CytoDyn Finalizes Development of Receptor Occupancy Test to Guide Pivotal Monotherapy Discussions With the FDA
Download as PDFJuly 25, 2019 6:00am EDT
- FDA face-to-face meeting granted to discuss pivotal monotherapy trial
- Conference call for investors and media on Tuesday, July 30, 2019 at 4:00 p.m. ET with introduction to Dr. Jonah Sacha for CURE and PrEP programs, Dr. Bruce Patterson for CCR5 receptor occupancy for HIV and cancer, and Dr. Jacob Lalezari for TNBC trial
VANCOUVER, Washington, July 25, 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, today announced the completion of development of the Receptor Occupancy Test to measure the expression of CCR5 in HIV and tumor cells that are occupied by leronlimab. Development of this test could more precisely guide CytoDyn in identification of patients at screening for monotherapy.
To date, over 830 HIV patients have participated in clinical trials with leronlimab (PRO140), including over 600 patients in ongoing and previous monotherapy trials. There have been no drug related serious adverse events (“SAEs”) reported in any of the HIV patients treated with leronlimab. In addition, the response rate for the first 10 weeks of leronlimab monotherapy in HIV patients has approximated 95% with the 525 mg dosage. Identifying the patients who can respond to leronlimab monotherapy at the screening is critical for therapeutic success. As such, the development of the Receptor Occupancy Test is a significant milestone that may further increase the monotherapy response rate.
“The development of the Receptor Occupancy Test is an important milestone for CytoDyn because it may allow more precise screening for leronlimab monotherapy,” stated CytoDyn President and CEO, Nader Pourhassan, Ph.D. “Over 600 HIV patients that have taken leronlimab as a single agent over the years have had no drug related SAEs,” continued Dr. Pourhassan. “The potential for leronlimab to be a safe and effective treatment for HIV with highly accurate dosing is an important driver of continued excitement and support from key opinion leaders within the medical community,” Dr. Pourhassan concluded.
Significantly, CytoDyn has been granted an in-person meeting with the U.S. FDA to discuss its pivotal monotherapy protocol that could lead to label expansion approval should leronlimab have its first approval as a combination therapy. To date, 110 patients have reached approximately one year of monotherapy trial with six patients in the extended portion reaching almost three years. Four patients in the extension arm of a previously reported Phase 2 monotherapy trial have continued on leronlimab monotherapy for nearly five years with no drug related SAEs and no viral breakthroughs.
The Company will host a conference call for investors and media on Tuesday, July 30, 2019, to discuss the latest developments, provide a comprehensive update about CytoDyn, along with comments from Drs. Sacha, Patterson and Lalezari.
Date: Tuesday, July 30, 2019
Time: 4:00 p.m. ET/1:00 p.m. PT
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