It was a trifecta to remember for Neurotrope Inc. on Wednesday as the company cast revealing light on a seemingly failed clinical program involving its lead candidate, had the NIH offer a grant to create a phase II trial to explore the program’s strengths, and then found institutional investors and individuals to pony up an $18 million registered direct offering for the company’s securities. It was a re-examination of data that resurrected Neurotrope’s hopes for its lead candidate months after a confirmatory phase II of bryostatin-1 failed to outperform a placebo in people with moderately severe to severe Alzheimer’s disease (AD) in the absence of Namenda (memantine, Allergan plc), an NMDA receptor antagonist.
BEIJING – With promising phase II data in hand – and newly designated FDA orphan drug status – Suzhou, China-based Tennor Therapeutics Suzhou Co. Ltd. is gearing up to move into pivotal testing with TNP-2092 to treat prosthetic joint infections.
BEIJING – Hong Kong-headquartered Hutchison China Meditech Ltd.’s (Chi-Med) called an early stop to its phase III pivotal study of surufatinib in advanced pancreatic neuroendocrine tumors (NET) in China after it met the predefined primary endpoint of progression-free survival.
What’s new inevitably includes an element of the old. Clene Nanomedicine Inc., which just completed enrollment and dosed the first patient in its phase II trial in amyotrophic lateral sclerosis (ALS), literally contains an element of the old in its lead nanocatalytic therapy: gold.
LONDON – Three years after the implementation of new U.S. legislation requiring clinical trials to report results within 12 months of completion, more than half are not published on time and compliance is not improving.
A new study of 30 patients has demonstrated that embolization coils adequately seal the left atrial appendage after implant of LAA closure devices, but the author of an accompanying editorial expressed concerns regarding the absence of understanding of both the causes and implications of these leaks.
China-based Innovent Biologics Inc. will need to get on two new tasks this year: Preparing for the first clinical trial for an anti-TIGIT antibody in China and investigating the combination therapy of its Tyvyt (sintilimab) and Sirnaomics Inc.’s STP-705.
Abbott Park, Ill.-based Abbott Laboratories has gained the U.S. FDA’s nod for a clinical trial that will compare the effectiveness of Mitraclip to open-heart mitral valve surgical repair in people with primary mitral regurgitation (MR) who are eligible for open-heart surgery. The prospective, randomized REPAIR MR clinical trial is expected to enroll 500 patients.
While companies have seen plenty of success treating blood cancers with T-cell therapies, solid tumors have largely remained the holy grail for T cells. But Adaptimmune Therapeutics plc has early data from its Specific Peptide Enhanced Affinity Receptor T-cell platform suggesting it may be on the right path for a platform with a wide breadth.
With a label broadened by the FDA in December and two aspiring competitors apparently picked off via late-stage trial blowups, Amarin Corp. plc finds itself in strong position with fish oil therapy Vascepa (icosapent ethyl) – at least pending the outcome of court proceedings that involve challengers to patents for the cardiovascular (CV) drug.