Anika Therapeutics Inc., of Bedford, Mass., enrolled the first patient in its pivotal phase III study of its hyaluronan-based scaffold, Hyalofast, with autologous bone marrow aspirate concentrate for the treatment of articular knee cartilage defect lesions. The prospective, randomized, active treatment-controlled, evaluator-blinded study will enroll about 200 patients in an effort to demonstrate superiority. Hyalofast is CE Marked in Europe and is available commercially in 18 countries.
Discovery Laboratories Inc., of Warrington, Pa., initiated its Aerosurf phase IIb trial in premature infants 26 to 32 weeks gestational age receiving non-invasive nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome. The trial is designed to evaluate premature infants receiving aerosolized KL4 surfactant, including potentially repeat doses, compared to nCPAP alone. Two dose groups will be evaluated. The primary objective of the trial is to demonstrate evidence of efficacy and, if successful, inform the design of a phase III clinical program. (See BioWorld Today, Nov. 13, 2015.)
Epizyme Inc., of Cambridge, Mass., said the first patient has been dosed in the phase II study of tazemetostat in adult patients with genetically defined tumors. The phase I dose-escalation study in pediatric patients with the same tumor types is also now open for enrollment. The cancers being studied in these trials, INI1-negative tumors, certain SMARCA4-negative tumors and synovial sarcomas, are aggressive cancers that are poorly served by current treatments, the company noted.
Minerva Neurosciences Inc., of Waltham, Mass., said the FDA accepted the investigational new drug application for MIN-101, a first-in-class 5-HT2a and sigma2 antagonist in clinical development for the treatment of schizophrenia. The company also said it completed enrollment of a total of 244 patients in a randomized, placebo-controlled double-blind European phase IIb trial of the compound.
Neuroderm Ltd., of Rehovot, Israel, started patient enrollment in a first efficacy trial of ND0612H, the company's continuously administered subcutaneous levodopa/carbidopa (LC/CD) solution. The treatment is intended to be an alternative to current treatments for patients with advanced Parkinson's disease that require surgical intervention. The multicenter international phase II study will compare the efficacy, safety and tolerability of ND0612H to the baseline oral standard of care. ND0612H, administered through a belt pump, is designed to deliver steady LD/CD levels and improve motor fluctuations that cannot be adequately controlled with oral therapy and might otherwise require surgical intervention, the company said.
Pharmacyte Biotech Inc., of Silver Spring, Md., provided an update on its pancreatic cancer and diabetes programs. Included is a complete redesign of the trial in advanced pancreatic cancer in an attempt to satisfy a critical unmet medical need that exists for patients with inoperable, but not metastatic, pancreatic cancer whose tumors no longer respond after four to six months of treatment with the current "gold standard" for the disease, the combination of Abraxane (nab-paclitaxel, Celgene Corp.) plus gemcitabine. (See BioWorld Today, Aug. 3, 2015.)