Company (Location) |
Product |
Description |
Indication |
Status |
Date |
CANCER | |||||
Aeterna Zentaris Inc. (Quebec) |
Perifosine |
P13K/Akt inhibitor |
Neuroblastoma |
Phase I data showed a 50% progression-free survival rate at 12 months and included one complete remission based on a normalized MIBG scan and normalized bone marrow histology over prolonged follow-up |
6/22/12 |
Argos Therapeutics Inc. (Durham, N.C.) |
AGS-009 |
A monoclonal antibody-based lupus therapy |
Lupus |
Phase Ia data showed that treated patients trended toward normal interferon-alpha signatures after a single dose |
6/8/12 |
Azaya Therapeutics Inc. (San Antonio, Texas) |
ATI-1123 |
Liposomal docetaxel |
Solid tumors |
Phase I data showed 79% of heavily pretreated patients received benefit from the compound |
6/14/12 |
Celtic Pharmaceutical Holdings LP (London) |
Xerecept |
Corticorelin acetate |
Cerebral tumors |
Phase I/II data showed it is safe and can reduce or eliminate the need for steroids in pediatric patients |
6/28/12 |
e-Therapeutics (Oxford, UK) |
ETS2101 |
Anticancer agent |
Brain cancer |
Started a first clinical trial; the Phase I will enroll up to 24 patients with brain cancer |
6/20/12 |
Immunomedics Inc. (Morris Plains, N.J.) |
Epratuzumab and veltuzumab |
Humanized anti-CD22 antibody labeled with the radioisotope yttrium-90 and humanized anti-CD20 antibody |
Non-Hodgkin's lymphoma |
Half of the first 10 patients receiving the combination showed an overall objective response, with one diffuse large B-cell lymphoma patient having a complete response that persisted at nine months |
6/14/12 |
Immunomedics Inc. (Morris Plains, N.J.) |
TF2 |
A DNL-bispecific antibody that binds to the carcinoembryonic antigen and the peptide IMP288 |
Advanced colorectal cancer |
Phase I study of pretargeted radioimmunotherapy showed rapid tumor localization of radio-labeled IMP288 in CRC patients within one hour following injection of the peptide |
6/14/12 |
Innate Immunotherapeutics Ltd. (Auckland, New Zealand) |
MIS416 |
The lead product from the company's immune |
Chronic progressive multiple sclerosis |
Phase I/II data showed it to be well tolerated and identified a dose for further evaluation |
6/19/12 |
Micromet Inc. (Rockville, Md.) |
Blinatumomab |
Bispecific antibody |
B-precursor acute lymphoblastic leukemia |
Phase II data showed that 72% of treated patients achieved a complete remission and complete remission with partial hematologic recovery |
6/18/12 |
Oncothyreon Inc. (Seattle) |
PX-866 |
Small-molecule P13K inhibitor |
BRAF-mutant cancer |
Started a Phase I/II trial |
6/4/12 |
Onyx Pharmaceuticals Inc. (South San Francisco) |
Kyprolis |
Carfilzomib |
Multiple |
Results of carfilzomib in combination with lenalidomide and low-dose dexamethasone, resulted in complete or near complete remission in a majority of patients in the Phase I/II trial |
6/5/12 |
Oxigene Inc. (South San Francisco) |
Zybrestat |
Fosbretabulin |
Tumors |
Phase I data indicated it induced profound tumor vascular changes maintained by the addition of Avastin |
6/8/12 |
Pharmacyclics Inc. (Sunnyvale, Calif.) |
PCI-32765 |
Bruton's tyrosine kinase inhibitor ibrutinib |
Chronic lymphocytic leukemia/small lymphocytic lymphoma |
Phase Ib/II data showed it did not produce any new safety signals and hematologic toxicities were uncommon |
6/19/12 |
Tau Therapeutics LLC (Charlottesville, Va.) |
Mibefradil |
A T-type calcium channel blocker mibefradil |
Recurrent high-grade glioma |
Launched a Phase Ib trial |
6/1/12 |
Tengion Inc. (Winston-Salem, N.C.) |
Neo-Urinary conduit |
A combination of a patient's own cells and bioabsorbable scaffold |
Bladder cancer |
Tengion successfully implanted a fifth patient in an ongoing Phase I trial |
6/12/12 |
Yakult Honsha Co. (Tokyo) |
Perifosine |
Oral PI3K/Akt inhibitor |
Multiple |
Began a Phase I trial |
6/29/12 |
CARDIOVASCULAR | |||||
Portola Pharmaceuticals Inc. (South San Francisco) |
PRT4445 |
Factor Xa inhibitor antidote |
Life-threatening bleeding |
Enrolling subjects in the second cohort of a Phase I trial |
6/18/12 |
CENTRAL NERVOUS SYSTEM | |||||
Affiris AG (Vienna, Austria) |
PDO1A |
Vaccine |
Parkinson's disease |
Initiated a global Phase I trial |
6/6/12 |
Neuralstem Inc. (Rockville, Md.) |
Stem cells |
Spinal cord neural stem cells |
Amyotrophic lateral sclerosis |
The 16th patient in an ongoing Phase I trial has been treated |
6/20/12 |
Neuralstem Inc. (Rockville, Md.) |
NSI-189 |
Lead compound in Neuralstem's small-molecule platform |
Major depressive disorder |
The first patients were dosed in Phase Ib of its ongoing trial |
6/26/12 |
Palatin Technologies Inc. (Cranbury, N.J.) and AstraZeneca plc (London) |
AZD2820 |
A subcutaneously administered peptide melanocortin-4 receptor partial agonist |
Obesity |
Phase I trial was halted after the trial met a predefined stopping criterion involving a serious adverse event |
6/20/12 |
Zalicus Inc. (Cambridge, Mass.) |
Z944 |
Oral, T-type calcium channel blocker |
Seizures |
Completed a Phase I trial that indicated it was generally well tolerated and a maximum-tolerated dose was achieved |
6/20/12 |
DIABETES | |||||
Ampio Pharmaceuticals Inc. (Greenwood Village, Colo.) |
Optina |
Orally administered ultra-low dose of danazol |
Diabetic macular edema |
Analysis of a 32-patient study confirmed a significant interaction between the patient's body mass index and efficacy at the different doses |
6/12/12 |
Genkyotex SA (Geneva) |
GKT137831 |
An inhibitor of NOX1 and NOX4 enzymes |
Diabetic nephropathy |
Phase Ia data showed it is safe and well tolerated following oral administration of single doses in healthy subjects |
6/25/12 |
Transition Therapeutics Inc. (Toronto) |
TT-401 |
Once-weekly peptide that is a dual agonist of the GLP-1 receptor and a second metabolic target |
Type II diabetes |
Phase I data demonstrated an acceptable safety and tolerability profile in nondiabetic obese patients and exhibited the expected pharmacological effect on glucose and pharmacodynamics biomarkers at doses that were safe and tolerable |
6/19/12 |
INFECTION | |||||
Immunovaccine Inc. (Halifax, Nova Scotia) |
DPX-Survivac |
Consists of survivin-based peptide antigens formulated with the DepoVax adjuvanting platform |
Infections |
Results from the first cohort of a dose-ranging Phase I study showed it was well tolerated with no serious adverse events |
6/21/12 |
Kenta Biotech (Zurich-Schlieren, Switzerland) |
KBSA301 |
A fully human antibody |
Severe pneumonia caused by S. aureus |
The first patient was enrolled in a Phase I/II trial |
6/18/12 |
Presidio Pharmaceuticals Inc. (San Francisco) |
PPI-668 |
NS5A inhibitor |
Hepatitis C virus |
Completed Phase Ib testing, showing consistently rapid, marked reductions in patients' serum viral load that were dose-related |
6/27/12 |
Savara Inc. (Austin, Texas) |
AeroVanc |
A dry powder formulation of vancomycin |
Respiratory methicillin-resistant Staphylococcus aureus infection |
Phase I data showed it was safe and well tolerated and produced high concentrations of vancomycin in the sputum |
6/13/12 |
Theraclone Sciences Inc. (Seattle) |
TCN-202 |
Fully human monoclonal antibody |
Human cytomegalovirus infection |
Dosed the first subjects in a Phase I trial |
6/15/12 |
VaxInnate Corp. (Cranbury, N.J.) |
VAX161 |
An H5 vaccine candidate |
To prevent pandemic avian influenza |
Started a Phase I trial |
6/13/12 |
MISCELLANEOUS | |||||
Alexion Pharmaceuticals Inc. (Cheshire, Conn.) |
Soliris |
Eculizumab |
Atypical hemolytic uremic syndrome |
An analysis of 19 children showed Soliris significantly reduced the formation of blood clots in small blood vessels, leading to improved kidney function and eliminating the need for dialysis in half of patients |
6/19/12 |
Alnylam Pharmaceuticals Inc. (Cambridge, Mass.) |
ALN-TTR02 |
An RNAi therapeutic targeting the transthyretin gene |
TTR-mediated amyloidosis |
Completed enrollment in its Phase I trial |
6/8/12 |
Chiasma Inc. (New York) |
Octreolin |
An oral formulation of injectable ocreotide |
Acromegaly |
Reduced pituitary growth hormone secretion in healthy volunteers |
6/27/12 |
Oxygen Biotherapeutics Inc. (Morrisville, N.C.) |
Dermacyte |
Oxygen concentrate |
Histamine-induced pruritis |
The drug produced a larger reduction in Visual Analogue Scale scores after standard histamine skin prick than placebo; the study included 30 healthy volunteers |
6/1/12 |
Prolor Biotech Inc. (Nes-Ziona, Israel) |
hGH-CTP |
Long-acting human growth hormone |
Growth hormone deficiency |
Phase II data showed it has the potential for once-weekly administration; the drug also appeared to be safe and well tolerated |
6/27/12 |
RXi Pharmaceuticals Corp. (Worcester, Mass.) |
RXI-109 |
RNAi compound made to reduce or prevent skin scarring following trauma or surgery |
To reduce disfiguring hypertophic scarring and keloids |
Started a Phase I trial testing the compound |
6/27/12 |
|
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. | |||||