| Company (Location) |
Product |
Description |
Indication |
Status (Date)# |
AUTOIMMUNE | ||||
| Anacor Pharmaceuticals Inc. (Palo Alto, Calif.) |
AN2728 and AN2898 |
Compounds from Anacor's boron chemistry platform |
Mild to moderate atopic dermatitis |
Dosed the first patient in a Phase II trial (5/19) |
| Ardea Biosciences Inc. (San Diego) |
Lesinurad |
An oral, once-daily inhibitor of URAT1 |
Gout |
Phase IIb extension data show adding lesinurad to allopurinol produced a 91% response rate at 28 weeks in gout patients who failed to respond to allopurinol alone (5/27) |
| BioCryst Pharmaceuticals Inc. (Research Triangle Park, N.C.) |
BCX4208 |
Enzyme inhibitor |
Gout |
Phase II data showed that when the drug was combined with allopurinol it brought a larger proportion of patients to serum uric acid levels below 6 mg/dL compared to allopurinol alone (5/27) |
| Centocor Ortho Biotech Inc. (Horsham, Pa.) |
CNTO 136 |
Monoclonal IgG1 kappa antibody sirukumab |
Rheumatoid arthritis |
Improved the symptoms despite treatment with methotrexate in a Phase II study (5/26) |
| Metabolex Inc. (Hayward, Calif.) |
MBX-102 |
Arhalofenate |
Hyperuricemia in gout |
Started a Phase II trial (5/20) |
| Provectus Pharmaceuticals Inc. (Knoxville, Tenn.) |
PH-10 |
An aqueous hydrogel formulation of Rose Bengal disodium for topical administration |
Psoriasis |
Completed patient accrual in its Phase IIc trial (5/25) |
| CANCER | ||||
| Agennix AG (Planegg, Germany) |
Talactoferrin |
Oral therapy |
Non-small-cell lung cancer |
Phase II data showed it increased the confirmed response rate compared to placebo (5/27) |
| Astellas Pharma Inc. (Tokyo) and Medivation Inc. (San Francisco) |
MDV3100 |
An oral androgen receptor agonist |
Prostate cancer |
Treated the first patient in a Phase II trial (5/10) |
| CureTech Ltd. (Yavne, Israel) and Teva Pharmaceutical Industries Ltd. (Jerusalem) |
CT-011 |
An anti-PD-1 antibody |
Diffuse large B-cell lymphoma following autologous stem cell transplantation |
It significantly improved progression-free survival and overall survival in a Phase II trial (5/18) |
| Cytheris SA (Paris) |
CYT107 |
Human interleukin-7 |
Metastatic breast cancer |
Began Phase IIa trials of CYT107 and Xeloda (5/12) |
| Enzon Pharmaceuticals Inc. (Bridgewater, N.J.) |
PEG-SN38 |
The pegylated version of SN38 |
Metastatic colorectal cancer |
Enzon is discontinuing work following the conclusion of an ongoing Phase II trial (5/20) |
| Jennerex Inc. (San Francisco) |
JX-594 |
Oncolytic virus |
Liver cancer |
Phase II data showed it improves survival, reducing the risk of death by more than 50% compared to a low-dose control (5/20) |
| Micromet Inc. (Bethesda, Md.) |
Blinatumo-mab |
An anti-CD19 antibody |
Acute lymphoblastic leukemia |
Phase II data showed it produced durable remissions in front-line ALL (5/18) |
| OncoSec Medical Inc. (San Diego) |
Electro-Immuno-therapy |
A DNA plasmid coding for IL-12 delivered using electroporation |
Melanoma, merkle cell carcinoma and cutaneous T-cell lymphoma |
Started three Phase II trials (5/27) |
| Oncothyreon Inc. (Seattle) |
PX-866 |
P13K inhibitor |
Tumors |
Started a Phase II portion of its ongoing Phase I/II trial of PX-866 in combination with Erbitux following successful completion of the Phase I dose-escalation portion (5/25) |
| Onyx Pharmaceuticals Inc. (Emeryville, Calif.) |
Carfilzomib |
A next-generation proteasome inhibitor |
Relapsed and refractory multiple myeloma |
Phase IIb data showed a clinical benefit rate of 37% with a duration of response of 8.3 months; overall response rate was 24% with a median duration of response of 7.8 months (5/23) |
| Tigris Pharmaceuticals Inc. (Bonita Springs, Fla.) |
AFP-464 |
An aminoflavone prodrug that activates p53 and apoptosis |
Estrogen receptor-positive breast cancer |
Started a Phase II trial (5/27) |
| CARDIOVASCULAR | ||||
| Action Pharma A/S (Aarhus, Denmark) |
AP214 |
Designed to target the melanocortin receptors |
Kidney injury in cardiac surgery patients |
Completed dosing in a Phase IIb trial (5/10) |
| Cardio3 BioSciences SA (Mont-Saint-Guibert, Belgium) |
C3BS-CQR-1 |
A stem cell therapy based on the firm's Cardiopoiesis technology |
Heart failure |
Phase II data showed it produced improvements in heart function and exercise capacity at six months (5/17) |
| Celladon Corp. (La Jolla, Calif.) |
Mydicar |
Genetically targeted enzyme replacement therapy |
Advanced heart failure |
Phase II data showed continued improvements in clinical outcomes (5/24) |
| Pearl Therapeutics Inc. (Redwood City, Calif.) |
PT003 |
Bronchodilator |
Chronic obstructive pulmonary disease |
Efficacy and safety results from its Phase IIb study showed a statistically significant improvement in mean FEV1 AUC of 47% over Foradil and 49% over Spiriva after one week of dosing (5/19) |
| Relypsa Inc. (Santa Clara, Calif.) |
RLY5016 |
Nonabsorbed oral potassium binder |
Heart failure and chronic kidney disease |
Phase II data showed it maintained normal serum potassium levels (5/24) |
| Revotar Biopharmaceut-icals AG (Berlin) |
Bimosiamose |
Inhaled solution |
Chronic obstructive pulmonary disease |
Phase II data confirmed earlier results showing a significant anti-inflammatory effect with clear improvement of lung function (5/20) |
| Santarus Inc. (San Diego) |
Rhucin |
Recombinant human C1 inhibitor |
Angioedema |
Open-label study supported safety and efficacy conclusions from earlier studies (5/24) |
CENTRAL NERVOUS SYSTEM | ||||
| Allon Therapeutics Inc. (Vancouver, British Columbia) |
Davunetide |
Neuroprotective candidate |
Progressive supranuclear palsy |
Phase II/III trial has enrolled about half of its 300 patients needed (5/19) |
| EnVivo Pharmaceuticals Inc. (Watertown, Mass.) |
EVP-6124 |
Alpha-7 agonist |
Schizophrenia |
Phase IIb data showed it achieved its primary endpoint by significantly improving cognition (5/18) |
| Evotec AG (Hamburg, Germany) and Roche AG (Basel, Switzerland) |
EVT 101 |
NR2B subtype selective NMDA antagonist |
Treatment-resistant depression |
Companies are terminating the first proof-of-concept study and the whole program due to difficulties in recruiting patients (5/19) |
| Neurologix Inc. (Fort Lee, N.J.) |
NLX-P101 |
Gene therapy |
Parkinson's disease |
One-year follow-up data from a Phase II trial showed that 63% of patients receiving NLX-P101 achieved moderate-to-large clinically meaningful symptom improvements at 12 months, compared to 50% at six months (5/27) |
| Psyadon Pharmaceuticals Inc. (Germantown, Md.) |
Ecopipam |
A dopamine D1 antagonist |
Tourette syndrome |
Company is collaborating with the Tourette Syndrome Association in a Phase IIa trial (5/12) |
| Xenon Pharmaceuticals Inc. (Vancouver, British Columbia) |
XEN402 |
An ointment targeting sodium channels including subtype Nav1.7 |
Postherpetic neuralgia |
Phase IIa data showed significant and clinically meaningful pain reductions in a Phase IIa trial (5/3) |
| DIABETES | ||||
| Derma Sciences Inc. (Princeton, N.J.) |
DSC127 |
A topical angiotensin analogue |
Diabetic foot ulcers |
A significant majority of patients in a Phase II trial showed complete healing at 24 weeks (5/26) |
| INFECTION | ||||
| Agennix AG (Planegg, Germany) |
Talactoferrin |
An oral biologic |
Severe sepsis |
Phase II data showed proteins that were measured play an important role in the initiation and propagation of the damaging inflammatory response (5/20) |
| Chimerix Inc. (Durham, N.C.) |
CMX-001 |
Broad-spectrum antiviral |
Viral infections |
clinical data showed that the majority of immunocompromised patients with severe adenovirus infections had a greater than 99% decrease in viral load compared to baseline after two weeks of therapy (5/12) |
| Hatchtech Pty Ltd. (Melbourne, Australia) |
DeOvo |
A topical formulation of a known metalloprotease inhibitor |
Head lice |
Started a Phase IIb trial (5/3) |
| Medivir AB (Huddinge, Sweden) |
TMC435 |
HCV Therapy |
Chronic hepatitis C virus |
Phase IIb data showed the addition of TMC435 to pegylated interferon and ribavirin demonstrated substantially higher virologic response rates, compared with pegylated interferon and ribavirin alone (5/23) |
| Pharmasset Inc. (Princeton, N.J.) |
PSI-7977 |
Nucleotide polymerase inhibitor |
Hepatitis C virus |
Started a Phase IIa trial combining PSI-7977 with Bristol-Myers Squibb Co.'s NS5A replication complex inhibitor BMS-790052 (5/27) |
| Starpharma Holdings Ltd. (Sydney, Australia) |
VivaGel |
Topical microbicide |
Bacterial vaginosis |
Open-label study supported safety and efficacy conclusions from earlier studies (5/24) |
| ViroPharma Inc. (Exton, Pa.) |
VP 20621 |
Non-toxigenic C. difficile |
To prevent recurrence of Clostridium difficile infection |
Started a Phase II study (5/20) |
| MISCELLANEOUS | ||||
| Agile Therapeutics Inc. (Princeton, N.J.) |
AG200-15 |
A hormonal contraceptive patch containing ethinyl estradiol |
For contraception |
Phase II data showed it is well tolerated and did not cause differences in ovulation in obese vs. nonobese women (5/3) |
| Akebia Therapeutics Inc. (Cincinnati) |
AKB-6548 |
An oral hypoxia-inducible factor-prolyl hydroxylase inhibitor |
Chronic kidney disease |
Completed a Phase IIa trial that showed a controlled rise in hemoglobin and a decrease in ferritin (5/4) |
| FibroGen Inc. (San Francisco) |
FG-4592 |
A hypoxia-inducible factor prolyl hydroxylase inhibitor |
End-stage renal disease |
Phase II data showed it maintained correction of hemoglobin without I.V. iron supplementation (5/4) |
| Meritage Pharma Inc. (San Diego) |
Budesonide |
Oral suspension |
Eosinophilic esophagitis |
Phase IIb data showed it met its primary endpoint (5/11) |
| SARcode Corp. (Brisbane, Calif.) |
SAR 1118 |
Topically administered small-molecule integrin antagonist that inhibits T-cell mediated inflammation |
Dry eye disease |
Phase II data showed a reduction in corneal staining, increased tear production and improved visual-related function as compared to placebo (5/5) |
| Siena Biotech SpA (Siena, Italy) |
SEN0014196 |
6-chloro-2,3,4,9-tetrahydro-1H-carbazole-1-carboxamide |
Huntington's disease |
Started Phase II testing (5/2) |
| Stem Cell Therapeutics Corp. (Calgary, Alberta) |
NTx-428 |
A human chorionic gonadotropin and epoietin alfa therapy |
Traumatic brain injury |
Enrolled the first patient in an open-label Phase IIa trial testing its safety profile (5/2) |
| Sucampo Pharmaceuticals Inc. (Bethesda, Md.) |
UF-021 |
Unoprostone isopropyl |
Retinal pigmentosa |
Phase II data showed it met its primary endpoint of 2 degrees change from baseline in retinal sensitivity of 2 degrees in the high-dose group (5/6) |
| TheraVida Inc. (Mountain View, Calif.) |
THVD-201 |
A combination of tolterodine and a salivary stimulant |
Overactive bladder and urge urinary incontinence |
Started a Phase II trial (5/18) |
| Tissue Gene Inc. (Rockville, Md.) |
TG-C |
To regenerate cartilage |
Osteoarthritis of the knee |
Started patient enrollment for a U.S. Phase II trial (5/20) |
| Verona Pharma plc (London) |
RPL554 |
Respiratory candidate dosed through a nebulizer |
Asthma |
Began a Phase II trial (5/13) |
| 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. | ||||
