• PharmaMar SA, of Madrid, Spain, a subsidiary of Zeltia, said it completed a Phase Ib trial testing PM01183 in combination with doxorubicin, with the combination displaying antitumor activity in all types of cancer included in the study. Complete and partial radiological remissions were observed in patients with small-cell lung, bladder, breast, endometrial and ovarian cancers, neuroendocrine tumors and synovial sarcoma. The company is planning a potential pivotal trial in small-cell lung cancer and a confirmatory activity trial in endometrial cancer. PM01183 is an interfacial inhibitor if transactivated transcription.

• Rib-X Pharmaceuticals Inc., of New Haven, Conn., said it started a Phase III trial testing delafloxacin, a fluoroquinolone antibiotic, in patients with acute bacterial skin and skin structure infections. The PROCEED (PROve Clinical Efficacy and Effect of Delafloxacin) study is designed to test delafloxacin 300 mg, given intravenously every 12 hours, compared to vancomycin 15 mg/kg plus aztreonam 2 g I.V., also given every 12 hours. The study includes clinical and microbiological endpoints to assess the efficacy. Rib-X reached agreement with the FDA on a special protocol assessment for the trial, and it raised $67.5 million in an equity financing in November 2012 to support the study. Delafloxcin previously demonstrated efficacy against infections caused by methicillin-resistant Staphylococcus aureus and a range of Gram-positive and Gram-negative bacteria. A second Phase III study, evaluating an oral formulation of the drug, is set to start later this year or early in 2014. (See BioWorld Today, Nov. 30, 2012.)

• Syndax Pharmaceuticals Inc., of Waltham, Mass., said Phase II results published in the Journal of Clinical Oncology showed that HDAC inhibitor entinostat extended both progression-free survival (PFS) and overall survival when added to exemestane in postmenopausal women with estrogen receptor-positive breast cancer whose cancer had progressed after treatment with a nonsteroidal aromatase inhibitor. Based on an intent-to-treat analysis from the 130-patient randomized trial, patients treated with entinostat saw improved median PFS to 4.3 months vs. 2.3 months in the placebo group. Median survival improved to 28.1 months in entinostat-treated patients vs. 19.8 months in placebo patients.