Cytodyn Inc (CYDY)

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From: Bruce Patterson <[e-mail]>
Date: Wed, Mar 17, 2021 at 12:19 PM
Subject: Letter of Support
To: <[e-mail]>, <[e-mail]>, <[e-mail]>, <[e-mail]>


Dear Esteemed Colleagues,



First of all, thank you for your tireless work under the most daunting circumstances. I am not one to write letters as I would rather have my work speak for itself. Like many, I started my research career in HIV and in fact collaborated by Dr. Fauci and Tae-Wook Chun in the mid-nineties. I say this because of the many similarities politically and scientifically between the two pandemics. Interestingly, I worked on a project in 1994-1995 that has relevance to this letter. I received 7 samples to perform intracellular viral replication studies in HIV-1 patient with CD4 counts less than 25. I mentioned to the PI David Ho that there weren’t enough CD4 cells to even analyze. There were no controls because these patients were about to die. That 1995 paper on 7 patients published in Nature on protease inhibitors and how they dramatically reduced plasma viral load and increased CD4 count changed. This study of only 7 patients changed the course of HIV therapy to this day. I had déjà vu when leronlimab, a CCR5 antagonist, decreased IL-6 by orders of magnitude, increased CD8% (which was dangerously reduced in these patients), and decreased plasma viral in 11 patients close to death. Though trial design, changing SOC, and statistical power were obstacles, the double blind, placebo controlled data were quite compelling.

1) When leronlimab was used in additional to “commonly used COVID-19 treatments” a clear benefit was seen in the primary endpoint of all-cause mortality at day 28 with an absolute risk reduction of death of 6.5% with a relative risk reduction of death of 28.1% (N = 309, p = .0319).

2) When leronlimab was used in combination with dexamethasone, a clear benefit was seen in the primary endpoint of all-cause mortality at day 28 with an absolute risk reduction of death of 5.7% with a relative risk reduction of 26.2% (N=233, p=.055)

3) The mean length in hospital stay was decreased by 5.5 days in the critically ill population (p = .005)

4) Mortality status at day 28 when leronlimab was used in addition to “commonly used COVID-19 treatments” in the critically ill population with an age < 65 showed a clear mortality benefit with an absolute risk reduction of death of 20.9% with a relative risk reduction of death of 73% (N=40, p=.03)

5) Mortality status at day 28 when leronlimab was used in addition to dexamethasone in the critically ill population showed a clear mortality benefit with an absolute risk reduction of death of 6.5% and a relative risk reduction of death of 23.5% (N=35, p=.04)

6) Length of hospital stay in critically ill patients < 65-years-old showed a clear benefit with a reduction of 6.8 days (N=44, p=.006)



I know you have been inundated by a very vociferous crowd of leronlimab supporters but it is because of the miraculous stories from last Spring. I took care of a woman (letter attached) who was on ECMO for 30 days who failed hydroxychloroquine, failed remdesivir and was given her last rights. She was given leronlimab through an EIND and her immunologic markers improved in 3 days and she was off ECMO in 5 days later to be discharged. People like to call these anecdotes but in pathology the best control is an internal negative control. She served as her own control having been given the SOC at the time and off all other therapies before the administration of leronlimab.

Given the documented safety record of leronlimab and the “do no harm” oath we physicians swear to, this drug should be given a chance (my opinion only) through an EUA not a full approval. I am not involved with Cytodyn as I am busy with our long hauler program but as a physician/scientist from the early days of HIV and as a physician who witnessed intimately the efficacy of this drug in COVID I would like to see this immune modulator help as we face new variants that ultimately will affect virus-specific therapies. I am happy to discuss any time.



Sincerely and with gratitude,



Bruce





Bruce K. Patterson, MD

CEO and Founder,

IncellDx, Inc

1541 Industrial Road
San Carlos, CA 94070
Tel: [phone]
Fax: [phone]
www.incelldx.com

Dear Bruce,
It has been a VERY REAL, very long journey for our family, and it continues to be a long road as we navigate our family’s pain and loss but celebrate our blessings.
I want to personally write because amidst our country’s two pandemics: Covid-19 and systemic racism, one way I could help towards this fight is to bring awareness and share how real my experience is.
You have been respectful in keeping my situation confidential and of our family’s privacy and we had been hesitant to share our story and experience with Covid 19 because not long ago, there was still uncertainty with my Mom’s recovery, even after my Mom’s discharge from ICU to an LTAC (long term-acute care facility) for rehabilitation. However, because of the rising numbers in COVID cases and no assurance of any vaccine or cure; now that my Mother is home, regaining her strength and ALIVE, we feel compelled to share, along with our vigilant prayers, what I believe saved our Mom’s life.
Leronlimab Saved my Mom’s Life
It was late February 2020 when our parents started feeling flu like symptoms, cold chills, a fever, dry cough and a sharp pinning headache. Their symptoms were not unusual to flu like symptoms. Day 4 into their fever and symptoms they went to see a doctor, but the doctor assured us there was nothing concerning and advised them to hydrate and rest. Although we had expressed our concern given the worldwide news about the Corona Virus spread, still no tests were conducted. They did not fit the criteria to be tested and had not traveled internationally nor were they in close contact with anyone we knew who had traveled internationally. Another 3 days passed, and symptoms did not improve. My mother’s fever was now at 103. Worried, we took them to urgent care and now, flu tests and chest x-rays were conducted. Dad was sent home with a course of 7 day antibiotics and Mom was admitted immediately into the hospital for bilateral pneumonia. Her respiratory rate declined rapidly and within a week, she was put into an induced coma and intubated to preserve her lung function- the medical professionals said this was CDC protocol.

On March 9th our mom was transferred to another hospital in hopes to access the ECMO machine as a last measure to try and save my mom’s life. (ECMO- Extracorporeal membrane oxygenation, also known as extracorporeal life support. A technique of providing prolonged cardiac and respiratory support to persons whose heart and lungs are unable to provide an adequate amount of gas exchange or perfusion to sustain life). Doctor’s prepared us for the worse. She was also the sickest COVID patient in their hospital. Her health was declining quickly, and they were doing every aggressive life saving measure. She was on 100% ECMO support, receiving a number of drugs to keep her “stable” and was also given Remsedivir (a drug that is being commonly tested to treat covid).

On top of this adversity, our Dad also battling this virus, had symptoms that worsened- fevers persisted, and now had difficulty breathing. We drove him to the emergency room, different from the hospital our Mom was being treated in hopes that another hospital might be able to save his life since our mom had a grim prognosis. That same night, only 2 hours of examinations and tests, our Dad was also put in an induced coma and intubated. BOTH parents were now in ICU and fighting for their lives.

A number of drugs were provided to our parents along with investigational drugs, in hopes to save them. NOTHING was working. At this point, both parents had grave prognosis’ and we were granted 1 visit for each as they offer families at this time for “end of life” patients. Our family prayed for a miracle.
We were fortunate to have been introduced to you, Dr. Bruce Patterson and learn that Dr. Patterson and his team were working on a treatment and vaccine for Covid19. The drug is called Leronlimab – it had been in its testing phase to treat other conditions like HIV and breast cancer but had positive outcomes in those conditions. We consulted both hospital teams, begged them to give our parents this drug. This drug was our families last hope. Doctors where our mother was hospitalized agreed to give Leronlimab under the FDA’s eIND program (Emergency Investigational New Drug). Doctors where our father was hospitalized at, deliberated over the use of the investigational drug but refused the use of it even against our last wishes for him. Our dear father passed on March 21, 2020.

Our mom was on day 31 in the ICU and going on 23 days on the ECMO machine. We knew there were no guarantees, but we had heard about the positive results of the drug Leronlimab to 15 other patients in NYC. On just day 3 after giving our mom Leronlimab, there were significant improvements to our mom’s condition. There were no negative side effects. On day 6, she was taken OFF support of the ECMO machine. She was given another dose of Leronlimab on day 7 and again, the drug proved to strengthen her condition and oxygen levels. Day after day she was getting better and better and was requiring less and less ventilator support. There were small improvements, but she was headed in the right direction. Doctors continuously shared positive news. On April 20th our mom was given a trachea (A tracheostomy is a medical procedure-either temporary or permanent- that involves creating an opening in the neck in order to place a tube into a person's windpipe. The tube is inserted through a cut in the neck, allowing air to enter the lungs) as the next step to her recovery. Sedations were eventually turned down and it was the first time our mom smiled after hearing our voices through FaceTime. We knew she was still in there, fighting to return to us.

May 1st our mom was transferred out of ICU to an (LTAC- long term care facility) rehabilitation center- to start rebuilding her strength back. There she was weaned off the ventilator, learned how to swallow, drink and eat again, walk again, a lot of the basic movements she was once so independent and doing. With still a lot of uncertainty every day she had shown progress. Doctors had expressed how miraculous it is and how far she has come along after being intubated for 2 months. Doctors were optimistic that with the support of therapies she would soon come off the ventilator.

There are so many unknowns to this virus, but one thing is for sure, had it not been for this miracle drug Leronlimab and the doctors who were open to consider this new drug, my mother would not be here with us today.

It is now July 1st and our mom is ALIVE, at home, without a tube feed, without a ventilator or trach.

We are thankful for everyone who stood by us and supported us.
We are thankful, because this miracle drug gave my mom life again. Our hope is this drug- Leronlimab will somehow reach others and SAVE lives.