• Achaogen Inc., of South San Francisco, said all objectives were met in a Phase II study of plazomicin compared to levofloxacin for the treatment of complicated urinary tract infections and acute pyelonephritis in adults. Plazomicin was well tolerated and demonstrated favorable microbiological and clinical outcomes at the test-of-cure visit, five days to nine days after the end of therapy, which were the primary and secondary outcome measures in the study, respectively. Achaogen is developing plazomicin, a next-generation aminoglycoside designed to overcome common bacterial resistance mechanisms, as an intravenous treatment for serious Gram-negative bacterial infections, including those caused by multidrug-resistant E. coli and Klebsiella pneumoniae.

• Adamas Pharmaceuticals Inc., of Emeryville, Calif., said it held an end-of-Phase II meeting with the FDA to discuss proposed registrational studies for Arimenda (memantine HCl extended-release and donepezil HCl) capsules, a once-daily fixed-dose combination for Alzheimer's dementia. Adamas said the FDA agreed to its proposed Phase III safety studies, which, if successful, should be sufficient for a new drug application (NDA). The company is on track to submit an NDA in 2013.

• Cubist Pharmaceuticals Inc., of Lexington, Mass., said Phase II studies of CB-5945 (formerly ADL5945) in patients with chronic noncancer pain and opioid-induced constipation each met its primary endpoint of change from baseline in the number of spontaneous bowel movements (SBMs) over a four-week treatment period. Of all doses and dosing regimens studied, twice-daily dosing of CB-5945 was associated with the greatest change from baseline in SBM frequency (p = 0.0003). There also was a 30 percent increase in the proportion of overall SBM responders, defined as three or more SBMs per week and an increase of at least one SBM per week from baseline for three of four weeks (26 percent placebo, 56 percent 0.25 BID; p = 0.005).

• Galectin Therapeutics Inc., of Newton, Mass., said the first patient was dosed in a Phase I/II trial testing GM-CT-01, its carbohydrate-based galectin inhibitor, in combination with a peptide vaccine furnished by the Ludwig Institute for Cancer Research in advanced metastatic melanoma. The primary endpoint is partial or complete response.

• Juventas Therapeutics Inc., of Cleveland, said it is enrolling in a Phase IIa study of JVS-100 in patients with Rutherford Class 4 or 5 critical limb ischemia. The dose-ascending STOPc-CLI (Sdf-1 plasmid Treatment fOr Patients with Critical Limb Ischemia) is expected to recruit about 100 patients and will evaluate the drug's safety and efficacy, with patient outcome measures including safety, time to amputation, wound closure, TcPO2, ankle-brachial index and toe-brachial index. JVS-100 is designed to encode stromal cell-derived factor 1, which has been shown to repair damaged tissue through recruitment of circulating stem cells to the site of injury, prevention of ongoing cell death and restoration of blood flow.

• Novelos Therapeutics Inc., of Madison, Wis., said it completed the first cohort in its Phase Ib dose-escalation trial of cancer-targeted molecular radiotherapeutic compound I-131-CLR1404 (HOT) in patients with advanced solid tumors. The first two-patient cohort was successfully dosed with about 20 mCi of HOT, triggering enrollment into the second cohort at about 40 mCi.

• Telik Inc., of Palo Alto, Calif., reported data from a Phase I dose-ranging study showing that Telintra (ezatiostat), a glutathione S-transferase P1-1 inhibitor, in combination with Revlimid (lenalidomide, Celgene Corp.) showed multilineage responses and good tolerability. Data were published in the Journal of Hematology & Oncology.

• TG Therapeutics Inc., of New York, said the FDA cleared its investigational new drug application for TGTX-1101, also known as ublituximab, a third-generation chimeric monoclonal antibody targeting an epitope on the CD20 antigen found on B lymphocytes. The company is set to start a Phase I/II study this summer, enrolling up to 36 patients with B-cell lymphomas in the Phase I dose-escalation portion and up to 77 patients, stratified by B-cell lymphoma subtype, in the second portion.

• Theraclone Sciences Inc., of Seattle, reported top-line data from a Phase I trial in healthy volunteers showing that TCN-032, a broadly protective, fully human monoclonal antibody in development for influenza A infections, was well tolerated throughout the study, with no dose-limiting toxicities or serious adverse events observed. It also demonstrated a favorable immunogenicity profile. Based on the data, the company anticipates moving into a Phase II influenza viral challenge trial. The Phase I study was supported in part by partner Zenyaku Kogyo Co. Ltd., of Tokyo.