• Aduro BioTech Inc., of Berkeley, Calif., said it enrolled the first patient in a Phase Ib study of CRS-207, a therapeutic cancer vaccine, combined with chemotherapy in patients newly diagnosed with malignant pleural mesothelioma. Patients will receive two prime vaccinations with CRS-207, followed by standard-of-care chemotherapy.

• Astex Pharmaceuticals Inc., of Dublin, Calif., said it started a Phase II study evaluating SGI-110, a small-molecule DNA-hypomethylating agent, in combination with carboplatin in platinum-resistant recurrent ovarian cancer patients. The trial will have two stages: The first stage will treat patients with escalating doses of SGI-100 and carboplatin to identify the maximum-tolerated dose and preliminary biological and clinical activity, while the second stage will randomize patients to receive SGI-100 plus carboplatin or one of three treatments of choice as determined by the clinical investigator – toptecan, pegylated liposomal doxorubicin or paclitaxel. The primary endpoint in the second stage will be a comparison of progression-free survival, and secondary endpoints will assess response rate and overall survival.

• Athersys Inc., of Cleveland, completed enrollment of the first patient cohorts in its Phase II study of MultiStem, its adult stem cell therapy for administration to patients within approximately one to two days following an ischemic stroke. The independent safety committee reviewed data from the initial patients, determined that both doses under evaluation were safe and well tolerated and recommended proceeding with high-dose administration for the remainder of the trial. The study is evaluating the safety and efficacy of MultiStem in moderate to moderately severe stroke, as defined by a National Institutes of Health Stroke Scale score of 8 to 20. The first part of the Phase II study included two cohorts, each with a placebo group and a treatment group – one receiving a low dose of MultiStem and the second receiving a higher dose. The third cohort has a placebo group and treatment group, randomized 1:1 and is expected to enroll approximately 136 patients.

• Curis Inc., of Lexington, Mass., said the first patient was treated in a Phase I study of an oral formulation of CUDC-101 in advanced and refractory solid tumors. The dose-escalation trial will evaluate the tablet form of the drug, with primary objectives of determining the maximum-tolerated dose and recommended Phase II dose and to assess the bioavailability and pharmacokinetics. Secondary objectives include safety and tolerability, the evaluation of biomarkers and assessments of preliminary anticancer activity. CUDC-101 is a small-molecule candidate designed to inhibit histone deacetylase, epidermal growth factor receptor and epidermal growth factor receptor 2.

• Diartis Pharmaceuticals Inc., of Mountain View, Calif., reported Phase I data showing that Type II diabetes candidate VRS-859 (exenatide-XTEN), a long-acting glucagon-like peptide-1 analogue, was well tolerated in repeated dosings of 200 mg per month. Results also showed statistically significant reductions in HbA1c levels at 30 days after only a single 200-mg dose of VRS-859, which the company said is predicted to have a reduction in HbA1c of 1.6 percent to 2.2 percent at six months. Those data were presented at the European Association for the Study of Diabetes meeting in Berlin.

• Genzyme Corp., of Cambridge, Mass., a unit of Sanofi SA, of Paris, reported that ENGAGE, the first Phase III trial of its investigational oral therapy, eliglustat tartrate, met its primary endpoint in previously untreated Gaucher disease Type I. Patients treated with eliglustat tartrate had a statistically significant improvement in spleen size at nine months, compared with placebo. The initial safety analysis suggested eliglustat tartrate was well tolerated. No serious adverse events were reported in the primary analysis period, and no clinically meaningful differences in related adverse events were reported between the two treatment groups. Genzyme said it would present full results from ENGAGE at the Lysosomal Disease Network WORLD meeting in February 2013 in Orlando, Fla. Top-line data from Genzyme's second Phase III trial, ENCORE, also are expected in early 2013. Production of Genzyme's Gaucher drug Cerezyme (imiglucerase) and Fabry disease drug Fabrazyme (agalsidase beta) have seen production disruptions. (See BioWorld Today, Oct. 22, 2009.)

• Merrimack Pharmaceuticals Inc., of Cambridge, Mass., said Phase I data showing that two potential therapies targeting ErbB3, a signaling receptor believed to be responsible for triggering tumor growth and resistance in a number of malignancies, were found to be safe, with signs of clinical benefit. MM-121, which is being developed in collaboration with partner Sanofi SA, of Paris, was tested in a combination regimen with weekly paclitaxel in advanced metastatic breast and ovarian cancers, while MM-111 was tested in multiple HER2-targeted regimens in advanced HER2-positive (ErbB2-positive or HER2-positive) solid tumors. Data were presented at the European Society for Medical Oncology meeting in Vienna, Austria.

• Neurocrine Biosciences Inc., of San Diego, said it started a Phase IIb trial (the Kinect Study) testing NBI-98854, its vesicular monoamine transporter 2 compound. The 12-week study is expected to enroll about 120 subjects with moderate to severe tardive dyskinesia and underlying schizophrenia or schizoaffective disorder. Top-line data are anticipated in the second quarter of 2013.

• Noven Pharmaceuticals Inc., of Miami, a subsidiary of Hisamitsu Pharmaceutical Co. Inc., said it started a Phase II study of d-Amphetamine Transdermal System (d-ATS) in attention deficit hyperactivity disorder in children and adolescents. The study is designed to test d-ATS against placebo in subjects between the ages of 6 and 17. About 90 subjects are expected to be enrolled, and the trial is anticipated to conclude in the second quarter of 2013.

• Omeros Corp., of Seattle, said the FDA cleared its investigational new drug application for a Phase I trial of OMS825, the lead compound from its phosphodiesterase 10 program for schizophrenia and other cognitive disorders. The planned dose-ranging study, set to start before the end of this year, will evaluate the drug's safety, tolerability and pharmacokinetics in healthy subjects.

• Provectus Pharmaceuticals Inc., of Knoxville, Tenn., reported top-line data from its Phase II trial of PV-10 for metastatic melanoma showing an objective response (OR) rate of 51 percent in subjects' target lesions (25 percent complete response and 26 percent partial response), and 69 percent disease control in those lesions. Results also showed that 33 percent of subjects having an untreated bystander melanoma lesion achieved an OR in their bystander lesions, while 50 percent achieved disease control in those lesions. Stage III subjects experienced a substantially higher target lesion response rate (60 percent OR and 79 percent disease control) vs. Stage IV subjects (22 percent OR and 33 percent disease control). Overall survival data also were presented by disease stage, with Stage III subjects achieving a mean overall survival of at least 12.6 months vs. 7.3 months for Stage IV subjects. Data were presented at the European Society for Medical Oncology meeting in Vienna, Austria.

• Thrombolytic Science International LLC (TSI), of Cambridge, Mass., initiated a Phase I study of TS01 , a new-generation clot-dissolving therapy in acute ischemic stroke. The first-in-human study is assessing the overall safety and tolerability of TS01 in 50 to 70 healthy adults. TS01 selectively targets occlusive clots that cause strokes and spares hemostatic clots, resulting in a superior safety profile and reduced risk of intracranial hemorrhage. The compound is based on a mutant form of pro-urokinase, a natural thrombolytic.

• Zealand Pharma A/S, of Copenhagen, Denmark, said partner Sanofi SA, of Paris, reported data at the European Association for the Study of Diabetes meeting in Berlin supporting the use of once-daily glucagon-like peptide-1 receptor agonist lixisenatide in combination with basal insulin in Type II diabetes. Among data presented were results from a 28-day study showing that lixisenatide significantly delayed gastric emptying, accompanied by a significant lowering of postprandial glucose throughout the day. Sanofi also reported data from the GetGoal Duo1 and GetGoal-L Phase III studies. Lixisenatide is under review for Type II diabetes in Europe and Japan. (See BioWorld Today, June 12, 2012.)