Company* (Country; Symbol) |
Product | Description | Indication | Status (Date) |
CANCER | ||||
Acacia Pharma Ltd.* (UK) | APD 405 | An injectable formulation of a currently marketed oral drug | Nausea and vomiting after surgery and after chemo treatment | Initiated its first clinical trial, a Phase I study (9/22) |
AVEO Pharmaceuticals Inc.* | AV-299 | SCH900105; an antibody to hepatocyte growth factor | Relapsed or refractory solid tumors or lymphoma | Initiated a Phase I trial (9/23) |
Biogen Idec Inc. (BIIB) and Elan Corp. plc (Ireland; NYSE:ELN) | Tysabri (FDA-approved) | Natalizumab | Relapsed or refractory multiple myeloma | Started a Phase I/II trial (9/5) |
Cytokinetics Inc. (CYTK) | Ispinesib | Kinesin spindle protein inhibitor | Tumors | Interim Phase I/II data showed that two of seven patients treated at the 14-mg/m2 dose level had protocol-defined dose-limiting toxicities of transient Grade 3 increases in the liver enzymes ALT and AST following cycle 1, day 15 dosing (9/8) |
Cytopia Ltd. (Australia; ASX:CYT) | CYT997 | A vascular-disrupting agent | Glioblastoma multiforme | Started enrollment in its Phase Ib/II study (9/5) |
Five Prime Therapeutics Inc.* | FP-1039 | An FGFR1:Fc fusion protein | Advanced solid tumors | First patient was enrolled in a Phase I trial (9/8) |
Micromet Inc. (MITI) | MT201 | Anti-EpCAM antibody adecatumumab | Cancer | Phase Ib data of MT201 in combination with docetaxel showed the combination appeared to be feasible with clinically manageable diarrhea being the main toxicity at higher doses (9/15) |
Northwest Biotherapeutics Inc. (OTC BB: NWBO) | DCVax-Brain | A personalized immuno-therapy for cancer that is made from a patient's own dendritic cells and antigens from the patient's own tumor tissue | Glioblastoma multiforme | Phase I and Phase I/II follow-up data showed that 84% of patients that received the therapy have lived longer than the median survival of 14.6 months under standard of care (9/11) |
Progenics Pharmaceuticals Inc. (PGNX) | PSMA | Prostate-specific membrane antigen antibody-drug conjugate | Prostate cancer | Started a Phase I trial (9/8) |
S*BIO Pte Ltd.* (Singapore) | SB1518 | An orally active JAK2 inhibitor | Leukemia and certain types of lymphoma | Began Phase I trials (9/18) |
Threshold Pharmaceuticals Inc. (THLDD) | TH-302 | A hypoxia-activated prodrug that specifically targets tumor hypoxia | Soft-tissue sarcoma | Started a Phase I/II trial (9/16) |
TransMolecular Inc.* | 1311-TM601 | 131 Iodine radiolabeled TM601, a novel synthetic peptide derived from scorpion venom | Recurrent malignant glioma | Began dosing in a Phase I/II trial (9/29) |
CARDIOVASCULAR | ||||
CV Therapeutics Inc. (CVTX) | CVT-3619 | Oral compound | Cardiometabolic diseases | Enrolled the first patient in a Phase I trial (9/2) |
Cytokinetics Inc. (CYTK) | CK-1827452 | Plasma concentration | Stable heart failure | Interim analysis demonstrated statistically significant correlations between CK-1827452 and measures of cardiac systolic function (9/24) |
Diffusion Pharmaceuticals LLC* | TSC | Trans-sodium crocetinate | Intermittent claudication associated with peripheral arterial disease | Initiated a Phase I/II trial (9/3) |
GlycoMimetics Inc.* | GMI-1070 | A glycomimetic inhibitor of E-, P- and L-selectins | Sickle cell disease | Started a Phase I trial (9/5) |
Othera Pharmaceuticals Inc.* | OT-730 | Topical beta-blocker | Ocular hypertensionand glaucoma | Started dosing in a Phase I/II trial (9/15) |
Palatin Technologies Inc. (AMEX:PTN) | PL-3994 | A long-acting natriuretic peptide receptor A agonist | Heart failure | Hit the primary endpoint, a reduction in systemic blood pressure, in a Phase I study (9/23) |
PolyMedix Inc. (OTC BB:PYMX) | PMX-60056 | Part of the new heptagonist class; a reversing agent for heparin | For use as an anticoagulant | Began a Phase I study (9/23) |
Regado Biosciences Inc.* | REG1 | A two-component system composed of an aptamerbased anticoagulant, RB006, and its matched, active reversal agent, RB007, which binds to and neutralizes RB006 | To prevent blood clotting | Phase I data showed RB006 inhibited the activity of factor IXa and RB007 rapidly, safely and specifically reversed the activity of RB006 (9/2) |
RegeneRx Bio-pharmaceuticals Inc. (AMEX:RGN) | RGN-352 | An injectable formulation of T(beta)4 | To reduce cardiac damage following acute myocardial infarction | Completed a Phase Ia trial (9/8); enrolled the first subject in a Phase Ib trial (9/22) |
CENTRAL NERVOUS SYSTEM | ||||
7TM Pharma* (Denmark) | TM30339 | Designed to work via the Y4 receptor to mimic a natural satiety signal from the gastrointestinal tract involved in the regulation of food | Obesity and related metabolic disorders | Started a Phase I/IIa trial (9/2) |
Aeolus Pharmaceuticals Inc. (OTC BB:AOLS) | AEOL 10150 | Small-molecule catalytic antioxidant | Amyotrophic lateral sclerosis | Began a follow-on Phase I study (9/30) |
Memory Pharmaceuticals Corp. (MEMY) | R4996/MEM 63908 | A partial agonist of the nicotinic alpha-7 receptor | Alzheimer's disease | Completed a Phase I study (9/26) |
Oxford BioMedica (UK; LSE:OXB) | ProSavin | Gene-based treatment | Parkinson's disease | Phase I/II interim data showed improvements in disease symptoms for the first three patients in the first-dose cohort (9/9) |
Paion AG (Germany; BE:PA8) | CNS 7056 | A short-acting sedative/anaestetic that acts on GABAA receptors in the brain | For sedation | The Phase I study has progressed to the dose levels that induce pronounced sedation (9/22) |
Phosphagenics Ltd. (Australial LSE:PSG) | TPM/lidocaine | Transdermal delivery system | Pain | Started a Phase I trial (9/23) |
Plexxikon Inc.* | PLX5568 | Kinase inhibitor | Pain and polycystic kidney disease | Initiated a Phase I trial (9/3) |
VGX Pharmaceuticals Inc.* | VGX-1027 | An orally active, small-molecule compound | Inflammation | Phase I data showed it was generally safe and well tolerated (9/29) |
DIABETES | ||||
Biocon Ltd. (India; NSE:BIOCON) | IN-105 | Oral insulin drug | Type II diabetes | Data showed it was safe and well tolerated (9/8) |
Hollis -Eden Pharmaceuticals Inc. (HEPH) | Triolex | HE3286 | Obesity | Phase I/II data showed it was safe and well tolerated in obese insulin resistant subjects (9/25) |
OSI Pharmaceuticals Inc. (OSIP) | PSN821 | An orally available agonist of the G-protein coupled receptor GPR119 | Type II diabetes | Initiated a first-in-human clinical study (9/3) |
XOMA Ltd. (XOMA) | XOMA 052 | An antibody drug candidate with an ultra-high binding affinity of 300 femtomolar | Type II diabetes | Phase I data demonstrated biological activity in patients with Type II diabetes as measured by diabetes and inflammatory markers (9/8) |
INFECTION | ||||
Anadys Pharmaceuticals Inc. (ANDS) | ANA598 | An oral, non-nucleoside polymerase inhibitor | Hepatitis C virus | Phase I data showed it was well tolerated at all doses analyzed to date, and no serious adverse events were reported (9/24) |
Enanta Pharmaceuticals Inc.* | EDP-322 | A first-in-class methicillin-resistant Staphylococcus aureus-active Bicyclolide | Hospital-and community-acquired Gram-positive infections | Began a Phase I study (9/15) |
InterMune Inc. (ITMN) | ITMN-191 | A hepatitis C virus NS3 protease inhibitor | Hepatitis C virus | Was shown to be safe and well tolerated (9/24) |
Myriad Genetics Inc. (MYGN) | Vivecon | HIV viral maturation inhibitor | HIV | Completed dose escalation in the Phase I trial of Vivecon (9/17) |
Pharmasset Inc. (VRUS) | R7128 | A nucleoside analogue polymerase inhibitor of HCV | Hepatitis C virus | Phase I data showed significant short-term antiviral activity (9/8) |
VaxInnate Corp.* | | Hemagglutinin-flagellin flu vaccine candidate | Influenza | Started a Phase I trial (9/30) |
MISCELLANEOUS | ||||
Concert Pharmaceuticals Inc.* | CTP-347 | A deuterium-containing serotonin modulator | Vasomotor symptoms | Started a Phase I study (9/25) |
ESBATech AG* (Switzerland) | ESBA105 | A single-chain antibody fragment directed against tumor necrosis factor-alpha | Ophthalmic indications | Completed a Phase I trial (9/8) |
Insmed Inc. (INSM) | Iplex | A complex of recombinant human insulin-like growth factor and its predominant binding protein IGFBP-3 | Retinopathy of prematurity | Clinical data demonstrated that it increased serum IGF-1 levels into the normal range in significantly premature infants (9/23) |
Sunesis Pharmaceuticals Inc. (SNSS) and SARcode Corp. | – | A small-molecule LFA-1 product candidate | Dry eye and allergic rhinitis | Started a Phase I trial (9/5) |
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; BE = Berlin Stock Exchange; LSE = London Stock Exchange; NSE = National Stock Exchange of India; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board. | ||||