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Amarex, an NSF International Company, Executes Five Rush COVID-19 Related Submissions to the FDA
April 2, 2020ShareTweetEmail
Submissions include an IND, IND Amendment and Compassionate Use Approval for CytoDyn’s product Leronlimab, a Compassionate Use Approval for a treatment device, and an EUA for a PCR-based IVD for COVID-19 detection
GERMANTOWN, Md. – In early March 2020, Amarex Clinical Research LLC, an NSF International company, executed a rush submission of an emergency use Investigational New Drug (IND) application to add COVID-19 as a new indication for CytoDyn’s monoclonal antibody product, Leronlimab. The product is currently being tested for HIV infection, and oncology indications, and has the potential to modulate the “cytokine storm” sometimes seen in COVID-19 patients. A “cytokine storm” is an overproduction of immune cells and their activating compounds, which can contribute to life-threatening respiratory distress.
CytoDyn received rapid approval from the FDA for the emergency treatment of extremely ill COVID-19 patients. On March 27, CytoDyn released initial positive results in the first four patients treated, having seen a reduction of the hyper-immune response three days following treatment initiation. As of April 1, CytoDyn reported that a total of 10 patients have received treatment under emergency use. On March 30, FDA cleared a second IND for a Phase II randomized trial to treat mildly to moderately ill coronavirus patients with Leronlimab, with enrollment to begin immediately. Amarex is currently managing the trial. On April 1, CytoDyn reported that it filed an IND amendment with the FDA for a protocol to treat severely ill COVID-19 patients with Leronlimab where the primary endpoint is mortality rate at two weeks. Amarex also prepared this submission.
On March 25, Amarex also executed a rush submission to the U.S. FDA for a Compassionate Use Approval (CUA) for treatment of COVID-19 patients with a device that is currently in testing under an existing Investigational Device Exemption (IDE) for a different medical condition. Based on the mechanism of action there is reason to believe that the device may be an effective treatment for COVID-19 patients displaying serious symptoms. Amarex prepared the submission in a matter of days, which included writing a new clinical trial protocol; the typical submission process can take five weeks or more.
On March 27, Amarex executed a rush submission to the U. S. FDA of an Emergency Use Authorization (EUA) for a PCR-based IVD for the rapid detection of the coronavirus (SARS-CoV-2). The FDA quickly acknowledged receipt of the EUA and Amarex awaits a decision. The IVD has been through the regulatory approval process in Korea, and Amarex and its client are therefore hopeful for a rapid FDA approval result.
“I count myself lucky to work with our Amarex team,” said Amarex President and CEO Dr. Kazem Kazempour. “They’re incredibly caring, dedicated people as well as skilled experts who have been quick to adapt to this rapidly-changing situation.”
About Amarex Clinical Research LLC, an NSF International Company
Since 1998, Amarex has been helping biotech, pharmaceutical, medical device and diagnostic companies conduct scientifically sound clinical trials and navigate complex regulatory environments in a wide range of therapeutic indications, including oncology, central nervous system, wound healing, infectious disease, cardiovascular and urology.
As part of NSF International, Amarex supports companies with regulatory affairs, project/trial management, clinical operations, biostatistics, data management, pharmacovigilance, data monitoring committees, medical writing and consulting.
About NSF International
NSF International has been protecting and improving human health for over 75 years. As a global public health organization NSF facilitates standards development, and tests and certifies products for the food, water, health sciences and consumer goods sectors to minimize adverse health effects. Founded in 1944, NSF is committed to protecting human health and safety worldwide. NSF International is a Pan American Health Organization/World Health Organization (WHO) Collaborating Center on Food Safety, Water Quality and Indoor Environment.
NSF’s health sciences services include training and education, consulting, clinical research, regulatory guidance, corporate compliance and, separately, auditing, DNA testing, certification and R&D for the pharma biotech, medical device and dietary supplement industries throughout the product lifecycle. NSF facilitated the development of the only American National Standard (NSF/ANSI 173) that verifies the health and safety of dietary supplements and also tests and certifies products to this standard.
About CytoDyn Inc.
CytoDyn Inc. is a biotechnology company developing innovative treatments for multiple therapeutic indications based on Leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and in immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with Leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for Leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in the first quarter of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with Leronlimab as a once-weekly monotherapy for HIV-infected patients and plans to initiate a registration-directed study of Leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that Leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that Leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on Leronlimab monotherapy remaining virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate Leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with Leronlimab in metastatic triple-negative breast cancer. More information is at www.cytodyn.com.
Amarex, an NSF International Company, Executes Five Rush COVID-19 Related Submissions to the FDA
April 2, 2020ShareTweetEmail
Submissions include an IND, IND Amendment and Compassionate Use Approval for CytoDyn’s product Leronlimab, a Compassionate Use Approval for a treatment device, and an EUA for a PCR-based IVD for COVID-19 detection
GERMANTOWN, Md. – In early March 2020, Amarex Clinical Research LLC, an NSF International company, executed a rush submission of an emergency use Investigational New Drug (IND) application to add COVID-19 as a new indication for CytoDyn’s monoclonal antibody product, Leronlimab. The product is currently being tested for HIV infection, and oncology indications, and has the potential to modulate the “cytokine storm” sometimes seen in COVID-19 patients. A “cytokine storm” is an overproduction of immune cells and their activating compounds, which can contribute to life-threatening respiratory distress.
CytoDyn received rapid approval from the FDA for the emergency treatment of extremely ill COVID-19 patients. On March 27, CytoDyn released initial positive results in the first four patients treated, having seen a reduction of the hyper-immune response three days following treatment initiation. As of April 1, CytoDyn reported that a total of 10 patients have received treatment under emergency use. On March 30, FDA cleared a second IND for a Phase II randomized trial to treat mildly to moderately ill coronavirus patients with Leronlimab, with enrollment to begin immediately. Amarex is currently managing the trial. On April 1, CytoDyn reported that it filed an IND amendment with the FDA for a protocol to treat severely ill COVID-19 patients with Leronlimab where the primary endpoint is mortality rate at two weeks. Amarex also prepared this submission.
On March 25, Amarex also executed a rush submission to the U.S. FDA for a Compassionate Use Approval (CUA) for treatment of COVID-19 patients with a device that is currently in testing under an existing Investigational Device Exemption (IDE) for a different medical condition. Based on the mechanism of action there is reason to believe that the device may be an effective treatment for COVID-19 patients displaying serious symptoms. Amarex prepared the submission in a matter of days, which included writing a new clinical trial protocol; the typical submission process can take five weeks or more.
On March 27, Amarex executed a rush submission to the U. S. FDA of an Emergency Use Authorization (EUA) for a PCR-based IVD for the rapid detection of the coronavirus (SARS-CoV-2). The FDA quickly acknowledged receipt of the EUA and Amarex awaits a decision. The IVD has been through the regulatory approval process in Korea, and Amarex and its client are therefore hopeful for a rapid FDA approval result.
“I count myself lucky to work with our Amarex team,” said Amarex President and CEO Dr. Kazem Kazempour. “They’re incredibly caring, dedicated people as well as skilled experts who have been quick to adapt to this rapidly-changing situation.”
About Amarex Clinical Research LLC, an NSF International Company
Since 1998, Amarex has been helping biotech, pharmaceutical, medical device and diagnostic companies conduct scientifically sound clinical trials and navigate complex regulatory environments in a wide range of therapeutic indications, including oncology, central nervous system, wound healing, infectious disease, cardiovascular and urology.
As part of NSF International, Amarex supports companies with regulatory affairs, project/trial management, clinical operations, biostatistics, data management, pharmacovigilance, data monitoring committees, medical writing and consulting.
About NSF International
NSF International has been protecting and improving human health for over 75 years. As a global public health organization NSF facilitates standards development, and tests and certifies products for the food, water, health sciences and consumer goods sectors to minimize adverse health effects. Founded in 1944, NSF is committed to protecting human health and safety worldwide. NSF International is a Pan American Health Organization/World Health Organization (WHO) Collaborating Center on Food Safety, Water Quality and Indoor Environment.
NSF’s health sciences services include training and education, consulting, clinical research, regulatory guidance, corporate compliance and, separately, auditing, DNA testing, certification and R&D for the pharma biotech, medical device and dietary supplement industries throughout the product lifecycle. NSF facilitated the development of the only American National Standard (NSF/ANSI 173) that verifies the health and safety of dietary supplements and also tests and certifies products to this standard.
About CytoDyn Inc.
CytoDyn Inc. is a biotechnology company developing innovative treatments for multiple therapeutic indications based on Leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and in immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with Leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for Leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in the first quarter of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with Leronlimab as a once-weekly monotherapy for HIV-infected patients and plans to initiate a registration-directed study of Leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that Leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that Leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on Leronlimab monotherapy remaining virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate Leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with Leronlimab in metastatic triple-negative breast cancer. More information is at www.cytodyn.com.
