CytoDyn Inc (OTCMKTS:CYDY) said Thursday that it will share final results of its Phase 3 pivotal clinical trial of leronlimab (PRO 140) as a combination therapy with HAART for heavily treated HIV patients at the American Society for Microbiology (ASM) Microbe Conference.
The four-day ASM Microbe Conference will kick off on June 20 at the Moscone Center in San Francisco.
Vancouver, Washington-based CytoDyn’s management team will be available for investor and industry meetings throughout the four-day conference, said the company.
“We are extremely proud to be selected to present the results of our pivotal trial of leronlimab at this year’s ASM Conference in both oral and poster presentations,” said CytoDyn CEO Nader Pourhassan. “The results of this pivotal trial is the basis for our current Biologics License Application (BLA) filing.”
The BLA is a request for permission to introduce a biologic product for interstate commerce.
“As previously announced, we expect to submit the remaining two parts of our BLA filing for rolling review with the U.S. Food and Drug Administration by the third quarter of 2019 and remain actively engaged in potential strategic discussions related to leronlimab,” said Pourhassan.
The company is slated to make its oral presentation and share the final results of its pivotal study of PRO 140 in heavily treatment-experienced HIV patients on June 21, at 2:00 pm Pacific Time.
The poster presentation will also take place on June 21 at 11:00 a.m. until 12:00 p.m. There will be another poster presentation at 4:00 p.m. The poster board number is AAR-713.
Fast Track designation
The FDA has granted fast track designation to CytoDyn for two potential indications of leronlimab for battling 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. The drug has successfully completed nine clinical trials in over 700 people, including meeting its primary endpoints in a pivotal Phase 3 trial of leronlimab in combination with standard anti-retroviral therapies in HIV-infected, treatment-experienced patients.
A viral entry inhibitor
In the HIV/AIDS setting, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells.
Leronlimab has been the subject of “nine clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in humans,” said the company.
CytoDyn’s leronlimab appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.
Contact Uttara Choudhury at [email protected]