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Medical

Phase 1b study of FluGen’s intranasal flu vaccine in older adults gets underway

FluGen said that the first subject has been dosed in a Phase 1b study of its M2SR intranasal live single replication flu vaccine and an intramuscular high dose inactivated vaccine (IIV) in adults aged 65 to 85 years. The study, which is funded by the US Department of Defense, will evaluate each of the vaccines separately, as well as the intranasal and IIV vaccines … [Read more...] about Phase 1b study of FluGen’s intranasal flu vaccine in older adults gets underway

Oragenics says preclinical data support further development of its intranasal COVID-19 vaccine

Oragenics has published data from studies of its NT-CoV-2-1 proteosome adjuvanted intranasal vaccine candidate against SARS-CoV-2 in mice and hamsters that support further development of the vaccine, the company said. The data were published June 13, 2022 in an article in Nature's Scientific Reports titled "Intranasal Immunization with a Proteosome-Adjuvanted … [Read more...] about Oragenics says preclinical data support further development of its intranasal COVID-19 vaccine

Phase 3 ReOpen2 trial of Optinose’s Xhance intranasal fluticasone meets primary endpoints

Optinose has announced that the Phase 3 ReOpen2 trial of Xhance fluticasone propionate nasal spray (OPN-375) in patients with chronic sinusitis without nasal polyps demonstrated significant improvement compared to placebo in both patient reported symptoms at week 4 and inflammation measured by CT scan at week 24. The FDA approved Xhance in 2017 for the treatment of … [Read more...] about Phase 3 ReOpen2 trial of Optinose’s Xhance intranasal fluticasone meets primary endpoints

Tiziana reports positive results for intranasal foralumab in second MS patient

Tiziana Life Sciences has announced that a second multiple sclerosis patient who received the company's intranasal foralumab for three months as part of an expanded access program at Brigham and Women’s Hospital (BWH) has showed significant improvement.  According to Tiziana, PET imaging demonstrated inhibition of microglial activation, and the patient also showed … [Read more...] about Tiziana reports positive results for intranasal foralumab in second MS patient

BiondVax announces development plans for inhaled NanoAb for COVID-19

Following an advice meeting with the Paul Erhlich Institute, Israeli biopharm company BiondVax Pharmaceuticals announced plans for development of its lead candidate, an inhaled COVID-19 nanosized antibody (NanoAb) therapy. The company said that it hopes to initiate a Phase 1/2a clinical trial of the inhaled NanoAb in COVID-19 patients in 2023, following completion of … [Read more...] about BiondVax announces development plans for inhaled NanoAb for COVID-19

FDA clears IND for Codagenix intranasal RSV vaccine

According to Codagenix, the FDA has cleared the company's IND for CodaVax-RSV intranasal live-attenuated vaccine (LAIV) for the prevention of respiratory syncytial virus (RSV) infection, and plans are in progress for a Phase 1 study in children aged 6 months to 5 years. Codagenix previously conducted a Phase 1 study of CodaVax-RSV in adults aged … [Read more...] about FDA clears IND for Codagenix intranasal RSV vaccine

SoftOx reports positive Phase 1 results for its hypochlorous acid inhalation solution

SoftOx Solutions has announced that a Phase 1 study of its SoftOx inhalation solution (SIS) demonstrated that nebulized SIS was well tolerated with no serious adverse effects observed and no adverse effects related to pulmonary function. The study enrolled 57 healthy volunteers who got either SIS or placebo delivered via jet nebulizer 4 times per day for 5 days, with … [Read more...] about SoftOx reports positive Phase 1 results for its hypochlorous acid inhalation solution

Moderna highlights partnership with Vertex on inhaled mRNA therapy for CF

According to Moderna Therapeutics, the company used its annual "Science and Technology Day" to highlight its work on lipid nanoparticle (LNP) mRNA formulations, and CEO Stéphane Bancel made special note of the company's advances in pulmonary delivery, including a partnership with Vertex on development of an inhaled mRNA formulation that could give CF patients the … [Read more...] about Moderna highlights partnership with Vertex on inhaled mRNA therapy for CF

Positive Phase 1 results for Pneumagen’s Neumifil antiviral nasal spray

Pneumagen has announced that a Phase 1 dose escalation study of its Neumifil carbohydrate binding module nasal spray demonstrated that the nasal spray was well tolerated and had no dose limiting toxicity. Pneumagen announced the initiation of the Phase 1 trial in November 2021. The company previously announced data from pre-clinical studies showing that Neumifil has … [Read more...] about Positive Phase 1 results for Pneumagen’s Neumifil antiviral nasal spray

Pieris warns of potential delays in clinical trial of PRS-060/AZD1402 DPI

In a business update, Pieris Pharmaceuticals warned that an ongoing clinical trial of its dry powder PRS-060/AZD1402 IL-4 receptor alpha inhibitor may take longer than expected, saying "Given the geopolitical situation, along with broader challenges amidst an ongoing pandemic, there is a heightened risk that more time will be required to deliver the topline study … [Read more...] about Pieris warns of potential delays in clinical trial of PRS-060/AZD1402 DPI

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