Company* |
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. |