Frequency Therapeutics said today that the first patients have been treated in a Phase I/II clinical trial to assess its first-in-class drug candidate for hearing restoration. The 24-patient trial is slated to include people with stable sensorineural hearing loss. Participants will receive an injection of Frequency’s FX-322 or a placebo in one ear, with a follow-up […]
Clinical Trials
OncoSec inks research deal to analyze clinical trial participants
OncoSec Medical (NSDQ:ONCS) said today that it inked a research deal with Dr. Roger Lo and his research team at the University of California Los Angeles to study participants from the biotech company’s Pisces/Keynote-695 Phase IIb clinical trial. Dr. Lo and his team are slated to perform genetic, transcriptomic and methylomic analyses of patients from OncoSec’s […]
Nemaura touts data from home-use study of wearable glucose monitor
Nemaura Medical (NSDQ:NMRD) said today that it launched a study of its wearable glucose monitor in the hopes of winning regulatory approval in the U.S. The England-based company touted positive interim data from the study, focusing on the at-home use of the sugarBeat device. The company’s interim results included findings from 25 patients with either Type […]
Biogen, Eisai shares down after critics voice concerns over Alzheimers drug study
Biogen (NSDQ:BIIB) and Eisai yesterday released six months of detailed results from a clinical study of its BAN2401 experimental drug for treating Alzheimers, but criticisms quickly emerged casting doubt on the results and sending shares in both companies down. Researchers working with Eisai and Biogen released trial results showing that high doses of the drug resulted […]
Genentech touts positive data for tiny, refillable eye implant
Roche‘s (OTC:RHHBY) Genentech touted positive top-line data today from a Phase II study of its Port Delivery System, an eye implant designed to administer a sustained dose of ranibizumab in patients with wet age-related macular degeneration. The refillable device, which is slightly longer than a grain of rice, is intended to enable wet-AMD patients to go for […]
Acorda’s CEO on failure, perseverance and the profound risks of drug development
Dr. Ron Cohen isn’t easily deterred. The physician-turned-executive has spent decades in the biotech industry and weathered a number of setbacks – he learned in his early years at the now-defunct Advanced Tissue Sciences that to succeed, he needed resilience. “I learned that it took hundreds of millions of dollars if not billions to develop […]
Going public, Provention Bio looks to tackle immune-mediated diseases
Shares in Oldwick, N.J.-based Provention Bio began trading today following the close of its $64 million initial public offering last week. The biopharmaceutical company, lead by co-founder & CEO Ashleigh Palmer, is developing a number of products that aim to prevent or stop the spread of immune-mediated diseases, including Lupus, Crohn’s disease and Type I diabetes. […]
Takeda touts data from late-stage trial of subcutaneous ulcerative colitis therapy
Takeda Pharmaceutical (TYO:4502) touted top-line data today from its pivotal Phase III Visible 1 trial evaluating an investigational subcutaneous formulation vedolizumab as a maintenance therapy for adults with moderate to severe ulcerative colitis. The trial specifically focused on patients who experienced a clinical response at six weeks following two doses of open-label vedolizumab IV induction therapy. […]
Pulmatrix touts data from first-in-human trial of inhaled anti-fungal therapy
Pulmatrix (NSDQ:PULM) said today that all dosing and follow-up visits have finished for its first-in-human study of an inhaled formulation of itraconazole as a treatment of allergic bronchopulmonary aspergillosis in people with asthma. The inhaled iSperse formulation, called Pulmazole, was well-tolerated, according to the Lexington, Mass.-based company. Pulmatrix plans to launch a Phase II trial of […]
RenovoRx sets its sights on localized treatment of pancreatic cancer
People living with pancreatic cancer find themselves facing devastating odds – the five-year survival rate is in the single digits, according to the American Cancer Rate. Pursuing treatment often means dealing with the side effects of systemic chemotherapy, including hair loss, fatigue and neuropathy. Shaun Bagai and his team at RenovoRx think that their catheter […]