| Company* (Country; Symbol) | Product | Description | Indication | Status (Date) |
| AUTOIMMUNE | ||||
| Alpharma Inc. (NYSE:ALO) | ALO-01 | An extended-release morphine sulfate plus sequestered naltrexone | Osteoarthritis | Phase II data showed it provided similar effectiveness to Kadian capsules in osteoarthritis patients with moderate to severe chronic pain (10/15) |
| Can-Fite BioPharma Ltd. (Israel; TEL:CFBI) | CF101 | Agent that targets the A3 adenosine receptor | Rheumatoid arthritis | Phase IIb showed no difference with placebo in the ACR20 response endpoint, but there was a substantial difference in the ACR 50, ACR 70 and the EULAR (10/23) |
| Centocor Inc. (unit of Johnson & Johnson) | CNTO 1275 | Ustekinumab | Plaque psoriais | Phase III data showed that more than two-thirds of patients receiving two doses achieved at least a 75% reduction in psoriasis at week 12 (10/3) |
| CombinatoRx Inc. (CRXX) | CRx-102 | Dipyridamole and prednisolone | Hand osteoarthritis | Phase IIa data showed it is effective at reducing pain (10/26) |
| Cutanea Life Sciences* | Omiganan | Topical gel | Papulopustular rosacea | Phase II data showed the formulation was safe and well tolerated at all doses tested (10/17) |
| Manhattan Pharmaceuticals Inc. (AMEX:MHA) | PTH (1-34) | Topical treatment | Psoriasis | The first patient has received the initial dose in the Phase IIa study (10/31) |
| Ocera Therapeutics Inc.* | AST-120 | Oral spherical adsorptive carbon | Crohn's disease | Completed patient enrollment (10/8) |
| CANCER | ||||
| Access Pharmaceuticals (OTC BB:ACCP) | ProLindac | A DACH platinum prodrug | Ovarian cancer | Phase II data showed there was a reduction of the CAL25 biomarker in five of the six patients receiving the higher dose once every three weeks (10/24) |
| Active Biotech AB (Sweden; SSE:ACTI) | Anyara | Antibody linked to a toxin designed to stimulate immune system to target and kill cancer cells | Non-small-cell lung cancer | Phase I data of Anyara in combination with Taxotere showed it was safe (10/24) |
| Advanced Viral Research Corp. (ADVR) | AVR118 | Topically applied spray formulation | Recurrent or advanced malignancies | Enrolled the first patient in a Phase II open-label study (10/3) |
| Advaxis Inc. (OTC BB:ADXS) | Lovaxin C | Listeria vaccine | Cancers that result from human papillomavirus | Clinical data showed it was safe to administer intravenously (10/9) |
| Adventrx Pharmaceuticals Inc. (AMEX:ANX) | CoFactor | ANX-510; active metabolite of leucovorin | Metastatic colorectal cancer | Missed its primary endpoint of reducing serious hematological or gastrointestinal adverse events associated with 5-fluorouracil in a Phase IIb (10/1) |
| Adventrx Pharmaceuticals Inc. (AMEX:ANX) | ANX-530 | Novel, emulsion formulation of vinorelbine tartrate | Non-small-cell lung cancer | Completed patient enrollment in a crossover comparison study of ANX-530 and Navelbine (10/10) |
| Aegera Therapeutics* (Canada) | AEG35156 | Second generation anti-sense therapeutic targeting the X-linked inhibitor of apoptosis | Acute myeloid leukemia, pancreatic cancer, breast cancer and non-small-cell lung cancer | Company started a Phase II in AML and three Phase I/II trials in the other three indications (10/2) |
| Antigenics Inc. (AGEN) | Oncophage | Vitespen | Recurrent glioma | Started a Phase II trial (10/10) |
| Antisoma plc (UK; LSE:ASM) | ASA404 | Small-molecule vascular disrupting agent designed to target blood vessels that nourish tumors | Hormone-refractory prostate cancer | Phase II data showed PSA response rates were markedly higher in patients receiving ASA404 (10/15) |
| ArQule Inc. (ARQL) | ARQ 197 | An orally administered, small molecule inhibitor of the c-Met receptor tyrosine kinase | MiT tumors and pancreatic cancer | Began two Phase II trials (10/31) |
| BioCryst Pharmaceuticals Inc. (BCRX) | Forodesine HCL | Blocks an enzyme called purine nucleoside phosphorylase | Cutanenous T-cell lymphoma | Started enrollment in a pivotal trial (10/12) |
| Biothera* | Imprime PGG | A biological response modifier that enhances innate immune cell responses without inducing pro-inflammatory cytokines | Metastatic colorectal cancer | Initiated enrollment of patients in a Phase Ib/IIa trial evaluating it with Erbitux (10/9) |
| Cell Therapeutics Inc. (CTIC) | Brostallicin | A synthetic, second-generation DNA minor groove binder | Advanced solid tumors | Enrolled the first patient in a Phase Ib trial (10/18) |
| Cephalon Inc. (CEPH) | Treanda | Bendamustine | Non-Hodgkin's lymphoma | Met its endpoint in a pivotal trial (10/24) |
| ChemGenex Pharmaceuticals Ltd. (Australia; CXSP) | Ceflatonin | Omacetaxine mepesuccinate | Chronic myeloid leukemia | Phase II/III data suggested the drug could benefit patients with T3151 point mutations (10/1) |
| Chemokine Therapeutics Corp. (Canada; TSX:CTI; OTC BB:CHKT) | CTCE-9908 | Chemokine CXCR4 antagonist | Late-stage cancer | Completed recruitment of its Phase I/II study (10/2) |
| Cougar Biotechnology Inc. (OTC BB:CGRB) | CB7630 | Abiraterone acetate | Prostate cancer | Of 44 patients in a Phase I/II trial, 61% experienced a confirmed decline in prostate specific antigen levels of greater than 50% and 25% experienced PSA declines of greater than 90%; it also was well tolerated in a Phase II trial in 28 patients who had failed docetaxel-based chemotherapy (10/12) |
| CuraGen Corp. (CRGN) | Velafermin | Growth factor that promotes both epithelial and mesenchymal cell proliferation | Severe oral mucositis | Failed to meet the primary end-point in a Phase II trial, but was safe and well tolerated (10/11) |
| Curis Inc. (CRIS) and Genentech Inc. (NYSE:DNA) | Systemic hedgehog antagonist | Locally advanced or metastatic cancers | Started an expansion cohort in its ongoing Phase I trial (10/16) | |
| Dendreon Corp. (DNDN) | Provenge | Sipuleucel-T | Advanced prostate cancer | Completed enrollment of more than 500 patients in the Phase III IMPACT trial (10/23) |
| Diatos SA* (France) | DTS-201 | Doxorubicin prodrug | Cancer | Phase I data showed it was well tolerated and resulted in clinical benefit for 40% of the 25 cancer patients (10/22) |
| EntreMed Inc. (ENMD) | Panzem NCD | 2-methoxyestradiol | Platinum-refractory epithelial ovarian cancer | Phase II data showed one patient had a partial response of their CA-125, and five of the 18 patients enrolled achieved stable disease (10/24) |
| Enzon Pharmaceuticals Inc.(ENZN) | EZN-2968 | An HIF-1 alpha antagonist | Advanced solid tumors or lymphoma | Started a Phase I trial (10/30) |
| EpiCept Corp. (EPCT) | EPC2407 | A small-molecule vascular disruption agent and apoptosis inducer | Advanced solid tumors and lymphomas | Completed a Phase I trial and identified the maximum tolerated dose (10/8) |
| Exelixis Inc. (EXEL) | XL184 | An inhibitor of MET, RET and VEGFR kinases | Advanced solid tumors or lymphoma | Phase I data showed antitumor activity at doses not associated with significant toxicity (10/24) |
| Genmab A/S (Denmark; CSE:GEN) | R1507 | Monoclonal antibody | Solid tumors | Phase I data showed nine of 34 patients had disease stabilization (10/24) |
| GenVec Inc. (GNVC) | TNFerade | Endoscopic ultrasound administration of an adenovector containing the gene for tumor necrosis factor-alpha | Locally advanced rectal cancer | Phase II data showed the treatment was feasible and well tolerated (10/31) |
| GPC Biotech AG (Germany; GPCB), Pharmion Corp. (PHRM) and Spectrum Pharmaceuticals Inc. (SPPI) | Satraplatin | Oral platinum compound | Hormone-refractory prostate cancer | Phase III data showed it missed its overall survival endpoint, coming in slightly below the control arm (10/31) |
| Hana Biosciences Inc. (HNAB) | Alocrest | Vinorelbine tartrate injection | Cancer | Interim Phase I data demonstrated antitumor activity (10/23) |
| Human Genome Sciences Inc. (HGSI) | HGS-ETR2 | Lexatumumab | Cancer | Phase Ib trial showed the drug was safe and well tolerated in combination with four different standard chemotherapy regimens (10/24) |
| ImmunoGen Inc. (IMGN) and Sanofi-Aventis (France) | SAR3419 | TAP compound | Non-Hodgkin's lymphoma and other B-cell malignancies | Entered Phase I testing (10/17) |
| Jennerex Bio-therapeutics* | JX-594 | Targeted lytic and immuno-stimulatory armed virus therapy | Treatment-refractory liver tumors | Phase I/II data demonstrated efficacy in 10 of the 13 evaluable patients (10/24) |
| Kosan Biosciences Inc. (KOSN) | KOS-1584/R1645 | An epothilone | Solid tumors | Phase I data demonstrated anti-tumor activity and tolerability (10/24) |
| Molecular Insight Pharmaceuticals Inc. (MIPI) | Azedra | Ultratrace iobenguane I 131, or Ultratrace MIBG | Cancer | Phase I data showed it was safe (10/18) |
| Micromet Inc. (MITI) | Adecatu-mumab | Human antibody targeting the epithelial adhesion molecule Ep-AM | Breast cancer | Phase II data showed preferential activity of adecatumumab on inhibiting the formation of new metastases (10/23) |
| Novacea Inc. (NOVC) | Asentar | DN-101; oral, intermittent, high-dose of calcitriol designed to activate the vitamin D receptor | Advanced pancreatic adenocarcinoma | Started a Phase II trial (10/11) |
| Novacea Inc. (NOVC) | AQ4N | Banoxantrone | Acute lymphoblastic leukemia | Started a Phase II trial (10/12) |
| OxiGene Inc. (OXGN) | Zybrestat | Combretastatin-A4 phosphate/CA4P | Advanced solid tumors | Phase Ib study showed it was safe and well tolerated (10/5) |
| Pharmion Corp. (PHRM) and MethylGene Inc. (Canada; TSX:MYG) | MGCD0103 | An isotype-selective histone deacetylase inhibitor | Solid tumors | Started a Phase I trial (10/10) |
| Pharmion Corp. (PHRM) | Amrubicin | A third-generation anthracycline | Small-cell lung cancer | Started a 480-patient pivotal trial (10/17) |
| Pro-Pharmaceuticals Inc. (AMEX:PRW) | Davant | Carbohydrate compound that targets sugar-specific binding sites on cancer cells | Colorectal cancer | Three of seven evaluable patients in its Phase II trial have experienced tumor shrinkage of greater than 30% (10/11) |
| Proteolix Inc.* and South Texas Accelerated Research Therapeutics* | Carfilzomib | A novel proteasome inhibitor | Recurrent or advanced solid tumors | Began enrollment in a Phase I trial (10/10) |
| Sunesis Pharmaceuticals Inc. (SNSS) | SNS-595 | Cell-cycle inhibitor | Ovarian cancer | Phase II data demonstrated anti-tumor activity with 88% of patients achieving stable disease or better (10/26) |
| Tapestry Pharmaceuticals Inc. (TPPH) | TPI 287 | A next-generation taxane | Pancreatic cancer | Started a Phase II study (10/3) |
| Threshold Pharmaceuticals Inc. (THLD) | Glufosfamide | Small molecule targeting abnormal glucose metabolism | Small-cell lung cancer | Stopped enrollment in a Phase II trial (10/12) |
| VioQuest Pharmaceuticals (OTC BB:VQPH) | Lenocta | Sodium stibogluconate; Inhibitor of SHP-1 and SHP-2 | Solid tumors | Completed enrollment in its Phase I trial (10/10) |
| ViRexx Medical Corp. (Canada; AMEX:REX) | OvaRex MAb | Monoclonal antibody | Stage III or Stage IV ovarian cancer | Both Phase III trials have reached the 118th relapse event (10/16) |
| WEX Pharmaceuticals Inc. (Canada; TSX:WXI) | Tectin | Tetrodotoxin; non-narcotic agent | Cancer pain | Data showed it did not hit its pain intensity difference end-point, but using a composite endpoint, the number of responders was significantly greater than with placebo (10/3) |
| Xanthus Pharmaceuticals Inc.* | Xanafide | Amonafide malate | Secondary acute myeloid leukemia | Started patient dosing in a pivotal Phase III trial (10/9) |
| ZymoGenetics Inc. (ZGEN) | IL-21 | Interleukin 21 | Renal-cell cancer | Phase I data of IL-21 in combination with Nexavar showed it is well tolerated (10/23) |
| CARDIOVASCULAR | ||||
| Anthera Pharmaceuticals Inc.* | A-002 | An inhibitor of secretory phospholipase A2 | Stable coronary artery disease | Completed enrollment and patient dosing in its Phase II study of A-002 (10/3) |
| Anthera Pharmaceuticals Inc.* | A-002 | Inhibits upstream steps in the inflammation cascade | To reduce cholesterol | Phase II data showed it resulted in significant reductions in blood levels of total cholesterol and of C-reactive protein (10/24) |
| Critical Therapeutics (CRTX) | Zyflo (FDA-approved) | Zileuton tablets | Chronic obstructive pulmonary disease | Began patient enrollment in a Phase III trial (10/15) |
| DeCODE genetics (Iceland; DCGN) | DG051 | Leukotriene A4 hydrolase inhibitor | To prevent heart attacks | Started enrolling patients for its Phase IIa clinical trial (10/9) |
| Gilead Sciences Inc. (GILD) | Ambrisentan | An endothelin receptor antagonist | Pulmonary arterial hypertension | Phase III data showed that 95% of patients were still alive at one year of treatment (10/24) |
| Isis Pharmaceuticals Inc. (ISIS) | ISIS 301012 | Second-generation antisense drug designed to inhibit apoE-100 | Heterozygous familial hyper-cholesterolemia | Phase II data showed it produced potent, dose-dependent, prolonged reductions in all atherogenic lipids (10/4) |
| Momenta Pharmaceuticals Inc. (MNTA) | M118 | Rationally engineered anticoagulant | Stable coronary artery disease | Treated the first patient in a Phase II study (10/11) |
| Nile Therapeutics Inc.* | CD-NP | A selective NPR-B agonist | Heart failure | Phase Ia data showed it can be safely administered and elicits pharmacological and clinical effects consistent with the proposed mechanism of action (10/11) |
| Omrix Biopharmaceuticals Inc. (OMRI) | Fibrin Patch | Contains biologics that form an instant clot when they come into contact with blood | To control bleeding | Phase I data showed the product was safe as an adjunct to hemostasis (10/17) |
| Surface Logix Inc.* | SLx-4090 | A first-in-class enterocyte-specific microsomal triglyceride transfer protein inhibitor | Dyslipidemia | Phase I data showed it significantly decreased plasma levels of both triglyceride and LDL-cholesterol compared with placebo (10/5) |
| The Medicines Co. (MDCO) | Cleviprex | Clevidipine butyrate injectable emulsion | Hypertension | Clinical data showed it reduced blood pressure and maintained blood pressure control (10/24) |
| CENTRAL NERVOUS SYSTEM | ||||
| Addex Pharmaceuticals Ltd. (Switzerland; SWX:ADXN) | ADX10061 | An orthosteric dopamine D1 receptor antagonist | Smoking cessation | Did not meet the primary end-point in a Phase IIa trial (10/1) |
| Adolor Corp. (ADLR) | ADL5859 | A delta opioid agonist | Pain | Started a second Phase II trial (10/18) |
| Affectis Pharmaceuticals AG* (Germany) | Cimicoxib | A selective Cox-2 inhibitor | Depression | Started a Phase II trial (10/15) |
| Allon Therapeutics Inc. (Canada; TSX:NPC) | AL-108 | An intranasally formulated eight amino acid neuro-protective-based on NAP | Alzheimer's disease | Completed enrollment in its Phase II trial (10/2) |
| Anesiva Inc. (ANSV) | Zingo | Lidocaine hydrochloride monohydrate via powder intradermal injection | Pain associated with venous procedures | Phase III data indicated Zingo reduced the pain in adult patients (10/16) |
| Avicena Group Inc. (OTC BB:AVGO) | AL-02 | A drug in development for ALS | Amyotrophic lateral sclerosis | Pooled analysis from three trials showed an increase of 1.47-fold in median survival compared to results in patients receiving placebo (10/18) |
| Avid Radio-pharmaceuticals Inc.* | 18F-AV-133 | An imaging compound that can detect losses in nigrostriatal neurons in the brain | Parkinson's disease and dementias, including Alzheimer's disease | Started enrolling patients in its proof-of-concept Phase I trial (10/3) |
| Bayhill Therapeutics Inc. * | BHT-3009 | Myelin basic protein-encoding DNA plasmid | Relapsing-remitting multiple sclerosis | Phase IIb data showed patients with high antimyelin basic protein antibodies in their cerebral spinal fluid had statistically significantly fewer gadolinium-enhancing lesions in their brain following treatment with BHT-3009 compared to placebo (10/5) |
| Biogen Idec Inc. (BIIB) and PDL BioPharma Inc. (PDLI) | Daclizumab (FDA-approved as Zenapax) | Humanized monoclonal antibody; interleukin-2 receptor antagonist | Active relapsing multiple sclerosis | Phase II data showed a significant reduction in new or enlarged gadolinium-enhancing lesions when daclizumab is added to interferon beta therapy (10/12) |
| BioLineRx Ltd.* (Israel) | BL-1020 | GABA enhanced anti-psychotic | Schizophrenia | Phase II data showed the drug reduced the Positive and Negative Syndrome Scale total score by 26.1 points from baseline and the negative score by 7.1 points from baseline (10/29) |
| BioMS Medical Corp. (Canada; TSX:MS) | MBP8298 | A synthetic peptide | Secondary, progressive multiple sclerosis | Phase III data showed a strong safety profile (10/15) |
| Celtic Pharmaceutical Holding LP* (Bermuda) | TA-NIC | Vaccine designed to raise anti-nicotine antibodies | Nicotine addiction | Completed enrollment of more than 520 patients (10/29) |
| Cerimon Pharmaceuticals Inc.* | Diclofenac sodium | A nonsteroidal anti-inflammatory drug | Acute musculoskeletal pain | Started a Phase I study (10/8) |
| Epix Pharmaceuticals Inc. (EPIX) | PRX-00023 | Selective for the 5-HT4 receptor in the brain | Major depressive disorder | Finished enrollment of 330 patients in a Phase IIb trial (10/25) |
| Evotec AG (Germany; FSE:EVT) | EVT 201 | Agent that acts on GABA-A receptors | Primary insomnia | Phase II data showed a highly significant improvement between both doses of EVT 201 and placebo on the primary endpoint of polysomnography derived Total Sleep Time (10/16) |
| Genaera Corp. (GENR) | MSI-1436 | Trodusquemine | Obesity | Phase I data showed it was well tolerated with no serious adverse events (10/23) |
| Genzyme Corp. (GENZ) | Campath (FDA-approved) | Alemtuzumab | Multiple sclerosis | Phase II data showed it provides a significant treatment effect that has been found to last three years (10/15) |
| Horizon Therapeutics Inc.* | HZT-501 | NSAID designed to be GI friendly | To relieve pain and reduce stomach acidity | Started a Phase III study in patients at risk for gastric ulceration (10/8) |
| MediciNova Inc. (MNOV) | MN-305 | Highly selective full agonist at the serotonin 5-HT1A receptor | Insomnia | Phase IIa data showed it failed to achieve statistical significance in its primary endpoint of reducing wake-after-sleep onset (10/19) |
| Memory Pharmaceuticals Corp. (MEMY) | MEM 1003 | Calcium channel modulator | Alzheimer's disease | Product failed in a Phase IIa trial (10/15) |
| Nastech Pharmaceutical Co. Inc. (NSTK) | PYY3-36 | Nasal spray | Obesity | Started a Phase II trial (10/1) |
| Noven Pharmaceuticals (NOVN) | Lithium QD | Lithium carbonate | Bipolar I disorder | Phase III data showed it did not meet its primary endpoint with statistical significance (10/8) |
| Orexigen Therapeutics Inc. (OREX) | Contrave | A fixed-dose combination of sustained-release bupropion and Orexigen's sustained-release naltrexone | Obesity | Started its third of four Phase III trials for its lead product Contrave in obesity (10/17) |
| Orexigen Therapeutics Inc. (OREX) | Contrave | A fixed dose combination of bupropion SR (sustained release) and Orexigen's novel formulation of naltrexone SR in a single tri-layer tablet | Obesity | Phase IIb data showed the Contrave 32/400-mg dose group demonstrated significantly greater improvement than the placebo or monotherapy groups (10/22) |
| Orexo AB (Sweden; SSE:ORX) | Sublinox | Contains zolpidem and is based on Orexo's sublingual technology for absorption across the oral mucosa | Sleep disturbances | Data showed the drug acts 30% faster than Ambien as a sleep aid for patients suffering from sleep disturbances (10/1) |
| Peptimmune Inc.* | PI-2301 | A second-generation peptide-copolymer | Multiple sclerosis and autoimmune diseases | Started a Phase I trial (10/3) |
| TorreyPines Therapeutics Inc. (TPTX) | NGX424 | AMPA/kainate antagonist tezampanel | Acute migraine | Phase IIb data showed that the 40-mg dose resulted in a statistically significant improvement in headache pain, but the 70-mg and 100-mg doses did not (10/22) |
| UCB Inc. (Belgium; BR:UCB) | Neupro | Rotigotine transdermal system | Parkinson's disease | Data from two clinical trials showed it controlled early morning motor impairment, improved sleep quality and was generally well tolerated for long-term use (10/8) |
| Vanda Pharmaceuticals Inc. (VNDA) | VSF-173 | A compound of unknown mechanism of action | Narcolepsy | Phase II data showed it did not reach statistical significance for wakefulness (10/31) |
| Vivus Inc. (VVUS) | Qnexa | A combination therapy of topiramate and phentermine | Obesity | Phase II data showed patients receiving Qnexa had significantly greater improvements than the topiramate and placebo groups in the physical function, self esteem and public distress domains (10/23) |
| DIABETES | ||||
| Aastrom Biosciences Inc. (ASTM) | VRCs | Vascular Repair Cells manufactured with Tissue Repair Cell technology | Chronic diabetic foot wounds associated with critical limb ischemia | Phase I/II data showed all 13 patients treated with VCRs had no major amputations, no cell-related adverse events and healing of all open wounds (10/4) |
| Alimera Sciences Inc.* | Medidur FA | Fluocinolone acetenoide | Diabetic macular edema | Enrollment is complete for the FAME Phase III study (10/8) |
| Altea Therapeutics Inc.* | A small transdermal patch delivering recombinant human insulin | Type I diabetes | Achieved sustained and steady basal levels of insulin (10/30) | |
| Amylin Pharmaceuticals Inc. (AMLN), Eli Lilly & Co. and Alkermes Inc. (ALKS) | Formulation of once-weekly exenatide long-acting release | Type II diabetes | Data showed a statistically significant improvement in A1C levels of about 1.9 percentage points from baseline in patients receiving the investigational formulation, compared with an improvement of 1.5 percentage points for Byetta (exenatide) (10/31) | |
| CardioVascular BioTherapeutics Inc. (OTC BB:CVBT) | CVBT-141B | Formulated with human fibroblast growth factor-1 | Diabetic or venous stasis ulcers | Finished a Phase I wound healing trial showing it was well tolerated (10/2) |
| ConjuChem Biotechnologies Inc. (Canada; TSX:CJB) | PC-DAC: Exendin-4 receptor | An insulinotropic peptide and an agonist for the glucagon-like peptide-1 | Type II diabetes | Phase I/II data showed the compound was well tolerated and effective (10/18) |
| Exelixis Inc. (EXEL) | XL784 | A small-molecule inhibitor of the metallo-protease enzymes MMP2 and ADAM10 | Proteinuria associated with diabetic nephtopathy | Completed Phase II study that showed it failed to meet its primary endpoint of reducing proteinuria compared to placebo (10/16) |
| Flamel Technologies Inc. (FLML) | FT-105 | A long-acting recombinant insulin formulation that uses a microparticulate adaptation of Flamel's Medusa nanoparticle delivery system | Diabetes | Phase I data showed it achieved a sustained release of insulin over a 36-hour period (10/18) |
| Hollis-Eden Pharmaceuticals Inc. (HEPH) | Triolex | HE3286; orally bioavailable small-molecule adrenal steroid hormone | Diabetes | Started a Phase I/II trial in obese, insulin-resistant volunteers (10/16) |
| Isis Pharmaceuticals Inc. (ISIS) | ISIS 325568 | Designed to selectively inhibit the production of glucagon receptor | Type II diabetes | Started a clinical trial (10/2) |
| Living Cell Technologies Ltd.* (Australia) | DiabeCell | Pig pancreatic cell product | Type I diabetes | Phase I/IIa trial showed two treated patients are well and have shown no adverse events (10/9) |
| MacuSight Inc.* | Sirolimus | Rapamycin | Diabetic macular edema | Phase I data showed the drug was safe and well tolerated (10/1) |
| Osiris Therapeutics Inc. (OSIR) | Prochymal | An I.V. formulation of its mesenchymal stem cells product | Type I diabetes | Launched a Phase II trial (10/25) |
| INFECTION | ||||
| Accentia Bio-pharmaceuticals Inc. (ABPI) | SinuNase | Intranasal amphotericin B | Chronic sinusitis | Completed enrollment of a target 300 patients in its Phase III trial (10/8) |
| Achillion Pharmaceuticals Inc. (ACHN) | Elvucitabine | An early stage nucleoside reverse transcriptase inhibitor | Wild-type HIV | Phase II data showed potent antiviral activity similar to 3TC at 12 weeks; it also was well tolerated with no serious adverse events (10/16) |
| AlphaVax Inc.* | Vaccine comprised of a replicon vector expressing the hemagglutinin gene derived from the A/Wyoming (H3N2) flu strain | Influenza | Concluded a Phase I study (10/31) | |
| Arpida Ltd. (Switzerland; SWX:ARPN) | Iclaprim | Antibiotic; an intravenous new member of the diamino-pyrimidine class | Complicated skin and skin structure infections | Pivotal data showed it exhibited high clinical cure rates and achieved its prespecified primary endpoint to noninferiority to linezolid (10/9) |
| Barrier Therapeutics Inc. (BTRX) | Pramiconazole | Oral broad-spectrum antifungal product candidate | Onychomycosis | Phase IIa data showed a marked onset of clinical improvement (10/19) |
| Biolex Therapeutics* and OctoPlus (the Netherlands; AMSTERDAM:OCTO) | Locteron | A controlled-release interferon alpha product | Hepatitis C virus | Phase IIa data showed the combination of Locteron and ribavirin resulted in any early virologic response in 100% of the HCV patients treated (10/12) |
| Canopus BioPharma Inc. (PK:CBIA) | SpirH | HIV-1 antiviral therapy | HIV | Began a 30-patient Phase II trial (10/10) |
| Crucell NV (the Netherlands; CRXL) | Antibody cocktail that uses MAbstract and PER.C6 technologies | Rabies | Phase I data showed it is well tolerated, provides the expected neutralizing activity and can be administered in combination with a rabies vaccine (10/3) | |
| Gilead Sciences Inc. (GILD) | Truvada (FDA-approved) | Emtricitabine and tenofovir disoproxil fumarate | HIV | Phase III data of patients taking Sustiva who switched from Combivir to Truvada maintained virologic suppression and decreased certain side effects (10/29) |
| Ocera Therapeutics Inc.* | AST-120 | Oral spherical adsorptive carbon | Active pouchitis | Phase II data showed that four weeks of treatment led to a significant decrease in symptoms and endoscopy scores in 10 patients (10/15) |
| Panacos Pharmaceuticals Inc. (PANC) | PA-457 | Bevirimat; HIV maturation inhibitor | HIV | Phase IIb data showed patients who received 300 mg had a mean viral load reduction of 1.02 log10 after 14 days of therapy (10/26) |
| Pharmasset Inc. (VRUS) | Clevudine | Once-daily pyrimidine nucleoside analogue | Hepatitis B virus | Started a Phase III trial (10/1) |
| Pharmasset Inc. (VRUS) | R7128 | A prodrug of PSI-6130, an oral cytidine nucleoside analogue polymerase inhibitor | Hepatitis C virus | Began dosing in a Phase I study (10/3) |
| Theratechnologies Inc. (Canada; TSX:TH) | TH9507 | Tesamorelin | HIV-associated lipodystrophy | Phase III data showed that patients treated for 52 weeks experienced a total reduction of 18% of their visceral adipose tissue (10/1) |
| MISCELLANEOUS | ||||
| Aastrom Biosciences Inc. (ASTM) | Bone repair cells | Severe non-union fractures | Phase I/II data showed an overall healing rate of 91% after one year (10/19) | |
| Addex Pharmaceuticals (Switzerland; SWX:ADXN) | ADX10059 | Orally available small-molecule compound that works as a negative allosteric modulator of the metabotropic glutamate receptor 5 | Gastroesophageal reflux disease | Phase IIa data showed there was a reduction in the number of episodes and the duration of episodes (10/29) |
| Affymax Inc.* | Hematide | Synthetic, peptide-based erythropoiesis stimulating agent | Anemia | Dosed the first patient in the Phase III program in chronic renal failure patients (10/11) |
| Alacrity Biosciences* | ALTY-0501 | Topical metalloproteinase inhibitor | Dry eye | Demonstrated statistically significant advantages over vehicle in its ability to control signs and symptoms of dry eye in a Phase II study (10/10) |
| Amicus Therapeutics (FOLD) | AT2220 | 1-deoxynojirimycin HCl | Pompe disease | Phase I data showed it was well tolerated (10/23) |
| BioXell SpA (Italy; SWX:BXLN) | Elocalcitol | Derived from BioXell's Vitamin D3 technology platform | Benign prostatic hyperplasia | Phase IIb data showed it met the primary endpoint of arresting prostate growth (10/12) |
| Centocor Inc. (unit of Johnson & Johnson) | Remicade (FDA-approved) | Infliximab; monoclonal antibody that targets tumor necrosis factor alpha | Active ulcerative colitis | Data showed it significantly reduced the incidence of colectomy surgeries (10/15) |
| Critical Therapeutics Inc. (CRTX) | Zileuton | Injection | Asthma | Started a Phase II trial (10/3) |
| Critical Therapeutics Inc. (CRTX) | R-positive zileuton; comprised of racemic zileuton | Asthma | Started a Phase I trial to test an oral, single-dose in healthy subjects (10/1) | |
| Dynavax Technologies Corp. (DVAX) | Tolamba | ISS molecule linked to Amb a 1 | Ragweed allergy | Began dosing in a 300-subject study (10/23) |
| Dynogen Pharmaceuticals Inc.* | DDP733 | Pumosetrag | Nocturnal gastroesophageal reflux disease | Phase Ib data demonstrated proof-of-concept and overall safety and tolerability (10/15) |
| Exelixis Inc. (EXEL) | XL880 | An inhibitor of MET and vascular endothelial growth factor receptor 2 kinases | Kidney cancer | Phase II data showed 15 of 19 patients had a decrease in tumor size, including one patient with a partial response (10/25) |
| Gilead Sciences Inc. (GILD) | Aztreonam lysine | Product for inhalation | Cystic fibrosis patients who have pulmonary pseudomonas aeruginosa | Phase III data showed a 28-day treatment course improved respiratory symptoms (10/4) |
| Hyperion Therapeutics Inc.* | Glyceryl Tri (4-Phenylbutyrate) | A prodrug of Buphenyl | Urea cycle disorders | Enrolled the first patient in a Phase I/II trial(10/23) |
| Inspire Pharmaceuticals Inc. (ISPH) | Denufosal tetrasodium | An inhaled solution | Cystic fibrosis | Completed enrollment in the first of two planned pivotal Phase III trials (10/4) |
| Ipsat Therapies Ltd.* (Finland) | Ipsat P1A | A beta-lactamase compound | To inactivate antibiotics in patient GI tracts | Phase IIb data showed it met both primary endpoints (10/25) |
| Lexicon Pharmaceuticals Inc. (LXRX) | LX1031 | Orally-administered inhibitor of tryptophan hydroxylase | Irritable bowel syndrome | Phase I data showed LX1031 was well tolerated at all dose levels and that exposure levels in blood were low (10/16) |
| LifeCycle Pharma AS* (Denmark) | LCP-Tacro | Tacrolimus; a once-a-day immunosuppressant | For transplant patients | Interim Phase II data showed it was superior to Prograf (10/26) |
| MAP Pharmaceuticals Inc. (MAPP) | MAP0005 | A combination of a corticosteroid and a long-acting beta-2-agonist | Asthma and chronic obstructive pulmonary disease | Started a Phase IIa trial (10/31) |
| MGI Pharma Inc. (MOGN) and Helsinn Healthcare SA (Switzerland) | Aloxi | Palonosetron hydrochloride injection | Postoperative nausea and vomiting | Phase III data showed it met the primary endpoint of complete response in gynecologic or breast surgery patients (10/15) |
| MGI Pharma Inc. (MOGN) | Aquavan | Fospropofol disodium injection | For patients undergoing flexible bronchoscopy | Phase III data showed it met its primary and secondary endpoints (10/23) |
| Morria Biopharmaceuticals plc* (UK) | MRX-4 | Nasally administered | Allergic rhinitis | Started a Phase I tolerance study (10/23) |
| NPS Pharmaceutical Inc. (NPSP) | Gattex | Teduglutide; an analogue of glucagon-like peptide-2 | Short bowel syndrome | Phase III data showed it failed to meet its endpoint; only 25% showed a trend that did not reach statistical significance (10/11) |
| Nventa Biopharmaceuticals Corp. (TSX:NVN) | HspE7 | Immunotherapeutic made using recombinant DNA technology that covalently fuses a heat shock protein to an HPV E7 viral protein | Cervical intraepithelial neoplasia | Completed enrollment of the first cohort in its Phase I trial (10/18) |
| Osiris Therapeutics Inc. (OSIR) | Prochymal | Mesenchymal stem cell therapy | Acute graft-vs.-host disease | Company is entering Phase III after Phase II data showed that 77% of patients treated with Prochymal experienced complete remission of GVHD within 28 days (10/17) |
| Protox Therapeutics Inc. (Canada; CDNX:PRX) | PRX302 | Proaerolysin-based | Benign prostatic hyperplasia | Completed enrollment of a target 12 patients and reported positive interim data in a Phase I trial (10/3) |
| PTC Therapeutics Inc. (NYSE:PTC) | PTC124 | Oral agent that targets nonsense mutations | Cystic fibrosis | Phase II data showed statistically significant improvements in a measure of the function of the CF transmembrane conductance regulator protein (10/5) |
| PTC Therapeutics Inc. (NYSE:PTC) | PTC124 | Novel, orally administered small-molecule compound that targets a particular genetic alteration known as a nonsense mutation | Duchenne's muscular dystrophy | Phase II data showed the administration of the drug is associated with qualitative increases in muscle dystrophin expression and with reductions in serum creatine kinase values (10/18) |
| Regeneron Pharmaceuticals Inc. (REGN) and Bayer HealthCare AG (Germany) | VEGF Trap-Eye | VEGF inhibitor that binds and blocks 1-to-2 orders of magnitude | Wet age-related macular degeneration | Phase II data showed it met the primary endpoint of statistically significant reduction in retinal thickness after 12 weeks (10/1) |
| Salvat* (Spain) | SVT-40776 | Muscarinic receptor antagonist targeted to the M3 receptor in the bladder | Overactive bladder | Completed enrollment in a dose-finding Phase II trial (10/10) |
| Savient Pharmaceuticals Inc. (SVNT) | Puricase | Pegloticase | Treatment-failure gout | Completed the in-life portion of its two pivotal Phase III trials (10/16) |
| Sciele Pharma Inc. (SCRX) and Plethora Solutions Holdings plc (UK) | PSD502 | A proprietary formulation of lidocaine and prilocaine dispensed by a metered-dose aerosol | Premature ejaculation | Started patient enrollment for the Phase III trials in the U.S. (10/30) |
| Speedel Holding Ltd. (Switzerland; SWX:SPPN) | SPP301 | Avosentan | Diabetic kidney disease | Is resuming development after a Phase III was stopped in December 2006 from concerns about patient safety (10/23) |
| Summit Corp. plc* (UK) | SMT D002 | Designed to treat excessive sebum production | Seborrhoea | Began a Phase I trial (10/23) |
| Theravance Inc. (THRX) | TD-5108 | Selective 5-HT4 agonist | Chronic constipation | Phase II data showed clinical activity for all doses tested (10/17) |
| Tranzyme Pharma* | TZP-101 | A first-in-class prokinetic agent | To manage severe gastroparesis | Started a Phase IIb trial (10/30) |
| 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; BR = Brussels Stock Exchange; CDNX = Canadian Venture 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; TEL = Tel Aviv Stock Exchange; TSX = Toronto Stock Exchange. | ||||
