Company |
Product |
Description |
Indication |
Status |
Date |
CANCER | |||||
ArQule Inc. (Woburn, Mass.) |
ARQ 087 |
An oral multikinase inhibitor with pan-FGFR (fibroblast growth factor receptor) activity |
Metastatic solid tumors |
Began patient dosing in a Phase I trial |
12/13/12 |
BrainCells Inc. (San Diego) |
BCI-838 |
An oral prodrug of the company's Group II mGluR2/3 antagonist, BCI-632 |
Central nervous system disorders |
Completed a Phase I multiple-ascending-dose study, showing a favorable safety profile, with no treatment-related trends in clinical laboratory results, vital sign measurements, 12 lead ECG results or physical examination findings, and the drug was well tolerated |
12/6/12 |
Galena Biopharma (Lake Oswego, Ore.) |
NeuVax |
Nelipepimut-S |
Breast cancer |
Phase I/II data showed NeuVax is safe and effective at raising HER2 immunity |
12/10/12 |
Merrimack Pharmaceuticals Inc. (Cambridge, Mass.) |
MM-141 |
A fully human tetravalent antibody |
Cancer |
Enrolled the first patient in a Phase I study |
12/13/12 |
NeuroVive Pharmaceutical AB (Lund, Sweden) |
CicloMulsion |
A Cremophor-free intravenous cyclosporine formula |
Cardiac reperfusion injury |
Phase I data showed it was bioequivalent to Sandimmune injection and was safe and well tolerated |
12/5/12 |
NewLink Genetics Corp. (Ames, Iowa) |
HyperAcute |
Prostate cancer immunotherapy |
Prostate cancer |
Phase I dose-escalation study enrolled eight patients, who received a priming dose on day one, followed by 11 boost doses at two-week intervals; the study showed the product was safe, and that the first immunization increased anti-alphaGal IgG response compared with baseline |
12/14/12 |
OncoMed Pharmaceuticals Inc. (Redwood City, Calif.) |
OMP-52M51 |
Targets the Notch1 receptor |
Hematologic cancers |
Began dosing in a Phase I trial |
12/26/12 |
Jazz Pharmaceuticals plc (Dublin, Ireland) |
Erwinaze |
Asparaginase; erwinia chrysanthemi administered intravenously |
Acute lymphoblastic leukemia with hypersensitivity to E. coli-derived asparaginase therapy |
The first patient was enrolled and dosed in a 25-patient study |
12/5/12 |
Marina Biotech Inc. (Bothell, Wash.) and ProNAi Therapeutics Inc. (Plymouth, Mich.) |
PNT2258 |
An anti-Bcl-2 cancer drug which uses Smarticles delivery technology and targets Bcl-2-driven tumors |
Diffuse large B-cell lymphoma, follicular lymphoma and chronic lymphocytic leukemia |
Phase I data were favorable |
12/6/12 |
Patrys Ltd. (Melbourne, Australia) |
PAT-SM6 |
Cancer therapy |
Multiple |
Completed initial treatment of the first group of three patients in its Phase I/IIa trial |
12/11/12 |
Scancell Holdings plc (Nottingham, UK) |
SCIB1 DNA ImmunoBody |
Vaccine |
Stage III and IV malignant melanoma |
Phase I/II data showed a vaccine-induced T-cell response in four out of six patients in the 2-mg and 4-mg dose cohorts, who have received at least four doses |
12/7/12 |
TG Therapeutics Inc. (New York) |
TG-1101 |
Anti-CD20 monoclonal antibody |
Relapsed or refractory B-cell lymphoid malignancies |
Started a Phase I/II trial in combination with lenalidomide |
12/10/12 |
CENTRAL NERVOUS SYSTEM | |||||
Insero Health Inc. (Miami) |
INS001 |
Huperzine A, a naturally occurring compound |
Drug-resistant epilepsy |
Completed a Phase Ib trial |
12/14/12 |
Ironwood Pharmaceuticals Inc. (Cambridge, Mass.) |
IW-2143 |
BNC210; anti-anxiety drug |
Anxiety |
Phase I trial is under way |
12/26/12 |
Neuralstem Inc. (Rockville, Md.) |
Neural progenitor cells |
Spinal cord transplantation of neural progenitor cells |
Amyotrophic lateral sclerosis |
Phase I data showed that researchers were able to establish the long-term survival of the transplanted spinal cord stem cells in autopsied patients |
12/11/12 |
Omeros Corp. (Seattle) |
OMS824 |
Phosphodiesterase 10 inhibitor |
Schizophrenia and Huntington's disease |
Phase I data showed it was well tolerated with linear pharmacokinetics and expected pharmacological effects at its highest dose in healthy subjects |
12/7/12 |
PDC Biotech GmbH (Vienna, Austria) |
PDC31 |
A synthetic octapeptide designed to act as an allosteric modulator of the receptor for prostaglantin F2-alpha |
Preterm labor |
Completed a Phase I trial that showed PDC31 infusion was associated with a dose-dependent relief of pain, as well as a reduction in intrauterine pressure; the drug also was well tolerated, with no dose-limiting toxicities |
12/14/12 |
DIABETES | |||||
Isis Pharmaceuticals Inc. (Carlsbad, Calif.) |
ISIS-PTP1B, ISIS-GCGR and ISIS-GCCR |
ISIS-PTP1B is designed to target protein tyrosine phosphatase-1B, ISIS-GCGR is designed to target the glucagon receptor and ISIS-GCCR is designed to target the glucocorticoid receptor |
Metabolic disorders including Type II diabetes |
The three drugs were found to be safe and well tolerated in separate Phase I studies |
12/10/12 |
INFECTION | |||||
GeoVax Labs Inc. (Atlanta) |
Vaccine |
Recombinant DNA vaccine followed by boosting with recombinant modified vaccinia Ankara vaccine |
HIV |
Phase I trial was fully enrolled with 48 patients |
12/19/12 |
Hepatera Ltd. (Moscow) |
Myrcludex B |
Designed to inhibit the essential HBV receptor on the liver cell surface |
Chronic hepatitis B virus |
Enrolled the first three patients in its Phase Ib/IIa study |
12/13/12 |
InnaVirVax (Evry, France) |
VAC-3S |
Vaccine |
HIV |
Interim results of a Phase I/IIa trial showed good safety and tolerability |
12/4/12 |
Inovio Pharmaceuticals Inc. (Blue Bell, Pa.) |
SynCon |
H1N1 universal flu vaccine |
Influenza |
Phase I data showed that a single dose followed with a dose of a seasonal flu vaccine generated protective immune responses in 40% of trial subjects, compared with a 20% response rate in elderly patients who received the seasonal flu vaccine alone |
12/11/12 |
NovaDigm Therapeutics Inc. (Grand Forks, N.D.) |
NDV-3 |
Vaccine |
Candida and Staphylococcus aureus infections |
Phase I data showed a single dose of NDV-3 with alum adjuvant was safe, well tolerated and induced strong antibody and T-cell responses |
12/14/12 |
Novavax Inc. (Rockville, Md.) |
Vaccine |
Respiratory syncytial virus (RSV) fusion (F) recombinant nanoparticle vaccine |
RSV infection |
Phase I data showed the vaccine was well tolerated, with no evident dose-related toxicity or attributable severe adverse events |
12/7/12 |
Profectus BioSciences Inc. (Baltimore) |
Vaccine |
Recombinant vesicular stomatitis virus (rVSV)-vectored HIV vaccine |
Vesicular stomatitis virus |
Phase I study demonstrated the safety and immunogenicity of the vaccine |
12/5/12 |
MISCELLANEOUS | |||||
Auxilium Pharmaceuticals Inc. (Malvern, Pa.) |
Collagenase clostridium histolyticum |
Cellulite therapy |
Edematous fibrosclerotic panniculopathy |
Phase Ib study enrolled 99 women between 21 and 60 years |
12/14/12 |
Eleven Biotherapeutics Inc. (Cambridge, Mass.) |
EBI-005 |
A rationally designed topical protein designed to inhibit the interleukin-1 receptor |
Dry eye disease |
Started a Phase Ib trial |
12/11/12 |
Protalix BioTherapeutics Inc. (Carmiel, Israel) |
PRX-102 |
A plant cell-expressed, chemically modified recombinant alpha-galactosidase-A enzyme |
Fabry disease |
The first patient was treated in its Phase I/II trial |
12/11/12 |
RXi Pharmaceuticals Corp. (Westborough, Mass.) |
RXI-109 |
A self-delivering RNAi compound designed to reduce CTGF expression |
For the management of surgical and hypertrophic scars and keloids |
Started dosing in its three-cohort, nine-patient Phase I study |
12/6/12 |
Veloxis Pharmaceuticals A/S (Horsholm, Denmark) |
LCP-Tacro |
A once-daily formulation of the immunosuppressive drug tacrolimus |
Kidney transplant |
Preliminary results from the first 16 evaluable kidney transplant patients switching from tacrolimus showed a trend toward reduction of tremors, which are a common side effect of tacrolimus |
12/7/12 |
|
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. | |||||
