Company (Location) |
Product |
Description |
Indication |
Status |
Date |
CANCER | |||||
Advaxis Inc. (Princeton, N.J.) |
ADXS-HPV |
Immunotherapy candidate |
Human papillomavirus-positive head and neck cancer |
Two patients have been enrolled into a Phase I/II study |
5/9/12 |
Areva Med (Bethesda, Md.) |
212Pb-TCMC-Trastuxumab |
A monoclonal antibody carrying a radioisotope |
Intra-abdominal cancers |
Enrolling patients for the Phase I trial |
5/4/12 |
AVEO Pharmaceuticals Inc. (Cambridge, Mass.) |
AV-203 |
ErbB3-binding antibody |
Advanced solid tumors |
Started a Phase I study |
5/24/12 |
Bionomics Ltd. (Adelaide, Australia) |
BNC105 |
Vascular-disrupting agent |
Ovarian cancer |
Launched a Phase I/II trial |
5/25/12 |
Bio-Path Holdings Inc. (Houston) |
BP-100-1.01 |
Liposomal Grb-2 |
Blood cancers |
Completed treatment of the third dosage cohort of three patients in its Phase I trial |
5/30/12 |
Cancer Research UK (London) |
Caprelsa |
Vandetanib |
Non-small-cell lung cancer |
Opened the first trial testing the combination of Caprelsa and selumetinib |
5/17/12 |
Celtic Pharmaceutical Holdings LP (New York) |
Xerecept |
Corticorelin acetate |
Peritumoral brain edema |
Completed a Phase I/II study in pediatric patients who are dependent on the steroid Decadron; results showed Xerecept can reduce or eliminate the need for Decadron use and provide significant quality of life improvements |
5/23/12 |
Galectin Therapeutics Inc. (Newton, Mass.) |
GM-CT-01 |
Carbohydrate-based galectin inhibitor |
Advanced metastatic melanoma |
The first patient was dosed in a Phase I/II trial |
5/16/12 |
Marshall Edwards Inc. (San Diego) |
ME-344 |
Mitochondrial inhibitor |
Refractory solid tumors |
First patients were dosed in a Phase I trial |
5/30/12 |
MorphoSys AG (Martinsried, Germany) and Xencor Inc. (Monrovia, Calif.) |
MOR208 |
An anti-CD19 antibody with a modification to the Fc portion |
B-cell malignancies |
Completed patient enrollment in a Phase I trial |
5/23/12 |
Novelos Therapeutics Inc. (Madison, Wis.) |
I-131-CLR1404 |
Cancer-targeted molecular radiotherapeutic compound |
Advanced solid tumors |
Completed the first cohort in its Phase Ib dose-escalation trial |
5/16/12 |
Oncos Therapeutics Ltd. (Helsinki, Finland) |
CGTG-102 |
An oncolytic adenovirus |
Solid tumors |
Started a Phase I study |
5/30/12 |
CARDIOVASCULAR | |||||
AesRx LLC (Newton, Mass.) |
Aes-103 |
Anti-sickling agent |
Sickle cell disease |
Started a Phase I/IIa trial |
5/15/12 |
Alnylam Pharmaceuticals Inc. (Cambridge, Mass.) |
ALN-TTR01 |
An RNAi therapeutic |
TTR-mediated amyloidosis |
Phase I data showed that use of the drug resulted in statistically significant reductions in serum TTR protein levels |
5/11/12 |
Spectrum Pharmaceuticals Inc. (Henderson, Nev.) |
RenaZorb |
A lanthanum-based nanotechnology compound with phosphate-binding properties |
Hyperphos-phatemia |
Started patient enrollment in a Phase I study |
5/30/12 |
CENTRAL NERVOUS SYSTEM | |||||
Alder BioPharmaceuticals Inc. (Bothell, Wash.) |
ALD403 |
Targets the calcitonin gene-related peptide |
Migraine |
Started a Phase I study |
5/8/12 |
Alkermes plc (Dublin, Ireland) |
AKLS 5461 |
A combination of buprenorphine and opioid modulator ALKS 33 |
Major depressive disorder |
Phase I/II data showed it significantly reduced depressive symptoms |
5/31/12 |
Pharmanext AB (Stockholm, Sweden) |
SHACT |
Topical |
For pain relief from intrauterine device insertion |
First patient was dosed in a 15-patient, open-label Phase I study |
5/1/12 |
Pozen Inc. (Chapel Hill, N.C.) |
PA32540 |
A coordinated-delivery tablet containing immediate-release omeprazole layers around pH-sensitive aspirin |
Pain |
Phase I data showed it provided faster protection compared with delayed-release enteric-coated omeprazole as measured by mean time to gastric pH |
5/22/12 |
Zalicus Inc. (Cambridge, Mass.) |
Z160 |
Oral N-type calcium channel blocker |
Neuropathic pain |
Selected the most promising formulation of Z160 from a Phase I trial that showed it was well tolerated and demonstrated a sixfold improvement in Z160's bioavailability |
5/3/12 |
DIABETES | |||||
MonoSol Rx LLC (Warren, N.J.) and Midatech Ltd. (Oxford, UK) |
Midaform Insulin PharmFilm |
Nanoformulated transbuccal insulin film product |
Diabetes |
Phase I data showed positive bioavailability and pharmacokinetic results in 27 healthy volunteers |
5/4/12 |
Rhythm Pharmaceuticals Inc. (Boston) |
RM-131 |
Its ghrelin agonist |
Diabetic gastroparesis |
Phase Ib data showed that it greatly accelerated gastric emptying, with emptying time reduced by 66% |
5/23/12 |
INFECTION | |||||
Achillion Pharmaceuticals Inc. (New Haven, Conn.) |
ACH-3102 |
A second-generation pan-genotypic NS5A inhibitor |
Hepatitis C virus infection |
Started dosing in a Phase I trial |
5/10/12 |
Achillion Pharmaceuticals Inc. (New Haven, Conn.) |
ACH-2684 |
A second-generation protease inhibitor |
Chronic hepatitis C virus genotype 1 |
Phase Ib data showed it achieved a mean maximum 3.73 log10 reduction in HCV RNA after three-day 400-mg monotherapy with once-daily dosing |
5/22/12 |
Bionor Pharma ASA (Oslo, Norway), Eurocine Vaccines AB (Solna, Sweden) and Oslo University Hospital |
Vacc-4X and Endocine |
Vaccine and adjuvant |
Infection |
A trial produced vaccine-related immune responses in a nasal immunization study in human patients |
5/11/12 |
ChemoCentryx Inc. (Mountain View, Calif.) |
CCX168 |
An oral C5aR inhibitor |
Anti-neutrophil cytoplasmic antibody-associated renal vasculitis |
Phase I data established a targeted dosing level, and showed the compound was well tolerated and caused no serious adverse events |
5/30/12 |
GeoVax Labs Inc. (Atlanta) |
HVTN 094 |
Second-generation vaccine that includes granulocyte-macrophage colony-stimulating factor as an adjuvant |
HIV |
Opened enrollment for a Phase I trial |
5/23/12 |
Hemispherx Biopharma Inc. (Philadelphia) |
Ampligen |
Rintatolimod |
Influenza |
Ampligen was administered intranasally in conjunction with FluMist to healthy volunteers in a study at the University of Alabama |
5/1/12 |
Inovio Pharmaceuticals Inc. (Blue Bell, Pa.) |
SynCon |
Avian influenza vaccine |
Avian influenza |
Generated protective hemagglutination inhibition titers against six different unmatched strains of H5N1 in a Phase I trial |
5/17/12 |
Isconova AB (Uppsala, Sweden) |
Matrix M |
Vaccine adjuvant |
Influenza |
Phase I data showed it met both the primary and secondary endpoints when tested in a group of elderly subjects administered Vaxigrip |
5/15/12 |
Mucosis BV (Groningen, the Netherlands) |
FluGEM |
Mimopath mucosal vaccines |
Influenza |
Phase I provided proof-of-concept data that the vaccines are safe and well tolerated, and able to produce balanced immune responses in circulating blood and the respiratory tract |
5/11/12 |
NovaDigm Therapeutics Inc. (Grand Forks, N.D.) |
NDV-3 |
A prophylactic vaccine containing recombinant AIs3 |
Candida albicans |
Phase I data showed a single dose of NDV-3 was safe and well tolerated, with or without alum adjuvant, and induced strong antibody and T-cell immune responses |
5/8/12 |
Novavax Inc. (Rockville, Md.) |
VLP |
Monovalent virus-like particle vaccine candidate |
A/H5N1 avian influenza viruses |
Started enrollment in a Phase I trial; began a second Phase I trial |
5/3/12 |
Theraclone Sciences Inc. (Seattle) |
TCN-032 |
A fully human monoclonal antibody |
Influenza A infections |
Phase I data showed it was well tolerated with no dose-limiting toxicities or serious adverse events |
5/16/12 |
MISCELLANEOUS | |||||
Acucela Inc. (Seattle) |
ACU-4429 |
Small-molecule visual cycle modulator |
Advanced dry age-related macular degeneration/geographic atrophy |
Interim Phase IIa data showed that ACU-4429 produced a dose-dependent response and modulated rod visual cycle for doses up to 10 mg |
5/9/12 |
Catalyst Pharmaceutical Partners Inc. (Coral Gables, Fla.) |
CPP-115 |
A GABA aminotransferase inhibitor and vigabatrin analogue |
Infantile spasms |
Phase Ia data showed it was well tolerated at all six doses administered |
5/23/12 |
Medivir AB (Stockholm, Sweden) |
MIV-711 |
A cathepsin K inhibitor |
Bone disorders such as osteoporosis |
Phase I trial has been initiated |
5/30/12 |
Oxford BioMedica plc (Oxford, UK) and Sanofi SA (Paris) |
RetinoStat |
A gene-based treatment |
Wet age-related macular degeneration |
Phase I data showed that samples from six patients confirmed substantial increases in expression of endostatin and angiostatin proteins in the eye |
5/9/12 |
Promethera Biosciences SA (Mont-Saint-Guibert, Belgium) |
Promethera HepaStem |
A cell-based therapy |
Urea cycle disorders and Crigler-Najjar syndrome |
Treated the first two patients in a Phase I/II trial |
5/15/12 |
StemCells Inc. (Newark, Calif.) |
HuCNS-SC |
purified human neural stem cells |
Spinal cord injury |
Phase I/II data showed it was well tolerated |
5/18/12 |
Summit Corp. plc (Oxford, UK) |
SMT C1100 |
A small-molecule utrophin up-regulator |
Duchenne's muscular dystrophy |
Dosed the first cohort of patients in a Phase I study |
5/29/12 |
Ultragenyx Pharmaceutical Inc. (Novato, Calif.) |
UX001 |
Sialic acid |
Hereditary inclusion body myopathy |
Phase I data showed it was well tolerated |
5/2/12 |
Versartis Inc. (Redwood City, Calif.) |
VRS-317 |
A once-monthly form of recombinant human growth hormone |
Growth hormone deficiency |
Completed patient enrollment in a Phase I trial |
5/3/12 |
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. |