Company (Location) |
Product |
Description |
Indication |
Status (Date)# |
AUTOIMMUNE | ||||
Allozyne Inc. (Seattle) |
AZ01 |
A pegylated interferon beta 1-b drug |
Relapsing/remitting multiple sclerosis |
A Phase Ib trial showed the drug was well tolerated and has a half-life two to three times longer than other pegylated interferon beta therapeutics (10/20) |
TxCell SA (Valbonne, France) |
OvaSave |
An antigen-specific regulatory T-cell-based immunotherapy |
Crohn's disease |
Phase I/II data showed it was well tolerated and caused a response in 40% of Crohn's disease patients (10/26) |
Xencor Inc. (Monrovia, Calif.) |
SmAb5871 |
A humanized monoclonal antibody |
Lupus and rheumatoid arthritis |
Started a Phase I trial (10/24) |
CANCER | ||||
Celtic Pharmaceutical Holdings LP (New York) |
Xerecept |
Corticorelin acetate |
Peritumoral brain edema associated with cerebral tumors |
Completed enrollment in a 15-subject dose tolerance study (10/4) |
DelMar Pharmaceuticals Ltd. (Vancouver, British Columbia) |
VAL-083 |
A bifunctional alkylating agent |
Refractory glioblastoma multiforme |
Started an open-label Phase I/II trial (10/26) |
Galena Biopharma Inc. (Portland, Ore.) |
NeuVax |
Adjunct therapy |
Breast cancer |
Phase I/II data showed it was safe and effective in stimulating expansion of E75-specific cytotoxic T cells (10/21) |
Halozyme Therapeutics Inc. (San Diego) |
PEGPH20 |
Pegylated rHuPH20 |
Advanced solid tumors |
Phase I dose-finding studies showed it rapidly restored tumor perfusion and decreased metabolic activity in tumors (10/28) |
Intellikine Inc. (La Jolla, Calif.) |
INKN1117 |
A selective, orally available, small-molecule inhibitor of the P13K-alpha isoform |
Advanced solid malignancies |
Treated the first patient in a Phase I study (10/13) |
Keryx Biopharma-ceuticals Inc. (New York) |
KRX-0401 |
Perifosine |
Advanced multiple myeloma |
Data showed the combination of perifosine and bortezomib was active and well tolerated in patients previously treated with bortezomib (10/14) |
Molecular Insight Pharmaceuticals Inc. (Cambridge, Mass.) |
99mTc-MIP-1404 and 99mTc-MIP-1405 |
Small-molecule inhibitors of prostate-specific membrane antigen |
Metastatic prostate cancer |
Phase I data showed they rapidly dected both bone and lymph node lesions in six patients and, in some cases, demonstrated a greater number of lesions in bone than standard-of-care imaging such as bone scans (10/20) |
CARDIOVASCULAR | ||||
Apeptico GmbH (Vienna, Austria) |
AP301 |
An orally inhaled peptide |
Edematous respiratory failure |
AP301 was well tolerated in a Phase I trial (10/26) |
MediciNova Inc. (San Diego) |
MN-221 |
A selective beta(2)-adrenergic receptor agonist |
Chronic obstructive pulmonary disease |
Started a Phase Ib trial (10/31) |
Nile Therapeutics Inc. (San Mateo, Calif.) |
Cenderitide |
Subcutaneous bolus and subcutaneous infusion |
Chronic heart failure |
Completed dosing in an open-label Phase I trial (10/19) |
CENTRAL NERVOUS SYSTEM | ||||
Ampio Pharmaceuticals Inc. (Greenwood Village, Colo.) |
Ampion-In-Knee |
A low molecular fraction of commercial albumin |
Osteoarthritis of the knee |
Data showed it was well tolerated and reduced pain over and above steroids (10/27) |
AMRI (Albany, N.Y.) |
ALB-127158(a) |
MCH1 receptor antagonist |
Obesity |
Phase I data showed that cerebrospinal fluid drug levels were achieved with a single 400-mg oral dose of the drug (10/4) |
Neuralstem Inc. (Rockville, Md.) |
NSI-189 |
Stimulated new neuron growth in the hippocampus |
Major depressive disorder |
Completed Phase Ia in an ongoing safety trial (10/28) |
Neuralstem Inc. (Rockville, Md.) |
Stem cells |
Spinal cord stem cells |
Amyotrophic lateral sclerosis |
Received FDA clearance to transplant the cells into the cervical-spine region of patients with ALS in the ongoing Phase I trial (10/25) |
DIABETES | ||||
Boston Therapeutics Inc. (Manchester, N.H.) |
PAZ320 |
A polysaccharide; a chewable complex carbohydrate-based compound |
Type II diabetes mellitus |
Started the first clinical trial of PAZ320 (10/12) |
Catabasis Pharmaceuticals Inc. (Cambridge, Mass.) |
CAT-1004 |
A conjugate of omega-3 fatty acid docosahexaenoic acid and salicylate |
Type II diabetes |
Started a Phase I trial (10/6) |
Halozyme Therapeutics Inc. (San Diego) |
rHuPH20 |
Recombinant human hyaluronidase |
Type I diabetes |
Positive results from a Phase Ib study showed that pre-administration of 150 units of rHuPH20 led to consistent insulin exposure over the infusion set life and superior glucose control following meals (10/31) |
ViroMed Co. Ltd. (Seoul, South Korea) |
VM202-DPN |
Regenerates damaged nerve cells and nearby capillaries |
Diabetic neuropathy pain |
Phase I/II data showed about 80% of the 12 subjects who received three different doses experienced a reduction in diabetic neuropathy pain (10/14) |
INFECTION | ||||
Agenus Inc. (Lexington, Mass.) |
HerpV |
A recombinant therapeutic vaccine |
Genital herpes |
Phase I data showed patients had a statistically significant CD4-positive T-cell response to HSV-2 antigens, and the majority demonstrated a CD8-positive T-cell response (10/3) |
Elusys Therapeutics Inc. (Pine Brook, N.J.) |
Anthim |
Antitoxin |
Anthrax |
Started a new trial to further demonstrate safety (10/25) |
Genticel SA (Toulouse, France) |
ProCervix |
Liquid formulation vaccine |
Papillomavirus |
Completed patient recruitment for its Phase I trial (10/20) |
Intercell AG (Vienna, Austria) |
IC84 |
A recombinant protein vaccine |
Clostridium difficile |
Data from a Phase I trial showed good safety and immunogenicity (10/25) |
Karo Bio AB (Huddinge, Sweden) |
Eprotirome |
Liver-selective thyroid hormone receptor agonist |
Heterozygous familial hypercholesterolemia |
Enrolled the first patient in a trial (10/5) |
Novavax Inc. (Rockville, Md.) |
RSV vaccine |
Respiratory syncytial virus vaccine |
Respiratory syncytial virus |
Top-line Phase I data showed it was well tolerated and highly immunogenic (10/4) |
Pevion Biotech AG (Bern, Switzerland) |
PEV7 |
Vaccine |
Candida |
Clinical data showed high levels of specific antibodies and a 100% mucosal immune response rate (10/12) |
PolyMedix Inc. (Radnor, Pa.) |
PMX-30063 |
Defensin-mimetic antibiotic |
Staphylococcus aureus |
Phase I data demonstrated antimicrobial activity in human blood plasma against both resistant and susceptible strains (10/25) |
MISCELLANEOUS | ||||
Geron Corp. (Menlo Park, Calif.) |
GRNOPC1 |
Human embryonic stem cell-based therapy |
Spinal cord injury |
Phase I safety data showed no surgical complications during or after the procedures, no adverse events related to the injections or to GRNOPC1 and no evidence of cavitation in the spinal cord at the injury sites on MRI (10/21) |
IntelliCell BioSciences Inc. (New York) |
Mucograft |
Collagen matrix |
Gum recession |
A pilot study showed Mucograft combined with stromal vascular fraction treatments may be a viable treatment for gum recession (10/21) |
|
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. | ||||