Genta Inc., of Berkeley Heights, N.J., reported results from its Phase IIb confirmatory trial of tesetaxel in 41 patients with advanced gastric cancer who progressed on at least one prior chemotherapy regimen that included a platinum compound (cisplatin, oxaliplati or carboplatin) and a fluoropyrimidine compound (5-fluorouracil or capecitabine [Xeloda, Hoffman-La Roche
Immuron Ltd., of Melbourne, Australia, said the FDA cleared its investigational new drug application to begin a Phase IIb trial of bovine colostrum-derived Imm124-E for nonalcoholic steatohepatitis – a chronic inflammatory disorder of the liver – and fatty liver disease
Idenix Pharmaceuticals Inc., of Cambridge, Mass., reported interim data from a 12-week Phase IIb trial of IDX184, the company's lead product candidate for the treatment of hepatitis C virus (HCV) infection...The first 31 patients have completed 28 days of treatment in the Phase IIb study
Pearl Therapeutics Inc., of Redwood City, Calif., said it completed two Phase IIb studies of PT003, its inhaled combination bronchodilator product for moderate to severe chronic obstructive pulmonary disease...The two trials are part of the company's five-study Phase IIb program
AVI BioPharma Inc., of Bothell, Wash., said an independent data safety monitoring board determined that the Phase IIb study of eteplirsen in Duchenne's muscular dystrophy (DMD) was safe to proceed as planned following a review of the 12-week biopsy data from the highest dose cohort (50 mg/kg...Vacc-4x is a therapeutic HIV vaccine based on four synthetic, slightly modified peptide sequences from conserved parts of the P24 capsid protein of the HIV virus, and it has shown in Phase IIb testing to
Repros Therapeutics Inc., of The Woodlands, Texas, provided top-line results for the end-of-dosing analysis of its ZA-203 Phase IIb study of Androxal in secondary hypogonadal men with moderate to severe dysfunction
CytRx Corp., of Los Angeles, initiated a Phase IIb trial comparing tumor-targeting doxorubicin conjugate INNO-206 to native doxorubicin in soft tissue sarcoma
Celldex Therapeutics Inc., of Needham, Mass., completed accrual for its Phase IIb (EMERGE) trial of CDX-011 (glembatamumab vedotin) for metastatic breast cancer
Impax Pharmaceuticals, of Hayward, Calif., the branded products division of Impax Laboratories Inc., initiated a Phase IIb trial of its drug candidate IPX159 in 120 patients with moderate to severe restless legs syndrome (RLS
ThromboGenics NV, of Leuven, Belgium, and co-development partner BioInvent International AB, of Lund, Sweden, said they completed enrollment in a 632-patient Phase IIb trial of long-acting anticoagulant TB-402 (Factor VIII inhibitor) for the prophylaxis of venous thromboembolism after total hip surgery
Hatchtech Pty Ltd., of Melbourne, Australia, reported findings from its Phase IIb trial in head lice infestation suggesting that its compound DeOvo is safe and effective following a single application...Rib-X Pharmaceuticals Inc., of New Haven, Conn., reported top-line data from its Phase IIb study of antibiotic delafloxacin for acute bacterial skin and skin structure infections, including those caused by methicillin-resistant Staphylococcus aureus, indicating that delafloxacin met or exceeded
Pearl Therapeutics Inc., of Redwood City, Calif., reported that in a randomized, double-blind, Phase IIb trial of its long-acting muscarinic agonist (LAMA) drug glycopyrrolate via metered dose inhaler (GP MDI, PT001) in COPD, the drug showed statistically significant improvements in lung function compared to placebo
EnVivo Pharmaceuticals Inc., of Watertown, Mass., said results of a Phase IIb study of EVP-6124, an oral nicotinic alpha-7 agonist, showed statistically significant and clinically meaningful effects on both cognition and functional symptoms including global cognitive function, in schizophrenic patients...A Phase IIb study will test the product as a treatment for negative symptoms and cognitive dysfunction in schizophrenia
Anthera Pharmaceuticals Inc., of Hayward, Calif., reported interim biomarker data from the Phase IIb PEARL-SC study in systemic lupus erythematosus, which showed that weekly and monthly subcutaneous doses of blisibimod resulted in statistically significant reductions of B cells...Ceregene Inc., of San Diego, completed enrollment in a Phase IIb trial of CERE-120, a gene therapy product in development for Parkinson's disease
Alnylam Pharmaceuticals Inc., of Cambridge, Mass., completed enrollment in a Phase IIb trial of its RNAi therapy for respiratory syncytial virus, ALN-RSV01
Resverlogix Corp., of Calgary, Alberta, said its Phase IIb SUSTAIN study is fully enrolled with 176 subjects who have established atherosclerotic cardiovascular disease and low high-density cholesterol (HDL-C...Supernus Pharmaceuticals Inc., of Rockville, Md., initiated a Phase IIb clinical trial of its SPN-810 to treat impulsive aggression associated with attention deficit hyperactivity disorder in children ages 6 to 12
FibroGen Inc., of San Francisco, reported data from an ongoing Phase IIb dose-finding study of FG-4592, a hypoxia-inducible factor prolyl hydroxylase inhibitor for anemia correction and hemoglobin (Hb) maintenance in patients with Stage III or Stage IV chronic kidney disease who are not on dialysis...Substudy analyses of the company's Phase IIb RADAR trial of lead program REG1 suggested that the anticoagulant system provided nearly complete Factor IXa inhibition with a dose of 1 mg/kg of
The decision to remove the partial hold was prompted by Phase IIb data and a recommendation from the data safety monitoring board