Company
(Location)

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.