Positive data from one clinical trial evaluating lumateperone in patients with bipolar disorder wasn't enough to lift Intra-Cellular Therapies Inc.'s stock Monday as another trial's failure with the same drug severely dampened the price of shares, while analysts took the long, more optimistic view.
PERTH, Australia – Adelaide, Australia-based Bionomics Inc. reported another trial failure with its lead compound, BNC-210, in elderly patients with agitation, but it is still clinging on to hopes that the compound will show a clinical benefit for post-traumatic stress disorder (PTSD).
The artificial pancreas represents a dramatic improvement over existing approaches to management of diabetes, but Sernova Corp. of London, Ontario, is intent on going one better on conventional device technology. The company recently presented the results from an early phase study of its Cell Pouch device with pancreatic islet cells to a major medical conference, and the results suggest that the Cell Pouch with islets will pass the safety bar and may prove efficacious for several measures, including glycemic control.
Boston Biomedical Inc. shuttered phase III study Canstem111P of napabucasin for patients with metastatic pancreatic ductal adenocarcinoma, adding to the list of studies that have fallen in pancreatic cancer.
HONG KONG – Shanghai-based biopharma firm Harbour Biomed Therapeutics Ltd. has inked a 10-year pact with Erasmus MC from the University Medical Center Rotterdam to grow its footprint in Europe. Both sides will develop biotherapeutics to treat cancer and immunological diseases.
Adding I.V. sildenafil – the active ingredient in Viagra – to inhaled nitric oxide (iNO) therapy for newborns with persistent pulmonary hypertension (PPHN) failed to achieve a statistically significant reduction in treatment failure rates or time on iNO vs. iNO alone in the first part of a phase III study sponsored by Pfizer Inc.
Boston startup Beta Bionics Inc. is headed into a pair of ambitious pivotal trials in 2020: one starting for an autonomous bionic pancreas device with insulin only and another to follow for a bihormonal version that also includes glucagon. These are expected to offer more precise, easy-to-use blood glucose maintenance for type 1 diabetes patients.
NEW ORLEANS – The Apple Heart study has accumulated data from more than 400,000 participants in its evaluation of the ability of an algorithm to detect abnormalities that may be indicative of atrial fibrillation (AF), although the enrollment came up short of the target of half a million users. Nonetheless, Mintu Turakhia, a cardiologist at Stanford, Calif.-based Stanford University, said that while the study has some significant limitations, "we now have a footprint for evaluating technology such as this, and how to do this in an appropriate and scalable way."
LONDON – Themis Bioscience GmbH has announced positive phase II results for its vaccine against Chikungunya virus, as it moves to complete an IPO later this week to raise up to €55 million (US$62.6 million) to fund the launch of a pivotal phase III trial.