More Coronavirus Treatments Move Toward Human Trials
Novavax, a biotech company based in Maryland said it would start clinical trials in Australia in May for its vaccine candidate. Novavax is among many companies that have announced potential vaccine candidates that are moving quickly through the trial process.
Mesoblast , a stem-cell company, confirmed it was launching a 240-patient clinical trial, with support from the National Institutes of Health. This study would test whether stem cells, derived from bone marrow, could treat patients with the coronavirus.
Indeed, development of new vaccines and treatments normally would require years of teamwork. However, the industry is crunching the process with the support of nonprofit organizations, government agencies and regulatory authorities.
Moreover, Novavax observed that their vaccine candidate gave a strong immune response in lab and animal experiments, creating antibodies that could protect against the coronavirus. Novavax would still need to test their vaccine on people.
Furthermore, Moderna began their clinical trial on March 15. Inovio Pharmaceuticals started with their first clinical volunteers on Monday. Johnson & Johnson plans to begin clinical trials in September, and has been given $500 million by the U.S. Department of Health and Human Services.
“We’re all trying to do something which we have almost no precedents for, which is accelerating a vaccine in the middle of a pandemic,” said Dr. Peter Hotez, who is a co-director of the Texas Children’s Hospital Center for Vaccine Development at Baylor College of Medicine.
No approved therapy for Covid-19 is available.
President Trump has articulated a preference for two old malaria drugs. Both show limited evidence of efficacy with respect to the coronavirus. Trump has insisted that these drugs be applied broadly without the careful process of clinical trials followed normally to determine the safety and efficacy of treatments.
Mesoblast is proceeding with a more practiced method. They will apply their cell therapy in 240 patients at more than 20 medical centers across the USA. They will collaborate with the Cardiothoracic Surgical Trials Network, a program created by the N.I.H. Mesoblast will conduct a randomized trial. Researchers confirmed that trial data can become ready within months.
Even though most people with the coronavirus see mild symptoms, many patients encounter a severe case when their immune systems overreact and damage organs. This consequence is often called a “cytokine storm.”
Dr. Silviu Itescu, chief executive of Mesoblast, said they chose to treat these Covid-19 patients because their therapy had shown positive data in children who developed a similar deadly immune reaction called acute graft versus host disease. “We put two and two together and said, ‘We think we’ve got something that is safe and could have benefit,’” Dr. Itescu said.