Company (Location) |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
XenoPort Inc. (Santa Clara, Calif.) |
XP23829 |
A fumarate analogue |
Relapsing-remitting multiple sclerosis and psoriasis |
First subjects were dosed in a Phase I comparison study |
7/25/12 |
CANCER | |||||
Actinium Pharmaceuticals Inc. (Newark, N.J.) |
Actimab-A |
Consists of the isotope Actinium 225 attached to the anti-CD33 monoclonal antibody lintuzumab |
Acute myeloid leukemia |
Treated the first cohort of patients in a Phase I/II study |
7/20/12 |
Berg Pharma LLC (Boston) |
BPM 31543 |
Topical compound |
Chemotherapy-induced alopecia |
Began a Phase I trial |
7/24/12 |
Bio-Path Holdings Inc. (Houston) |
BP-100.1.01 |
Liposomal Grb-1 |
Blood cancers |
Started enrolling patients in the fourth dosage cohort for its Phase I trial |
7/26/12 |
CytRx Corp. (Los Angeles) |
Aldoxo-rubicin |
Formerly INNO-206; a tumor-targeting conjugate of doxorubicin |
Advanced solid tumors |
Started a Phase Ib trial |
7/26/12 |
ImmunoGen Inc. (Waltham, Mass.) |
IMGN853 |
A targeted antibody payload compound |
Ovarian cancer or other solid tumors |
Started a Phase I trial |
7/12/12 |
Momenta Pharmaceuticals Inc. (Cambridge, Mass.) |
M402 |
A heparin sulfate glycosaminoglycan mimetic engineered from low-molecular-weight heparin |
Pancreatic cancer |
Began dosing in a Phase I/II trial in combination with gemcitabine |
7/3/12 |
OncoMed Pharmaceuticals Inc. (Redwood City, Calif.) |
OMP-54F28 |
A fusion protein based on a truncated form of the Frizzled8 receptor |
Advanced solid tumor cancers |
Patient dosing has begun in a Phase I trial |
7/13/12 |
Peregrine Pharmaceuticals Inc. (Tustin, Calif.) |
Bavituximab |
Monoclonal antibody |
Rectal adenocarcinoma |
The open-label Phase I trial began and will enroll up to 18 patients |
7/17/12 |
Viral Genetics Inc. (San Marino, Calif.) |
HCQ |
Hydroxychlor-oquine |
Drug-resistant ovarian cancer |
First patient was enrolled in a Phase I trial |
7/20/12 |
CENTRAL NERVOUS SYSTEM | |||||
Acadia Pharmaceuticals Inc. (San Diego) |
AM-831 |
A small molecule that combines muscarinic m1 partial agonism with dopamine D2 and serotonin 5-HT2A antagonism |
Schizophrenia |
Discontinued development because it did not meet pre-determined criteria for further development in a Phase I trial |
7/16/12 |
Eisai Europe Ltd. (Hatfield, UK) |
E2609 |
A beta-site amyloid precursor protein-cleaving enzyme inhibitor |
Alzheimer's disease |
Phase I data showed a reduction in plasma amyloid beta levels, and a statistically significant reduction of cerebrospinal fluid amyloid beta levels |
7/25/12 |
BrainStorm Cell Therapeutics Inc. (New York) |
NurOwn |
Bone marrow-derived, autologous, differentiated mesenchymal stromal cells |
Amyotrophic lateral sclerosis |
Completed a planned interim safety review of its Phase I/II trial |
7/24/12 |
Convergence Pharmaceuticals Ltd. (Cambridge, Mass.) |
CNV2197944 |
Orally administered selective Cav2.2 blocker |
Neuropathic pain |
Phase I showed it was well tolerated with few adverse events reported at doses expected to fall within the predicted therapeutic range |
7/19/12 |
Orexo AB (Uppsala, Sweden) |
OX219 |
A formulation of buprenorphine with naloxone |
Drug abuse |
A study demonstrated comparative bioavailability for OX219 and Suboxone, as well as positive results for other product attributes |
7/3/12 |
Supernus Pharmaceuticals Inc. (Rockville, Md.) |
Trokendi XR |
A once-daily extended-release formulation of topiramate |
Epilepsy |
Received a tentative letter from the FDA, stating that the agency had completed its review and that no additional clinical trials are required; for final approval, it must wait until the period of exclusivity protection expires |
7/16/12 |
Zogenix Inc. (San Diego) |
Relday |
A candidate based on a combination of DosePro needle-free subcutaneous drug delivery system with its once-monthly formulation of risperidone |
Schizophrenia and schizoaffective disorder |
Started a Phase I trial testing Relday |
7/13/12 |
INFECTION | |||||
Gilead Sciences Inc. (Foster City, Calif.) |
GS-5885 |
NS5A inhibitor, used in combination with GS-7977 |
Hepatitis C virus |
Gilead started a Phase I bioavailability study of a single-pill fixed-dose combination of GS-7977 and GS-5885 |
7/30/12 |
Inovio Pharmaceuticals Inc. (Blue Bell, Pa.) |
H1N1 SynCon |
Universal influenza vaccine |
Influenza |
The first patients were treated in a Phase I trial |
7/11/12 |
Novavax Inc. (Rockville, Md.) |
Novavax Fusion |
Protein nanoparticle respiratory syncytial virus vaccine |
Respiratory syncytial virus |
Phase I data showed it was generally well tolerated |
7/6/12 |
MISCELLANEOUS | |||||
Advanced Cell Technology Inc. (Marlborough, Mass.) |
hESC RPE cells |
Human embryonic stem cell-derived retinal pigment epithelial cells |
Stargardt's macular dystrophy |
Treated the fourth patient in its Phase I/II trial; treated the final patient |
7/13/12; 7/31/12 |
Alnylam Pharmaceuticals Inc. (Cambridge, Mass.) |
ALN-TTR02 |
An RNAi therapeutic targeting transthyretin |
TTR-mediated amyloidosis |
Phase I data showed a 94% knockdown of serum TTR levels, which was highly statistically significant |
7/17/12 |
Conatus Pharmaceuticals Inc. (San Diego) |
IDN-6556 |
Emricasan; a pan-caspase inhibitor |
For islet cell transplants |
Treated the first patient in an islet cell transplant Phase I/II trial |
7/20/12 |
Ocular Therapeutix Inc. (Bedford, Mass.) |
OTX-TP1 |
Travoprost punctum plug |
Open-angle glaucoma |
Initial results found that intraocular pressure was reduced 23.5% from baseline over the 30-day study period |
7/30/12 |
Zalicus Inc. (Cambridge, Mass.) |
Z944 |
Oral T-type calcium channel blocker |
Seizures |
Started a Phase I multiple-ascending dose study |
7/11/12 |
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. |