Cynata Therapeutics Ltd., of Melbourne, Australia, said a scientific paper describing the use of Cymerus mesenchymal stem cells (MSCs) in a model of acute respiratory distress syndrome (ARDS) has been accepted for publication in the American Journal of Respiratory and Critical Care Medicine. The study was conducted in 14 sheep with severe ARDS supported by extracorporeal membrane oxygenation (ECMO), which were given an endobronchial infusion of either Cymerus MSCs (n=7) or placebo (n=7). Animals were monitored and supported for 24 hours, and the treatment was shown to exert several beneficial effects including: the severity of lung injury was significantly reduced, as shown by histological lung injury score (p=0.04); inflammation was significantly reduced, as shown by levels of the inflammatory cytokine IL-8 in the lungs at three, 13 and 23 hours after treatment (p=0.013, 0.016 and 0.028, respectively); and, there was a reduction in the depth and severity of circulatory shock, as shown by a highly significant increase in arterial blood pressure after four hours (p=0.001), and a significant reduction in the requirement for noradrenaline (a drug used to maintain blood pressure) over the entire study period (p=0.01).
Evolus Inc., of Newport Beach, Calif., said it has introduced a pre-emptive plan to support the U.S. aesthetic neurotoxin market during the COVID-19 pandemic. The company said its digital platform has enabled the rapid market uptake of Jeuveau (prabotulinumtoxinA-xvfs) injection, a prescription medicine injected into muscles and used to improve the look of moderate to severe frown lines. Going forward, the firm said it is expecting an increasing dependence on the platform to support customer experience. That shift will impact employees and, as a result, the company will become leaner. It also anticipates its cash on hand will fund the company for more than 12 months.
Halix BV, of Leiden, the Netherlands, said it joined a consortium of partners, under the guidance of the University of Oxford, to provide GMP manufacturing services supporting the large-scale production of a COVID-19 vaccine (ChAdOx1 nCoV-19), being developed by the University’s Jenner Institute. That GMP manufacturing scale-up is taking place alongside early phase clinical trials.
Highlight Therapeutics SL, of Madrid, Spain, which is developing RNA-based therapies against cancer, said it changed its name from Bioncotech.
Lipocine Inc., of Salt Lake City, said the FDA denied the citizen petition filed by Northbrook, Ill.-based Clarus Therapeutics Inc. Specifically, the agency declined to issue product-specific guidance on oral T-ester drug products and denied without comment Clarus' request regarding how the FDA should review and make approval decisions on any pending or future oral T-ester products. Clarus originally filed the petition requesting the FDA issue "clear, written guidance regarding the safety and efficacy standards required for oral testosterone-ester prodrugs as testosterone replacement therapy" and requested the FDA not to approve "any pending [NDA] for an oral T-ester to treat male hypogonadism that fails to meet the standards for approval set forth in [the] petition."
Nicox SA, of Sophia Antipolis, France, reported in its first-quarter 2020 update that it had expanded its existing collaboration with Shanghai-based Ocumension Therapeutics Shanghai Co. Ltd. in China to allow product candidate NCX-470 to enter two phase III glaucoma trials. The first, for lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension, is currently expected to start by the end of the second quarter, with top-line results expected in the third quarter of 2021. The Mont Blanc trial will be conducted principally in clinical sites in the U.S. and will include a small number of Chinese clinical sites. The second trial, jointly managed and equally funded by both companies, is currently expected to start in the second half of 2020. It will include clinical sites in both the U.S. and China, with majority of patients being in the U.S. to support an NDA filing.
Redhill Biopharma Ltd., of Tel-Aviv, Israel, said following the recently announced preliminary findings of clinical improvement in the first two COVID-19 patients treated with opaganib (Yeliva, ABC-294640) in Israel, three additional patients have been treated with opaganib, four of whom have demonstrated measurable improvement within days following treatment initiation. All five patients suffered from moderate to severe acute respiratory symptoms related to SARS-CoV-2 infection, required supplemental oxygenation and were hypoxic despite being treated with supplemental oxygen. The first patient has now completed 14 days of opaganib therapy, safely, with continuous improvement. Two patients were entirely weaned from supplemental oxygenation, one of whom has been discharged from the hospital, and another patient was released from the intensive care unit within a few days from treatment initiation with opaganib, which was administered to the hospitalized patients in addition to standard of care, which included hydroxychloroquine as background therapy.
Retrotope Inc., of Los Altos, Calif., started experiments to determine if RT-001, a drug that is able to down-regulate pro-inflammatory fatty acid oxidation in a number of diseases, may provide benefits against COVID-19-initiated lung damage. RT-001 is a chemically stabilized fatty acid that resists oxidation in mitochondrial and cellular membranes, as well as in atherosclerosis models by way of a proven mechanism.
Revive Therapeutics Ltd., of Toronto, engaged Complete Phytochemical Solutions LLC (CSP), of Cambridge, Wis., to advance the company’s research and development initiatives of psilocybin-based products for the pharmaceutical market. Revive has an intellectual property portfolio of psilocybin-based formulations ready to advance to the next stages of clinical development. CPS provides intellectual and technical expertise in phytochemistry.
Roche Holding AG, of Basel, Switzerland, disclosed the development and upcoming launch of its Elecsys anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to the virus that causes COVID-19.
Storm Therapeutics Ltd., of Cambridge, U.K., published a scientific paper in Nature Reviews Cancer, titled “Role of RNA modifications in cancer,” as a review of the field of RNA epigenetics. The paper describes insights into seven different internal RNA modifications, their mechanisms of actions (where known) and the evidence linking them to cancers.