| Company* (Country; Symbol) |
Product | Description | Indication | Status (Date) | ||||
| AUTOIMMUNE | ||||||||
| Alba Therapeutics Corp.* | AT-1001 | An oral inhibitor of gastrointestinal barrier dysfunction | To maintain remission in patients with celiac disease | Dosed the first patient in a Phase IIb trial (9/19) | ||||
| CollaGenex Pharmaceuticals Inc. (CGPI) | Incyclinide | A chemically modified, non-antibiotic tetracycline | Rosacea | Company discontinued development after Phase II results showed it failed to meet the primary endpoint (9/26) | ||||
| CombinatoRx Inc. (CRXX) | CRx-102 | An oral combination drug candidate | Immuno-inflammatory diseases | Dosed the first patient in a Phase IIb trial in knee osteoarthritis (9/26) | ||||
| Genzyme Corp. (GENZ) and Bayer Schering Pharma AG (Germany) | Campath (FDA-approved) | Alemtuzumab; humanized monoclonal antibody that binds to CD52 on cell surfaces | Multiple sclerosis | Dosed the first patient in the first of two Phase III studies comparing it to Rebif (9/26) | ||||
| Pharmacopeia Inc. (PCOP) and Bristol-Myers Squibb Co. | BMS-582949 | P38 kinase inhibitor | Moderate to severe psoriasis | Started a Phase II trial (9/18) | ||||
| Pozen Inc. (POZN) and AstraZeneca plc (UK) | PN 400 | A single-tablet combination of esomeprazole magnesium, a proton pump inhibitor, with naproxen, an NSAID | Arthritis | Started Phase III trials (9/7) | ||||
|
Trubion Pharmaceuticals Inc. (TRBN) |
TRU-015 | Small modular immuno-pharmaceutical drug | Rheumatoid arthritis | Phase IIb data showed it was well tolerated at various doses; the 800-mg dose met the primary endpoint of significantly improving Disease Activity Score at 12 weeks (9/11) | ||||
| CANCER | ||||||||
| Algeta ASA (Norway; OSLO:ALGETA) | Alpharadin | Alpha emitter | Hormone-refractoryprostate cancer | Phase II data showed the drug doubles survival rate overplacebo (9/25) | ||||
| Amgen Inc. (AMGN) | Aranesp (FDA-approved) | Darbepoetin alfa | Extensive-stage small-cell lung cancer | Phase III data demonstrated no statistically significant difference in risk of death or investigator-assessed progression-free survival (9/6) | ||||
| Amgen Inc. (AMGN) | Vectibix (FDA-approved) | Panitumumab | Refractory metastatic colorectal cancer | The European Committee for Medicinal Products for Human Use recommended marketing approval (9/21) | ||||
| Antisoma plc (UK; LSE:ASM) | ASA404 | Small-molecule vascular disrupting agent designed to target blood vessels that nourish tumors | Non-small-cell lung cancer | Phase II data of ASA404 in combi-nation with carboplatin and paclitaxel chemotherapy showed a median survival time of 14.9 months, median time to tumor progression of 5.5 months and tumor response rate of 37.9% (9/5) | ||||
| Ariad Pharmaceuticals Inc. (ARIA) | Deforolimus | A small-molecule com-pound that targets mTOR (mammalian target of rapamycin) | Metastatic soft-tissue and bone sarcomas | Launched a Phase III trial (9/24) | ||||
| BioAlliance Pharma SA (France; PARIS: BIO) | Lauriad | Miconazole; antifungal product | Head and neck cancer | Results from a 282-patient study showed once-daily treatment was not inferior to that of miconazole 500-mg oral gel administered four times per day (9/25) | ||||
| Biomira Inc. (BIOM) | Stimuvax | MUC-1 vaccine | Unresectable Stage IIIb non-small-cell lung cancer | Three-year survival data from its Phase II trial suggested that the drug, in combination with best supportive care, might provide survival benefits to patients who have responded or had stable disease following initial radio-chemotherapy (9/5) | ||||
| Callisto Pharmaceuticals Inc. (AMEX:KAL) | Atiprimod | Oral, small-molecule drug that inhibits secretion of VEGF and IL-6, and inhibits phosphorylation of kinases including Akt and STAT3 | Neuroendocrine carcinoma | Completed enrollment of a target 40 patients in its Phase II clinical trial (9/20) | ||||
| Celgene Corp. (CELG) | Revlimid (FDA-approved) | Lenalidomide | Chronic lymphocytic leukemia | Data showed an overall response to monotherapy of 58%, with 18% achieving a complete remission and 40% achieving partial remission (9/17) | ||||
| Cell Therapeutics Inc. (CTIC) | Pixantrone | An anthracenedione | Indolent non-Hodgkin's lymphoma | Launched a Phase III trial (9/12) | ||||
| Cell Therapeutics Inc. (CTIC) | Brostallicin | A second-generation DNA minor groove binder | Advanced solid tumors | Phase I data of brostallicin in combination with cisplatin showed the dose-limiting toxicities to be febrile neutropenia and fatigue (9/27) | ||||
| Cell Therapeutics Inc. (CTIC) | Xyotax | Paclitaxel poliglumex | Non-small-cell lung cancer | Company began a confirmatory Phase III trial of combination chemotherapy for women with the disease (9/24) | ||||
| Cephalon Inc. (CEPH) | Treanda | Bendamustine; purine analogue/alkylator hybrid | Non-Hodgkin's lymphomas | Submitted an NDA (9/21) | ||||
| ChemGenex Pharmaceuticals Ltd. (Australia; CXSP; ASX:CXS) | Ceflatonin | Homoharringtonine | Gleevec-resistant accelerated phase chronic myeloid leukemia | Ceflatonin showed clinical activity in CML associated with T3151 BCR-ABL kinase domain mutation (9/24) | ||||
| EntreMed Inc. (ENMD) | MKC-1 | Small-molecule cell-cycle inhibitor | Metastatic breast cancer | Phase II study demonstrated it was well tolerated without evidence of cumulative toxicity (9/10) | ||||
| Exelixis Inc. (EXEL) | XL647 | A receptor tyrosine kinase inhibitor | Non-small-cell lung cancer | Phase II data showed that more than 60% of patients had partial responses or stable disease as their best response (9/5) | ||||
| Genmab A/S (Denmark; CSE:GEN) | HuMax-CD20 | Ofatumumab | Rituximab-refractory follicular non-Hodgkin's lymphoma | Amended the design of its ongoing pivotal study to a single-arm trial that now will include about 81 patients (9/27) | ||||
| Idera Pharmaceuticals Inc. (AMEX:IDP) | IMO-2055 | A Toll-like receptor 9 agonist | Advanced solid tumors | Phase I trial of IMO-2055 in combination with gemcitabine and carboplatin showed a response rate, progression-free survival and overall survival rates of 5%, 4.1 months and 12.9 months, respectively (9/6) | ||||
| ImClone Systems Inc. (IMCL) and Merck KGaA (Germany) | Erbitux (FDA-approved) | Targets EGFR | Non-small-cell lung cancer | Phase III data showed that the drug, when combined with chemotherapy, met the primary end-point of increasing overall survival in advanced NSCLC compared to chemo alone (9/11) | ||||
| Introgen Therapeutics Inc. (INGN) | Advexin | Adenoviral vector containing the p53 tumor suppressor gene | Head and neck cancer | Phase II data showed a statistically significant correlation between the abnormal p53 bio-marker and tumor response after treatment (9/27) | ||||
| Kosan Biosciences Inc. (KOSN) | Alvespimycin | A second-generation Hsp90 inhibitor | Refractory HER2-positive metastatic breast cancer | Phase I data demonstrated anti-tumor activity and tolerability in combination with trastuzumab (9/10) | ||||
| MediciNova Inc. (MNOV) | MN-029 | A vascular disrupting agent | Solid tumors | Phase I data showed a statistically significant correlation between increasing exposure to MN-029 and Ktrans, an imaging marker of tumor blood flow and vascular permeability (9/27) | ||||
| Millennium Pharmaceutical Inc. (MLNM) | Velcade (FDA-approved) | Bortezomib | Multiple myeloma | Phase III data showed that when it was combined with two other drugs it yielded a highly statistically significant improvement in all efficacy measures, compared to melphalan and prednisone given alone (9/18); The Multiple Myeloma Research Consortium started a Phase I/II trial to explore the combination of Torisel and Velcade (9/18) | ||||
| Neoprobe Corp. (OTC BB:NEOP) | Lymphoseek | A radioactive tracing agent being developed for use in gamma detection devices in intraoperative lymphatic mapping | Melanoma or breast cancer | Phase II data showed an overall lymph node identification rate of 95% (9/10) | ||||
| Neose Technologies Inc. (NTEC) | NE-180 | A long-acting, GlycoPEG-ylated erythropoietin | Anemia in cancer | Dosing began in a Phase II trial (9/10) | ||||
| Pharmacyclics Inc. (PCYC) | Xcytrin | Motexafin gadolinium injection | Non-small-cell lung cancer | Phase II data demonstrated a confirmed response rate of 5%, or three partial responses (9/5) | ||||
| Novacea Inc. (NOVC) | Asentar | DN-101; a high-dose oral formulation of calcitriol, a biologically active form of vitamin D | Advanced pancreatic adenocarcinoma | Started a Phase II trial (9/26) | ||||
| Onyx Pharmaceuticals Inc. (ONXX) and Bayer HealthCare Pharmaceuticals | Nexavar (FDA-approved) | Sorafenib tablets | Hepatocellular carcinoma | CMPH recommended marketing authorization (9/21) | ||||
| Poniard Pharmaceuticals Inc. (PARD) | Picoplatin | Intravenous picoplatin; a new generation platinum chemotherapy agent | Recurrent small-cell lung cancer | Phase II data confirm an earlier analysis that picoplatin demonstrated a survival benefit in patients who have relapsed within six months of first-line therapy (9/4) | ||||
| Progen Pharmaceuticals Ltd. (Australia; PGLA) | PI-88 | Anti-angiogenesis drug also designed to inhibit tumor-promoting factors | Advanced non-small-cell lung cancer | Phase II data of PI-88 in combination with docetaxel showed it did not meet its primary end-point of significantly improving the progression-free rate at six months compared to docetaxel alone (9/24) | ||||
| Protox Therapeutics Inc. (Canada; CDNX:PRX) | PRX302 | Designed to kill prostate cancer and hyperplastic cells that overproduce the enzyme prostate specific antigen | Prostate cancer | Interim Phase I data showed the drug is safe and well tolerated (9/7) | ||||
| Provectus Pharmaceuticals Inc. (OTC BB:PVCT) | Provecta | Agent designed to be retained in tumor cells while leaving normal estrogen tissue unharmed | Metastatic melanoma | Phase I data demonstrated minimal side effects, significant efficacy and "bystander effect" on melanoma tumors in Stage III patients (9/18) | ||||
| Sonus Pharmaceuticals Inc. (SNUS) | Tocosol Paclitaxel | Formulation of paclitaxel using Sonus' vitamin E-based emulsion technology | Metastatic breast cancer | It failed to meet the primary endpoint in a Phase III trial (9/24) | ||||
| Spectrum Pharmaceuticals Inc. (SPPI) | EOquin | Apaziquone for intra-vesical instillation | Noninvasive bladder cancer | Began enrolling patients into its second and final pivotal Phase III trial (9/7) | ||||
| Sunesis Pharmaceuticals Inc. (SNSS) | SNS-595 | Cell-cycle inhibitor | Acute leukemias | Began patient dosing of SNS-595 with cytarabine in a Phase Ib trial (9/12) | ||||
| Sunesis Pharmaceuticals Inc. (SNSS) | SNS-314 | An Aurora kinase inhibitor | Advanced solid malignancies | Began patient dosing in a Phase I to evaluate SNS-314 (9/12) | ||||
| Threshold Pharmaceuticals Inc. (THLD) | Glufosfamide | Small molecule targeting abnormal glucose metabolism | Advanced pancreatic cancer | Phase II data of glufosfamide in combination with gemcitabine showed that six-month and one-year survival were 50% and 32%, respectively (9/26); Phase III data showed overall survival in patients who had relapsed after gemcitabine was 18% higher in the glufosfamide arm than in those receiving best supportive care, but the result did not reach statistical significance (9/27) | ||||
| Vion Pharmaceuticals Inc.* | VNP40101M | Cloretazine | Relapsed or progressive adult malignant gliomas | Started a trial to establish the maximum tolerated dose and safety profile of the drug when used with Temodar (9/17) | ||||
| YM BioSciences Inc. (Canada; AMEX:YMI) | Nimotuzumab | A humanized monoclonal antibody that targets the epidermal growth factor receptor | Non-small-cell lung cancer | Phase I data showed four partial responses and two stable diseases; the median overall survival of the group was 41.5 weeks (9/5) | ||||
| Ziopharm Oncology Inc. (ZIOP) | ZIO-101 | Darinaparsin; oral formulation | Solid tumors | Began dosing patients in a U.S. Phase I trial (9/10) | ||||
| Ziopharm Oncology Inc. (ZIOP) | ZIO-210 | Isophosphoramide mustard | Refractory sarcoma | Interim Phase II data showed that 14 of 31 patients had a clinically beneficial response (9/25) | ||||
| CARDIOVASCULAR | ||||||||
| Alkermes Inc. (ALKS) | ALKS 27 | An inhaled formulation of trospium chloride using Alkermes' AIR pulmonary delivery system | Chronic obstructive pulmonary disease | Phase IIa data showed a statistically significant improvement in lung function compared with placebo (9/26) | ||||
| CV Therapeutics Inc. (CVTX) | Ranexa | Ranolazine extended-release tablets | Arrhythmias | Data showed that Ranexa reduced both ventricular and atrial arrhythmias over placebo (9/5) | ||||
| Encysive Pharmaceuticals Inc. (ENCY) | Thelin | Sitaxsentan | Diastolic heart failure | Completed patient enrollment in the Phase II trial (9/4) | ||||
| Gilead Sciences Inc. (GILD) | DAR-201 | Darusentant | Resistant hypertension | Phase IIb data showed it significantly reduced placebo-corrected mean trough sitting systolic blood pressure from baseline by 11.5 mmHg after 10 weeks of treatment (9/25) | ||||
| Karo Bio AB (Sweden; SSE:KARO) and Wyeth Pharmaceuticals | LXR-623 | Targets the liver X receptor | Atherosclerosis | Companies discontinued development due to an unfavorable profile (9/20) | ||||
| Lev Pharmaceuticals Inc. (OTC BB:LEVP) | Cinryze | A C1 inhibitor | To prevent hereditary angioedema | Phase III data showed that the primary endpoint was achieved, showing a clinically and statistic-ally significant reduction in the number of HAE attacks (9/10) | ||||
| Medicure Inc. (Canada; AMEX: MCU) | MC-1 | A naturally occurring cardioprotective molecule | Coronary artery bypass graft surgery | Completed enrollment of the target 3,000 patients in a Phase III trial (9/20) | ||||
| Molecular Insight Pharmaceuticals Inc. (MIPI) | Zemiva | Iodofiltic acid I-123 or BMIPP | To detect acute coronary syndrome and to evaluate cardiac ischemia | Phase IIb data showed Zemiva compared favorably to published performance parameters of approved cardiac blood flow tracers (9/10) | ||||
| Pharmacopeia Inc. (PCOP) | PS433540 | A dual-acting angiotensin and endothelin-receptor antagonist | Hypertension and diabetic nephropathy | Phase I data showed no safety or tolerability issues in healthy volunteers (9/12); Phase I data confirmed the ability of PS433540 to block the angiotensin II response (9/27) | ||||
| Sinobiomed Inc. (China; OTC BB: SOBM) | rBat | The first batroxobin to be synthesized through gene recombination in a yeast expression system | Bleeding during surgery | Phase IIa data showed it was safe and efficacious in reducing both the amount of bleeding and bleeding time during surgery (9/18) | ||||
| Speedel Holding AG (Switzerland; SWX:SPPN) and Novartis AG (Switzerland) | SPP100 | Aliskiren; an oral inhibitor of renin | Heart failure | Phase II data showed a five-fold reduction in levels of brain naturietic peptide (9/5)** | ||||
| Syngis Pharma (Germany; FSE:LIO) | AX200 | Designed to stop neuronal cell death in the acute phase of stroke | Acute ischemic stroke | Phase IIa data showed it was safe and appeared to have efficacy in stroke patients (9/17) | ||||
| The Medicines Co. (MDCO) | Angiox (Angiomax; FDA-approved) | Bivalirudin; direct thrombin inhibitor | Acute coronary syndrome patients under-going percu-taneous coronary intervention | Phase III data showed nearly 50% less bleeding at 30 days and comparable mortality at one year when patients were treated with Angiox vs. unfractionated heparin or enoxaparin plus a glycoprotein IIb/IIIa inhibitor (9/4) | ||||
| ThromboGenics NV (Belgium; BR:THR) and BioInvent International AB (Sweden; SSE:BINV) | TB-402 | An antibody that binds Factor VIII | Venous thromboembolic disorders | Completed enrollment and initial follow-up of all 56 patients; it was well tolerated and met its efficacy endpoints (9/7) | ||||
| CENTRAL NERVOUS SYSTEM | ||||||||
| Allon Therapeutics Inc. (Canada; TSX:NPC) | AL-108 | An intranasally formulated ight amino acid neuro-protective peptide based on NAP | Schizophrenia-related cognitive impairment | Began enrollment in a Phase II trial (9/12) | ||||
| Anesiva Inc. (ANSV) | Adlea | A long-acting, nonopiate analgesic | Postoperative pain in patients undergoing total knee replacement surgery | Started a new Phase II study (9/13) | ||||
| Arena Pharmaceuticals Inc. (ARNA) | APD125 | Selective inverse agonist for 5-HT2A receptors | Chronic insomnia | Phase II data demonstrated statistically significant improvements in measurements of sleep maintenance vs. placebo (9/25) | ||||
| Avigen Inc. (AVGN) | AV650 | Tolperisone HCl | Spasticity associated with multiple sclerosis | Started a Phase II trial (9/5) | ||||
| Clinical Data Inc. (CLDA) | Vilazodone | Small-molecule drug | Depression | A 410-patient Phase III study hit the primary endpoint of mean change from baseline in the Montgomery-Asberg Depression Rating Scale score compared to placebo (9/4) | ||||
| DOV Pharmaceutical Inc. (DOVP) | DOV 21,947 | Triple reuptake inhibitor | Depression and obesity | Phase Ib data showed it was safe and well tolerated, and produced a statistically significant reduction in plasma triglyceride levels (9/25) | ||||
| Evotec AG (Germany; FSE:EVT) | EVT 201 | Agent that acts on GABA-A receptors | Primary insomnia | Results from the first Phase II trial showed that all endpoints achieved an even higher level of statistical significance than top-line data in June indicated (9/5) | ||||
| Icagen Inc. (ICGN) | ICA-105665 | A small-molecule compound designed to activate certain subtypes of KCNQ ion channels | Epilepsy | Started a Phase I study (9/5) | ||||
| Knopp Neurosciences Inc.* | KNS-760704 | A small-molecule therapy | Amyotrophic lateral sclerosis | Started a Phase I trial (9/24) | ||||
| Labopharm Inc. (Canada; DDSS; TSX:DDS) | Tramadol | Once-daily formulation | Acute low-back pain | Open-label, single-dose study of tramadol suggested that the formulation provided therapeutic plasma concentrations and onset of analgesic effect within one hour, similar to results cited for the immediate-release tramadol product (9/14) | ||||
| Labopharm Inc. (Canada; DDSS) | Trazodone | Antidepressant that uses Contramid controlled-release technology | Unipolar depressive disorder | Completed patient enrollment in a North American Phase III trial with more than 400 patients (9/25) | ||||
| Metabolex Inc.* | MBX-8025 | Believed to regulate fatty acid degradation, lipid storage/transport and insulin sensitivity | Obesity and high cholesterol and triglycerides | Began a 180-patient Phase II trial (9/25) | ||||
| Nabi Bio-pharmaceuticals (NABI) | NicVAX | Nicotine conjugate vaccine | Smoking cessation | Phase IIb data demonstrated efficacy in supporting statisticallysignificant and continuous abstinence rates by dose as well as by antibody response (9/6) | ||||
| NeurogesX Inc. (NGSX) | NGX-4010 | Pain patch | Postherpetic neuralgia | Met primary and secondary end-points in a third Phase III trial (9/4) | ||||
| NeuroSearch A/S (Denmark; CSE:NEUR) | Tesofensine | A triple monoamine reuptake inhibitor | Obesity | Phase IIb data showed it met the primary endpoint of resulting in weight loss greater than placebo (9/17) | ||||
| Orexigen Therapeutics Inc. (OREX) | Naltrexone | A sustained-release formulation | Obesity | Phase I data showed encouraging pharmacokinetic data when the product was tested alone and in combination with bupropion SR (9/25) | ||||
| Ovation Pharmaceuticals Inc.* | Clobazam | Adjunctive treatment; a 1,5 benzodiazepine with significant anticonvulsant properties | Lennox-Gastaut syndrome | Initiated a pivotal Phase III trial (9/4) | ||||
| Prana Biotechnology Ltd. (Australia; PRAN) | PBT2 | Small molecule that binds metal ions | Alzheimer's disease | Completed patient enrollment in a Phase IIa trial (9/24) | ||||
| Santhera Pharmaceuticals AG (Switzerland; SWX:SANN) | SNT-MC17 | Idebenone; small-molecule agent | Friedreich's ataxia | Began a Phase III program in the U.S. (9/28) | ||||
| TorreyPines Therapeutics Inc. (TPTX) | NGX267 | A functionally selective muscarinic agonist | Cognitive impairment associated with schizophrenia | Completed its third Phase I trial; it was found to be safe and well tolerated (9/10) | ||||
| Trophos SA* (France) | TRO19622 | Compound believed to promote the survival of a range of neurons | Spinal muscular atrophy | Began enrolling patients in a Phase Ib trial (9/28) | ||||
| DIABETES | ||||||||
| Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly and Co. | Byetta | Exenatide injection | Type II diabetes | Data showed one year of Byetta, compared with insulin glargine, markedly improved different indices of beta-cell function, along with similar glycemic improvement (9/21) | ||||
| AtheroGenics Inc. (AGIX) | AGI-1067 | Anti-inflammatory agent | Diabetes | Phase III data showed it significantly lowered levels of glycated hemoglobin A1c, with greater improvement seen in subjects with higher baseline A1c levels (9/5) | ||||
| Biodel Inc. (BIOD) | VIAject | A rapid-acting form of injectable human insulin | Type I diabetes | Phase II data demonstrated statistically significant and clinically relevant improved glycemic control compared to regular human insulin and lispro (9/18) | ||||
| DiObex Inc.* | DIO-902 | A cortisol synthesis inhibitor | Type II diabetes | Began dosing patients in a Phase IIb trial (9/26) | ||||
| Isis Pharmaceuticals Inc. (ISIS) | ISIS 325568 | An antisense drug designed to improve blood glucose control | Type II diabetes | Started a Phase I study (9/4) | ||||
| Nastech Pharmaceutical Co. Inc. (NSTK) | | Rapid-acting Insulin Nasal Spray | Type II diabetes | Began a Phase II trial in about 20 patients (9/26) | ||||
| Oculus Innovative Sciences Inc. (OCLS) | Microcyn | A controlled slow-release solution containing active chlorine and other gases resulting in a biocompatible technology for treating pathogens | Diabetic foot infections | Enrolled and randomized 42 patients of the total 60 targeted for its ongoing Phase II study (9/17) | ||||
| Pharmacopeia Inc. (PCOP) | PS433540 | A dual-acting angiotensin and endothelin receptor antagonist | Hypertension and diabetic neuropathy | Started a Phase IIa trial (9/17) | ||||
| Phenomix Corp.* | PHX1149 | Oral protease dipeptidyl peptidase-4 inhibitor | Type II diabetes | Started a Phase IIb trial (9/11) | ||||
| XOMA Ltd. (XOMA) | XOMA 052 | A monoclonal antibody targeting interleukin-1 beta | Type II diabetes | Began a second Phase I study (9/12) | ||||
| XTL Bio-pharmaceuticals Ltd. (XTLB) | Bicifadine | A serotonin and norepinephrine reuptake inhibitor | Diabetic neuropathic pain | Started a Phase IIb trial (9/10) | ||||
| INFECTION | ||||||||
| Ardea Biosciences Inc. (IBPI) | RDEA806 | An HIV non-nucleoside reverse transcriptase inhibitor | HIV | Two Phase I studies showed the drug was safe and well tolerated (9/19) | ||||
| Arpida Ltd. (Switzerland; SWX:ARPN) | Iclaprim | Antibiotic; an intravenous new member of the diamino-pyrimidine class | Skin and skin structure infections | Phase III data showed high microbiological eradication rates against major complicated skin and skin structure infection pathogens, comparable with linezolid (9/19) | ||||
| Avexa Ltd. (Australia; ASX:AVX) | ATC | Apricitabine; a cytidine analogue, an inhibitor of HIV reverse transcriptase | HIV | Positive 24-week data from the Phase IIb trial showed that in more than 80% of patients treated with the drug, the level of HIV in the blood was reduced to below detectable levels (9/4) | ||||
| Barrier Therapeutics Inc. (BTRX) | Hyphanox | An oral formulation of the antifungal agent itraconazole | Toenail onychomycosis | Completed patient enrollment in a pivotal Phase III study (9/28) | ||||
| Basilea Pharmaceutica Ltd. (Switzerland; SWX:BSLN) | Ceftobiprole | An anti-MRSA broad-spectrum cephalosporin | Community-acquired pneumonia | Top-line Phase III data showed a clinical cure rate at the test-of-cure visit of clinically evaluable patients of 86%, compared to 87% for the comparators (9/14) | ||||
| Basilea Pharmaceutica Ltd. (Switzerland; SWX:BSLN) | Ceftobiprole | An anti-MRSA broad-spectrum cephalosporin | Complicated skin infections | Phase III data demonstrated the drug's activity against infections involving pathogens ranging from methicillin-resistant Staphylococcus aureus to Pseudomonas aeruginosa (9/18) | ||||
| BioCryst Pharmaceuticals Inc. (BCRX) | Peramivir | A neuraminidase inhibitor | Influenza | Phase II trial failed to hit the end-point (9/20) | ||||
| Cytheris SA* (France) | CYT107 | A recombinant human interleukin-7 | HIV | Expanded its clinical program by initiating a Phase I/IIa trial (9/26) | ||||
| Dynavax Technologies Corp. (DVAX) | Heplisav | A hepatitis B vaccine | Hepatitis B | Phase III data showed Heplisav provided seroprotection to all subjects vs. 68.6% for those treated with Engerix-B (9/19) | ||||
| GenVec Inc. (GNVC) | | Vaccine produced using the 293-ORF6 cell line and associated manufacturing process | Malaria | Phase I/II data showed the vaccine induced strong T-cell responses against the target antigens in all subjects (9/19) | ||||
| Idera Pharmaceuticals Inc. (AMEX:IDP) | IMO-2125 | A Toll-like receptor 9 agonist | Hepatitis C virus | Dosed the first patient in a Phase I trial (9/17) | ||||
| InterMune Inc. (ITMN) | ITMN-191 | R7227; an NS3/4A protease inhibitor | Chronic hepatitis C virus | Began dosing the first patients in a Phase Ib trial (9/26) | ||||
| Iomai Corp. (IOMI) | Iomai patch | Immunostimulant patch | Influenza | Began dosing in a Phase I/II study (9/6) | ||||
| Iomai Corp. (IOMI) | | Patch-based travelers' diarrhea vaccine | Travelers' diarrhea | Data showed that travelers to Mexico and Guatemala were significantly less likely to be sickened after receiving the vaccine compared with those who received placebo (9/19) | ||||
| Maxygen Inc. (MAXY) and F. Hoffmann-La Roche Ltd. (Switzerland) | MAXY-alpha | A PEGylated interferon-alpha | Hepatitis B and C viruses | Roche placed a hold on development after Phase Ia data showed there were lower drug levels in serum than expected (9/21) | ||||
| Monogram Biosciences Inc. (MGRM) and Pfizer Inc. | Selzentry (FDA-approved) | Maraviroc; oral CCR5 antagonist | HIV | Results from a planned 48-week analysis showed that nearly three times as many patients receiving Selzentry in addition to an optimized background regimen achieved undetectable levels of virus compared to those receiving an optimized regimen alone (9/18) | ||||
| NanoBio Corp.* | NB-002 | Topical lotion | Serious skin infections | Phase I data showed it penetrates the skin deeply enough to target and eliminate the infection, without being systemically absorbed (9/12) | ||||
| NeurogesX Inc. (NGSX) | NGX-4010 | A dermal patch designed to manage peripheral neuropathic pain | Painful HIV- distal sensory polyneuropathy | Completed enrollment in a second Phase III trial (9/21) | ||||
| Pharmasset Inc. (VRUS) | R7128 | A prodrug of PSI-6130, an oral cytidine nucleoside analogue polymerase inhibitor | Hepatitis C virus | Company presented positive safety, tolerability, pharmacokinetic and food-effect data, following single ascending doses of R7128 (9/10); it demonstrated dose-dependent antiviral activity in a Phase I trial (9/12) | ||||
| 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 C virus | Completed patient enrollment in a Phase I/II trial (9/12) | ||||
| Salix Pharmaceuticals (SLXP) | | Granulated mesalamine product | Ulcerative colitis | Successfully completed the first of two Phase III trials on the safety and efficacy of its new granulated mesalamine product (9/5) | ||||
| Sinovac Biotech Ltd. (China; AMEX:SVA) | | Pandemic influenza H5N1 vaccine | Influenza | Started vaccination of volunteers for a Phase II study (9/11) | ||||
| Targanta Therapeutics Corp.* | Oritavancin | A semi-synthetic lipo-glycopeptide antibiotic agent | Complicated skin and skin structure infections | Started a Phase II trial (9/13) | ||||
| Theravance Inc. (THRX) | Telavancin | An injectable antibiotic; lipoglycopeptide | Gram-positive complicated skin and skin structure infections | Phase III data showed that the telavancin-treated patients had higher clinical cure, bacterial eradication and overall response rates than those given vancomycin (9/19) | ||||
| Tibotec Pharmaceuticals Ltd.* (Ireland) | Prezista | Darunavir | HIV | Phase III data showed that 84% of treatment-naive HIV-1 infected adults reached an undetectable viral load at week 48, compared to 78% of patients in the control arm (9/18) | ||||
| VaxInnate Corp.* | | Vaccine designed to target the M2 ectodomain portion of the flu virus | Influenza | Began the first Phase I trial (9/25) | ||||
| Virxsys Corp.* | VRX496 | An HIV-based lentiviral vector gene delivery system | HIV | Phase I and II studies confirmed previous safety findings (9/18) | ||||
| MISCELLANEOUS | ||||||||
| Acceleron Pharma Inc.* | ACE-011 | A bone-forming agent | Bone repair | Phase I data showed the drug was well tolerated, with no serious adverse events (9/19) | ||||
| Critical Therapeutics Inc.* | Zyflo (FDA-approved) | Zileuton; extended-release tablets | Moderate persistentasthma | Trial results showed Zyflo significantly improved lung function compared to placebo (9/13) | ||||
| Depomed Inc. (DEPO) | Omeprazole | Proton pump inhibitor | Gastroesophageal refluxdisease | Phase IIa data showed advantages of the drug's delivery in twoevening pulses to patients suffering with nocturnal acidbreakthrough associated with GERD (9/5) | ||||
| Depomed Inc. (DEPO) | Gabapentin GR | An extended-release formulation of gabapentin | Menopausal hot flashes | Completed patient enrollment in a Phase II trial(9/19) | ||||
| Halozyme Therapeutics Inc.(HALO) | Chemophase | Uses the rHuPH20 technology to enhance deliveryof chemotherapeutics | Superficial bladder cancer | Completed enrollment in a Phase I/IIa trial (9/26) | ||||
| MGI Pharma Inc. (MOGN) | Aquavan | A sedative-hypnotic agent | For use in minor surgical ordiagnostic procedures | Filed an NDA (9/27) | ||||
| Nektar Therapeutics Inc. (NKTR) | NKTR-118 | Oral PEG-naloxol | Opioid-bowel dysfunction | Phase I data showed the drug antagonized the morphine-induced delay in gastrointestinal transit time without reversing thecentral opioid effect as measured by pupillometry (9/26) | ||||
| Nventa Bio-pharmaceuticals Corp. (TSX:NVN) | HspE7 | Vaccine for human papillomavirus-related diseases | Cervical intra-epithelialneoplasia | Started a Phase I trial (9/10) | ||||
| Osteologix Inc. (OTC BB:OLGX) | NB S101 | Dual-acting bone agent | Osteoporosis | Phase I data showed it had greater strontium bioavailability thana similar osteoporosis drug, Protelos (9/19) | ||||
| Palatin Technologies Inc. (AMEX:PTN) | Bremelanotide | Melanocortin receptor agonist | Female sexual arousal disorder | Phase II data showed statistically significant improvements,compared to baseline and placebo, in desire and arousal success rates, and overall satisfaction at one and two months(9/27) | ||||
| Plethora Solutions Holdings plc (UK; LSE:PLE) | PSD597 | Formulation of an analgesic agent | Interstitial cystitis andpainful bladdersyndrome | Phase II data showed patients treated with the drug experienced a statistically significant improvement in their symptoms(9/6) | ||||
| PrimeCell Therapeutics LLC* | | Autologous adult bone-marrow stem cells | Spinal cord injuries | Clinical results in 38 patients showed that some patients experienced restored function (9/24) | ||||
| Progenics Pharmaceuticals Inc. (PGNX) and WyethPharmaceuticals | MNTX | Methylnaltrexone; a peripherally acting muopioid receptor antagonist | Opioid-induced constipation andpostoperative ileus | Started three new trials, two investigating its use in constipationpatients outside of the palliative care population as a subcutaneous treatment; a third trial, a Phase III, will investigate intravenous MNTX for managing postoperative ileus (9/11) | ||||
| Regeneron Pharmaceuticals Inc. (REGN) | Rilonacept | IL-1 Trap | Chronic active gout | Treatment demonstrated a statistically significant reduction inpatient pain scores in a single-blind, controlled study of 10 patients (9/10) | ||||
| Salix Pharmaceuticals (SLXP) | Xifaxan (FDA-approved) | Rifaximin; gut-selective oral antibiotic | Diarrhea-associatedirritable bowel syndrome | Phase IIb data showed a statistically significant improvement inboth adequate relief of symptoms and adequate relief ofbloating, compared to placebo (9/5) | ||||
| Spectrum Pharmaceuticals Inc. (SPPI) | Ozarelix | Fourth-generation luteinizing hormone-releasing hormone antagonist | Benign prostatichypertrophy | Phase II data showed that ozarelix significantly improvedscores for International Prostate Symposium Score, the primaryendpoint (9/5) | ||||
| Sucampo Pharmaceuticals Inc.* and Takeda Pharmaceuticals Inc. | Lubiprostone (FDA-approved as Amitiza) | 24 mcg, oral gel capsules; a chloride channel activator | Opioid-induced boweldysfunction | First patient has been enrolled in a Phase III study (9/13) | ||||
| Sucampo Pharmaceuticals Inc. (SCMP) | SPI-8811 | Cobiprostone | Non-steroidal anti-inflammatory drug-induced ulcers and othergastrointestinal injuries | Started a Phase II trial (9/20) | ||||
| Tengion Inc.* | Neo-bladder construct | Derived from a patient's own cells | Neurogenic bladder due tospinal cord injuries | Started a Phase II trial (9/17) | ||||
| ThromboGenics NV (Belgium;Euronext:THR) | Microplasmin | A truncated form of the natural human proteinplasmin | Vitreomacular traction | Completed patient enrollment in a Phase IIa study (9/21) | ||||
| Vical Inc. (VICL) | NV1FGF | Uses Vical's nonviral DNA delivery technology;a plasmid DNA therapy encoding fibroblastgrowth factor 1 | To prevent major amputation or death | Started a Phase III trial (9/20) | ||||
| XenoPort Inc. (XNPT) | XP19986 | A transported prodrug of R-baclofen | Gastroesophageal refluxdisease and spasticity | Phase I data demonstrated sustained levels over 24 hours andenabled identification of suitable doses for further clinical studies(9/10) | ||||
| Zelos Therapeutics Inc.* | Ostabolin-C | A cyclic parathyroid hormone analogue | Osteoporosis | Phase II data showed the drug met its primary endpoint of a significant change in lumbar spine bone mineral density atone year (9/19) | ||||
| 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; CDNX = Canadian Venture Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange. | ||||||||
