Company |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Idera Pharmaceuticals Inc. (Cambridge, Mass.) |
IMO-3100 |
An antagonist of specific Toll-like receptors |
Moderate to severe plaque psoriasis |
Completed enrollment in a Phase II |
10/16/12 |
Lexicon Pharmaceuticals Inc. (The Woodlands, Texas) |
LX-1032 |
Oral, serotonin-reducing therapy; telotristat etiprate |
Carcinoid syndrome |
Phase II data determined that 250 mg and 500 mg are the best doses given three times daily |
10/15/12 |
Receptos Inc. (San Diego) |
RPC1063 |
Selective spingosine-1-phosphate receptor 1 modulator |
Relapsing-remitting multiple sclerosis |
Was administered to the first patient in a Phase II/III study |
10/23/12 |
XBiotech Inc. (Austin, Texas) |
MABp1 |
True Human monoclonal antibody |
Moderate to severe psoriasis |
Phase II data indicated a relatively rapid response in skin lesion severity following an initial subcutaneous injection, and continued improvement over 70 days with a maximum of three injections |
10/18/12 |
CANCER | |||||
Acacia Pharma Ltd. (Cambridge, UK) |
APD403 |
Comprises a marketed dopamine D2/D3 antagonist |
To prevent acute nausea and vomiting in cancer |
Phase IIa data showed it had encouraging benefit, especially in controlling nausea; when combined with ondansetron, a complete response in 19 of 23 patients was achieved |
10/2/12 |
Active Biotech AB (Lund, Sweden) and Ipsen SA (Paris) |
Tasquinimod |
Believed to have a pleiotropic mode of action that includes immunomodulatory, anti-angiogenic and antimetastatic activity |
Advanced metastatic castrate-resistant prostate cancer |
Started a Phase II proof-of-concept study |
10/4/12 |
Astex Pharmaceuticals Inc. (Dublin, Calif.) |
SGI-110 |
A small-molecule DNA-hypomethylating agent |
Platinum-resistant recurrent ovarian cancer |
Started a Phase II study |
10/3/12 |
Astex Pharmaceuticals Inc. (Dublin, Calif.) |
ATI3387 |
Hsp90 inhibitor |
Anaplastic lymphoma kinase-positive non-small-cell lung cancer |
Started an open-label Phase II trial |
10/25/12 |
Athersys Inc. (Cleveland) |
MultiStem |
Adult stem cell therapy |
Ischemic stroke |
Completed enrollment of the first patient cohorts in its Phase II study |
10/3/12 |
Cyclacel Pharmaceuticals Inc. (Berkeley Heights, N.J.) |
Sapacitabine |
Oral therapy |
Myelodysplastic syndromes |
Phase II data showed a median overall survival rate for all 63 patients of 252 days, or about eight months |
10/15/12 |
Eleison Pharmaceuticals LLC (Princeton, N.J.) |
ILC |
Inhaled lipid-complexed cisplatin |
Pediatric osteosarcoma |
Enrolled the first patient in a Phase II study |
10/23/12 |
Ipsen SA (Paris) |
Tasquinimod |
Designed to have immunomodulatory and anti-angiogenic properties |
Cancer |
Plans to start a Phase II trial |
10/22/12 |
NewLink Genetics Corp. (Ames, Iowa) |
HyperAcute Lung |
Tergen-pumatucel-L |
Stage IIIb/IV non-small-cell lung cancer |
Launched an open-label, adaptive design Phase IIb/III study |
10/4/12 |
Oncolytics Biotech Inc. (Calgary, Alberta) |
Reolysin |
Intravenous oncolytic virus |
Advanced or metastatic pancreatic cancer |
Completed patient enrollment in a Phase II trial of Reolysin in combination with gemcitabine |
10/25/12 |
Oxford BioMedica plc (Oxford, UK) |
TroVax |
MVA-5T4; cancer vaccine |
Progressive hormone-refractory prostate cancer |
Company plans to close the U.S. Phase II study |
10/11/12 |
Progenics Pharmaceuticals Inc. (Tarrytown, N.Y.) |
PSMA ADC |
A targeted anticancer therapeutic that uses a monoclonal antibody to deliver a cell-killing drug to malignant cells |
Cancer |
Opened enrollment in a Phase II study |
10/1/12 |
Provectus Pharmaceuticals Inc. (Knoxville, Tenn.) |
PV-10 |
Designed to selectively target and destroy cancer cells without harming surrounding healthy tissue |
Metastatic melanoma |
Phase II data showed an objective response rate of 51% in subjects' target lesions, and 69% disease control in those lesions |
10/3/12 |
Seattle Genetics Inc. (Bothell, Wash.) |
Adcetris |
Brentuximab vedotin; CD30-targeted antibody-drug conjugate |
Newly diagnosed Hodgkin lymphoma |
Started a Phase II study |
10/18/12 |
VentiRx Pharmaceuticals Inc. (Seattle) |
VTX-2337 |
A Toll-like receptor 8 agonist |
Recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer |
Started a Phase II trial of VTX-2337 in combination with Doxil |
10/23/12 |
Ziopharm Oncology Inc. (New York) |
Ad-RTS IL-12 |
A DNA-based therapeutic candidate |
Advanced melanoma |
First patient has been dosed in a Phase II trial |
10/26/12 |
CARDIOVASCULAR | |||||
AIM Therapeutics Inc. (Toronto) |
AIM-102 |
A class of oral, nonsterioidal, immune-modulating anti-inflammatory drugs |
Asthma and chronic obstructive pulmonary disease |
Started dosing in a Phase II study |
10/23/12 |
Pearl Therapeutics Inc. (Redwood City, Calif.) |
PT003 |
Inhaled combination bronchodilator product |
Chronic obstructive pulmonary disease |
Completed its dose-ranging Phase IIb trial |
10/25/12 |
Sangart Inc. (San Diego) |
MP4OX |
An ischemic rescue therapy designed to improve perfusion and oxygen delivery to tissues |
Hemorrhagic shock |
Completed patient enrollment |
10/9/12 |
Trevena Inc. (King of Prussia, Pa.) |
TRV027 |
A next-generation G protein-coupled receptor-based drug |
Advanced heart failure |
Completed a Phase IIa study in patients with reduced ejection fraction |
10/9/12 |
CENTRAL NERVOUS SYSTEM | |||||
BioLineRx Ltd. (Jerusalem) |
BL-1020 |
Orally available GABA-enhanced antipsychotic |
Schizophrenia |
A recent analysis of data from its Phase IIb trial indicated it demonstrated a significant increase in efficacy at improving cognitive impairment associated with the condition |
10/10/12 |
Euthymics Bioscience Inc. (Cambridge, Mass.) |
Amitifadine |
A serotonin-preferring triple reuptake inhibitor; formerly EB-1010 |
Major depressive disorder |
Completed enrollment in the Phase IIb/IIIa study |
10/12/12 |
Grupo Zeltia (Madrid, Spain) |
Tideglusib |
A GSK-3 inhibitor |
Mild-to-moderate Alzheimer's disease |
The primary cognitive endpoint and two of the secondary endpoints were not met in the 26-week ARGO Phase IIb trial |
10/12/12 |
ISTO Technologies Inc. (St. Louis) |
NuQu |
Cell-based therapy |
Pain and disability associated with degenerated spinal discs |
Started a Phase II trial |
10/23/12 |
Nabi Biopharma-ceuticals Inc. (Rockville, Md.) |
NicVAX |
Nicotine conjugate immunotherapeutic |
Smoking cessation |
Phase II data showed that NicVAX in combination with Chantix did not meet the study's primary endpoint |
10/18/12 |
Neurocrine Biosciences Inc. (San Diego) |
NBI-98854 |
Vesicular monoamine transporter 2 compound |
Tardive dyskinesia and underlying schizophrenia or schizoaffective disorder |
Started a Phase IIb trial |
10/3/12 |
Noven Pharmaceuticals Inc. (Miami) |
d-ATS |
D-Amphetamine Transdermal System |
Attention deficit hyperactivity disorder |
Started a Phase II study |
10/3/12 |
DIABETES | |||||
Intarcia Therapeutics Inc. (Hayward, Calif.) |
ITCA 650 |
Continuous subcutenaous delivery of exenatide |
Type II diabetes |
Phase II data showed two doses produced a 1% mean reduction in HbA1c at week 12, compared to a 0.7% reduction for patients receiving twice-daily Byetta |
10/4/12 |
Resverlogix Corp. (Calgary, Alberta) |
RVX-208 |
A small molecule designed to inhibit BET bromodomains |
Pre-diabetes mellitus |
Started a Phase II trial |
10/17/12 |
INFECTION | |||||
Agenus Inc. (Lexington, Mass.) |
HerpV |
A recombinant off-the-shelf therapeutic vaccine, containing the QS-21 Stimulon adjuvant |
Genital herpes |
Started a Phase II study |
10/24/12 |
Cempra Inc. (Chapel Hill, N.C.) |
Solithromycin |
A macrolide antibiotic |
Uncomplicated urogenital gonorrhea |
Top-line data showed it cleared infections in a Phase II study |
10/5/12 |
Novavax Inc. (Rockville, Md.) |
Vaccine |
RSV-F protein nanoparticle vaccine with and without aluminum phosphate as the adjuvant |
Respiratory syncytial virus |
Enrollment started in a Phase II dose-ranging trial |
10/9/12 |
Theraclone Sciences Inc. (Seattle) |
TCN-032 |
A fully human monoclonal antibody |
Influenza A infections |
Started a Phase II study |
10/26/12 |
MISCELLANEOUS | |||||
Alexion Pharmaceuticals Inc. (Cheshire, Conn.) |
Soliris |
Eculizumab |
Severe, relapsing neuromyelitis optica |
Phase II data in 14 patients showed it met its primary endpoint with high degrees of clinical and statistical significance |
10/10/12 |
Amicus Therapeutics Inc. (Cranbury, N.J.) |
AT2220 |
Duvoglustat |
Pompe disease |
The open-label, drug-drug interaction experiment found enzyme hikes across all three cohorts of the trial |
10/12/12 |
Lpath Inc. (San Diego) |
iSONEP |
Ocular formulation of a monoclonal antibody that targets sphingosine-1 phosphate |
Wet age-related macular degeneration |
Started the dosing in a Phase II study |
10/5/12 |
Ocular Therapeutix Inc. (Bedford, Mass.) |
OTX-TP2 |
Sustained-release travoprost |
Glaucoma and ocular hypertension |
Phase II data showed results comparable to topical brand name opthalmic solutions travatan, Lumigan and Xalatan |
10/31/12 |
Prolor Biotech Inc. (Nes-Ziona, Israel) |
hGH-CTP |
Long-acting human growth hormone |
Growth hormone deficiency |
Phase II data confirm it can be administered once weekly to adults and is safe and well tolerated |
10/19/12 |
QLT Inc. (Vancouver, British Columbia) |
Latanoprost |
Punctal plug delivery system |
Ocular hypertension and open-angle glaucoma |
Demonstrated positive trends on the efficacy and safety of the delivery system |
10/26/12 |
Sarepta Therapeutics Inc. (Cambridge, Mass.) |
Eteplirsen |
Exon-skipper |
Duchenne muscular dystrophy |
Phase IIb data showed it hit the primary endpoint, an increase in novel dystrophin |
10/4/12 |
Sophiris Bio Inc. (La Jolla, Calif.) |
PRX302 |
An inactive prodrug genetically engineered to be activated by prostate-specific antigen |
Benign prostatic hyperplasia |
Phase IIb data showed it produced a clinically significant improvement in the subjective symptom score and the objective measure of mean peak urinary flow rate sustained over 12 months |
10/10/12 |
Tarsa Therapeutics Inc. (Philadelphia) |
Calcitonin |
Oral recombinant salmon calcitonin |
To prevent postmenopausal osteoporosis |
Phase II testing yielded statistically significant, clinically relevant improvements in BMD at the lumbar spine |
10/17/12 |
The Medicines Co. (Parsippany, N.J.) |
MDCO-2010 |
A serine protease inhibitor |
To reduce blood loss during surgery |
Voluntarily discontinued its Phase IIb dose-ranging study due to serious unexpected patient safety issues |
10/8/12 |
Ultragenyx Pharmaceutical Inc. (Novato, Calif.) |
UX001 |
Extended-release sialic acid |
Hereditary inclusion body myopathy |
Completed enrollment in a Phase II trial |
10/31/12 |
Notes: Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue. The date indicated refers to the BioWorld Today issue in which the news item can be found. |