Company (Location) |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
BioCryst Pharmaceuticals Inc. (Research Triangle Park, N.C.) |
BCX4208 |
Ulodesine |
Gout |
Phase IIb data of BCX4208 added to allopurinol showed favorable 52-week safety results and sustained efficacy |
7/25/12 |
CANCER | |||||
Apogenix GmbH (Heidelberg, Germany) |
APG101 |
A fully human fusion protein |
Glioblastoma |
Phase II data showed it met and exceeded expectations, which was to increase the percentage of patients reaching progression-free survival for six months by 100%; median progression-free survival was 19.7 weeks in the treated group compared to 10.8 weeks in the control arm |
7/27/12 |
Cerulean Pharma Inc. (Cambridge, Mass.) |
CRLX101 |
A nanopharmaceutical that inhibits both topoisomerase 1 and hypoxia-inducible factor-1 alpha |
Non-small-cell lung cancer |
Completed enrollment in a Phase II trial |
7/3/12 |
Cerulean Pharma Inc. (Cambridge, Mass.) |
CRLX101 |
A nanopharmaceutical that inhibits both topoisomerase 1 and hypoxia-inducible factor-1 alpha |
Platinum-resistant ovarian cancer |
Dosed the first patient in a Phase II trial |
7/24/12 |
Diamyd Medical AB (Stockholm, Sweden) |
NP2 Enkephalin |
Gene therapy |
Cancer pain |
Missed the primary endpoint in a Phase II trial, showing no difference in average pain scores when compared with placebo |
7/5/12 |
EntreMed Inc. (Rockville, Md.) |
ENMD-2076 |
Aurora A/angiogenic kinase inhibitor |
Triple-negative breast cancer |
Launched a dual-institutional Phase II study |
7/26/12 |
Exelixis Inc. (South San Francisco) |
Cabozantinib |
Targets MET, VEGFR2 and RET |
Non-small-cell lung cancer |
Initiated a Phase II trial in NSCLC and a Phase I trial in patients with relapsed or refractory multiple myeloma |
7/27/12 |
Immatics biotechnologies GmbH (Tubingen, Germany) |
IMA901 |
A cancer vaccine |
Cancer |
Phase II data showed that patients experience longer survival times when their immune system responds to more than one of the peptides in the vaccine, and a single dose of cyclophosphamide prior to first vaccination reduced regulatory T cells and was associated with a better outcome |
7/31/12 |
ImmunoCellular Therapeutics Ltd. (Los Angeles) |
ICT-107 |
A dendritic cell-based vaccine targeting multiple tumor-associated antigens |
Glioblastoma multiforme |
Is expanding its Phase IIb trial from 102 patients to up to 123 patients |
7/3/12 |
Jennerex Inc. (San Francisco) |
JX-594 |
Administered weekly by intravenous infusions |
Advanced hepatocellular carcinoma |
Treated the first patient in a Phase II study |
7/26/12 |
Noxxon Pharma AG (Berlin) |
NOX-A12 |
An anti-CXCL12/SDF-1 Spiegelmer |
Chronic lymphocytic leukemia |
Treated the first cohort of the three chronic lymphocytic leukemia patients in its Phase IIa trial |
7/12/12 |
Oxford BioMedica plc (Oxford, UK) |
TroVax |
Therapeutic vaccine |
Inoperable metastatic colorectal cancer |
Started a Phase II trial |
7/11/12 |
PharmaMar SA (Madrid, Spain) |
PM01183 |
DNA minor groove covalent binder |
Breast cancer |
Began a Phase II trial |
7/3/12 |
Spectrum Pharmaceuticals Inc. (Henderson, Nev.) |
Lucanthrone |
An orally administered topoisomerase II and AP endonucelase inhibitor |
Glioblastoma multiforme |
Started a Phase II trial |
7/5/12 |
Theravance Inc. (South San Francisco) |
TD-1211 |
An oral peripherally selective multivalent inhibitor of the mu opioid receptor |
Chronic, noncancer pain |
Phase IIb data showed it met its primary endpoint of change from baseline in average complete spontaneous bowel movements per week |
7/12/12 |
Topotarget A/S (Copenhagen) |
Belinostat |
HDAC inhibitor |
Cancer of unknown primary origin |
Phase II data showed it missed its primary endpoint of progression-free survival, but showed a statistically significant benefit in terms of objective response rate |
7/2/12 |
CARDIOVASCULAR | |||||
Angion Biomedica Corp. (Uniondale, N.Y.) |
BB3 |
A small-molecule mimetic of hepatocyte growth factor |
Heart attack |
The first patient was dosed in a Phase II trial |
7/19/12 |
BioInvent International AB (Lund, Sweden) and Genentech Inc. (South San Francisco) |
BI-204 |
A monoclonal antibody |
Stable atherosclerotic vascular disease |
Phase IIa data showed no statistically significant reduction in inflammatory activity in an index arterial vessel compared to placebo |
7/12/12 |
Inspiration Biopharma-ceuticals Inc. (Cambridge, Mass.) |
OBI-1 |
A recombinant porcine Factor VIII |
Hemophilia A |
An interim analysis from a Phase II/III study showed all seven participants experienced control and subsequent resolution of their bleeds |
7/10/12 |
Osiris Therapeutics Inc. (Columbia, Md.) |
Prochymal |
Remestemcel-L |
Acute myocardial infarction |
Interim one-year results from its 220-patient Phase II trial showed significantly less cardiac hypertrophy, compared to placebo |
7/3/12 |
CENTRAL NERVOUS SYSTEM | |||||
Biotie Therapies Oyj (Turku, Finland) |
Tozadenant |
Selective adenosine 2A receptor inhibitor |
Parkinson's disease |
Completed enrollment in its Phase IIb trial |
7/6/12 |
EnVivo Pharmaceuticals Inc. (Watertown, Mass.) |
EVP-6124 |
An alpha-7 agonist |
Alzheimer's disease |
Phase IIb trail showed it met both the primary endpoints at the 2-mg dose, with statistically significant positive effects on cognition and clinical function |
7/19/12 |
Nektar Therapeutics Inc. (San Francisco) |
NKTR-181 |
Opioid analgesic candidate |
Chronic pain from osteoarthritis of the knee |
First patient has been enrolled in a Phase II study |
7/25/12 |
Psyadon Pharmaceuticals Inc. (Germantown, Md.) |
Ecopipam |
A dopamine D1 antagonist |
Tourette syndrome |
Stopped a Phase II trial following an interim analysis that showed a statistically significant reduction in the severity of tic symptoms |
7/25/12 |
DIABETES | |||||
Lexicon Pharmaceuticals Inc. (The Woodlands, Texas) |
LX4211 |
Oral therapy |
Type II diabetes |
Phase IIa data showed significant improvements in multiple measures of glycemic control; another trial showed statistically significant reductions in HbA1c, body weight and blood pressure |
7/2/12 |
INFECTION | |||||
Chimerix Inc. (Research Triangle Park, N.C.) |
CMX001 |
Cidofovir combined with the company's Lipid-Antiviral-Conjugate technology |
To prevent cytomegalovirus |
Phase II data showed it reduced incidences of hematuria and serum creatinine elevations |
7/24/12 |
Medigene AG (Martinsried, Germany) |
Veregen |
Sinecatechins |
Genital warts |
Received marketing authorization in France |
7/3/12 |
Novavax Inc. (Rockville, Md.) |
VLP |
Seasonal influenza virus-like particle candidate |
Influenza |
Top-line Phase II data showed the product had immunogenicity against all four viral strains, and was well tolerated with no vaccine-related serious adverse events |
7/26/12 |
MISCELLANEOUS | |||||
Ampio Pharmaceuticals Inc. (Greenwood Village, Colo.) |
Optina |
Danazol |
Diabetic macular edema |
A further analysis of Phase II data showed six out of seven subjects who received the optimal low dose saw a clinically relevant change in retinal thickness after 12 weeks |
7/10/12 |
Healthpoint Biotherapeutics Inc. (Ft. Worth, Texas) |
HP802-247 |
Allogeneic living cell bioformulation |
Venous leg ulcers |
Phase IIb data showed that 83% of wounds were healed in the cell-treated group compared to 58% in the vehicle group |
7/26/12 |
Pergamum AB (Stockholm, Sweden) |
PXL-01 |
Therapeutic peptide |
For use in patients undergoing tendon repair surgery |
Phase II data showed it failed to meet the primary endpoint in the prevention of postsurgical adhesions, though results suggest the drug may improve hand mobility |
7/11/12 |
Sarepta Therapeutics Inc. (formerly AVI BioPharma Inc.) |
Eteplirsen |
Exon-skipping compound |
Duchenne's muscular dystrophy |
Phase IIb data showed it resulted in a 69.5 meter benefit on the primary clinical outcome, the six-minute walk test, compared to placebo for 24 weeks followed by 12 weeks of eteplirsen in an open-label extension |
7/25/12 |
Repros Therapeutics Inc. (The Woodlands, Texas) |
Proellex-V |
Vaginally delivered Proellex |
Uterine fibroids |
Repros completed enrollment in its Phase II study |
7/24/12 |
Tonix Pharmaceuticals Holding Corp. (New York) |
TNX-102 |
Cyclobenzaprine 2.4 mg sublingual tablets |
Fibromyalgia |
Data showed TNX-102 SL delivered cyclobenzaprine to the systemic circulation more efficiently than a sublingual solution of a simulated crushed tablet and faster than an ingested tablet; company is planning a pivotal trial |
7/31/12 |
Ultragenyx Pharmaceutical Inc. (Novato, Calif.) |
UX001 |
An extended-release oral tablet formulation of sialic acid |
Sialic acid deficiency |
Dosed the first two patients in a Phase II trial |
7/6/12 |
|
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. | |||||