• Celsion Corp., of Columbia, Md., said that its drug safety monitoring board has reviewed safety data from the ThermoDox 40-mg/m2 cohort in the company's Phase I/II DIGNITY trial and recommended that the firm continue to enroll patients, with new patients receiving the drug at the 50-mg/m2 dosage. The trial, which plans to enroll 109 patients, is testing ThermoDox in combination with hyperthermia as a treatment for recurrent chest wall breast cancer.

• Clinical Data Inc., of Newton, Mass., said results of two Phase I studies showed Stedivaze (apadenoson), a selective agonist of the adenosine A2A receptor subtype, was safe and well tolerated in patients with asthma and chronic obstructive pulmonary disease. In 49 patients with mild to moderate asthma and 50 patients with moderate to severe COPD, Stedivaze had no effects on pulmonary function tests. Adverse events were similar to previous studies of Stedivaze in patients without lung disease, and support its potential for improved tolerability. Most frequently observed adverse events included palpitations, flushing, chest discomfort and shortness of breath.

• Genta Inc., of Berkeley Heights, N.J., has initiated a confirmatory Phase IIb trial of tesetaxel as a therapy for patients with advanced gastric cancer. The firm said the trial is open to enrollment at Northwestern University in Chicago, which will be joined by M.D. Anderson Cancer Center in Houston and several additional sites.

• Omeros Corp., of Seattle, said data from a 143-subject Phase II trial of OMS103HP, its PharmacoSurgery product candidate for arthroscopy, demonstrated that patients treated with the drug during arthroscopic knee meniscectomy surgery achieved statistically significant clinical benefits. Data showed that the drug provided greater efficacy than vehicle as measured by visual analogue scale pain scores, passive knee flexion and patient-reported functional scores. OMS103HP is designed to improve postoperative joint function and motion and to reduce postoperative pain.

• Oncolytics Biotech Inc., of Calgary, Alberta, said the Cancer Therapy & Research Center at the University of Texas Health Science Center has started patient enrollment in a Phase II trial using intravenous administration of Reolysin in combination with carboplatin and paclitaxel in patients with squamous cell carcinoma of the lungs. In the single-arm, open-label study, known as REO 021, patients will receive Reolysin intravenously with paclitaxel and carboplatin every three weeks. Up to 55 patients are expected to be treated.

• QRxPharma Ltd., of Sydney, Australia, started a Phase I trial to test the pharmacokinetic profiles of experimental controlled-release morphine and oxycodone formulations that will be incorporated into MoxDuo CR, intended for twice-daily dosing in patients experiencing chronic pain. The two-part pilot study will compare the rate at which key components of the controlled-release formulation are absorbed, distributed, metabolized and eliminated by the body to the pharmacokinetic profiles of co-administered MS Contin 30 mg (sustained-release morphine) and Oxycontin 20 mg (sustained-release oxycodone).

• Repros Therapeutics Inc., of The Woodlands, Texas, said it is replying to the FDA's Division of Metabolism and Endocrinology Products following its receipt of FDA comments on the proposed Phase II study of Androxal (enclomiphene) in Type II diabetes. The agency previously informed the company that the study was "adequate for exploring the effect of enclomiphene on blood glucose in the specific population," though it recommended increasing the number of subjects per arm, from 20 to between 40 and 50, to improve the study's power. Repros still awaits a decision from the FDA's Division of Reproductive and Urologic Products regarding Androxal's use for the indication of secondary hypogonadism in men wanting to preserve fertility.

• SciClone Pharmaceuticals Inc., of Foster City, Calif., reported top-line results from its Phase II trial of SCV-07 for the prevention of severe oral mucositis (OM) caused by chemoradiotherapy regimens used to treat head and neck cancer. Patients receiving the highest dose (0.1 mg/kg) showed a trend toward delay to onset of severe OM, the primary endpoint, while patients in the low-dose treatment arm (0.02 mg/kg) appeared to do worse than placebo. SCV-07 also was found to be safe and well tolerated with no dose-related serious adverse events reported.

• Stem Cell Therapeutics Corp., of Calgary, Alberta, closed patient enrollment in its modified Phase IIb stroke trial of NTx-265 and plans to analyze the data as they become available for the 96 patients using a modified statistical approach. The study, designated REGENESIS-LED, was modified after failing to recruit additional North American patients with the new data analysis designed to allow the trial to achieve its endpoint with fewer patients. SCT anticipates completing the 90-day endpoint assessment by the end of April, with data analysis to follow soon after.

• Titan Pharmaceuticals Inc., of South San Francisco, started a Phase III trial of Probuphine in opioid addiction. The confirmatory study is expected to enroll about 250 patients randomized into three arms: 100 patients each in the Probuphine and Suboxone (buprenorphine with naltrexone, Reckitt Benckiser) arms and 50 patients in the placebo arm. Probuphine, which is designed to deliver six months of continuous buprenorphine, has completed three Phase III trials to date.

• ViroPharma Inc., of Exton, Pa., started an open-label, single-dose Phase II study to test doses of Cinryze (C1 esterase inhibitor) in acute angioedema attacks in children younger than 12 with hereditary angioedema. The objectives are to evaluate the dose response and the pharmacokinetics/pharmacodynamics of intravenous administration of the drug and to determine safety and tolerability in 12 pediatric patients. The primary efficacy endpoint will be based on clinical response observed within four hours after dosing. Cinryze gained approval in 2008 as a routine prophylaxis in adolescent and adult HAE patients.