Company (Location) |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Alvine Pharmaceuticals Inc. (San Carlos, Calif.) |
ALV003 |
An oral mixture of a glutamine-specific cysteine protease and a proline-specific prolyl endopeptidase |
Celiac disease |
Phase IIa trial met the primary endpoint showing it can diminish gluten-induced intestinal mucosal injury in well-controlled celiac disease patients |
5/23/12 |
MediciNova Inc. (San Diego) |
MN-221 |
A beta(2) adrenergic receptor agonist |
Asthma |
Phase IIb data showed it failed to meet its primary endpoint of improved forced expiratory volume in one second compared to placebo |
5/25/12 |
Pharmos Corp. (Iselin, N.J.) |
S-tofisopam |
Levotofisopam |
Gout |
Completed a Phase IIa trial |
5/21/12 |
Zalicus Inc. (Cambridge, Mass.) |
Synavive |
A low-dose glucocorticoid |
Rheumatoid arthritis |
Completed enrollment with 292 patients in a Phase IIb trial |
5/1/12 |
CANCER | |||||
Advaxis Inc. (Princeton, N.J.) |
ADXS-HPV |
Immunotherapy |
Recurrent/refractory cervical cancer |
Completed enrollment in a 110-patient, randomized Phase II trial |
5/30/12 |
Amgen Inc. (Thousand Oaks, Calif.) |
AMG 103 |
A bi-specific T-cell engager antibody |
Acute lymphoblastic leukemia |
Phase II data showed it helped achieve a high rate of complete response in 72% of adults |
5/22/12 |
Celldex Therapeutics Inc. (Needham, Mass.) |
CDX-011 |
Glembatumumab vedotin; glycoprotein NMB-targeting antibody-drug conjugate |
Breast cancer |
Phase IIb data showed impressive response rates in three subsets of heavily pretreated patients |
5/25/12 |
Cyclacel Pharmaceuticals Inc. (Berkeley Heights, N.J.) |
Sapacitabine |
An oral nucleoside analogue |
Acute myeloid leukemia or myelodysplastic syndromes |
Completed enrollment of the Phase II portion of the Phase II/III trial comparing sapacitabine to low-dose cytarabine in patients with previously untreated AML or high-risk myelodysplastic syndromes who are unfit for intensive chemotherapy |
5/15/12 |
Diamyd Medical AB (Stockholm, Sweden) |
NP2 Enkephalin |
Based on the company's Nerve Targeting Drug Delivery System |
Cancer pain |
Completed enrollment in its Phase II study |
5/23/12 |
Esperance Pharmaceuticals Inc. (Baton Rouge, La.) |
EP-100 |
A targeted membrane-disrupting peptide |
Advanced ovarian cancer |
Began enrolling patients in a Phase II trial of EP-100 plus paclitaxel |
5/18/12 |
Generon Corp. Ltd. (Shanghai, China) |
F-627 |
A newer-generation recombinant human granulocyte colony-stimulating factor |
Breast cancer |
Started a Phase II trial |
5/7/12 |
Genta Inc. (Berkeley Heights, N.J.) |
Tesetaxel |
An orally absorbed taxane |
Advanced gastric cancer |
The first patient was accrued to a randomized trial, which will enroll 260 patients over the next 12 to 15 months; completed a Phase II trial, confirming its activity is at least equivalent to docetaxel, but with an improved safety profile |
5/9/12; 5/25/12 |
Geron Corp. (Menlo Park, Calif.) |
Imetelstat |
Designed to inhibit telomerase |
Locally recurrent or metastatic breast cancer |
Completed enrollment in a Phase II study of imetelstat in combination with paclitaxel |
5/4/12 |
GTx Inc. (Memphis, Tenn.) |
Capesaris |
A selective estrogen receptor alpha agonist |
Prostate cancer |
FDA removed its full clinical hold on the investigational new drug application following review of the company's complete response and its new Phase II protocol |
5/9/12 |
Idera Pharmaceuticals Inc. (Cambridge, Mass.) |
IMO-2055 |
A Toll-like 9 receptor-targeting candidate |
Recurrent or metastatic squamous cell carcinoma of the head and neck |
Top-line Phase II data of IMO-2055 in combination with Erbitux showed it did not meet its primary endpoint of improved progression-free survival compared to Erbitux alone |
5/4/12 |
ImmunoCellular Therapeutics Ltd. (Woodland Hills, Calif.) |
ICT-107 |
A vaccine |
Glioblastoma multiforme |
Phase II trial was initiated at 25 sites, and has enrolled 189 patients |
5/10/12 |
Mologen AG (Berlin) |
MGN1703 |
DNA-based immunotherapy |
Metastatic colorectal cancer |
Hit the primary endpoint in a Phase II trial |
5/15/12 |
NewLink Genetics Corp. (Ames, Iowa) |
Algenpan-tucel-L |
HyperAcute Pancrease immunotherapy |
Pancreas cancer |
Phase II data showed 12-month disease-free survival of 62%, the primary endpoint of the study |
5/23/12 |
Onconova Therapeutics Inc. (Newtown, Pa.) |
Estybon |
Rigosertib |
Solid tumors and hematologic malignancies |
Advanced the oral formulation into a new Phase II study |
5/11/12 |
Oxigene Inc. (South San Francisco) |
Zybrestat |
Fosbretabulin tromethamine, CA4P |
Anaplastic thyroid cancer |
Phase II/III data showed that improvements were observed in median survival and one-year survival in patients with prior thyroidectomy followed by Zybrestat and chemotherapy, compared to patients without surgery who received chemotherapy alone |
5/1/12 |
Peregrine Pharmaceuticals Inc. (Tustin, Calif.) |
Bavituximab |
Phosphatidylserine-targeting antibody |
Non-small-cell lung cancer |
Phase IIb data of bavituximab plus docetaxel showed it doubled the overall response rates when compared to docetaxel plus placebo |
5/22/12 |
PCI Biotech Holding ASA (Oslo, Norway) |
Amphinex |
Photosensitizer |
Head and neck cancer |
The first patient was included in the Phase II study of Amphinex in combination with cytotoxic agent bleomycin |
5/17/12 |
Rexahn Pharmaceuticals Inc. (Rockville, Md.) |
Archexin |
Akt protein kinase inhibitor |
Ovarian cancer |
Submitted a Phase II protocol to test Archexin |
5/9/12 |
Seattle Genetics Inc. (Bothell, Wash.) |
Adcetris |
Brentuximab vedotin |
Relapsed cutaneous T-cell lymphoma |
Phase II data showed that 12 of 16 evaluable patients achieved a partial remission |
5/11/12 |
Seattle Genetics Inc. (Bothell, Wash.) |
SGN-35 |
Brentuximab vedotin |
Relapsed or refractory systemic anaplastic large-cell lymphoma |
Phase II data showed 86% of patients achieved the primary endpoint of objective response rate, with a median duration of response of 12.6 months |
5/24/12 |
Spectrum Pharmaceuticals Inc. (Henderson, Nev.) |
Zevalin |
Ibritumomab tiuxetan injection |
Follicular B-cell non-Hodgkin's lymphoma |
Initiated a Phase II study |
5/18/12 |
Syndax Pharmaceuticals Inc. (Waltham, Mass.) |
Entinostat |
HDAC inhibitor |
Non-small-cell lung cancer |
Phase II data demonstrated an improved overall survival in a subset of NSCLC patients with tumors expressing elevated levels of E-cadherin treated with entinostat and Tarceva |
5/1/12 |
CARDIOVASCULAR | |||||
Elevation Pharmaceuticals Inc. (San Diego) |
EP-101 |
Delivered via the eFlow nebulizer device |
Chronic obstructive pulmonary disease |
Phase IIb data showed that those with moderate disease had a clinically meaningful and statistically significant improvement in lung function vs. placebo |
5/17/12 |
FibroGen Inc. (San Francisco) |
GF-3019 |
A human monoclonal antibody against connective tissue growth factor |
Idiopathic pulmonary fibrosis |
Expanded an ongoing Phase II study, adding a second, higher-dose group |
5/4/12 |
Isis Pharmaceuticals Inc. (Carlsbad, Calif.) |
ISIS-APOCIIIRx |
An inhibitor of apolipoprotein C-III |
Hypertri-glyceridemia |
Started a Phase II study |
5/7/12 |
Neurocrine Biosciences Inc. (San Diego) |
Urocortin 2 |
Infusion |
Acute decompensated heart failure |
Phase II data showed it was generally well tolerated and there were no treatment-related serious adverse events |
5/21/12 |
Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) and Sanofi SA (Paris) |
SAR236553/REGN727 |
A subcutaneously delivered fully human antibody targeting PCSK9 |
High cholesterol |
Phase II data showed it reduced LCL-cholesterol from baseline across the four dosing regimens tested for 12 weeks, with 28.9% to 67.9% in the treatment groups showing decreased LDL-C vs. 10.7% in the placebo |
5/30/12 |
Resverlogix Corp. (Calgary, Alberta) |
RVX-208 |
A small molecule designed to stimulate endogenous ApoA-I production |
Cardiovascular disease |
Phase IIb trial has been completed on schedule |
5/10/12 |
Sorbent Therapeutics Inc. (Sunnyvale, Calif.) |
CLP1001 |
A non-absorbable, super-absorbent cross-linked polyelectrolyte polymer |
Heart failure |
Phase IIa data showed it demonstrated improvement in heart failure symptoms compared to placebo |
5/23/12 |
CENTRAL NERVOUS SYSTEM | |||||
Avraham Pharmaceuticals Ltd. (Yavne, Israel) |
Ladostigil |
A cholinesterase and brain-selective monoamine oxidase inhibitor |
Mild cognitive impairment; mild to moderate Alzheimer's disease |
Initiated a Phase II trial; completed enrollment in a Phase II in Alzheimer's |
5/18/12 |
Catalyst Pharmaceutical Partners Inc. (Coral Gables, Fla.) |
CPP-109 |
Vigabatrin; a GABA analogue |
Cocaine addiction |
Reached patient recruitment goal of 210 subjects in a Phase IIb trial |
5/22/12 |
Cerecor Inc. (Baltimore) |
FP01 |
Lozenges |
Upper respiratory tract infections |
Started dosing in a Phase II acute cough study |
5/22/12 |
Cubist Pharmaceuticals Inc. (Lexington, Mass.) |
CB-5945 |
A potent, peripherally acting mu opioid receptor antagonist |
Chronic noncancer pain and opioid-induced constipation |
Phase II studies met the primary endpoint of change from baseline in the number of spontaneous bowel movements over a four-week treatment period |
5/16/12 |
S.L.A. Pharma AG (Basel, Switzerland) |
Nalcol |
An oral formulation of naloxone |
Opioid-induced constipation in noncancer pain |
Phase II data showed statistical significance for increasing spontaneous bowel movements against placebo and baseline |
5/15/12 |
INFECTION | |||||
Achaogen Inc. (South San Francisco) |
Plazomicin |
A next-generation aminoglycoside |
Gram-negative bacterial infections |
All objectives were met in a Phase II study |
5/16/12 |
Alnylam Pharmaceuticals Inc. (Cambridge, Mass.) |
ALN-RSV01 |
RNAi candidate |
Progressive bronchiolitis obliterans syndrome in lung transplant patients |
Drug failed to hit its primary endpoint in a Phase IIb trial |
5/31/12 |
Genetic Immunity Inc. (McLean, Va.) |
DermaVir |
Vaccine |
HIV |
Human proof-of-concept trial indicated the induction of long-lasting memory T-cell responses after a single immunization |
5/18/12 |
Insmed Inc. (Monmouth Junction, N.J.) |
Arikace |
Liposomal amikacin for inhalation |
Nontuber-culous mycobacterial lung disease |
Began screening patients for a Phase II trial |
5/24/12 |
NovaBay Pharmaceuticals Inc. (Emeryville, Calif.) |
NVC-422 |
Lead Aganocide compound |
Adenoviral conjunctivitis |
Enrolled the first patients in its Phase IIb study, named BAYnovation |
6/21/12 |
MISCELLANEOUS | |||||
Acacia Pharma Ltd. (Cambridge, UK) |
APD421 |
Comprises a new use for a marketed dopamine D2/D3 antagonist |
Postoperative nausea and vomiting |
Phase II data showed it significantly reduced the incidence of nausea and vomiting compared to placebo |
5/30/12 |
AltheRx Pharmaceuticals Inc. (Malvern, Pa.) |
Solabegron |
A beta3-adrenoreceptor agonist |
Overactive bladder |
Phase II data showed a 65.6% reduction from baseline in incontinence episodes, a statistically significant adjusted mean difference from placebo of 21% |
5/22/12 |
Auxilium Pharmaceuticals Inc. (Malvern, Pa.) |
Xiaflex |
Collagenase clostridium histolyticum; a first-in-class biologic |
Peyronie's disease |
Phase IIb data demonstrated a statistically significant change compared with placebo at 36 weeks in improvement in penile curvature deformity |
5/10/12 |
Azelon Pharmaceuticals Inc. (West Conshohocken, Pa.) |
ZT-034 |
Nasal spray |
Low bone mass |
Completed a Phase IIa trial |
5/3/12 |
Cytochroma Ltd. (Markham, Ont.) |
CTAP101 |
Capsules |
Chronic kidney disease |
Phase IIb data showed it effectively and safely lowered elevated plasma intact parathyroid hormone |
5/14/12 |
Flexion Therapeutics Inc. (Woburn, Mass.) |
FX005 |
A p38 MAP kinase inhibitor |
Osteoarthritis |
Demonstrated significant pain relief over placebo at four weeks in a Phase II trial |
5/31/12 |
Juventas Therapeutics Inc. (Cleveland) |
JVS-100 |
Designed to encode stromal cell-derived factor 1 |
Critical limb ischemia |
Enrolling in a Phase IIa trial |
5/16/12 |
Lightlake Therapeutics Inc. (London) |
Intranasal naloxone |
Opioid antagonist nasal spray |
Binge eating disorder |
Phase II data showed no adverse events and naloxone-treated patients had a highly significant reduction in their time spent binge eating compared with placebo |
5/4/12 |
Nymox Pharmaceutical Corp. (Hasbrouck Heights, N.J.) |
NX-1207 |
Single injection |
Benign prostatic hyperplasia |
Data showed that subjects in the NX-1207 2.5 mg cohort had mean improvements in their BPH symptoms that reached statistical significance |
5/22/12 |
Ocera Therapeutics Inc. (San Diego) |
OCR-002 |
Ornithine phenylacetate |
Cirrhosis of the liver and upper gastrointestinal bleeding |
Phase II data showed it is well tolerated and provided a rapid, durable ammonia reduction after 36 hours of treatment |
5/30/12 |
Prolor Biotech Inc. (Nes-Ziona, Israel) |
hGH-CTP |
Long-acting version of human growth hormone |
Growth hormone deficiency |
Phase II data reaffirmed the company's prior Phase II findings, showing that a single weekly injection has the potential to replace seven consecutive daily injections of marketed human growth hormone |
5/8/12 |
Repros Therapeutics Inc. (The Woodlands, Texas) |
Proellex-V |
Vaginally delivered Proellex |
Uterine fibroids |
Proellex-V was well tolerated at all doses, and reliable cessation of menses was induced at doses as low as 3 mg |
5/2/12 |
Sigmoid Pharma Ltd. (Dublin, Ireland) |
CyCol |
Delivers cyclosporine orally in a format called SmPill |
Ulcerative colitis |
Completed a Phase II trial |
5/18/12 |
Vertex Pharmaceuticals Inc. (Cambridge, Mass.) |
Kalydeco |
Ivacaftor |
Cystic fibrosis |
Corrected Phase II clinical data of Kalydeco with VX-809 showed that only 35% of CF patients with the F608del mutation experienced an absolute improvement in lung function of 5% or more, rather than the 46% as reported previously |
5/30/12 |
Zytoprotec GmbH (Vienna, Austria) |
PD-protec |
A dialysate used in perioneal dialysis |
Kidney failure |
Completed a Phase I/II trial showing it is safe and well tolerated and may improve survival of abdominal cells in peritoneal dialysis |
5/24/12 |
|
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. | |||||