by Daniel Moskowitz
A TREEment Grows in the Bronx
“Dr. Harish Seethramraju is a hero!” “Hero”… a word justifiably ascribed to the essential workers upon whose backs the rest of society have coped with the COVID-19 Pandemic. But Dr. Seethramraju, an organ transplant specialist at Montefiore Hospital, together with his colleagues at Albert Einstein College of Medicine, may well have earned the title “Super Hero”. Why?” Read on.
COVID-19 has ravaged the world’s population and economy, taking particular aim at NYC. As of June 12, the CDC has reported for Bronx County alone- 46,316 cases and 3269 deaths. Confronted by the virus’ deadly outcome for his kidney and liver transplant patients tethered to ventilators, Dr. Seethramraju advocated with the FDA for “compassionate use” to treat his patients with an experimental investigational new drug called Leronlimab, developed by CytoDyn, Inc.
CytoDyn is a biotechnology company based in Vancouver, Washington that has been conducting trials for Leronlimab’s treatment for HIV, and more recently, a deadly form of breast cancer-triple negative metastatic, and other diseases. Dr. Bruce K. Patterson, a clinical research scientist at CytoDyn, theorized early on in the migration of COVID-19 to the United States, that the virus followed the same pathway into healthy human cells as HIV and Cancer. That receptor pathway has been identified as CCR5 which needed to be blocked. Leronlimab has proven to be a CCR5 inhibitor.
Dr. Seethramraju researched Leronlimab early on in the Pandemic and realized its therapeutic potential. Theory is one thing. Practical administration of Leronlimab on severely ill COVID-19 patients is another matter. As Dr. Seethramraju explained “such patients all too often seem to be recovering, but then crash and burn when their lungs are overwhelmed by an inflammatory reaction that makes breathing impossible. The FDA is concerned that there is no treatment for these people.”
From a safety perspective, Leronlimab had proved to have minimal, if any, side effects in over 800 patients that participated in CytoDyn’s HIV trials. But no other doctor in the country had tried Leronlimab to treat the virus. In mid-March 10 terminally ill COVID-19 patients were presented with a life or death choice by Dr. Seethramraju. Following treatment with Leronlimab, Dr. Seethramraju and Dr. Patterson observed rapid reduction in the cytokine inflammation storm in the patients. Of the 10 terminally ill patients, 5 survived.
News of Leronlimab’s candidacy for COVID-19 treatment has spread within the medical community both at home and abroad. Dr. Otto Yang, an infectious disease expert at the at UCLA, reported that 23 patients were injected with Leronlimab. Six were in critical condition, intubated on ventilators, 17 were severely ill requiring oxygen support. Of the 6 critical patients, three were extubated off ventilators, 2 patients remained relatively stable and still breathing and 1 patient had shown deterioration in respiratory parameters. Of the 17 severe cases, 11 patients demonstrated lung improvement, 8 were discharged from the hospital, 2 have shown lung deterioration. Information is pending for 2 recently treated patients. No deaths have been reported.
At Emory Hospital in Atlanta, Dr. Khush Dody and Dr. Nicholas Agresti reported that three intubated patients were treated successfully with injections of Leronlimab. Mexico’s National Institute of Public Health is evaluating the drug. But can Leronlimab travel the road from Anecdote to Antidote?
Encouraged by Leronlimab’s efficacy, Dr. Seethramraju and his colleagues at Montefiore and Albert Einstein, in collaboration with CytoDyn and other medical researchers such as Dr.Dhody and Dr.Yang received approval from the FDA to conduct a Phase 2 double blinded trial of Leronlimab for mild to moderate symptoms of COVID-19 with an enrollment target of 75 patients, and a Phase 2b/3 trial for severely ill COVID-19 with an enrollment target of 390 patients.
On June 11, Dr. Nader Pourhassan (Ph.D.) President and CEO of CytoDyn announced that the 75 patient enrollment goal in the double blinded Phase 2 study for mild-moderate cases has been met. The Company expects the evaluation clinical patient data to be available two weeks after the last patient is enrolled. Because there are more patients who have been screened for enrollment, final enrollment is expected to exceed 75. Dr. Pourhassan, commented, “Based upon our understanding of clinical outcomes from severe and critically ill COVID-19 patients, we are guardedly optimistic about the potential results from the mild-to-moderate patients. Furthermore, CytoDyn will do an interim analysis of patient data in the Phase 3 trial for severe and critically ill COVID-19 patients and we hope to have these important results in 2 to 3 weeks.”
It was Dr. Pourhassen who first described Dr. Seemrathraju as a “hero.” If the medical evidence from these trials prove that Leronlimab is a safe and effective treatment for COVID-19, then the superlative of “Saviors” will best describe Dr. Seemrathraju along with the Bronx based team of physicians and clinical scientists at Montefiore/Albert Einstein, and Dr. Patterson of CytoDyn.
A TREEment Grows in the Bronx
“Dr. Harish Seethramraju is a hero!” “Hero”… a word justifiably ascribed to the essential workers upon whose backs the rest of society have coped with the COVID-19 Pandemic. But Dr. Seethramraju, an organ transplant specialist at Montefiore Hospital, together with his colleagues at Albert Einstein College of Medicine, may well have earned the title “Super Hero”. Why?” Read on.
COVID-19 has ravaged the world’s population and economy, taking particular aim at NYC. As of June 12, the CDC has reported for Bronx County alone- 46,316 cases and 3269 deaths. Confronted by the virus’ deadly outcome for his kidney and liver transplant patients tethered to ventilators, Dr. Seethramraju advocated with the FDA for “compassionate use” to treat his patients with an experimental investigational new drug called Leronlimab, developed by CytoDyn, Inc.
CytoDyn is a biotechnology company based in Vancouver, Washington that has been conducting trials for Leronlimab’s treatment for HIV, and more recently, a deadly form of breast cancer-triple negative metastatic, and other diseases. Dr. Bruce K. Patterson, a clinical research scientist at CytoDyn, theorized early on in the migration of COVID-19 to the United States, that the virus followed the same pathway into healthy human cells as HIV and Cancer. That receptor pathway has been identified as CCR5 which needed to be blocked. Leronlimab has proven to be a CCR5 inhibitor.
Dr. Seethramraju researched Leronlimab early on in the Pandemic and realized its therapeutic potential. Theory is one thing. Practical administration of Leronlimab on severely ill COVID-19 patients is another matter. As Dr. Seethramraju explained “such patients all too often seem to be recovering, but then crash and burn when their lungs are overwhelmed by an inflammatory reaction that makes breathing impossible. The FDA is concerned that there is no treatment for these people.”
From a safety perspective, Leronlimab had proved to have minimal, if any, side effects in over 800 patients that participated in CytoDyn’s HIV trials. But no other doctor in the country had tried Leronlimab to treat the virus. In mid-March 10 terminally ill COVID-19 patients were presented with a life or death choice by Dr. Seethramraju. Following treatment with Leronlimab, Dr. Seethramraju and Dr. Patterson observed rapid reduction in the cytokine inflammation storm in the patients. Of the 10 terminally ill patients, 5 survived.
News of Leronlimab’s candidacy for COVID-19 treatment has spread within the medical community both at home and abroad. Dr. Otto Yang, an infectious disease expert at the at UCLA, reported that 23 patients were injected with Leronlimab. Six were in critical condition, intubated on ventilators, 17 were severely ill requiring oxygen support. Of the 6 critical patients, three were extubated off ventilators, 2 patients remained relatively stable and still breathing and 1 patient had shown deterioration in respiratory parameters. Of the 17 severe cases, 11 patients demonstrated lung improvement, 8 were discharged from the hospital, 2 have shown lung deterioration. Information is pending for 2 recently treated patients. No deaths have been reported.
At Emory Hospital in Atlanta, Dr. Khush Dody and Dr. Nicholas Agresti reported that three intubated patients were treated successfully with injections of Leronlimab. Mexico’s National Institute of Public Health is evaluating the drug. But can Leronlimab travel the road from Anecdote to Antidote?
Encouraged by Leronlimab’s efficacy, Dr. Seethramraju and his colleagues at Montefiore and Albert Einstein, in collaboration with CytoDyn and other medical researchers such as Dr.Dhody and Dr.Yang received approval from the FDA to conduct a Phase 2 double blinded trial of Leronlimab for mild to moderate symptoms of COVID-19 with an enrollment target of 75 patients, and a Phase 2b/3 trial for severely ill COVID-19 with an enrollment target of 390 patients.
On June 11, Dr. Nader Pourhassan (Ph.D.) President and CEO of CytoDyn announced that the 75 patient enrollment goal in the double blinded Phase 2 study for mild-moderate cases has been met. The Company expects the evaluation clinical patient data to be available two weeks after the last patient is enrolled. Because there are more patients who have been screened for enrollment, final enrollment is expected to exceed 75. Dr. Pourhassan, commented, “Based upon our understanding of clinical outcomes from severe and critically ill COVID-19 patients, we are guardedly optimistic about the potential results from the mild-to-moderate patients. Furthermore, CytoDyn will do an interim analysis of patient data in the Phase 3 trial for severe and critically ill COVID-19 patients and we hope to have these important results in 2 to 3 weeks.”
It was Dr. Pourhassen who first described Dr. Seemrathraju as a “hero.” If the medical evidence from these trials prove that Leronlimab is a safe and effective treatment for COVID-19, then the superlative of “Saviors” will best describe Dr. Seemrathraju along with the Bronx based team of physicians and clinical scientists at Montefiore/Albert Einstein, and Dr. Patterson of CytoDyn.
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