CytoDyn Submits 510(k) Pre-Submission Application
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Posted On: 06/19/2019 9:12:17 AM
CytoDyn Submits 510(k) Pre-Submission Application to U.S. FDA for ProstaGene™ Prognostic Test
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DR. RICHARD PESTELL, WHO LEADS CYTODYN’S CANCER, NASH AND GVHD PROGRAMS, RECENTLY NAMED TO THE ORDER OF AUSTRALIA, ESTABLISHED BY QUEEN ELIZABETH II
VANCOUVER, Washington, June 19, 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 filing of a pre-submission application for a meeting with the U.S. Food and Drug Administration (“FDA”) to discuss the 510(k) application for FDA clearance of the ProstaGene™ Prognostic Test. The ProstaGene™ Prognostic Test is intended for use in patients who have undergone a prostate biopsy and been found to have prostate cancer by the Gleason score. The ProstaGene™ Prognostic Test was developed by Dr. Richard Pestell, A.O., M.D., Ph.D., F.A.C.P., M.B.A., CytoDyn’s Chief Medical Officer. The test became an asset of CytoDyn upon its acquisition in November 2018 of ProstaGene, a biotechnology company founded by Dr. Pestell.
The application for FDA clearance of the ProstaGene™ Prognostic Test will be supported by a previously published retrospective clinical study in two populations of men (79 and 139 men) and a subsequent study in 130 men. A recent study of 218 men determined that the signature provided substantial value added to the Gleason score in patients with an intermediate Gleason score. The prognostic test has been developed to use certain gene technology platforms.
“The inability to determine which cases of prostate cancer may be aggressive leads to significant and, often, unnecessary highly invasive treatment,” stated Dr. Pestell. “The over-treatment of prostate cancer carries with it significant and potentially life-long debilitating quality of life issues and significant unnecessary costs,” continued Dr. Pestell. “The development of an FDA-cleared prostate cancer prognostic test may aid patients and physicians in better decision-making. We are currently assessing commercialization alternatives for the ProstaGene™ Prognostic Test, including potentially value-accretive partnerships,” concluded Dr. Pestell.
“With today’s significant step forward on the road to seeking FDA clearance for the ProstaGene™ Prognostic Test, we stand at the doorstep of potentially transforming how prostate cancer is diagnosed,” stated Nader Pourhassan, Ph.D., CytoDyn’s President and CEO. “And we owe it all to Dr. Pestell, the inventor of the ProstaGene™ Prognostic Test, who as our Chief Medical Officer, leads our cancer, NASH and GvHD programs,” continued Dr. Pourhassan. “The progress that we are announcing today with the ProstaGene™ Prognostic Test is particularly notable because this asset offers a potentially significant opportunity for non-dilutive financing through a strategic partnership,” he added. “CytoDyn acquired the ProstaGene™ Prognostic Test just eight months ago as part of the acquisition of ProstaGene, which has since added a new dimension of opportunities for our lead drug candidate leronlimab in numerous metastatic solid tumors, NASH and GvHD indications,” Dr. Pourhassan concluded.
“All of us at CytoDyn also want to take this opportunity to publicly congratulate Dr. Pestell on being awarded The Order of Australia by Her Majesty Queen Elizabeth II,” stated Dr. Pourhassan. The Order of Australia was established in 1975 by Her Majesty Queen Elizabeth II on the recommendation of the Prime Minister of Australia to recognize Australian citizens for distinguished service of a high degree to Australia or to humanity at large.
“I am deeply humbled by this honor,” stated Dr. Pestell. “The award, coming on the cusp of what may very well be a defining year in CytoDyn’s history, provides recognition to the entire CytoDyn team for the momentous efforts to hopefully bring leronlimab to FDA approval,” Dr. Pestell continued. “Thank you to Her Majesty Queen Elizabeth II and The Governor General of Australia for this recognition,” concluded Dr. Pestell.
Download PDF
DR. RICHARD PESTELL, WHO LEADS CYTODYN’S CANCER, NASH AND GVHD PROGRAMS, RECENTLY NAMED TO THE ORDER OF AUSTRALIA, ESTABLISHED BY QUEEN ELIZABETH II
VANCOUVER, Washington, June 19, 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 filing of a pre-submission application for a meeting with the U.S. Food and Drug Administration (“FDA”) to discuss the 510(k) application for FDA clearance of the ProstaGene™ Prognostic Test. The ProstaGene™ Prognostic Test is intended for use in patients who have undergone a prostate biopsy and been found to have prostate cancer by the Gleason score. The ProstaGene™ Prognostic Test was developed by Dr. Richard Pestell, A.O., M.D., Ph.D., F.A.C.P., M.B.A., CytoDyn’s Chief Medical Officer. The test became an asset of CytoDyn upon its acquisition in November 2018 of ProstaGene, a biotechnology company founded by Dr. Pestell.
The application for FDA clearance of the ProstaGene™ Prognostic Test will be supported by a previously published retrospective clinical study in two populations of men (79 and 139 men) and a subsequent study in 130 men. A recent study of 218 men determined that the signature provided substantial value added to the Gleason score in patients with an intermediate Gleason score. The prognostic test has been developed to use certain gene technology platforms.
“The inability to determine which cases of prostate cancer may be aggressive leads to significant and, often, unnecessary highly invasive treatment,” stated Dr. Pestell. “The over-treatment of prostate cancer carries with it significant and potentially life-long debilitating quality of life issues and significant unnecessary costs,” continued Dr. Pestell. “The development of an FDA-cleared prostate cancer prognostic test may aid patients and physicians in better decision-making. We are currently assessing commercialization alternatives for the ProstaGene™ Prognostic Test, including potentially value-accretive partnerships,” concluded Dr. Pestell.
“With today’s significant step forward on the road to seeking FDA clearance for the ProstaGene™ Prognostic Test, we stand at the doorstep of potentially transforming how prostate cancer is diagnosed,” stated Nader Pourhassan, Ph.D., CytoDyn’s President and CEO. “And we owe it all to Dr. Pestell, the inventor of the ProstaGene™ Prognostic Test, who as our Chief Medical Officer, leads our cancer, NASH and GvHD programs,” continued Dr. Pourhassan. “The progress that we are announcing today with the ProstaGene™ Prognostic Test is particularly notable because this asset offers a potentially significant opportunity for non-dilutive financing through a strategic partnership,” he added. “CytoDyn acquired the ProstaGene™ Prognostic Test just eight months ago as part of the acquisition of ProstaGene, which has since added a new dimension of opportunities for our lead drug candidate leronlimab in numerous metastatic solid tumors, NASH and GvHD indications,” Dr. Pourhassan concluded.
“All of us at CytoDyn also want to take this opportunity to publicly congratulate Dr. Pestell on being awarded The Order of Australia by Her Majesty Queen Elizabeth II,” stated Dr. Pourhassan. The Order of Australia was established in 1975 by Her Majesty Queen Elizabeth II on the recommendation of the Prime Minister of Australia to recognize Australian citizens for distinguished service of a high degree to Australia or to humanity at large.
“I am deeply humbled by this honor,” stated Dr. Pestell. “The award, coming on the cusp of what may very well be a defining year in CytoDyn’s history, provides recognition to the entire CytoDyn team for the momentous efforts to hopefully bring leronlimab to FDA approval,” Dr. Pestell continued. “Thank you to Her Majesty Queen Elizabeth II and The Governor General of Australia for this recognition,” concluded Dr. Pestell.
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