CytoDyn Inc (OTCQB:CYDY), which has been utilizing its flagship drug candidate leronlimab as a treatment for the coronavirus (COVID-19), told investors Monday that the first five patients with mild-to-moderate symptoms given the drug were able to be taken off oxygen after treatment.
So far, the company has treated more than 30 patients at four hospitals and clinics with authorization from the US Food and Drug Administration under Emergency Investigational New Drug applications.
The company has received requests from 25 hospitals all over the country.
CytoDyn is also conducting a pair of medical trials of its drug, one for coronavirus patients with mild-to-moderate symptoms and another for patients with severe symptoms.
READ: CytoDyn says severe coronavirus patients treated with leronlimab drug show significant improvement
Twelve patients have begun treatment in the Phase 2 mild-to-moderate trial so far, but because it is a double-blinded, placebo-controlled trial, results are not yet available.
The company added that a site has been cleared to enroll patients in Phase 2b/3 severe trial starting today. The trial is for 390 patients and will be double-blinded with a 2:1 drug to placebo ratio. Patients are expected to be given leronlimab for two weeks, and the primary endpoint of the study is the mortality rate after 28 days.
“We continue to coordinate around the clock with healthcare professionals across the country to deliver leronlimab to patients, and we are in regular contact with the FDA to ensure they receive current patient data,” CEO Nader Pourhassan said in a statement. “We are planning to rapidly enroll 75 patients and report the results to the FDA as quickly as possible.”
New chief medical officer
CytoDyn also announced the appointment of Chairman Scott Kelly as chief medical officer and head of business development.
Kelly has served as a director since 2017 and chairman since December 2018, a position he will retain.
He previously worked at Atlanta-based Resurgens Orthopaedics since 2002, including as Director of the Safety Council since 2013 and as Medical Director of the Resurgens Orthopaedics' Spine Center since 2007.
“I have decided to leave clinical medicine to focus on CytoDyn,” Kelly said. “Dr Nader Pourhassan has done an excellent job in expanding the pipeline of opportunities for leronlimab and navigating the regulatory pathways toward approval. This is a tremendous opportunity to become more deeply involved with the management team to advance the multi-pathway evaluation of leronlimab.”
In addition to its potential as a treatment for the coronavirus, leronlimab has other therapeutic indications as a treatment for metastatic triple-negative breast cancer, immunologic diseases such as graft-versus-host disease and NASH.
“We are honored Dr Kelly agreed to increase his commitment to the company,” Pourhassan said. “Dr. Kelly has been instrumental in progressing CytoDyn to explore the many opportunities for leronlimab and to continue to expand its pipeline. With Dr. Kelly as part of our team, I am very confident many strong achievements will be realized in an expedited fashion for our company and its shareholders.”
-- Updates with new chief medical officer and business development head --
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