https://www.cytodyn.com/newsroom/press-releas...pplication
CytoDyn Submits Completed Biologics License Application (BLA) to the FDA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients
Download as PDFApril 27, 2020 9:12am EDT
During the FDA’s review period, the Company will dedicate all resources to ensure availability of leronlimab for COVID-19 patients; Cancer programs continue with positive results
VANCOUVER, Washington, April 27, 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, today announced the Company has submitted the clinical, and the CMC (chemistry, manufacturing and controls) portions of its BLA to the U.S. Food and Drug Administration (FDA) for leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients. The FDA previously granted both Fast Track designation for leronlimab and rolling review for the Company’s BLA in HIV indication.
“The submission of the final two parts of the BLA is a significant milestone for the Company, and initiates its transition from a development-stage company to a commercial organization. We are excited about the opportunity to introduce a novel therapeutic to HIV patients. In addition to the BLA submission, once the ongoing investigative trial for leronlimab as a once-weekly monotherapy for HIV-infected patients has reached its objectives, we plan to initiate a registration-directed study. Leronlimab’s strong safety profile demonstrated in eleven clinical trials with over 800 people supports its long-term potential,” said Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn. With the BLA filing for a combination therapy now complete, we are continuing our efforts on commercialization-readiness, as well as advancing leronlimab in the other important therapeutic areas of COVID-19, cancer and immunology. The BLA filing is a monumental achievement for our Company, and was made possible through the sheer determination and commitment of CytoDyn’s team and Amarex Clinical Research team led by Dr. Kush Dhody, Senior Vice President of Clinical Operations. I would like to especially recognize Dr. Nitya Ray, the Company’s Chief Technology Officer, whose work in leading the CMC program was very crucial to CytoDyn. Dr. Ray was also instrumental in consummating the Samsung Biologics contract to ensure we have sufficient large-scale biologics manufacturing capacity in place to meet the expected demand growth in a cost-effective and timely fashion. I would like to thank all of those involved for their tireless efforts,” concluded Dr. Pourhassan.
CytoDyn Submits Completed Biologics License Application (BLA) to the FDA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients
Download as PDFApril 27, 2020 9:12am EDT
During the FDA’s review period, the Company will dedicate all resources to ensure availability of leronlimab for COVID-19 patients; Cancer programs continue with positive results
VANCOUVER, Washington, April 27, 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, today announced the Company has submitted the clinical, and the CMC (chemistry, manufacturing and controls) portions of its BLA to the U.S. Food and Drug Administration (FDA) for leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients. The FDA previously granted both Fast Track designation for leronlimab and rolling review for the Company’s BLA in HIV indication. “The submission of the final two parts of the BLA is a significant milestone for the Company, and initiates its transition from a development-stage company to a commercial organization. We are excited about the opportunity to introduce a novel therapeutic to HIV patients. In addition to the BLA submission, once the ongoing investigative trial for leronlimab as a once-weekly monotherapy for HIV-infected patients has reached its objectives, we plan to initiate a registration-directed study. Leronlimab’s strong safety profile demonstrated in eleven clinical trials with over 800 people supports its long-term potential,” said Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn. With the BLA filing for a combination therapy now complete, we are continuing our efforts on commercialization-readiness, as well as advancing leronlimab in the other important therapeutic areas of COVID-19, cancer and immunology. The BLA filing is a monumental achievement for our Company, and was made possible through the sheer determination and commitment of CytoDyn’s team and Amarex Clinical Research team led by Dr. Kush Dhody, Senior Vice President of Clinical Operations. I would like to especially recognize Dr. Nitya Ray, the Company’s Chief Technology Officer, whose work in leading the CMC program was very crucial to CytoDyn. Dr. Ray was also instrumental in consummating the Samsung Biologics contract to ensure we have sufficient large-scale biologics manufacturing capacity in place to meet the expected demand growth in a cost-effective and timely fashion. I would like to thank all of those involved for their tireless efforts,” concluded Dr. Pourhassan.
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