. (OREX) | Contrave | A fixed-dose combination of sustained-release bupropion and Orexigen's sustained-release naltrexone | Obesity | Started the fourth trial in its Phase III program (12/12) |
| Oxford BioMedica (UK; LSE:OXB) | ProSavin | Gene-based treatment | Parkinson's disease | Started a Phase I/II trial (12/13) |
| Pain Therapeutics Inc. (PTIE) | Remoxy | An abuse-deterrent version f long-acting oxycodone | Pain | Achieved its primary endpoint in a second Phase III trial (12/6) |
| Phosphagenics Ltd. (Australia; FSE:OEZ) | TPM | Delivery technology for oxycodone | Pain | Phase I data showed it delivered pain relief drug oxycodone through the skin without causing disruption or irritation of any kind (12/17) |
| Plethora Solutions Holdings plc (UK; LSE:PLE) | PSD508 | A nonsteroidal anti-inflammatory administered intravaginally | Menstrual pain | First patients have been recruited into a Phase IIb study (12/6) |
| Prana Biotechnology Ltd. (Australia; PRAN) | PBT2 | Selected from the company's library of Metal Protein Attenuating Compounds | Alzheimer's disease | Completed final patient dosing in its Phase IIa trial (12/18) |
| QRxPharma Pty. Ltd. (Australia; PK:QRXPF) | Q80031R | An immediate-release dual-opioid pain therapy | Moderate to severe pain | Started its second Phase III trial (12/14) |
| Targacept Inc. (TRGT) | TC-2696 | A small-molecule modulator of the alpha4beta2 NNR | Pain relief after third molar extraction surgery | It failed to outperform placebo in a Phase II trial (12/3) |
| Targacept Inc. (TRGT) | TC-6499 | A small molecule | Neuropathic pain | Started a Phase I trial (12/10) |
| Titan Pharmaceuticals Inc. (AMEX:TTP) and Vanda Pharmaceuticals Inc. (VNDA) | Iloperidone | Atypical antipsychotic | Schizophrenia | Data from four Phase III trials demonstrated that iloperidone is associated with significantly greater improvements in the symptoms of schizophrenia vs.placebo and has a favorable safety and tolerability profile (12/13) |
| TorreyPines Therapeutics Inc. (TPTX) | NGX426 | Oral prodrug of texampanel | Acute migraine | Phase I data showed the area under the curve of a single, 80-mg dose of NGX426 is comparable to the AUC of a single, 40-mg subcutaneous dose of tezam-panel (12/10) |
| Transition Therapeutics Inc. (TTHI) and Elan Corp. plc (Ireland; NYSE:ELN) | ELND005 (AZD-103) |
Scyllo-cyclohexanehexol; oral agent that acts on beta amyloid | Alzheimer's disease | Dosed the first patient in a Phase II study (12/26) |
| DIABETES | ||||
| Adolor Corp. (ADLR) | ADL5859 | Delta opioid agonist | Pain associated with diabetic peripheral neuropathy | Started its third Phase IIa trial (12/14) |
| Amylin Pharmaceuticals Inc. (AMLN) | Byetta | Exenatide injection | Type II diabetes | Patients taking 5 mcg or 10 mcg of monotherapy Byetta twice daily showed significant reductions in A1C by 0.7 percentage points and 0.9 percentage points from an average baseline A1C ranging from 7.8% to 7.9% (12/6) |
| AtheroGenics Inc. (AGIX) | AGI-1067 | An oral anti-inflammatory antioxidant agent | Type II diabetes | Completed enrollment of its Phase III ANDES trial (12/18) |
| Innocoll Inc.* | CollaRx Gentamicin Topical | A biodegradable and fully resorbable gentamicin-collagen sponge formulated and manufactured using Innocoll's collagen-based drug delivery technology, CollaRx | Diabetic foot ulcers | Started dosing patients in the first of its three planned Phase II trials (12/18) |
| Karo Bio AB (Sweden; SSE: KARO) | KB3305 | A liver-targeted gluco-corticoid antagonist designed to suppress hepatic glucose production | Diabetes | Entered Phase I development (12/4) |
| Oculus Innovative Sciences Inc. (OCLS) | Microcyn | Oxychlorine solution | Diabetic foot ulcers | Completed enrollment of a targeted 67 patients in its Phase II trial (12/5) |
| Sangamo BioSciences Inc. (SGMO) | SB-509 | A ZFP therapeutic | Diabetic neuropathy | Completed enrollment of its Phase II trial (12/4) |
| Speedel Holding AG (Switzerland; PK:SPDHF) | SPP635 | A next-generation renin inhibitor | Hypertension in diabetic patients | Began a Phase IIa trial (12/10) |
| INFECTION | ||||
| Alnylam Pharmaceuticals Inc. (ALNY) | ALN-RSV01 | Antiviral drug delivered via inhalation | RSV infection | Phase I data showed all major objectives were met and a safe and well tolerated dose and regimen was defined (12/13) |
| Arpida Ltd. (Switzerland; SWX:ARPN) | Iclaprim | Antibiotic; an intravenous new member of the diam-ino-pyrimidine class | Hospital-acquired pneumonia, ventilator-associated pneumonia and health-care associated pneumonia | Started a Phase II trial (12/11) |
| BTG (UK; LSE:BGC) | BGC20-0582 | Gel-based formulation for use as a topical treatment; non-pesticidal and derived from a natural source | Head lice infestation | Completed patient enrollment and treatment in its U.S.-based Phase II trial (12/13) |
| Crucell NV (the Netherlands) and Aeras Global TB Vaccine Foundation | AdVac-based tuberculosis vaccine | Tuberculosis | Started a Phase I trial (12/21) | |
| Epiphany Biosciences* | EPB-348 | Valomaciclovir | Acute infectious mononucleosis | Began a Phase II trial (12/7) |
| Gilead Sciences Inc. (GILD) and Bristol-Myers Squibb Co. | Atripla | Efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate | HIV-1 infection | European Commission granted marketing approval (12/17) |
| GlobeImmune Inc.* | GI-5005 Tarmogen | A whole, heat-killed recombinant yeast genetically modified to express HCV-specific protein targets | Chronic hepatitis C infection | Started a Phase II trial (12/19) |
| Immtech Pharmaceuticals Inc. (AMEX:IMM) | Pafuramidine | An aromatic cationic compound that binds to segments of DNA to block enzymes that enable microbial growth | Trypanosomiasis and Pneumocystis carinii pneumonia | Phase III compound was placed on clinical hold after abnormal liver function was found in several subjects in a 100-volunteer South African safety trial (12/26) |
| Inhibitex Inc. (INHX) | FV-100 | A nucleoside analogue | Shingles | Completed its initial Phase I trial and results showed no serious adverse events; the compound appeared to be generally well tolerated (12/14) |
| InSite Vision Inc. (AMEX:ISV) | AzaSite (FDA-approved) | Azithromycin ophthalmic solution 1% | Conjunctivitis | Filed a new drug submission with Health Canada (12/3) |
| Migenix Inc. (TSX:MGI) | Celgosivir | An oral apha glucosidase I inhibitor | Hepatitis C virus | Four-week interim results from a Phase II trial indicated that it has no negative effects on the tolerability, pharmacokinetics and viral kinetics when combined with the standard-of-care drugs (12/3) |
| Novavax Inc. (NVAX) | H5N1 VLP vaccine | Non-adjuvanted pandemic influenza virus-like particle vaccine candidate | Influenza | Phase I/IIa results showed it was well tolerated in all study groups (12/20) |
| Panacos Pharmaceuticals Inc. (PANC) | Bevirimat | HIV maturation inhibitor | HIV | Phase IIb data showed a lower mean viral load reduction and fewer responders with the 350-mg solution compared to the 300-mg dose previously tested (12/11) |
| Phynova Group plc (UK; LSE:PYN) | PYN17 | Contains extracts of four plants that reduce liver inflammation, improve hepatic function and stimulate the immune system | Chronic hepatitis | Phase I/II data showed it was well tolerated, with a low level of relatively minor adverse events (12/3) |
| Sinovac Biotech Ltd. (China; AMEX:SVA) | Pandemic influenza (H5N1) whole viron inactivated vaccine | Influenza | Phase II data suggested that the 5 mcg, 10 mcg or 15 mcg doses could induce varying degrees of immune response (12/26) | |
| Theratechnologies (Canada; TSX:TH) | TH9507 | Tesamorelin | HIV patients with lipo-dystrophy | Phase III data showed it improves excess visceral fat (12/6) |
| Theravance Inc. (THRX) | Telavancin | An injectable antibiotic; lipoglycopeptide | Hospital-acquired pneumonia | Achieved its endpoint in a second pivotal program; it demonstrated noninferiority to vancomycin (12/6) |
| VGX Pharmaceuticals Inc.* | Cellectra | Vaccine delivery device | To deliver vaccines for HIV, cervical cancer and other diseases | Company completed its first study showing patients had a moderate level of short-lived discomfort during the procedure (12/27) |
| MISCELLANEOUS | ||||
| Amicus Therapeutics Inc. (FOLD) | Amigal | Migalastat hydrochloride | Fabry disease | Phase II data showed that Amigal produced an increase in alpha-galactosidase A enzyme in 24 of 26 patients (12/20) |
| Astion Pharma AS* (Denmark) | ASF-1057 | Glycerol monocaprylate formulated in a base cream containing the excipient nicotinamide | Seborrheic dermatitis | Started enrolling patients for three pivotal Phase III studies (12/10) |
| Auxilium Pharmaceuticals Inc. (AUXL) | Xiaflex | Clostridial collagenase for injection | Dupuytren's contracture | Completed patient enrollment in its second U.S. Phase III pivotal trial and its Australian Phase III study (12/17) |
| AVI BioPharma Inc. (AVII) | AVI-4658 | Based on the company's Exon Skipping Pre-RNA Interference Technology drug platform | Duchenne's muscular dystrophy | Dosed the first patient in a proof-of-concept trial (12/26) |
| Celtic Pharmaceutical Holdings LP* | Xerecept | Corticorelin acetate injection | Peritumoral brain edema | Interim results of an extension trial showed that 20 of the first 32 patients enrolled received the drug daily for at least 20 weeks and it was well tolerated (12/4) |
| Conatus Pharmaceuticals Inc.* | CTS-1027 | Designed to inhibit the activity of matrix metalloproteinases | Liver disease | Started a trial of CTS-1027 in 100 patients who have failed approved standard-of-care treatments (12/20) |
| Corcept Therapeutics Inc. (CORT) | Corlux | Cortisol receptor antagonist | Endogenous Cushing's syndrome | Started a Phase III trial (12/19) |
| Genzyme Corp. (GENZ) | Myozyme | Alglucosidase alfa | Pompe disease | Its Late Onset Treatment Study met its co-primary efficacy end-points (12/13) |
| InSite Vision Inc. (AMEX:ISV) | AzaSite Plus | Formulated in InSite's DuraSite sustained delivery vehicle; designed as a topical combination antibiotic/corticosteroid product | Blepharo conjunctivitis | Started pivotal Phase III trials (12/20) |
| Javelin Pharmaceuticals Inc. (AMEX:JAV) | Dyloject | Diclofenac sodium solution for injection | For use in orthopedic surgery | Met its primary and secondary endpoints in the first of two pivotal studies (12/14) |
| LifeCycle Pharma A/S* (Denmark) | LCP-Tacro | An immunosuppressant to prevent organ rejection | To prevent organ rejection in liver transplant recipients | Started a Phase II trial (12/3) |
| Nventa Bio-pharmaceuticals Corp. (TSX:NVN) | HspE7 | A therapeutic vaccine targeting human papilloma-virus-related diseases | Cervical dysplasia | Completed enrollment and initiated dosing of the second cohort of patients in its Phase I trial (12/6) |
| Rigel Pharmaceuticals Inc. (RIGL) and Pfizer Inc. | R343 | Inhaled formulation of a small-molecule syk kinase inhibitor | Allergic asthma | Began a Phase I trial (12/6) |
| Savient Pharmaceuticals Inc. (SVNT) | Puricase | Pegloticase | Treatment-failure gout | The compound met its primary endpoints in two Phase III trials (12/13) |
| ThromboGenics NV (Belgium; BR:THR) | Microplasmin | A truncated form of the natural human protein plasmin | Vitreomacular traction | Phase II data showed positive results; it was safe and welltolerated (12/4) |
| Titan Pharmaceuticals Inc. (AMEX:TTP) | Probuphine | Product designed to continuously deliver the approved drug buprenorphine | Opioid dependence | Completed enrollment early in a Phase III trial with 150 patients (12/3) |
|
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; BR = Brussels Stock Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; PK = Pink Sheets; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange. | ||||
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