| Company* (Country; Symbol) | Product | Description | Indication | Status (Date) |
| CANCER | ||||
| AEterna Zentaris Inc. (AEZS) | AEZS-108 | A luteinizing hormone-releasing hormone agonist linked to doxorubicin | Endometrial cancer | Entered the second stage of patient recruitment for its Phase II trial (11/3) |
| Bionovo Inc. (BNVI) | BZL101 | Causes energy collapse in cancer cells by inhibiting glycolysis | Metastatic breast cancer | Successfully completed a Phase Ib trial, showing it is safe and well tolerated, and is now advancing to Phase II (11/4) |
| Celator Pharmaceuticals Inc.* | CPX-351 | A liposomal formulation of cytarabine and dauno-rubicin | Acute myeloid leukemia | First patient has been treated in a randomized Phase II study (11/19) |
| CuraGen Corp. (CRGN) | CR011-vcMMAE | An antibody-drug conjugate that targets GPNMB | Unresectable Stage III or Stage IV melanoma | Phase II data showed a median overall progression-free survival to data of about 4.5 months, compared to a historical expectation of 1.7 months (11/3) |
| Epeius Biotechnologies Corp.* | Rexin-G | Tumor-targeted drug | Tumors | Phase I/II and Phase II data showed no major toxicity and demonstrated significant control of tumor growth (11/21) |
| ImClone Systems Inc. (IMCL) | IMC-1121B | Fully human, IgG1 anti-vascular growth factor receptor-2 monoclonal antibody | Advanced non-small-cell lung cancer | A Phase II trial of IMC-1121B in combination with paclitaxel and carboplatin as first-line therapy has opened enrollment (11/11) |
| ImClone Systems Inc. (IMCL) | IMC-A12 | A fully human, IgG1 anti-insulin-like growth factor-1 receptor monoclonal antibody | Breast cancer | Phase II trial began patient enrollment (11/19) |
| Oncolytics Biotech Inc. (Canada; ONCY) | Reolysin | Intravenous administration | Bone and soft-tissue sarcomas | Phase II data showed it is well tolerated and that 21% of evaluable patients experienced stable disease for more than 16 weeks (11/6) |
| Thallion Pharmaceuticals Inc. (Canada; TSX:TLN) | TLN-232 | A seven amino-acid peptide designed to target pyruvate kinase M2 | Metastatic melanoma | Enrolled the first patient in its Phase II trial (11/18) |
| YM BioSciences Inc. (Canada; AMEX:YMI) | Nimotuzumab | Anti-EGFR monoclonal antibody | Advanced non-small-cell lung cancer and unresectable brain metastases | Phase II data of nimotuzumab in combination with whole brain radiation therapy showed a 91.6% disease control rate compared to 44.4% for the radiation alone arm (11/4) |
| CARDIOVASCULAR | ||||
| Aastrom Biosciences Inc. (ASTM) | Cardiac Repair Cells | An autologous, mixed-cell product containing expanded populations of stem and early progenitor cells | Dilated cardiomyopathy | First patient was treated in its Phase II trial (11/21) |
| Anthera Pharmaceuticals Inc.* | Varespladib | Cholesterol-lowering and anti-inflammatory drug | Coronary heart disease | Phase II data showed that it had a significant anti-inflammatory effect in patients currently on statin therapy (11/11) |
| ARYx Therapeutics Inc. (ARYX) | ATI-5923 | A vitamin K epoxide reductase inhibtor | To reduce blood clots | Completed enrollment in a Phase II/III trial (11/3); data showed that exposure and elimination rate are unaffected by CYP 2C9/3A4 inhibitor fluconazole treatment, while the levels of warfarin were dramatically increased; data also showed that patients had more stable control of anticoagulation with ATI-5923 than with prior warfarin therapy (11/17) |
| Chelsea Therapeutics International Ltd. (CHTP) | Droxidopa | An orally active synthetic precursor of norepinephrine | Intradialytic hypotension | Completed patient enrollment in its Phase II trial (11/19) |
| Corthera Inc.* | Relaxin | Naturally occurring peptide hormone that acts as a targeted vasodilator with systemic and renal hemodynamic effects | Acute heart failure | Interim analysis of top-line data from the Phase II portion of a Phase II/III trial showed favorable efficacy and safety (11/13) |
| Cytokinetics Inc. (CYTK) | CK-1827452 | A cardiac myosin activator | Heart failure | Phase IIa data showed it significantly improved systolic ejection time, fractional shortening and stroke volume (11/10) |
| Essentialis Inc.* | DCCR | Diazoxide choline controlled release; an ATP-dependent potassium channel agonist | Cardiovascular and metabolic diseases | Completed enrollment in a 92-patient Phase II trial in dyslipidemic patients (11/24) |
| Johnson & Johnson Pharmaceutical Research & Development LLC | Rivaroxaban | Anticoagulant | Cardiovascular events | Phase II data showed it was associated with a 21% reduction in risk of death, myocardial infarction, stroke or severe recurrent ischemia, although the result was not statistically significant (11/10) |
| LifeCycle Pharma A/S* (Denmark) | LCP-AtorFen | A fixed-dose combination product of atorvastatin | Dyslipidemia | Reported positive data obtained in a 12-week Phase II study in about 220 patients (11/11) |
| Metabolex Inc.* | MBX-8025 | Believed to regulate fatty acid degradation, lipid storage/transport and insulin sensitivity | Dyslipidemia | Phase II data showed that patients receiving the drug experienced a 30% reduction in triglycerides and a 20% drop in LDL cholesterol vs. placebo |
| Molecular Insight Pharmaceuticals Inc. (MIPI) | Zemiva | Lodofiltic acid I 123; a fatty acid analogue | Cardiac ischemia | Phase IIb data showed that conducting SPECT imaging along with Zemiva helped identify patients at risk of acute ACS (11/10) |
| Mpex Pharmaceuticals Inc.* | MP-376 | Its formulation of levofloxacin inhalation solution | Chronic obstructive pulmonary disease | Started a Phase II study (11/3) |
| Portola Pharmaceuticals Inc.* | Betrixaban | Its oral Factor Xa inhibitor anticoagulant | To prevent stroke in patients with atrial fibrillation | Began enrollment in a Phase II trial (11/3) |
| Portola Pharmaceuticals Inc.* | PRT060128 | An antiplatelet drug | Stable coronary artery disease | Clinical data of 20 patients showed it can overcome high platelet reactivity in patients who do not respond to Plavix (11/12) |
| Raptor Pharmaceuticals Corp. (OTC BB: RPTP) | Convivia | Oral formulation of 4-methylpyrazole | ALDH2 deficiency, or ethanol intolerance | Reported positive results from its Phase IIa study, showing it significantly reduced heart palpitations (11/11) |
| VIA Pharmaceuticals Inc. (VIAP) | VIA-2291 | A reversible inhibitor of 5-lipoxygenase, an enzyme involved in the biosynthesis of leukotrienes | Acute coronary syndromes | Phase II data showed that it inhibited leukotrienes associated with vascular inflammation (11/10) |
| ViroPharma Inc. (VPHM) | Cinryze (FDA-approved) | C1 inhibitor therapy | Acute hereditary angioedema | An ongoing, open-label study showed it successfully treated all types of HAE attacks seen in the study through the date of analysis (11/12) |
| CENTRAL NERVOUS SYSTEM | ||||
| Ceregene Inc.* | CERE-120 | Composed of an adeno-associated virus vector carrying the gene for neurturin | Advanced Parkinson's disease | Phase II data showed the study did not demonstrate an appreciable difference between advanced patients treated with CERE-120 vs. those in the control group (11/28) |
| Memory Pharmaceuticals Corp. (MEMY) | R3487/MEM 3454 | Lead alpha-7 nicotinic receptor agonist | Cognitive impairment associated with schizophrenia | Achieved the enrollment goal of 212 patients for its Phase II trial (11/19) |
| Proteo Inc. (OTC BB:PTEO) | Elafin | Produced naturally in humans and inhibits enzymes responsible for the formation of circulating factors (cytokines) that promote inflammatory reactions | Inflammation | Began patient recruitment in a Phase II trial (11/17) |
| Repligen Corp. (RGEN) | RG2417 | Oral formulation of uridine | Bipolar depression | Began a Phase IIb trial (11/6) |
| Synosia Therapeutics* (Switzerland) | SYN-117 | Nepicastat | Post-traumatic stress disorder | Started a Phase IIa trial (11/3) |
| XenoPort Inc. (XNPT) and Astellas Pharma Inc. (Japan) | XP13512 | A transported prodrug of gabapentin | Painful diabetic neuropathy | Terminated a Phase II study after an analysis showed it was unlikely the trial would reach statistical significance (11/6) |
| DIABETES | ||||
| ConjuChem Biotechnologies Inc. (Canada; TSX:CJB) | PC-DAC-Exendin-4 | An insulinotropic peptide and GLP-1 receptor agonist | Type II diabetes | Dosing is complete for its Phase II trial (11/5) |
| Derma Sciences Inc. (OTC BB:DSCI) | DSC127 | A biologically active angiotensin analog | Diabetic foot ulcers | First patient was enrolled in its Phase II study (11/3) |
| Halozyme Therapeutics Inc. (HALO) | Humulin R and Humalog | Regular insulin human injection and insulin lispro | Type I diabetes | Started a Phase II trial (11/3) |
| Metabasis Therapeutics Inc. (MBRX) | MBO7803 | Its second-generation fructose-1,6-bisphosphatase inhibitor | Type II diabetes | Phase IIa data showed it was safe and well tolerated and met the primary efficacy endpoint of a significant reduction in fasting plasma glucose (11/3) |
| 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 | Diabetic nerve damage | Phase II showed that SB-509 was no different than placebo (11/11) |
| XTL Biopharmaceuticals Ltd. (XTLB) | Bicifadine | A serotonin and norepinephrine reuptake inhibitor | Diabetic nerve pain | Did not meet any of its objectives in a Phase II study (11/18) |
| INFECTION | ||||
| Avexa Ltd. (Australia; ASX:AVX) | APC | Apricitabine | HIV | Phase IIb data showed it provided significant and durable antiviral activity over the treatment period, and had a favorable safety profile (11/13) |
| Bavarian Nordic A/S (Denmark; CSE:BAVA) | Imvamune | Smallpox vaccine | For use in HIV patients | Completed a safety report from a large Phase II study, confirming an excellent safety profile (11/6) |
| Genetic Immunity LLC* | DermaVir Patch | A nanomedicine candidate | Treatment-naive HIV-infected patients | Company treated the first subject in a Phase II study (11/14) |
| Medarex Inc. (MEDX) | MDX-066 and MDX-1388 | Two fully human antibodies that neutralizeC. difficile toxins A and B, respectively | C. difficile-associated diarrhea | Phase II trial successfully met its primary objective (11/3) |
| Medivir AB (Sweden; MVIRB) and Tibotec BVBA* (Belgium) | TMC435350 | Protease inhibitor | Hepatitis C virus | Phase IIa data demonstrated dose-dependent antiviral activity; it was well tolerated in combination with PEG-interferon alpha-2a and ribavirin in treatment-naive HCV genotype 1 patients up to 28 days (11/4) |
| NovaBay Pharmaceuticals Inc. (AMEX:NBY) | NVC-422 | Aganocide compound | Preventing catheter-associated urinary tract infections | Started patient enrollment in a Phase II study (11/18) |
| Novexel* (France) | NXL104/ceftazidime | Broad-spectrum beta-lactamase inhibitor combined with a cephalosporin antibiotic | Complicated urinary tract infections | Entered Phase II trials (11/12) |
| Romark Laboratories LC* | | Thiazolide nitazoxanide | Hepatitis C virus | Phase II data showed that of patients pretreated for four weeks, 80% experienced a 24-week sustained viral response (SVR24), while 61% of patients pretreated for 12 weeks achieved an SVR24 (11/3) |
| Theratechnologies Inc. (Canada; TSX:TH) | TH9507 | Tesamorelin | HIV-associated lipodystrophy | Last patient in the extension phase of a confirmatory Phase III trial completed treatment (11/13) |
| Tibotec BVBA (unit of Johnson & Johnson) | TMC435 | Protease inhibitor | Hepatitis C virus | Phase IIa data demonstrated that 89% of patients treated with the highest dose combined with standard of care achieved undetectable HCV RNA levels at four weeks (11/3) |
| Valeant Pharmaceuticals International (NYSE:VRX) | Taribavirin | A prodrug of ribavirin | Chronic hepatitis C | Phase IIb data continued to show comparable reductions in viral load for weight-based doses of taribavirin and ribavirin (11/24) |
| Vertex Pharmaceuticals Inc. (VRTX) | Telaprevir | Protease inhibitor | Hepatitis C virus | Phase IIb interim data in treatment-experienced patients showed that 52% of patients achieved a 12-week sustained viral response, while only 30% on the standard-of-care regimen had undetectable HCV RNA levels at 36 weeks, and it was expected to drop to between 10% and 12% (11/3) |
| Vical Inc. (VICL) | | DNA vaccine | To prevent cytomegalovirus reactivation and disease in immunosuppressed stem cell transplant recipients | Completed enrollment in a Phase II trial (11/12) |
| MISCELLANEOUS | ||||
| Affymax Inc. (AFFY) | Hematide | A synthetic PEGylated peptide-based erythropoiesis-stimulating agent | Chronic renal failure | Phase II data showed that 182 patients with anemia using Hematide once every four weeks for up to 23 months successfully maintained average hemoglobin levels within an 11 g/dL to 12 g/dL target range (11/6) |
| Antares Pharma Inc. (AMEX:AIS) | | A novel contraceptive advanced transdermal delivery gel containing the progestin Nestorone and a form of estrogen, called estradiol | To suppress ovulation | Started a Phase II trial (11/24) |
| BioCis Pharma Ltd.* (Finland) | ProtoCure | Emulsion cream; topical drug | Dermatology | Began a Phase IIa trial (11/6) |
| CPEX Pharmaceuticals Inc. (CPEX) and Serenity Pharmaceuticals* | | Intranasal drug candidate delivered using CPEX's delivery platform | Urology indication | Started a Phase II trial (11/17) |
| EyeGate Pharma* | EGP-437 | A corticosteroid solution | Dry eye | Enrolled the first patient in a Phase II trial (11/10) |
| Gene Signal International SA* (Switzerland) | GS-101 | Eye drops; an oligo-nucleotide approach aimed at blocking blood vessel formation | To prevent corneal graft rejection | Phase II data demonstrated significant regression of corneal neovascularization (11/10) |
| Morria Biopharmaceuticals plc* (UK) | MRX-4 | Intranasal spray formulation | Allergic rhinitis | Phase II data demonstrated a statistically significant therapeutic effect vs. placebo (11/6) |
| Pervasis Therapeutics Inc.* | Vascugel | An allogeneic cell therapy product designed to restore natural repair and regeneration pathways in the vasculature | Hemodialysis patients with end-stage renal disease | Phase I and Phase II trials involving 65 patients found that treatment with Vascugel was safe with a lower incidence of local wound infection, access intervention and acute thrombosis compared to placebo (11/6); data also showed improved patency and extended time to first intervention (11/19) |
| Phosphagenics Ltd. (Australia; LSE:PSG) | Phospha E | A derivative of vitamin E | Metabolic syndrome | Completed recruitment of the Phospha E Phase II trial (11/5) |
| Protox Therapeutics Inc. (Canada; TSX:PRX) | PRX302 | A prodrug activated by prostate-specific antigen | Benign prostatic hyperplasia | PRX302 improved International Prostate Symptom Scores in a single-arm, open-label, Phase II trial of 18 patients (11/25) |
| Tercica Inc. (FSE:TCK) | Increlex (FDA-approved) | Mecasermin (rDNA origin) injection | Primary IGF-1 deficiency | Phase IIb data demonstrated that it achieved statistically significant, dose-dependent first-year height velocity increases (11/12) |
| Vantia Therapeutics* (UK) | VA106483 | A vasopressin agonist | Nocturia | Started Phase II trials (11/3) |
| Notes: | ||||
| * Privately held. | ||||
| Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
| AMEX = American Stock Exchange; ASX = Australian 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; TSX = Toronto Stock Exchange. | ||||
