Polarityte Inc.’s Skinte product met primary and secondary endpoints in a randomized clinical trial evaluating healing of diabetic foot ulcers. Skinte is a human cellular and tissue-based product made from a patient’s own skin. Results from the trial and data from the product’s use from 2017 to 2021 during a period of enforcement discretion by the FDA were used by the company in its filing earlier this week of an investigational new drug application for Skinte.
Another shoe dropped on Oncopeptides AB when the U.S. FDA issued an alert July 28 citing trial data showing an increased risk of death with the company’s only marketed drug, Pepaxto, used in combination with dexamethasone to treat multiple myeloma. The agency said it’s continuing to evaluate the Ocean trial results and may hold a public meeting to discuss the safety findings and explore the continued marketing of Pepaxto (melphalan flufenamide), which was granted accelerated approval in February as a fifth-line treatment for relapsed or refractory multiple myeloma.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Axon, Biogen, Cerecor, Effector, Eisai, Entasis, Grunenthal, Infinity, Merck, Redx, Relmada, Xylocor.
Shionogi & Co. Ltd. started a phase I trial in Japan for S-217622, its orally administered 3CL protease inhibitor for treating COVID-19. Should the drug be approved by Japanese regulators, it would be the first Japanese-developed COVID-19 treatment to be approved in the country.
New data on the addition of Infinity Pharmaceuticals Inc.'s oral PI3K-gamma inhibitor, eganelisib, to PD-(L)1 in both urothelial and triple-negative breast cancer patients appeared to evidence benefits for the combination. Benefit for company shares (NASDAQ:INFI), however, was nowhere to be seen, as they fell 31.5% to $1.52 on July 27. In a same-day earnings report, the Cambridge, Mass.-based company said it had a cash balance of $97.3 million to fund further development of the drug and filed to raise the maximum amount of capital it may raise in future sales of its shares.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Allegro Ophthalmics, Cassava, Da Volterra, GNT, Inmune, Iveric, Lee's, Radius, Sorrento, Synaptogenix, Tarsus, Tonix, Virios.
TORONTO – What do ER doctors want most for their patients? Never to return to the ER, said Giovanni Ferrara, a professor at Edmonton’s University of Alberta Hospital's Division of Pulmonary Medicine. Ferrara is heading a feasibility project to see if a wearable device developed by Rochester, N.Y.-based Heath Care Originals Inc. can predict with scientific certainty when the condition of a patient with lung disease is worsening and requires another visit to the hospital.
The first COVID-19 patient has been enrolled the U.S. NIH’s ACTIV-4 Host Tissue trial, a study of four agents designed to fight dysregulation of the renin-angiotensin-aldosterone system and the immune system caused by a COVID-19 infection.
As amyotrophic lateral sclerosis continues to make headlines, candidates bearing varied approaches proliferate and the indication likely allows for multiple players, given the prospect of a combo regimen.
Shionogi & Co. Ltd. started a phase I trial in Japan for S-217622, its orally administered 3CL protease inhibitor for treating COVID-19. Should the drug be approved by Japanese regulators, it would be the first Japanese-developed COVID-19 treatment to be approved in the country.
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