| Company* (Country; Symbol) |
Product | Description | Indication | Status (Date) |
| AUTOIMMUNE | ||||
| Avigen Inc. (AVGN) | AV650 | Tolperisone HCl | Spasticity associated with multiple sclerosis | Completed the double-blind portion of its Phase IIb trial (9/18) |
| BioCryst Pharmaceuticals Inc. (BCRX) | BCX-4208 | An orally available small-molecule inhibitor of purine nucleoside phosphorylase | Moderate to severe plaque psoriasis | Phase IIa data showed it met its primary objectives of safety and tolerability and displayed dose-dependent reductions in peripheral blood lymphocyte counts (9/4) |
| Genentech Inc. (NYSE:DNA) and Biogen Idec Inc. (BIIB) | Rituxan (FDA-approved) | Rituximab | Primary-progressive multiple sclerosis | Phase II/III showed that although the trial missed its endpoint, full data indicated an impact on disease activity (9/22) |
| Incyte Corp. (INCY) | INCB18424 | A selective janus-associated kinase inhibitor | Mild to moderate psoriasis | Phase IIa data showed the compound was well tolerated at all doses and significantly improved overall total lesion score as compared to vehicle (9/18) |
| MediciNova Inc. (MNOV) | MN-166 | Works by inhibiting leukotriene activity, phosphodiesterases and nitric oxide synthase | Multiple sclerosis | Phase II data showed that sustained disability progression was significantly less likely in patients receiving MN-166 at either 30 mg or 60 mg per day for 24 months than in those receiving the drug for 12 months (9/19) |
| NPS Pharmaceuticals Inc. (NPSP) | NPSP558 | Recombinant full-length human parathyroid hormone | Hypopara- thyroidism | Phase II data demonstrated that treatment with PTH 1-84 had a beneficial effect on abnormal bone skeletal properties (9/15) |
| Opexa Therapeutics Inc. (OPXA) | Tovaxin | T-cell vaccination therapy | Multiple sclerosis | Phase IIb data showed a positive trend in the reduction in annualized relapse rate for patients treated with Tovaxin as compared to placebo (9/19); missed its primary endpoint of reducing the number of brain lesions in a Phase IIb trial (9/22) |
| Pipex Pharmaceuticals Inc. (AMEX:PP) | Estriol | The active ingredient in Trimesta | Multiple sclerosis | Phase IIa data demonstrated that estriol decreased matrix metalloproteinase, which plays a role in the migration of inflammatory cells (9/19) |
| CANCER | ||||
| Antisoma plc (UK; LSE:ASM) | AS1411 | An aptamer designed to bind specifically to nucleolin | Kidney cancer | Started a Phase II study (9/4) |
| Antisoma plc (UK; LSE:ASM) | AS1402 | Targets a cancer-associated form of the cell-surface protein MUC1 | Advanced breast cancer | Started a Phase II trial of AS1402 added to letrozole in post-menopausal women (9/30) |
| Argos Therapeutics Inc.* | AGS-003 | Second-generation, dendritic cell-based personalized immuno-therapy | Advanced renal cell carcinoma | Began a Phase IIa trial (9/10) |
| Calando Pharmaceuticals Inc.* | IT-101 | A conjugate of campto-thecin and cyclodextrin polymer nanoparticle | Platinum-sensitive ovarian cancer | Started a Phase II trial (9/11) |
| Celgene International (Switzerland; CELG) | Revlimid (FDA-approved) | Lenalidomide | Aggressive non-Hodgkin's lymphoma | Phase II data demonstrated an objective response in 35% of patients eligible for response evaluation (9/2) |
| CuraGen Corp. (CRGN) | CR011-vc MMAE | An antibody-drug conjugate composed of a fully human monoclonal antibody against glyco-protein NMB attached to a synthetic drug monomethyl auristatin E | Advanced melanoma | Completed enrollment of a targeted 36 patients into its Phase II trial (9/11) |
| Genmab A/S (Denmark; CSE:GEN) | HuMax-CD20 | Ofatumumab | Follicular non-Hodgkin's lymphoma | Completed recruitment of 56 untreated patients in the Phase II study in combination with cyclo-phosphamide, doxorubicin, vincristine and prednisone (9/22) |
| Human Genome Sciences Inc. (HGSI) | HGS-ETR1 | Mapatumumab | Advanced multiple myeloma | Phase II data in combination with Velcade showed it was well tolerated and suggested the disease response was comparable for that combination vs. Velcade alone (9/3) |
| ImClone Systems Inc. (IMCL) | IMC-A12 | Fully human, IgG1 anti-insulin-like growth factor-1 receptor monoclonal antibody | Advanced breast cancer | Started patient enrollment in a Phase II trial (9/25) |
| ImClone Systems Inc. (IMCL) | IMC-1121B | Fully human, IgG1 antivascular growth factor receptor-2 monoclonal antibody | Advanced ovarian cancer | First patient was treated in its Phase II trial (9/30) |
| Medarex Inc. (MEDX) and Bristol-Myers Squibb Co. | Ipilimumab | Immunotherapy | Advanced metastatic melanoma | Phase II data showed that about half of patients on ipilimumab remained alive beyond one year (9/15) |
| MediGene AG (Germany; FSE:MDG) | EndoTAG-1 | A combination of paclitaxel and a delivery system made up of cationic lipids; designed to specifically destroy the blood vessels of tumors | Pancreatic cancer | Phase II data of EndoTAG-1 in combination with Gemcitabine showed noticeably higher survival rates than patients treated with Gemcitabine alone (9/16) |
| Oncolytics Biotech Inc. (Canada; ONCY) | Reolysin | Intravenous administration | Non-small-cell lung cancer with K-RAS or EGFR-activated tumors; head and neck cancers | Initiated a Phase II trial (9/2); started enrolling patients in a Phase II trial (9/8) |
| Synta Pharmaceuticals Corp. (SNTA) | Elesclomol | Small-molecule, oxidative stress inducer | Metastatic melanoma | Phase IIb data showed that elesclomol combined with paclitaxel had two-year overall survival of 27% (9/15) |
| Thallion Pharmaceuticals Inc. (Canada; TSX:TLN) | TLN-232 | A novel 7-amino-acid peptide targeting pyruvate kinase M2 | Renal cell carcinoma | Phase II data demonstrates that it was generally safe and well tolerated (9/15) |
| Thallion Pharmaceuticals Inc. (Canada; TSX:TLN) | TLN-4601 | A novel small molecule derived from a nonpatho-genic microorganism | Glioblastoma multiforme | Enrolled the first patient in its Phase II trial (9/26) |
| Ziopharm Oncology Inc. (ZIOP) | ZIO-210 | Isophosphoramide mustard | Soft-tissue sarcoma | The first patient was dosed in a Phase II trial (9/5) |
| CARDIOVASCULAR | ||||
| CardioVascular BioTherapeutics Inc. (OTC BB: CVBT) | FGF-1 | Contains human fibroblast growth factor-1 | Severe coronary heart disease | Opened patient enrollment for its Phase II trial (9/9) |
| Cytokinetics Inc. (CYTK) | CK-1827452 | A cardiac myosin activator | Acutely decompensated or chronic heart failure | Phase IIa data showed statistically significant correlations between CK-1827452 concentration and increases in systolic ejection time, stroke volume, fractional shortening and cardiac output (9/2); began its third Phase IIa trial (9/5) |
| Fibrex Medical* | FX06 | A peptide that binds to vascular endothelial cadherin | Heart attack | Phase II data indicated a statistically significant reduction in myocardial necrosis compared to placebo (9/2) |
| Omrix Bio-pharmaceuticals Inc. (OMRI) | Fibrin Pad | Comprised of a biologically active component and thrombin embedded in a biodegradable matrix | Mild to moderate bleeding | Completed enrollment of the first 90 patients in its Phase II trial (9/22) |
| Orexo AB (Sweden; SSE:ORX) | OX914 | PDE4 inhibitor | Inflammatory airway diseases, including asthma, chronic obstructive pulmonary disease and rhinitis | Began a Phase II program (9/2) |
| Osiris Therapeutics Inc. (OSIR) | Prochymal | Formulation of adult mesenchymal stem cells | Moderate to severe chronic obstructive pulmonary disease | Completed enrollment of 62 patients in a Phase II trial (9/23) |
| ThromboGenics NV (Belgium; BR:THR) | Microplasmin | Intravenous administration | Acute ischemic stroke | Phase II data showed it was generally well tolerated with no evidence of increased bleeding risk (9/29) |
| VIA Pharmaceuticals Inc. (VIAP) | VIA-2291 | A small-molecule drug that targets inflammation in the blood vessel wall | Acute coronary syndrome | Completed the last patient visit in the Phase II study (9/24) |
| CENTRAL NERVOUS SYSTEM | ||||
| Cerimon Pharmaceuticals Inc.* | | Diclofenac sodium patch; once-daily, topical and 15 mg | Pain due to ankle sprains | Achieved statistical significance in its primary endpoint in a Phase II study involving 170 patients (9/11) |
| CoLucid Pharmaceuticals Inc.* | COL-144 | A highly potent and selective 5HT1F receptor agonist | Acute migraine | Phase II data showed it was safe and effective in relieving head-aches (9/8) |
| Columbia Laboratories Inc. (CBRX) | Lidocaine | Vaginally-administered | Dysmenorrhea | Phase II showed it did not achieve its primary endpoint; results showed no significant difference with placebo (9/29) |
| Evotec AG (Germany; EVTC) | EVT 302 | A reversible and highly selective inhibitor of monoamine oxidase B | Smoking cessation | Began a Phase II trial; an exploratory Phase II craving study showed it was well tolerated (9/11) |
| Logical Therapeutics Inc.* | LT-NS001 | A prodrug designed to convert in the bloodstream to naproxen | Inflammation | Started a double-blind, randomized, active-controlled study of LN-NS001 (9/8) |
| NeurAxon Inc.* | NXN-188 | Small-molecule product that incorporates both 5-HT agonist and inhibition of neuronal nitric oxide synthase | Migraine pain | Phase II data showed a 15% greater effect than placebo in pain relief at two hours, which did not meet the primary end-point (9/5) |
| Obecure Ltd.* (Israel) | Histalean | Comprised of betahistine, an H1 receptor agonist and partial H3 receptor antagonist | Obesity | Began a Phase II trial (9/8) |
| Rexahn Pharmaceuticals Inc. (AMEX:RXN) | Serdaxin | A dual enhancer of serotonin and dopamine neurotransmitters | Major depressive disorders | Will begin a Phase II trial (9/10) |
| Sangamo BioSciences Inc. (SGMO) | SB-509 | An injectable formulation of a plasmid encoding a zinc finger DNA-binding protein transcription factor designed to up-regulate the expression of the gene encoding vascular endothelial growth factor | Amyotrophic lateral sclerosis | Opened a Phase II trial (9/3) |
| Targacept Inc. (TRGT) | AZD3480 | TC-1734; selective alpha4 beta2 neuronal nicotinic receptor agonist | Alzheimer's disease | Phase IIb data was inconclusive due to a strong placebo effect (9/16) |
| DIABETES | ||||
| Sangamo BioSciences Inc. (SGMO) | SB-509 | ZFP therapeutic program | Diabetic neuropathy | Phase II data demonstrated an improvement in nerve conduction velocity (9/15) |
| Metabasis Therapeutics Inc. (MBRX) | MB07803 | An inhibitor of fructose-1, 6-bisphosphatase | Type II diabetes | Initiated a dose-optimization trial (9/24) |
| Oramed Pharmaceuticals Inc. (Israel; OTC BB:ORMP) | ORMD 0801 | An oral insulin capsule | Type I diabetes | Initiated a Phase IIa trial (9/24) |
| Transition Therapeutics Inc. (Canada; TTHI; TSX:TTH) | TT-223 | Gastrin analogue | Type II diabetes | The first patient was dosed in a Phase II study with 80 patients (9/12) |
| INFECTION | ||||
| Arpida Ltd. (Switzerland; SWX:ARPN) | Iclaprim | Oral antibiotic | Complicated skin and skin structure infections | Completed enrollment in a Phase II trial (9/23) |
| Idenix Pharmaceuticals Inc. (IDIX) | IDX899 | A non-nucleoside reverse transcriptase inhibitor | HIV-1 | Completed the proof-of-concept study demonstrating that the 100-mg/day cohort achieved a mean plasma viral load reduction of 1.87 log10 after seven days of treatment (9/4) |
| Intercell AG (Austria; Vienna:ICLL) | IC41 | Hepatitis C vaccine | Hepatitis C virus | Six-month follow-up data from a Phase II study showed a statistically significant reduction of viral load in the blood of chronically infected patients up to two weeks after the last vaccination (9/3) |
| Medivir AB (Sweden; SSE:MVIRB) | TMC435350 | Protease inhibitor | Hepatitis C virus | Phase IIa data shows it to be safe, with no serious adverse events, no safety-related treatment discontinuations and no dose-related safety findings (9/24) |
| Novavax Inc.(NVAX) | | Virus-like particle-based seasonal influenza vaccine | Influenza | Started vaccination of healthy volunteers in a Phase II trial (9/16); completed enrollment of 300 healthy volunteers in a Phase IIa trial (9/19) |
| SciClone Pharmaceuticals Inc. (SCLN) | SCV-07 | Immunomodulatory compound | Hepatitis C virus | Phase II data demonstrated activity in some treated patients in the higher dosage groups, and the decrease in viral load was accompanied by an increase in an immunological biomarker (9/22) |
| Targanta Therapeutics Corp. (TARG) | Oritavancin | Semisynthetic lipoglyco-peptide antibiotic candidate with potent bactericidal activity | Complicated skin and skin structure infections | Phase II data demonstrated comparable efficacy and safety to a three-to-seven day course of oritavancin therapy (9/2) |
| Transgene SA (France; Paris: TNG) | TG4010 | Vaccine that consists of a Modified Vaccinia Ankara viral vector incorporating the gene sequences for the tumor-associated antigen MUC1 and the cytokine Interleukin 2 | Non-small-cell lung cancer | Phase IIb data showed that after 17 months of follow-up, 39% of treated patients are alive, compared to 23% of control patients (9/15) |
| Trius Therapeutics Inc.* | TR-701 | Second-generation oxazolidinone anti-bacterial drug | Complicated skin and skin structure infections | Started Phase II testing (9/19) |
| MISCELLANEOUS | ||||
| ActoGeniX NV* (Belgium) | AG011 | An ActoBiotic, orally administered, protein-based drug | Ulcerative colitis | Initiated a Phase IIa trial (9/11) |
| Agile Therapeutics Inc.* | AG-200-15 | Low-dose, once-weekly, contraceptive patch | For contraception | Completed two Phase IIb trials (9/3) |
| Auxilium Pharmaceuticals Inc. (AUXL) | Xiaflex | Clostridial collagenase for injection | Peyronie's disease | Dosed the first patients in a Phase IIb trial (9/17) |
| Axentis Pharma AG* (Switzerland) | | Formulation that allows an established therapeutic agent to be delivered directly to the site of infection | Cystic fibrosis | Initiated a Phase IIa trial (9/4) |
| Bionovo Inc. (BNVI) | MF101 | Estrogen receptor beta selective modulator | Menopausal hot flashes | Showed improved sleep quality for women in a Phase II study (9/15) |
| BioSante Pharmaceuticals Inc. (BPAX) | Pill-Plus | Triple hormone therapy oral contraceptive | Contraception | Completed a Phase II trial showing that the addition of an oral androgen resulted in restoration of testosterone levels to the normal and physiological range for healthy women (9/8) |
| Circassia Ltd.* (UK) | ToleroMune | Designed to use small sections of allergens (T-cell epitomes) to rapidly desensitize allergy sufferers | Cat allergies | Phase II data showed the treatment can substantially reduce allergic reactions to the allergen that causes most cat allergies (9/10) |
| Hollis-Eden Pharmaceuticals Inc. (HEPH) | Triolex | HE3286; a first-in-class insulin sensitizer | Ulcerative colitis | Interim data from five patients in its dose-ranging trial showed that one of the three patients treated with the lowest dose of 5 mg given once-daily for 28 days had a clinical response (9/12) |
| MediciNova Inc. (MNOV) | MN-221 | A highly selective beta2-adrenergic receptor agonist | Moderate to severe, stable asthma | Phase II data showed marked and clinically significant improvement in FEV1, a measure of lung function; the drug was well tolerated (9/9) |
| Neurocrine Biosciences Inc. (NBIX) | Elagolix | Orally active nonpeptide gonadotropin-releasing hormone receptor antagonist | Endometriosis | Phase II data showed it did not induce significant bone loss over a six-month treatment of patients, while providing both rapid and significant pain reduction (9/3) |
| NPS Pharmaceuticals Inc. (NPSP) and GlaxoSmithKline plc (UK) | Ronacaleret | SB-751689; an oral, small-molecule antagonist of the calcium-sensing receptors on the surface of the para-thyroid gland | Osteoporosis | NPS said GSK prematurely halted a Phase II trial after a planned interim analysis showed a lack of efficacy (9/26) |
| Nymox Pharmaceutical Corp. (NYMX) | NX-1207 | Investigational agent for BPH | Benign prostatic hyperplasia | Phase II data showed that men treated with NX-1207 had statistically significant improvement in symptoms associated with benign prostatic hyperplasia three months after a single treatment, with no reported serious drug-related effects (9/25) |
| Protox Therapeutics Inc. (Canada; TSX:PRX) | PRX302 | A prodrug engineered to be activated by prostate-specific antigen | Benign prostatic hyperplasia | Completed enrollment in a Phase II trial (9/3) |
| Regeneron Pharmaceuticals Inc. (REGN) | Arcalyst (FDA-approved) | Rilonacept; IL-1 Trap | Gout | Produced a statistically significant reduction in uric acid levels vs. placebo in the incidence of gout flares in a Phase II study (9/3) |
| XenoPort Inc. (XNPT) | XP19986 | A transported prodrug of R-baclofen | Acute back spasms | Plans to initiate a Phase II trial (9/10) |
|
Notes: * Privately held. Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.AMEX = American 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; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange. | ||||
