CytoDyn Files Modified IND and Protocol for Phase 2 Clinical Trial for Treatment of Patients with Coronavirus with Leronlimab (PRO 140) and Advises Correction to Press Release Issued on March 12, 2020

VANCOUVER, Washington, March 16, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the Company filed a modified IND and protocol for its Phase 2 clinical trial with leronlimab (PRO 140) as a therapy for patients who experience respiratory complications as a result of contracting Coronavirus Disease 2019 (COVID-19). The modification came at the behest of the U.S. Food and Drug Administration (FDA) in response to the Company’s filing of its IND and protocol for its Phase 2 clinical trial on March 9, 2020.

The modified protocol is a Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab in Patients with Coronavirus Disease 2019 (COVID-19) and calls for 75 planned patients in up to 10 centers in the United States. Patients enrolled in the trial are expected to have a treatment window of approximately 6 weeks.

Jacob Lalezari, M.D., CytoDyn’s Interim Chief Medical Officer commented: “We appreciate the FDA’s timely input on protocol design and hope to start the treatment study in the very near future.”

Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn said: “We are pleased with the new trial design and are rapidly sending supplies of leronlimab to the clinics to begin patient treatment.”

With respect to the Company’s press release issued on March 12, 2020, management announces the following correction: Patient #1 had missed one treatment of carboplatin and will continue to be treated with carboplatin and leronlimab. Additional updates about this patient will be included in the next Company update on all cancer patients.

About Leronlimab (PRO 140)
The U.S. Food and Drug Administration (FDA) have 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.  Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases including NASH.  Leronlimab has successfully completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients).