Just spent the whole day giving myself high blood pressure trying to get Cytodyn recognized by the Washington State Department of Health bureaucracy.
After looking at the chart posted by Dr. Zaius last night showing all of the Fed bureaus that would weigh in on the decision to grant Leronlimab EUA status and trying to contact the CDC last night as detailed in my post 49080, I decided I needed big help negotiating that bureaucracy.
Actually, I decided I would try to get the Washington State Department of Health to navigate it for me. Oh, what a headache! Filters, filters everywhere!
If you call the Health Dept. contact center, they don't know how to send you up the bureaucratic ladder, only down. I had an Org chart from their website that showed me who I should contact but almost no one answered their phone because they were all furloughed of reorganized because of the Covid crisis. No one knew the new phone numbers.
The person I wanted to talk to was now directly under the Secretary of Health and was called the Deputy Secretary of COVID Response. If you call the top public phone number on the website, you get to leave a message and ask for a call back. Six hours later I have received no call back.
So I did compose an email to the top dogs and it is posted below. But I also called Cytodyn and told them what I was doing and my strategy for getting to the people at the top of the State heap. The woman who answered liked my efforts and said she would tell others in the office about my efforts. My hope is that they may try to seek an ally at State Health to rattle the Fed bureaucracy over EUA approval.
There may be some ethical issues around a state advocating for a company in their own state but that is not my problem. I just want them to get Cytodyn on the Fed's radar like the Big Boys are. Is that too much to ask? I said in my letter to the state health department that Cytodyn would make Washington proud! Yes they will!
So here is my email -
Vancouver, WA Pharmaceutical Company Holds Key to Ending Covid-19 Pandemic
To:
Dr. John Wiesman, Secretary of Health, Washington State
Lacy Fehrenbach, Deputy Secretary for COVID Response
Dear Department of Health, Washington,
You have, right in Vancouver, Washington, a small pharmaceutical company, Cytodyn, that has developed a monoclonal antibody that can stop the Covid-19 pandemic and get the economy back to normal.
The antibody was originally being developed for HIV but, when tested against Covid-19, had terrific success knocking it out. Its safety was establish during HIV trials and the results were outstanding. Because of that work, Cytodyn was given emergency permission to proceed with a Phase 2 trial for Mild to Moderately ill patients and a Phase 2/3 trial for Severe to Critical patients.
The Phase 2 trial ended a couple weeks ago and the results were submitted to the FDA yesterday. The results were excellent. The patients were not terribly sick so the test was to see if the Cytodyn drug, Leronlimab, could prevent the treated group of patients from getting any sicker and ending up in the hospital versus the untreated group without treatment. As I said, the results were excellent.
I am writing you about Cytodyn and Leronlimab because they need your help. Being small, they have two major problems.
First, they are asking for Emergency Use Authorization. They absolutely deserve it but they are virtually invisible. A New York Times "Drug and Treatment Tracker" lists 20 anti-Covid candidates but not Cytodyn. They are unknown to a whole host of Federal Bureaus that have never heard of them and yet they are supposed to weigh in on Leronlimab's Emergency Use Authorization. Cytodyn does not know how to navigate this bureaucracy and could use your help being seen.
Second, and this is much more important, it takes time to make monoclonal antibodies.
Big pharmaceutical companies are now receiving billions of dollars for billions of doses of anti-Covid drugs that are completely unproven. The only supply of Leronlimab that will be available when they are approved is a measly 1.2 million doses paid for by the company itself. Each treatment for Covid-19 takes four doses that are injected. That means there is, as of now, only enough Leronlimab for 300,000 treatments. We need billions and we need it yesterday. The Federal government has several large funding programs for Covid-19 drug development but Cytodyn has applied for none of it.
Would you please reach out to Cytodyn just to hear from the horse's mouth what they and Leronlimab are about? I have no doubt they will make Washington State very proud!
Their website is Cytodyn.com and their phone number is 360-980-8524.
Below is the press release on the Cytodyn Phase 2 trial results.
Many other articles and videos are, of course, on the web.
Thank you so much for your time.
Cassandra X
xxxxxxx@aol.com
XXX-XXX-XXXX
CytoDyn Announces Clinically Significant Top-line Results from its Phase 2 Trial in Mild-to-Moderate COVID-19 Patients
August 11, 2020 9:15am EDT
VANCOUVER, Washington, Aug. 11, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"
, a late-stage biotechnology company announced today the Top-line results from its recently completed, randomized, double-blind, Phase 2 trial for COVID-19 patients with mild-to-moderate symptoms. CytoDyn will submit its Top-line Report for this trial to the U.S. Food and Drug Administration for review later this week. The Top-line Report revealed the following information:
Clinical improvement assessed by change in total clinical symptom score:
In patients with Total Clinical Symptom Score of ≥ 4 at baseline (higher scores equate to poorer health state): At Day 3, more subjects treated with leronlimab reported improvement in total clinical symptom score compared to the placebo group (90% on leronlimab arm vs. 71% on placebo). The subgroup analysis indicates that among patients with more symptoms at baseline, those who received leronlimab had a greater treatment effect than patients who received the placebo.
The National Early Warning Score 2 (NEWS2):
The National Early Warning Score (NEWS) is an objective scale developed by the Royal College of Physicians to identify patients at risk for rapid clinical deterioration requiring critical care intervention. NEWS2 (the latest version), is being used as an endpoint in several other COVID-19 clinical trials, including CytoDyn's severe-to-critical COVID-19 Phase 3 trial. It measures clinical parameters including respiratory rate, oxygen saturation, supplemental oxygen, temperature, systolic blood pressure, heart rate, and level of consciousness. In all treated patients, at the End of Treatment (or Day 14), patients in the leronlimab group were more than twice as likely to experience a beneficial improvement in scores compared to patients in the placebo group (50% vs 20%; p=0.0223).
Similar, statistically significant, results were observed at Day 3 and Day 14 in the analysis of per protocol population (p<0.03 and p<0.02, respectively).
Safety Endpoints:
The incidence, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs) were lower in the leronlimab group compared to the placebo group. Patients treated with placebo were more than twice as likely to experience SAEs or AEs compared to patients treated with leronlimab.
Harish Seethamraju, M.D., Lead Principal Investigator at Montefiore Medical Center NY, stated, “The results demonstrate that CCR5 blockade by leronlimab given as a weekly subcutaneous injection in mild-to-moderate COVID-19 patients is reasonably safe and associated with rapid improvement in viral symptoms with fewer adverse events than when compared to placebo.”
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “In the mild- to-moderate population, it is important to have a therapeutic option for COVID-19 in patients who are showing signs of rapid clinical deterioration. Patients receiving leronlimab showed a statistically significant improvement using NEWS2 clinical parameters. We will make a case for immediate approval of leronlimab for this population of COVID-19 patients, not only in the U.S., but in the U.K. and other countries around the world.”
Scott A. Kelly, M.D., Chief Medical Officer of CytoDyn, said, “We are thrilled with the results of leronlimab in mild-to-moderate COVID-19 patients. It is paramount to determine which patients will deteriorate and require critical care interventions, including patients at risk for ICU admission, cardiac arrest, or death within 24 hours. The NEWS2 aims to identify those patients most at risk. We are pleased that leronlimab showed a statistically significant result in a randomized, double-blinded study for NEWS2. The decreased probability in serious adverse events, as well as overall adverse events with leronlimab compared to placebo further supports the use of leronlimab as a treatment option for COVID-19.”
Jacob P. Lalezari, M.D., Senior Science Advisor to CytoDyn, said, "Treatment with leronlimab demonstrated reductions in both serious adverse events, as well as predictors of pulmonary collapse in patients with mild-to-moderate COVID-19. We initiated the study hoping to reduce flu-like symptoms, such as fever, cough, and muscle aches. In the end, use of leronlimab was not only correlated with improved symptom scores in patients with measurable symptoms at baseline, but also provided significant and consequential benefits on far more serious endpoints. Demonstrating these efficacy signals in a population with mostly mild illness at study entry bodes well for leronlimab’s activity in patients with more severe illness.”
About Leronlimab (PRO 140)
The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses.
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. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
In the setting of HIV/AIDS, 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 could significantly reduce or control HIV viral load in humans. The leronlimab antibody 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.
In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.
The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted “orphan drug” designation to leronlimab for the prevention of GvHD.
About CytoDyn
CytoDyn is a late-stage 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 critical 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 immune-mediated illnesses, such as GvHD and NASH.
CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The Company has requested a Type A meeting with the FDA and is working diligently to analyze and present new dosing information from a recently completed trial in order to resubmit its Biologics License Application for this HIV combination therapy.
CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it 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. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six 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.
After looking at the chart posted by Dr. Zaius last night showing all of the Fed bureaus that would weigh in on the decision to grant Leronlimab EUA status and trying to contact the CDC last night as detailed in my post 49080, I decided I needed big help negotiating that bureaucracy.
Actually, I decided I would try to get the Washington State Department of Health to navigate it for me. Oh, what a headache! Filters, filters everywhere!
If you call the Health Dept. contact center, they don't know how to send you up the bureaucratic ladder, only down. I had an Org chart from their website that showed me who I should contact but almost no one answered their phone because they were all furloughed of reorganized because of the Covid crisis. No one knew the new phone numbers.
The person I wanted to talk to was now directly under the Secretary of Health and was called the Deputy Secretary of COVID Response. If you call the top public phone number on the website, you get to leave a message and ask for a call back. Six hours later I have received no call back.
So I did compose an email to the top dogs and it is posted below. But I also called Cytodyn and told them what I was doing and my strategy for getting to the people at the top of the State heap. The woman who answered liked my efforts and said she would tell others in the office about my efforts. My hope is that they may try to seek an ally at State Health to rattle the Fed bureaucracy over EUA approval.
There may be some ethical issues around a state advocating for a company in their own state but that is not my problem. I just want them to get Cytodyn on the Fed's radar like the Big Boys are. Is that too much to ask? I said in my letter to the state health department that Cytodyn would make Washington proud! Yes they will!
So here is my email -
Vancouver, WA Pharmaceutical Company Holds Key to Ending Covid-19 Pandemic
To:
Dr. John Wiesman, Secretary of Health, Washington State
Lacy Fehrenbach, Deputy Secretary for COVID Response
Dear Department of Health, Washington,
You have, right in Vancouver, Washington, a small pharmaceutical company, Cytodyn, that has developed a monoclonal antibody that can stop the Covid-19 pandemic and get the economy back to normal.
The antibody was originally being developed for HIV but, when tested against Covid-19, had terrific success knocking it out. Its safety was establish during HIV trials and the results were outstanding. Because of that work, Cytodyn was given emergency permission to proceed with a Phase 2 trial for Mild to Moderately ill patients and a Phase 2/3 trial for Severe to Critical patients.
The Phase 2 trial ended a couple weeks ago and the results were submitted to the FDA yesterday. The results were excellent. The patients were not terribly sick so the test was to see if the Cytodyn drug, Leronlimab, could prevent the treated group of patients from getting any sicker and ending up in the hospital versus the untreated group without treatment. As I said, the results were excellent.
I am writing you about Cytodyn and Leronlimab because they need your help. Being small, they have two major problems.
First, they are asking for Emergency Use Authorization. They absolutely deserve it but they are virtually invisible. A New York Times "Drug and Treatment Tracker" lists 20 anti-Covid candidates but not Cytodyn. They are unknown to a whole host of Federal Bureaus that have never heard of them and yet they are supposed to weigh in on Leronlimab's Emergency Use Authorization. Cytodyn does not know how to navigate this bureaucracy and could use your help being seen.
Second, and this is much more important, it takes time to make monoclonal antibodies.
Big pharmaceutical companies are now receiving billions of dollars for billions of doses of anti-Covid drugs that are completely unproven. The only supply of Leronlimab that will be available when they are approved is a measly 1.2 million doses paid for by the company itself. Each treatment for Covid-19 takes four doses that are injected. That means there is, as of now, only enough Leronlimab for 300,000 treatments. We need billions and we need it yesterday. The Federal government has several large funding programs for Covid-19 drug development but Cytodyn has applied for none of it.
Would you please reach out to Cytodyn just to hear from the horse's mouth what they and Leronlimab are about? I have no doubt they will make Washington State very proud!
Their website is Cytodyn.com and their phone number is 360-980-8524.
Below is the press release on the Cytodyn Phase 2 trial results.
Many other articles and videos are, of course, on the web.
Thank you so much for your time.
Cassandra X
xxxxxxx@aol.com
XXX-XXX-XXXX
CytoDyn Announces Clinically Significant Top-line Results from its Phase 2 Trial in Mild-to-Moderate COVID-19 Patients
August 11, 2020 9:15am EDT
VANCOUVER, Washington, Aug. 11, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"
, a late-stage biotechnology company announced today the Top-line results from its recently completed, randomized, double-blind, Phase 2 trial for COVID-19 patients with mild-to-moderate symptoms. CytoDyn will submit its Top-line Report for this trial to the U.S. Food and Drug Administration for review later this week. The Top-line Report revealed the following information: Clinical improvement assessed by change in total clinical symptom score:
In patients with Total Clinical Symptom Score of ≥ 4 at baseline (higher scores equate to poorer health state): At Day 3, more subjects treated with leronlimab reported improvement in total clinical symptom score compared to the placebo group (90% on leronlimab arm vs. 71% on placebo). The subgroup analysis indicates that among patients with more symptoms at baseline, those who received leronlimab had a greater treatment effect than patients who received the placebo.
The National Early Warning Score 2 (NEWS2):
The National Early Warning Score (NEWS) is an objective scale developed by the Royal College of Physicians to identify patients at risk for rapid clinical deterioration requiring critical care intervention. NEWS2 (the latest version), is being used as an endpoint in several other COVID-19 clinical trials, including CytoDyn's severe-to-critical COVID-19 Phase 3 trial. It measures clinical parameters including respiratory rate, oxygen saturation, supplemental oxygen, temperature, systolic blood pressure, heart rate, and level of consciousness. In all treated patients, at the End of Treatment (or Day 14), patients in the leronlimab group were more than twice as likely to experience a beneficial improvement in scores compared to patients in the placebo group (50% vs 20%; p=0.0223).
Similar, statistically significant, results were observed at Day 3 and Day 14 in the analysis of per protocol population (p<0.03 and p<0.02, respectively).
Safety Endpoints:
The incidence, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs) were lower in the leronlimab group compared to the placebo group. Patients treated with placebo were more than twice as likely to experience SAEs or AEs compared to patients treated with leronlimab.
Harish Seethamraju, M.D., Lead Principal Investigator at Montefiore Medical Center NY, stated, “The results demonstrate that CCR5 blockade by leronlimab given as a weekly subcutaneous injection in mild-to-moderate COVID-19 patients is reasonably safe and associated with rapid improvement in viral symptoms with fewer adverse events than when compared to placebo.”
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “In the mild- to-moderate population, it is important to have a therapeutic option for COVID-19 in patients who are showing signs of rapid clinical deterioration. Patients receiving leronlimab showed a statistically significant improvement using NEWS2 clinical parameters. We will make a case for immediate approval of leronlimab for this population of COVID-19 patients, not only in the U.S., but in the U.K. and other countries around the world.”
Scott A. Kelly, M.D., Chief Medical Officer of CytoDyn, said, “We are thrilled with the results of leronlimab in mild-to-moderate COVID-19 patients. It is paramount to determine which patients will deteriorate and require critical care interventions, including patients at risk for ICU admission, cardiac arrest, or death within 24 hours. The NEWS2 aims to identify those patients most at risk. We are pleased that leronlimab showed a statistically significant result in a randomized, double-blinded study for NEWS2. The decreased probability in serious adverse events, as well as overall adverse events with leronlimab compared to placebo further supports the use of leronlimab as a treatment option for COVID-19.”
Jacob P. Lalezari, M.D., Senior Science Advisor to CytoDyn, said, "Treatment with leronlimab demonstrated reductions in both serious adverse events, as well as predictors of pulmonary collapse in patients with mild-to-moderate COVID-19. We initiated the study hoping to reduce flu-like symptoms, such as fever, cough, and muscle aches. In the end, use of leronlimab was not only correlated with improved symptom scores in patients with measurable symptoms at baseline, but also provided significant and consequential benefits on far more serious endpoints. Demonstrating these efficacy signals in a population with mostly mild illness at study entry bodes well for leronlimab’s activity in patients with more severe illness.”
About Leronlimab (PRO 140)
The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses.
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. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
In the setting of HIV/AIDS, 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 could significantly reduce or control HIV viral load in humans. The leronlimab antibody 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.
In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.
The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted “orphan drug” designation to leronlimab for the prevention of GvHD.
About CytoDyn
CytoDyn is a late-stage 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 critical 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 immune-mediated illnesses, such as GvHD and NASH.
CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The Company has requested a Type A meeting with the FDA and is working diligently to analyze and present new dosing information from a recently completed trial in order to resubmit its Biologics License Application for this HIV combination therapy.
CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it 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. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six 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.
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