BEIJING – Cell therapies specialist Nanjing Iaso Biotherapeutics Co. Ltd. became the latest Chinese biotech to enter the country's fierce CAR T race, after China regulators granted an IND approval to CT-103A, a fully-human BCMA CAR T for treating relapsed or refractory multiple myeloma.
HONG KONG – South Korea's Helixmith Co. Ltd. has announced the results of a phase III trial extension testing VM-202 (donaperminogene seltoplasmid), a regenerative plasmid DNA gene therapy candidate, in diabetic peripheral neuropathy (DPN). But, while the Seoul-based company, formerly known as Viromed, said VM-202 met the primary safety and secondary efficacy endpoints for a DPN therapy at 12 months, investors are doubting that the results are trustworthy.
Top-line data from Relmada Therapeutics Inc.'s phase II study of REL-1017 (dextromethadone) in patients with treatment-resistant depression caused the stock to more than double Tuesday, a great day on the market.
Reata Pharmaceuticals Inc.'s surprise victory in the pivotal, second part of the phase II study called Moxie with Nrf2 activator omaveloxolone in patients with Friedreich's ataxia (FA) energized Wall Street and sharpened appetites for data due shortly with another candidate in the class, bardoxolone methyl, in the works for Alport syndrome (AS).
Polarityte Inc., of Salt Lake City, reported positive results from a pilot study of its Skinte regenerative skin product in the closure of venous stasis leg ulcers (VLUs) after standard treatments have failed. The findings were reported at the Symposium on Advanced Wound Care fall meeting, Oct. 12-14, in Las Vegas.
PERTH, Australia – Following stunning interim clinical results for its Celgro nerve regeneration treatment in quadriplegic patients, regenerative medicine company Orthocell Ltd. will focus all its efforts on gaining early FDA approval based on the early results.
Synthetic biology is seeing rapid advances, but the medical applications have thus far remained largely elusive. But now researchers from the Wyss Institute for Biologically Inspired Engineering at Harvard University and Harvard Medical School (HMS) have developed a tool that can track specific populations of bacteria in the gut of living organisms and document population changes over time.
The first patients have been treated in Kodiak Sciences Inc.'s phase II DAZZLE trial of anti-VEGF antibody biopolymer conjugate KSI-301 in patients with treatment-naïve wet age-related macular degeneration. At least 368 patients worldwide are expected to enroll in the study. The primary endpoint will be assessed at one year and each patient will be treated and followed for two years.
San Clemente, Calif.-based Glaukos Corp. has finished enrolling patients in its U.S. investigational device exemption (IDE) trial for the Istent Infinite trabecular micro-bypass system, which is intended for standalone use in lowering intraocular pressure (IOP) in refractory glaucoma patients. If all goes as planned, the company is looking to commercially launch the treatment in the U.S. in 2021.
LONDON – There is no evidence for increased mortality in patients receiving paclitaxel-eluting stents and drug-coated balloons (DCBs) to treat peripheral arterial disease, according to the largest real-world safety analysis to date. The findings may come as a relief to many, particularly after a meta-analysis published in December 2018 led to safety warnings and restrictions on the use of coated and drug-eluting devices.