CytoDyn unveils further clinical trial plans in bid to fight coronavirus pandemic

CytoDyn unveils further clinical trial plans in bid to fight coronavirus pandemic

Proactive Investors

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CytoDyn Inc (OTCQB:CYDY) is set to submit a clinical trial design to the US FDA to compare the effectiveness of leronlimab versus remdesivir, and in combination with remdesivir for the treatment of coronavirus (COVID-19), it told investors on Monday. It comes as the firm is is currently enrolling patients in two clinical trials in a bid to combat the global killer virus. READ: CytoDyn partner offers free lab testing for coronavirus-linked Childhood Inflammatory Diseases These are a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population and a Phase 2b/3 randomized clinical trial for those severely and critically ill in the USA. Leronlimab has already been administered to over 60 patients with COVID-19 under emergency Investigational New Drug (eINDs) authorizations granted by the FDA and preliminary results from this led to the Phase 2b/3 clinical trial. CytoDyn plans to update the public regarding current eIND results later this week, it said in Monday's statement. “We believe the randomized head-to-head comparison of leronlimab to remdesivir and in combination will provide answers to the lingering question regarding effective treatment options for patients suffering from COVID-19," said Dr Jacob Lalezari, chief science officer of CytoDyn.   "We look forward to working both in the United States and with potential international sites to help provide effective treatment options for COVID-19." Nader Pourhassan, CEO at the firm, added: "Unfortunately, COVID-19 remains a global public health challenge, and its economic impact continues to devastate the world economy.  "With a second wave of potential cases threatening to surface in the fall and winter of 2020, it is more important than ever to be sure successful treatment options are available to protect the lives of patients. CytoDyn has assurance from its manufacturer that it will have available over 1 million vials this year and could ramp up production to 2-3 million vials this year alone." The coronavirus pandemic has rapidly become a global emergency. Clinical manifestations in patients have ranged from non-existent to severe and fatal. There are currently minimal treatment options. The FDA has granted a 'Fast Track' designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Contact the author at giles@proactiveinvestors.com

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