CytoDyn Announces Major Discovery for its Monother

CytoDyn Announces Major Discovery for its Monotherapy Indication

CytoDyn and IncellDx Report the Successful Development and Validation of an Assay to Assess the Responders for Monotherapy HIV Patients

This assay could predict in 2 hours the responder’s rate for a monotherapy patient candidate and the appropriate dose for each patient at the time of screening

VANCOUVER, Washington, June 18, 2019 (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 significant progress in securing the therapeutic effect and safety of leronlimab (PRO 140) with the development of an assay that can reliably determine a patient’s CCR5 status. Currently, all new patients in the Company’s monotherapy trial are being evaluated with this newly developed screening-level test with the objective of identifying patients expected to respond to a monotherapy versus those not expected to respond due to CCR5 density.

“The development and implementation of an assay that can rapidly and accurately identify potential responders to leronlimab offers a tremendous technical advancement with the potential to more precisely target leronlimab on patients most likely to respond to treatment,” stated Dr. Nader Pourhassan, President and CEO of CytoDyn. “We are excited about our partnership with IncellDx to provide the technical support to explore the power and potential of CCR5 inhibition,” continued Dr. Pourhassan. “With over 110 HIV active patients on leronlimab monotherapy for almost one year and five patients from our original Phase 2 monotherapy extension now reaching almost five years on monotherapy without viral breakthroughs, we are very excited with our collaboration with IncellDx and Bruce Patterson, M.D., former Medical Director of Virology at Stanford University Hospitals and Clinics. With Dr. Patterson’s expertise, we are confident that we will be able to much more efficiently identify responders in HIV, and potentially in many other indications, including our ongoing cancer research.” Dr. Pourhassan concluded, “The continued clinical success of leronlimab in HIV underpins our soon to begin partnership with Thai Red Cross AIDS Research Centre for the PrEP clinical trial that will exclusively utilize leronlimab as a monotherapy.”

“The HIV-co-receptor CCR5 has both genotypic differences in patients, as well as being a highly regulated receptor with different amounts expressed on different cells under certain conditions such as inflammation. The development of a portfolio of assays, including CCR5 genotyping and the assay being reported today that reliably and timely identifies a patient’s CCR5 status, offers a leap in the understanding of potential response to treatment with leronlimab,” stated Dr. Bruce Patterson, CEO and Founder of IncellDx. “I am excited to continue the very positive and effective partnership with CytoDyn to potentially help bring leronlimab to the right patients at the right time, in furtherance of the clear opportunity afforded by personalized medicine,” concluded Dr. Patterson.