PTM1,
Thanks for your request. I was shocked to find out that the hospital responded to our request for the use of leronlimab for my friend. The family is very excited especially since he was placed on a ventilator today. I thought that I might as well give it a chance so I contacted my friend, SeekingAlfa who put together some background information for me that I could send to the attending doctor at the hospital. I first had spoken to her with her with my friend's family and she suggested that I send her a fax with some information that she could provide her immunologist and oncologist.
In any event this is a summary of what I faxed and I hope it can help others as you suggest:
My fax started out that I had contacted Dr. Pourhassan of Cytodyn about the possibility of using Leronlimab for a friend of mine. And that Dr. Pourhassen provided his contact information and sent the message that the doctor has to send him an email and request EIND and they could proceed ASAP.
I then provided the information the following information on Cytodyn and Leronlimab that SeekingAlfa had provided me:
Leronlimab is a CCR5 blocker, which Dr. Bruce Patterson, formerly of Stanford and Northwestern, theorized would work to quell the cytokine storm in the lungs which has been so lethal to many patients. Patterson has labeled coronavirus as a RANTES disease (CCL5), and his paper is under peer review prior to publication in Nature.
A pre-print of Patterson's paper can be found here: https://www.medrxiv.org/content/10.1101/2020....20084673v1
Dr. Yo is a very good explainer of these kinds of technical things. https://www.youtube.com/watch?v=OW6IxELNtj4&t=10s
Below is a summary of results as of April 30, 2020.
Patients Treated with Leronlimab; Majority of Patients Have Demonstrated Remarkable Recoveries
GlobeNewswire
GlobeNewswire•April 30, 2020
54 eINDs approved by FDA and 49 patients have been treated with leronlimab thus far
VANCOUVER, Washington, April 30, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (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 updates on 49 COVID-19 patients who have received leronlimab under the U.S. Food and Drug Administration’s (FDA) emergency Investigational New Drug (eIND) program:
Eleven (11) Patients in NY hospital: All treated patients were in Intensive Care Units (ICU) because of acute respiratory failure, eight of whom were intubated (placed on mechanical ventilation). One patient was not intubated because of poor baseline pulmonary status (history of lung cancer and had undergone bilateral upper lobectomy). Seven patients were organ-transplant recipients (six patients were renal-transplant recipients and one patient had a history of heart transplant) and were on immunosuppressive regimen. Ten patients were on dialysis and nine were on vasopressors during hospitalization. Despite their pre-existing and severe conditions, we believe we were able to save the lives of four patients. All patient blood samples were evaluated and important powerful results from the effect of leronlimab were demonstrated in almost all of these patients. This data has been submitted to a prestigious journal and we expect the publication on Friday, May 1.
Twenty-three (23) patients in Southern California hospital: Six patients were in critical condition (intubated) and 17 patients were severely-ill, needing oxygen support. No death was reported. Out of 6 critical patients, all were intubated patients, 3 were extubated (taken off ventilator), 2 patients remain relatively stable and still breathing with the assistance of a ventilator and one patient has shown deterioration in respiratory parameters. Of 17 severe condition (but not critical) patients, 11 patients demonstrated improvement in respiratory parameters (8 of them were discharged from hospital, including one patient in the news, Samantha Mottet), 2 patients remain relatively stable, 2 have shown deterioration in respiratory parameters and information is pending for 2 recently treated patients.
Three (3) patients in Georgia hospital: All three ICU patients were intubated and two of them had renal failure at the start of leronlimab treatment. Of these 3 patients, 2 were extubated (taken off ventilator) and 1 patient remains on a ventilator but improving.
One (1) patient in another NY hospital: Patient was taken off oxygen and discharged from hospital after leronlimab treatment.
One (1) patient in Northern California hospital: Patient is now weaning from ventilator and transferred to rehabilitation hospital.
Updates are pending for 10 other patients. Five additional patients have been approved to receive leronlimab under eINDs, which increases the total eINDs approved by the FDA to 54 patients.
Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostics company and an advisor to CytoDyn, expanded on these findings by stating, “We are excited that patients are responding extremely well to leronlimab as expected from the novel mechanism of COVID-19 pathogenesis we discovered and will be reporting in the coming days.”
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, “We believe these results, although anecdotal, are very impressive and the number of patients treated under eIND is rapidly increasing. The enrollment for our Phase 2 double-blind and Phase 2b/3 trials is moving along rapidly and we believe the results from both studies will be very powerful due to the mechanism of action (MOA) of affecting the viral load and restoring the immune system. With our first major paper very close to publication, we expect to have a second paper published shortly thereafter, as our MOA is as unique as our results.”
About Coronavirus Disease 2019
CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.
_____________________
Please note that my friend is also a friend of Seeking Alfa and we are both ecstatic that we have moved this forward. We, however, wish it would have been approved when he was on oxygen.
I hope no one will have to be in the same situation but hopefully you can use the above to help you seek the use of leronlimab with your doctors.
Thanks to all again for the good wishes that you have sent.
Happy Memorial Day.
Thanks for your request. I was shocked to find out that the hospital responded to our request for the use of leronlimab for my friend. The family is very excited especially since he was placed on a ventilator today. I thought that I might as well give it a chance so I contacted my friend, SeekingAlfa who put together some background information for me that I could send to the attending doctor at the hospital. I first had spoken to her with her with my friend's family and she suggested that I send her a fax with some information that she could provide her immunologist and oncologist.
In any event this is a summary of what I faxed and I hope it can help others as you suggest:
My fax started out that I had contacted Dr. Pourhassan of Cytodyn about the possibility of using Leronlimab for a friend of mine. And that Dr. Pourhassen provided his contact information and sent the message that the doctor has to send him an email and request EIND and they could proceed ASAP.
I then provided the information the following information on Cytodyn and Leronlimab that SeekingAlfa had provided me:
Leronlimab is a CCR5 blocker, which Dr. Bruce Patterson, formerly of Stanford and Northwestern, theorized would work to quell the cytokine storm in the lungs which has been so lethal to many patients. Patterson has labeled coronavirus as a RANTES disease (CCL5), and his paper is under peer review prior to publication in Nature.
A pre-print of Patterson's paper can be found here: https://www.medrxiv.org/content/10.1101/2020....20084673v1
Dr. Yo is a very good explainer of these kinds of technical things. https://www.youtube.com/watch?v=OW6IxELNtj4&t=10s
Below is a summary of results as of April 30, 2020.
Patients Treated with Leronlimab; Majority of Patients Have Demonstrated Remarkable Recoveries
GlobeNewswire
GlobeNewswire•April 30, 2020
54 eINDs approved by FDA and 49 patients have been treated with leronlimab thus far
VANCOUVER, Washington, April 30, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (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 updates on 49 COVID-19 patients who have received leronlimab under the U.S. Food and Drug Administration’s (FDA) emergency Investigational New Drug (eIND) program: Eleven (11) Patients in NY hospital: All treated patients were in Intensive Care Units (ICU) because of acute respiratory failure, eight of whom were intubated (placed on mechanical ventilation). One patient was not intubated because of poor baseline pulmonary status (history of lung cancer and had undergone bilateral upper lobectomy). Seven patients were organ-transplant recipients (six patients were renal-transplant recipients and one patient had a history of heart transplant) and were on immunosuppressive regimen. Ten patients were on dialysis and nine were on vasopressors during hospitalization. Despite their pre-existing and severe conditions, we believe we were able to save the lives of four patients. All patient blood samples were evaluated and important powerful results from the effect of leronlimab were demonstrated in almost all of these patients. This data has been submitted to a prestigious journal and we expect the publication on Friday, May 1.
Twenty-three (23) patients in Southern California hospital: Six patients were in critical condition (intubated) and 17 patients were severely-ill, needing oxygen support. No death was reported. Out of 6 critical patients, all were intubated patients, 3 were extubated (taken off ventilator), 2 patients remain relatively stable and still breathing with the assistance of a ventilator and one patient has shown deterioration in respiratory parameters. Of 17 severe condition (but not critical) patients, 11 patients demonstrated improvement in respiratory parameters (8 of them were discharged from hospital, including one patient in the news, Samantha Mottet), 2 patients remain relatively stable, 2 have shown deterioration in respiratory parameters and information is pending for 2 recently treated patients.
Three (3) patients in Georgia hospital: All three ICU patients were intubated and two of them had renal failure at the start of leronlimab treatment. Of these 3 patients, 2 were extubated (taken off ventilator) and 1 patient remains on a ventilator but improving.
One (1) patient in another NY hospital: Patient was taken off oxygen and discharged from hospital after leronlimab treatment.
One (1) patient in Northern California hospital: Patient is now weaning from ventilator and transferred to rehabilitation hospital.
Updates are pending for 10 other patients. Five additional patients have been approved to receive leronlimab under eINDs, which increases the total eINDs approved by the FDA to 54 patients.
Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostics company and an advisor to CytoDyn, expanded on these findings by stating, “We are excited that patients are responding extremely well to leronlimab as expected from the novel mechanism of COVID-19 pathogenesis we discovered and will be reporting in the coming days.”
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, “We believe these results, although anecdotal, are very impressive and the number of patients treated under eIND is rapidly increasing. The enrollment for our Phase 2 double-blind and Phase 2b/3 trials is moving along rapidly and we believe the results from both studies will be very powerful due to the mechanism of action (MOA) of affecting the viral load and restoring the immune system. With our first major paper very close to publication, we expect to have a second paper published shortly thereafter, as our MOA is as unique as our results.”
About Coronavirus Disease 2019
CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.
_____________________
Please note that my friend is also a friend of Seeking Alfa and we are both ecstatic that we have moved this forward. We, however, wish it would have been approved when he was on oxygen.
I hope no one will have to be in the same situation but hopefully you can use the above to help you seek the use of leronlimab with your doctors.
Thanks to all again for the good wishes that you have sent.
Happy Memorial Day.
11
