Company*
(Country; Symbol)

Product

Description

Indication

Status (Date)#

AUTOIMMUNE

4SC AG (Germany)

Vidofludimus

An oral inhibitor of interleukin-17

Rheumatoid arthritis

Completed enrollment in its Phase IIb study (12/21)

BioCryst Pharmaceuticals Inc.

BCX4208

A purine nucleoside phosphorylase inhibitor

Gout

Started a Phase IIb study (12/23)

Lexicon Pharmaceuticals Inc.

LX2931

An orally delivered drug candidate

Rheumatoid arthritis

Phase IIa data suggested that 150-mg once daily of LX2931 showed an improvement in the percentage of patients achieving a response at week 12 (12/15)

Provectus Pharmaceuticals Inc.

PH-10

Topical drug

Psoriasis

Began a Phase IIc trial (12/15)

VBL Therapeutics Inc. (Israel)

VB-201

Lecinoxoid

Psoriasis

Researchers concluded that VB-201 serves as proof of concept that anti-inflammatory phospholipids might offer a therapeutic approach to treat immune-mediate disorders (12/2)

CANCER

Allos Therapeutics Inc.

Folotyn

Pralatrexate

Non-small-cell lung cancer

Phase IIb data of Folotyn showed a 16% reduction in the risk of death compared to Tarceva (12/13)

Cyclacel Pharmaceuticals Inc.

Seliciclib

An orally administered cell-cycle modulator

Non-small-cell lung cancer

Phase IIb data showed no difference between the seliciclib and placebo arms in terms of median progression-free survival (12/22)

CytRx Corp.

Tamibarotene

Retinoid drug candidate

Advanced non-small-cell lung cancer

Started Phase IIb trial; expected to enroll about 140 patients with Stage IIIB or Stage IV disease who will be treated with up to six cycles of paclitaxel plus carboplatin and either tamibarotene or placebo (12/2)

DARA BioSciences Inc.

KRN5500

Nonopioid analgesic agent

Neuropathic pain in cancer

It showed positive results in a Phase IIa trial, with a larger median decrease in pain associated with touch and cold compared to placebo (12/15)

EGEN Inc.

EGEN-001

Comprises an interluekin-12 gene formulated with a biocompatible delivery polymer

Recurrent ovarian cancer

Opened enrollment in the first Phase II trial (12/14)

EpiCept Corp.

EPC2407

Crolibulin; a vascular-disrupting and apoptosis-inducing agent

Anaplastic thyroid cancer

Started a Phase II trial of EPC2407 in combination with cisplatin (12/16)

Generex Biotechnology Corp.

AE37

Breast cancer vaccine

Breast cancer

Patients receiving AE37 and Herceptin simultaneously showed an increase in specific immune stimulation of T cells compared to AE37 given after trastuzumab therapy (12/7)

Geron Corp.

GRN163L

Imetelstat

Metastatic breast cancer

Enrolled the first patient in a Phase II trial of GRN163L with paclitaxel (12/3)

GTx Inc.

Capesaris (FTx-758)

An oral, selective estrogen receptor alpha agonist

Advanced prostate cancer

Phase II data showed that it achieved medical castration with a median time to castration in healthy men receiving the 1,000-mg and 1,500-mg doses of drug (12/14)

Myrexis Inc.

Azixa

Verubulin; a small molecule designed to act as a microtubule destablizing agent

Glioblastoma multiforme

Started a Phase IIb trial (12/27)

Nektar Therapeutics Inc.

NKTR-102

A topoisomerase I inhibitor-polymer conjugate

Breast cancer

Phase II data showed that when given as a single agent it resulted in an overall resonse rate of 32% for the q14d schedule and 26% for the q21d schedule (12/14)

Novelos Therapeutics Inc.

NOV-002

An immune

modulator

Breast cancer

Phase II data showed that NOV-002 plus chemotherapy doubled the rate of pathologic complete responses compared to a historical control (12/10)

Ohr Pharmaceutical Inc.

OHR/AVR118

Anti-inflammatory drug

Cancer cachexia

Enrolled the first patients at a new clinical site, the Ottawa Hospital Cancer Centre, in an ongoing Phase IIb trial (12/15)

Oncolytics Biotech Inc. (Canada)

Reolysin

Oncolytic virus candidate

Ovarian, fallopina tube or primary peritoneal cancer

Started enrollment in a Phase II study testing weekly paclitaxel vs. weekly paclitaxel with Reolysin (12/2)

Peregrine Pharmaceuticals Inc.

Cotara

A targeted monoclonal antibody linked to a radioisotope

Recurrent glioblastoma multiforme

Completed enrollment in its Phase II dose-confirmation trial (12/21)

Spectrum Pharmaceuticals Inc.

Belinostate

HDAC inhibitor

Carcinoma of unknown primary

Target enrollment was reached for the Phase II study (12/27)

Syndax Pharmaceuticals Inc.

Entinostat

A selective histone deacetylase inhibitor

Non-small-cell lung cancer

Phase II data showed there was a 9.4 month median survival in the subset of patients with elevated E-cadherin who receive entinostat in combination with Tarceva, vs. 5.4 months for those who received Tarceva alone (12/10)

Vicus Therapeutics LLC

VT-122

An oral, fixed-dose combination of the nonselective beta blocker propranolol and the nonsteroidal anti-inflammatory drug etodolac

Advanced liver cancer, systemic inflammation and cachexia

Started a Phase II trial of VT-122 plus Nexavar (12/28)

CARDIOVASCULAR

Biogen Idec Inc. and Swedish Orphan Biovitrum AB (Sweden)

rFVIIIFc

Recombinant factor VIII Fc fusion protein

Hemophilia A

Dosed the first patient in a Phase II/III trial (12/7)

Neurokine Pharmaceuticals Inc. (Canada)

NK-001

An encapsulated formulation of Enbrel

Alzheimer's disease patients undergoing coronary artery bypass graft surgery

Is starting a Phase II trial (12/10)

Pearl Therapeutics Inc.

PT003

Bronchodilator

Chronic obstructive pumonary disease (COPD)

Met the primary efficacy endpoint in a Phase IIb trial in patients with moderate to very severe COPD (12/2)

Theravance Inc. and GlaxoSmith-Kline plc (UK)

GSK961080

Inhaled bifunctional compound

Moderate to severe chronic obstructive pulmonary disease

The first patient started treatment in a Phase IIb study (12/23)

VBL Therapeutics Inc. (Israel)

VB-201

In a family of anti-inflammatory compounds developed by VBL called Lecinoxoids

Cardiovascular disease

Began Phase II trials (12/22)

Viron Therapeutics Inc.

VT-111

A protein produced by the myxoma virus

Acute coronary syndrome

Phase IIa data showed it met both its primary and secondary endpoints of safety and biological activity (12/16)

CENTRAL NERVOUS SYSTEM

Alkermes Inc.

ALKS 33

An oral opioid modulator

Reward disorders and other central nervous system disorders

Phase II data showed that once-daily administration was generally well tolerated at all three dose levels (12/9)

Cynapsus Therapeutics Inc. (Canada)

APL-130277

A reformulation of an approved drug

Parkinson's

disease

Completed proof-of-concept studies ahead of schedule comparing prototypes of APL-130277 to injectable apomorphine (12/3)

Cyrenaic Pharmaceuticals Inc.

CYR-101

Antipsychotic

Schizophrenia

Phase IIa data showed the drug alleviated symptoms, including negative and cognitive symptoms; the drug was safe and well tolerated (12/1)

Cytokinetics Inc.

CK-2017357

A fast skeletal muscle troponin activator

Amyotrophic lateral sclerosis

Phase IIa data generated encouraging results that are consistent with previous studies (12/14)

Euthymics Bioscience Inc.

EB-1010

Antidepressant

Major depressive disorder

Phase II data demonstrated that it is effective for treating major depressive disorder (12/9)

Genentech Inc.

RG6781

A glycine reuptake inhibitor

Schizophrenia

Phase II data showed clinically meaningful reduction in the negative symptoms of schizophrenia (12/7)

Rexahn Pharmaceuticals Inc.

Serdaxin

Antidepressant

Depression

Phase IIa data indicated Serdaxin enhances both the serotonin and dopamine activity of neural transmitters (12/9)

Synosia Therapeutics

SYN-115

Orally bioavailable adenosine 2A antagonist

Parkinson's disease

Phase IIa data showed that SYN-115 crosses the blood-brain barrier to affect areas of the brain linked to Parkinson's disease in a dose-dependent manner (12/2)

DIABETES

Spherix Inc.

D-tagatose

Originally developed as a reduced- calorie sugar substitute

Diabetes

Phase II data showed that the minimum dose capable of affecting HbA1c was 7.5 g three-times daily (12/10)

INFECTION

AiCuris GmbH & Co. KG

AIC316

A helicase-primase inhibitor

Genital HSV Type 2 infection

The last subject has completed a Phase II trial, ending the trial two months earlier than expected (12/9)

Amarillo Bioscience Inc.

Lozenges

Human interferon-alpha lozenges

Chronic hepatitis C virus

infection

Completed enrollment in a Phase II trial (12/15)

Argos Therapeutics Inc.

AGS-004

Personalized immunotherapy

HIV

Dosed its first patients in a Phase IIb trial (12/1)

GeoVax Labs Inc.

Vaccine

DNA-vectored vaccine

HIV

Phase IIa data showed cellular immune response rates similar to those observed in a Phase I trial (12/10)

Inhibitex Inc.

FV-100

An oral bicyclic nucleoside analogue

Herpes zoster, or shingles

It failed to show a statistically significant difference vs. valacyclovir in a Phase II trial (12/15)

Medicago Inc.

Vaccine

H5N1 avian influenza vaccine

Avian influenza

Completed the first part of its Phase II testing; results will come out in January (12/23)

Pharmasset Inc.

PSI-7977

A nucleotide analogue polymerase inhibitor

Chronic hepatitis C

Dosing has begun in an exploratory Phase II study (12/15)

SciClone Pharmaceuticals Inc.

SCV-07

Gamma-D-glutamyl-L-tryptophan; a small molecule believed to stimulate the immune system by inhibiting STAT3 signaling

Hepatitis C virus

Phase IIb data showed the drug achieved a clear biological signal but did not meet the primary efficacy endpoint of a 2 log reduction in viral load from baseline when used as a monotherapy and in combination with ribavirin in relapsed patients (12/17)

Vertex Pharmaceuticals Inc.

VX-222

HCV polymerase inhibitor

Hepatitis C virus

Halted one arm of a Phase II trial of telaprevir (1,125 mg) in combination with VX-222 (400 mg) due to viral breakthrough (12/23)

MISCELLANEOUS

Capstone Therapeutics

AZX100

Antifibrotic peptide

Keloid scarring

Phase IIa data showed it failed to hit statistical significance (12/15)

Creabilis SA (Luxembourg)

CT327

A topical TrkA kinase inhibitor

Atopic

dermatitis

Phase IIa data showed that it demonstrated a clinically significant improvement after eight days of treatment (12/16)

Ipsen SA (France)

BIM 23A760

Chimeric compound

Acromegaly

Missed its endpoint of showing inhibition of growth hormone and IGF-1 levels (12/16)

ISTA Pharmaceuticals Inc.

Bepotastine besilate

Nasal spray

Allergic rhinitis

Began Phase II trials (12/15)

Ocera Therapeutics Inc.

OCR-002

A drug designed to reduce toxic levels of ammonia in the blood

Liver cirrhosis

Completed two studies in healthy volunteers and patients with liver cirrhosis (12/16)

RegeneRx Bio-pharmaceuticals Inc.

RGN-259

A topical eye-drop formulation of Thymosin beta 4

Dry eye syndrome associated with graft-vs.-host disease

Enrolled the first patient in a Phase II study (12/23)

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.