• Acasti Pharma Inc., of Laval, Quebec, a subsidiary of Neptune Technologies & Bioressources Inc., reported positive results for its Phase II trial designed to assess the safety and efficacy of CaPre in the treatment of mild to severe hypertriglyceridemia. The compound was found to be safe and effective achieving significant mean triglyceride reductions above 20 percent after eight weeks of treatment with both daily doses of 4 g and 2 g. More than 230 patients completed the treatment, which exceeded the targeted number of evaluable patients. From the patient population, 88 percent had mild to moderate baseline triglycerides between 200 and 500 mg/dL (2.28 to 5.7 mmol/L). Patients under a daily dose of 4 g had a mean LDL decrease of 8.3 percent and non-HDL decrease of 14.3 percent, while lower doses did not show deleterious effect on LDL or non-HDL.

• Adial Pharmaceuticals LLC, of Charlottesville, Va., said a seminal article on the treatment of alcohol addiction using its drug, AD04, a serotonin-3 (5HT3) antagonist, in patients with selected genotypes, has been published in the American Journal of Psychiatry. The study is a major step toward developing a more personalized and effective approach to the treatment of alcohol use disorder based on a patient's genetic makeup. Bankole A. Johnson, the scientific founder and chairman of Adial, and his team at the University of Virginia have previously shown that variations in genes that encode the serotonin transporter can significantly impact drinking intensity, as measured in number of drinks per drinking day, percentage of days abstinent and percentage of heavy drinking days. The authors previously reported that two genotype combinations in the serotonin transporter gene predicted a significant reduction in the severity of alcohol consumption among patients receiving AD04. In the current publication, they reported that polymorphisms in the HTR3A and HTR3B genes, which directly regulate the functioning of 5-HT3 receptors and their binding to AD04, are also predictive of a positive response to AD04.

• Celator Pharmaceuticals Inc., of Princeton, N.J., said that patients have been enrolled in an investigator-initiated trial of CPX-351 (cytarabine: daunorubicin) liposome injection for myelodysplastic syndrome or acute myeloid leukemia, excluding acute premyelocytic leukemia who are at high risk for mortality. The trial will enroll up to 90 patients, evaluating two doses of CPX-351. In Phase I and II studies, complete response was observed in patients with relapsed or refractory AML at dose levels far below the maximum-tolerated dose, and the drug reduced early mortality among intensively treated older patients.

• Dance Biopharm Inc., of San Francisco, completed a Phase I/II trial of Adagio, an inhaled insulin for treatment of Type I diabetes. The study showed the product was well tolerated with no coughing, and delivered insulin consistently. The initial target population for Adagio will be patients with Type II diabetes, and it will be enrolling that population in its next study.

• Medical Developments International Ltd., of Sandown Village, Australia, said it completed a thorough Phase I QT/QTc trial of Penthrox (methoxyflurane), and there were no safety concerns nor any effect on heart rate, RR interval, PR interval, QRS duration or ECG morphology. The drug also did not have a QT prolongation of regulatory concern.

• MRI Interventions Inc., of Memphis, Tenn., said it treated its first patient in a Phase I trial of Uniqure BV's glial cell line-derived neurotrophic factor for Parkinson's disease. The open-label, dose-escalation safety study will enroll 24 patients in four cohorts. The first patient was dosed May 20, with no safety issues.