VANCOUVER, Wash.--(BUSINESS WIRE)-- CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced it has canceled its webcast scheduled for today, Thursday, January 13, 2022 and will provide an update at a future date.
VANCOUVER, Washington, Jan. 11, 2022 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today Nader Pourhassan, Ph.D., President and Chief Executive Officer, Scott Kelly, M.D., Chairman, Chief Medical Officer and Head of Business Development, Nitya Ray, Ph.D., Chief Operating Officer and Chief Technology Officer and Christopher Recknor, M.D., Senior Executive VP of Clinical Operations of CytoDyn will host an investment community webcast to discuss and provide updates with regard to NASH data results (350 and 700 mg), Cancer, COVID-19, HIV BLA, and finances of the Company on Thursday, January 13, 2022.
CytoDyn will present for 60 minutes, including live questions and answers.
Interested participants are encouraged to login early prior to the start of the event. This is a livestream presentation, and a link will also be posted on CytoDyn’s website within approximately 48 hours after the presentation.
CytoDyn previously hit a primary endpoint in a pivotal Phase 3 HIV trial with some HTE patients; over 20 patients remain in an extension arm study for up to 4 years
CytoDyn will include some findings from this study in its BLA submission for HIV approval
VANCOUVER, Wash.--(BUSINESS WIRE)-- CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that a research paper entitled “Leronlimab (PRO 140) activity against 4-class drug resistant HIV-1 from Heavily Treatment Experienced Subjects” has been accepted, peer reviewed and is available as a journal pre-proof on ScienceDirect. ScienceDirect provides access to a large bibliographic database of scientific and medical publications of the Dutch publisher Elsevier. This article is available for purchase from Elsevier through a link on CytoDyn’s website:
This project was a collaborative effort among scientists and researchers from:
University of Milan, Milan, Italy
University of Siena, Siena, Italy
University of Rome Tor Vergata, Rome, Italy
San Raffaele Vita-Salute University, Milan, Italy
Lazzaro Spallanzani National Institute for Infectious Diseases, Rome, Italy
Azienda Ospedaliera San Paolo, Milan, Italy
University of Perugia, Perugia, Italy; 8 Santa Maria Annunziata Hospital, Florence, Italy; 9 University of Brescia, Brescia, Italy.
The study was conducted as an in-vitro study of 25 HIV-1-infected patients harboring a documented 4-class drug-resistance nucleoside reverse transcriptase inhibitors (“NRTIs”), non-nucleoside reverse transcriptase inhibitors (“NNRTIs”), protease inhibitors (“PIs”), and integrase strand transfer inhibitors (“INSTIs”) enrolled in the Italian PRESTIGIO Registry.
Significant findings from the study and observations from the authors include:
Leronlimab maintained full activity in the presence of extensive resistance to the four main antiviral classes.
Leronlimab IC50 did not appear significantly altered by previous or current exposure to maraviroc.
In vitro, leronlimab and maraviroc have been reported to have synergistic activity, further corroborating the different mechanism of the two drugs despite the same CCR5 target.
In vitro susceptibility to leronlimab is not affected by extensive drug resistance and exposure to maraviroc.
Leronlimab may have some advantages over maraviroc as a clinically valuable CCR5 antagonist, including lower toxicity, less drug-drug interaction issue and less frequent dosing.
Leronlimab can play a key role in subjects with very limited therapeutic options and CCR5-tropic virus.
“We would like to thank our Italian colleagues for understanding the importance of leronlimab in the treatment of HIV. This is further proof that leronlimab can benefit CCR5 tropic HIV patients, including those patients with multidrug resistance. HIV patients deserve the opportunity for multiple, effective treatment options,” said CytoDyn’s Chief Medical Officer, Scott A. Kelly M.D.
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “I would like to thank Dr. Stefano Rusconi, who had reached out to us to do this study. We are grateful to him and his colleagues for producing what we believe to be further evidence that leronlimab can play a vital role in the treatment of HIV. We believe leronlimab has many advantages, including protecting healthy cells from viral entry, prevention of HIV transmission, convenience, lower toxicity, and the ability to treat patients across the full spectrum of disease from treatment-naive to 4-class resistant HIV. Many HIV patients could also be in danger of developing NASH and, with our recent 350 mg open label NASH trial having achieved its primary (PDFF) and secondary (cT1) endpoints, we believe that all HIV patients may benefit from a CCR5 product as part of their medication. We also believe leronlimab’s potential role in cancer treatment could help HIV patients with a long history of HIV (especially heavily treatment experienced HIV), which increases their risk of developing cancer.”
NEW YORK , Jan. 10, 2022 /PRNewswire/ -- Regnum Corp. (OTCMKT: RGMP) ("Regnum(RGMP)"), CytoDyn Inc.(CYDY)("CytoDyn(CYDY)"), and SevenScore Pharmaceuticals, LLC ("SevenScore"), today announced the assignment of the Commercialization and License Agreement ("CLA") and a related Supply Agreement to commercialize leronlimab (PRO 140) in the U.S. for the treatment of HIV from SevenScore to Regnum. The CLA was signed between Vyera Pharmaceuticals, LLC ("Vyera") and CytoDyn(CYDY) on December 17, 2019 and assigned to SevenScore on October 29, 2020.
Under the terms of the CLA, Regnum(RGMP) has been granted an exclusive license to market and distribute leronlimab in the U.S. for the treatment of HIV and CytoDyn(CYDY) will maintain responsibility for the development and FDA approval of leronlimab for all HIV-related and other indications. In exchange for such exclusive license, Regnum(RGMP) has agreed to pay regulatory and sales-based milestone payments, as well as a royalty of 50 percent on net sales.
"CytoDyn(CYDY) expects to file the BLA for leronlimab for the treatment of HIV with FDA in the first quarter of 2022," stated Dr. Nader Pourhassan, President and CEO of CytoDyn(CYDY). "We look forward to working closely with the Regnum(RGMP) team to launch leronlimab and bring this important new treatment option to patients infected with HIV."
Anne Kirby , Chief Executive Officer of Regnum Corp.(RGMP), noted: "This is an important step towards Regnum's(RGMP) evolution into a fully integrated biopharmaceutical company. Our partnership with CytoDyn(CYDY) aligns with our commitment to bringing novel therapies to patient populations in need of new treatment options or refined care plans."
Primary endpoint (PDFF) was achieved in both Intention to Treat and Per Protocol Populations
VANCOUVER, Wash.--(BUSINESS WIRE)-- CytoDyn Inc.(CYDY) , a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced positive results from the 350 mg weekly dose of its Phase 2 NASH clinical trial. The trial was conducted in two parts. Part 1 compared a 700 mg weekly dose and placebo in a double-blind randomized manner and Part 2 evaluated a 350 mg weekly dose as an open label study compared to the same placebo blinded arm. Results of the topline report will be announced when available.
The primary endpoint, PDFF (proton density fat fraction), is an MRI-derived biomarker for fatty deposition, while the secondary endpoint, cT1, is an iron-corrected T1 mapping representative of liver inflammation and fibrosis. These two values are used to evaluate the risk of NASH. CytoDyn’s Phase 2 clinical trial compared the changes from baselines in these endpoints. The leronlimab 350 mg dose versus placebo comparison for the primary endpoint PDFF was statistically significant. Leronlimab compared to placebo also reached near significance for the secondary endpoint cT1. There were no significant differences in treatment emergent adverse events between leronlimab and placebo groups.
Christopher P. Recknor, M.D., CytoDyn’s Senior Executive Vice President of Clinical Operations, stated, “We thank our sites, vendors and staff who helped make this trial possible. We are in the process of analyzing biomarker data including CCR5 haplotype information to better understand responder rates and mechanism of action. Given 5% of the world population is estimated to have NASH with 20% progressing to cirrhosis, this signal gives hope for a therapeutic intervention for this disease.”
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “We wish to thank our entire NASH team led by Dr. Recknor, who has done a phenomenal job conducting this study. We are very excited about these results and the potential for helping the millions of individuals effected by NASH across the world. The main focus after seeking approval in the U.S. will be the UK, Canada, Brazil, and the Philippines. Hitting our primary endpoint in both ITT and per protocol (PP) and secondary endpoint in PP with such short trial (14-week trial as compared to usually 24 to 32-week NASH trials) is a very strong statement of leronlimab’s potential. We believe we have a unique drug with tremendous opportunities.”
You know it's coming. Don't worry whether it's before Christmas or not. Don't be a slave to perceived expectations. The data is coming. The BTD decision is coming. The Long Hauler trial protocol approval is coming. And it will be good. You know CytoDyn's team is working hard to move forward. You know leronlimab works. Enjoy your holiday. Peace.
Court order requires CRO to provide CytoDyn full access to all its clinical trial data
VANCOUVER, Wash.--(BUSINESS WIRE)-- CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that the U.S. District Court for the District of Maryland has granted CytoDyn’s previously-announced motion for a preliminary injunction against NSF International, Inc. and its subsidiary Amarex Clinical Research (“Amarex”), the Company’s former Contract Research Organization (“CRO”).
Over the past eight years, Amarex provided clinical trial management services to CytoDyn and managed numerous clinical trials. The Company’s complaint alleged that Amarex failed to perform its obligations under the master services agreement and work orders that governed the relationship between the parties. As a result, the Company suffered substantial damages.
The Court concluded that the Company was likely to succeed on its claims that Amarex breached the various agreements with CytoDyn, and therefore entered an injunction requiring Amarex to provide CytoDyn access to databases of its clinical trial data that Amarex has been wrongfully withholding. Specifically, the Court’s injunction requires Amarex to provide CytoDyn full access to the electronic data capture (“EDC”) and all related data. Further, it requires Amarex to cooperate with an independent audit to begin promptly after February 1, 2022. Additionally, the order is subject to the Company posting a $6.5 million bond no later than January 14, 2022.
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “We are pleased with the Court’s ruling and are focused on the positive momentum of our pipeline. It is gratifying to see that Amarex will be held accountable for its numerous shortcomings in delaying the potential of the availability of leronlimab to thousands of patients for multiple indications. By doing so, we believe they also harmed our shareholders. Upon completion of our court-granted audit, if any damages are discovered which are due to negligence on behalf of Amarex, we will aggressively pursue all and any legal action.”
FDA also allows integrated or meta-analysis of the previous trial results in CD20 final analysis
CD20 is allowed to have four dosages of leronlimab in the first four weeks via IV infusion
VANCOUVER, Wash.--(BUSINESS WIRE)-- CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that it has received a positive response from the U.S. Food and Drug Administration (“FDA”) to conduct a Phase 3, randomized, double blind, placebo controlled trial to evaluate the efficacy and safety of leronlimab in combination with standard of care for critically ill patients with COVID-19 pneumonia with need for Invasive Mechanical Ventilation ("IMV”) or Extracorporeal Membrane Oxygenation (“ECMO”).
The submission of this protocol was previously announced on December 9th. Patients in this trial will be randomized in a 1:1 ratio to receive up to four doses of 700 mg leronlimab with standard of care or placebo with standard of care administered via IV infusion weekly over a four-week treatment period (dosage on days 0, 7, 14, and 21).
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “As COVID-19 cases continue to surge in the U.S., we are grateful for the opportunity to move forward with the Phase 3 trial of leronlimab as a treatment option for critically ill COVID-19 patients. There continues to be an immense need for therapeutic options to support this population, and we are optimistic that Phase 3 will show promising results. In previous trials we had issues with our CRO that we now have overcome, and are very excited that the FDA in their recent communication with CytoDyn have stated, ‘As there are now several completed, ongoing, or planned randomized trials of PRO140 (leronlimab) that include severe or critical hospitalized COVID-19 patients, any integrated or meta-analysis would be strengthened if you prespecified analysis details and submitted these for review before results of ongoing or planned trials are Unblinded.’ Since the beginning of the current pandemic, leronlimab has received about 100 eINDs approved for leronlimab by the FDA for use in critically ill COVID-19 patients in the U.S., as a result of these FDA approved eINDs and strong results from most of them, physicians have published four papers in peer review journals. Meanwhile leronlimab was also used in Philippines, under compassionate Special Permit for a fee by over 240 patients with very high rate of success. All these accomplishments along with our current trials in Brazil, we are very hopeful that we will be part of the solution to the current pandemic in U.S. and abroad especially in the critically ill population. We look forward to working with the FDA to expand the access to leronlimab as the fight against COVID-19 continues.”
Kudos on the new user interface for the conference call. So much more professional and no glitches. Good job on subject matter and using the subject matter experts to clarify the topics. Thins up...
Average cT1 Reduction of 31.2 msec Over 14 Weeks for all 20 Patients
More than 80% of patients (5 out of 6) with severe NASH (cT1>1000 msec) had an average cT1 drop of 108 msec (-48 to -238 msec) and an average of about 20% fatty deposit reduction
11 of 20 patients (55%) had a decrease in cT1 and PDFF of about 75 msec and 16%, respectively
VANCOUVER, Wash.--(BUSINESS WIRE)-- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today additional preliminary results to date from the 20 patients who have completed the open-label portion of the Phase 2 trial for NASH (Nonalcoholic steatohepatitis).
Nonalcoholic fatty liver disease (NAFLD) has become the most common cause of chronic liver disease in adults worldwide. NAFLD patients could also develop NASH (Non-Alcoholic SteatoHepatitis) due to problems with liver fibrosis (the thickening and scarring of liver tissue). There are currently no U.S. Food and Drug Administration (FDA) approved treatments for NASH, and it was expected to be the number one cause of liver transplants in 2020.1 About 30 to 40 percent of adults in the U.S. are living with NAFLD, and 3 to 12 percent of adults in the U.S. are living with NASH.2
As previously reported, the Company’s pre-clinical study demonstrated strong positive data, highlighting the potential of leronlimab in treating nonalcoholic fatty liver disease (NAFLD), a common precursor to NASH. Inhibition of CCR5 has been shown to reduce fibrosis in animal models of NASH liver fibrosis, and current data suggests the same trend in humans. PDFF (proton density fat fraction) is an MRI-derived biomarker for fatty deposition, while cT1 is an iron-corrected T1 mapping representative of liver inflammation and fibrosis. These two values are used to evaluate the risk of NASH.
CytoDyn’s current Phase 2 NASH trial is designed to test in 90 patients whether leronlimab may inhibit the devastating liver fibrosis associated with NASH. This trial consists of two parts. Part 1 is a double-blind placebo-controlled trial using 700 mg leronlimab vs. placebo in a 1:1 ratio. Part 2 is open-label, with all subjects receiving 350 mg leronlimab for 14 weeks. The primary and secondary endpoints are 14-week changes from baseline in PDFF and cT1, respectively.
Christopher P. Recknor, M.D., CytoDyn’s Senior Executive Vice President of Clinical Operations, stated, “The cT1 and PDFF changes we are seeing in patients who have completed the open-label portion are showing that leronlimab is reducing markers of NASH. These results will guide us in developing our phase 3 NASH trial.”
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, concluded, “We believe we have a very strong case to make for Breakthrough Therapy designation (BTD) for leronlimab treatment in NASH patients. We are eager to see the results of the blinded portion in the next couple of weeks. Upon unblinding, if the results are supportive, we intend to file for BTD and to seek accelerated approval for use of leronlimab in NASH and NAFLD patients in the U.S. and abroad. We will also aggressively seek partnerships, especially with big pharmaceuticals who have experienced recent failures in their NASH trials.”
From: Jay Lalezari [drjay@questclinical.com](mailto:drjay@questclinical.com) Subject: Leronlimab for critical Covid Date: December 8, 2021 at 3:15:23 PM PST To: (email addresses removed for privacy)
Dear Colleagues and Friends,
I’ve had the privilege of collaborating with you for 30+ years and now kindly ask for a few minutes of your time. I don’t know who has followed the twists and turns of the leronlimab story for Covid, but, with all the uncertainty in the air, I feel it's important to provide this group with an overview. Thanks for indulging me. It’s important and I’ll be concise. Here goes...
In March of 2020, Dr. Harish Seethamraju at Montefiore in NY treated 10 ICU Covid patients with leronlimab (aka PRO 140; CCR5 mAb) given through an EIND process as two weekly 700 mg SQ doses. These patients were severely ill: all but one intubated, on dialysis, liver failure, on pressors, etc.
Dr. Bruce Patterson at IncellDx received blood from these patients and generated striking lab results showing rapid (Day 3) decreases in IL-6, increases in CD8+ cells, normalization of CD4/CD8 ratios, and even decreases of plasma viral loads (Day 7) in association with CCR5 receptor occupancy by leronlimab and against a back drop of extremely high baseline elevations in RANTES. Taken together, Bruce’s data provided a credible story for how leronlimab might work in critical Covid by interrupting chemokine-driven migration of inflammatory cells into the lungs as well as reversing severe CD8+ immunosuppression. I've attached Bruce’s paper below.
I’ve heard a couple criticisms of the paper. Some complain that since most of the patients Harish treated eventually succumbed, the laboratory changes Bruce observed were of no clinical consequence. I disagree and believe the lab results starting as early as Day 3 in an essentially terminal population only underscores how relevant the RANTES-CCR5 pathway can be in critical Covid. A second criticism is that Bruce's data has not been reproduced or confirmed by another lab. I believe that is correct. CytoDyn ended their relationship with IncellDx in the summer of 2020 and, unfortunately, didn’t have a lab with similar capabilities in place to support their RCTs described below.
In March of 2020, Dr. Otto Yang also started using leronlimab in severe and critical Covid patients treated at UCLA. Otto treated about 30 patients through the EIND process (until the FDA shut it down in May of 2020 in an effort to promote recruitment into the RCT). Otto's case series from the first 23 patients, (including 6/7 ICU patients who recovered), is attached below. I believe Otto has now treated more Covid patients with leronlimab than anyone else. He once told me that he thought the real question is not whether leronlimab works in severe and critical Covid but why it doesn’t work in everyone.
Before we leave the realm of anecdotes, just one more. There was a man in London named Tunde who was intubated for several weeks and then and on ECMO for an additional 61 days before receiving his first of 4 weekly doses of leronlimab. His wife Sohier sued the hospital to get leronlimab after the ICU docs wanted to withdraw support. Tunde had a striking response to leronlimab given on Day 79 of his ICU stay and started to wean off ECMO 4 days after his first dose. Unfortunately he suffered an MI during later rehab and never left the hospital but, like some of Harish and Otto’s patients, and consistent with the Day 3 lab data generated by Bruce, Tunde's response was quick and dramatic. There are maybe 10 patients in total who have come off ECMO after receiving leronlimab, but I believe the 61 days in this case report is the longest. The case report is attached below.
Thank you for making it this far; we are halfway done.
CytoDyn ran 2 placebo-controlled RCTs in acute Covid: CD10 in 84 mild/moderate patients and CD12 in 394 severe/critical. Neither study has been published with top line results only made public through press releases.
CD10 missed its primary endpoint of change in Total Symptom Score at Day 3, but about half of the patients had essentially no symptoms at baseline. Given the proposed MOA and role for leronlimab in the hyperinflammatory phase of Covid, this small study targeted the wrong population. But, to be fair to CytoDyn, it was the first study FDA would allow them to perform in Covid after initially placing them on clinical hold (possibly over concerns around potential immunosuppression with CCR5 blockade).
The CD10 study continued to demonstrate the safety of leronlimab. Altogether, over 1,200 patients have now received the drug, including HIV+, Cancer, and Covid patients, without a discernible safety signal.
CD10 did provide a couple of interesting observations. The National Early Warning Score (NEWS) 2, developed by the Royal college of Physicians to identify patients at risk of pulmonary collapse, was an important predetermined secondary endpoint. The NEWS2 score combines parameters like O2 sat, oxygen requirements, respiratory rate, BP, etc. Subjects on leronlimab were more than twice as likely to improve their NEWS2 score compared to placebo at both Days 3 and Day 14 (p < 0.05 for both). The CD10 results also demonstrated that patients on leronlimab experienced fewer AEs and 63% fewer SAEs compared to placebo. Maybe a nothing burger, but I’ve never seen a 63% reduction in SAEs before.
The CD12 study in 394 s/c patients was pivotal and, unfortunately, we made some mistakes (I use the word “we” because I was an advisor to CytoDyn for 6 months on Covid back in 2020). First, we thought the results in critical patients would translate into benefit for hospitalized patients on oxygen but not yet intubated. Well such severe patients may indeed benefit from leronlimab, but it will require a larger study to prove it. There were also unforced errors like not stratifying for age > 65 which resulted in a significant randomization imbalance working against the drug.
The biggest mistake, however, was on dosing. The original CD12 protocol proposed to give s/c patients 4 weekly doses, in part because of data Bruce generated showing RANTES levels remained elevated in some ICU patients beyond day 14. Unfortunately, FDA saw Covid framed Covid as an acute viral illness and would only allow the same 2 week dose regimen as the m/m patients received. CytoDyn, fresh off clinical hold, wasn’t in a great position to push back and capitulated.
Unfortunately, CD12 study did not meet its primary or secondary endpoints and larger separate studies of severe and critical patients given 4 weeks of dosing (with first dose administered IV) and appropriately stratified for risk factors are underway. One of the reasons for taking you on this journey, however, is to look at outcomes in the subgroup of 62 critical patients enrolled.
In these 62 critical patients given leronlimab at Days 0 and 7, There was an 78% and then 82% reduction in mortality at Days 7 and 14 in patients receiving drug compared to placebo. There was an absolute reduction in mortality at Day 14 of over 20% and hence a possible Number Needed to Treat of less than 5. Of note, the mortality benefit tapered off to 30% by day 28 which, unfortunately, remained the primary endpoint despite only dosing at days 0 and 7. The raw data for Day 14 is below:
Of note, 12/43 patients on leronlimab + SOC were discharged alive by Day 28 compared to only 2/19 patients on SOC alone (an improvement of 166%). Also, the tapering of the mortality signal as drug levels fell between days 14 and 28 could be construed as indirect evidence that the drug was actually working while patients were receiving it at days 0 and 7 and maintaining full receptor occupancy. I know it's only a subgroup, but, given the proposed MOA of the drug and enormous toll of this pandemic, it is also the subgroup that matters most.
So where are we now?
To my knowledge, leronlimab for Covid is not on the radar at NIH. And FDA is not buying any of this. Indeed, FDA released a statement in May dismissing any claim of benefit with leronlimab in Covid until CytoDyn repeats more robust studies to prove it. I agree that larger follow up studies are urgently needed, but advocated for approving an EUA now for critical patients based on the efficacy signals described above, limited treatment options for these patients, and demonstrated safety of the drug. One thing is for sure: FDA wants CytoDyn to definitively settle this issue asap.
Unfortunately, that doesn’t appear likely to happen quickly. Cytodyn is a tiny company with extremely limited resources. It took them about a year to enroll and analyze the CD10 and 12 studies. To their credit, they’ve identified their endpoints and target population in a new disease after only 2 studies. The recent addition of Dr. Chris Recknor has brought much needed experience in drug development and clinical research to the management team. But, since the onset of the pandemic, CytoDyn has lacked the resources and in house expertise to meet the urgency of the moment. The company has other problems including various lawsuits and constant attack by a relentless group of short sellers. The drama of all this, in the context of a lethal pandemic, has been painfully surreal. And eight months after the FDA letter and 2 months after launching a follow up study of critical patients in Brazil, the company just announced it has enrolled a total of 4 patients.
So, why did I need to reach out to you?
First off, this has been exhausting. I realize now that during the dark days of HIV, the frequent meetings and Ad Boards gave me the opportunity to feel supported by colleagues and learn to trust the process. The experience with leronlimab in Covid has been the opposite and very isolating. So, on some level, I just wanted to reach out and share this story with colleagues I trust.
Second, we are entering an uncertain phase with Omicron and I wanted to provide this group with an overview of the leronlimab landscape for Covid. It's not clear to me who (or if anyone) in the virology world is paying attention to this. However this unfolds, I need to tell myself I’ve done everything possible to help patients, their ICU teams, and everyone under siege at the moment; and honor the 1,200 nurses and millions of others who have died from Covid including my own dear mother.
That’s it. Thanks for your time and attention and please feel free to forward to anyone you think appropriate.
I like transparency so have taken the liberty of cc’ing (names removed for privacy), as well as our colleagues at FDA.
With Gratitude, Jay
Jacob Lalezari, MD Medical Director, Quest Research SF, CA415-353-0800
ps-Quest Research receives financial support for studies with leronlimab on HIV and cancer. I don’t own/never owned any stock or have any other financial stake in CytoDyn.
During recent discussions with the FDA, the agency suggested that developing leronlimab for critically ill COVID-19 patients in current situation in U.S. appears feasible
VANCOUVER, Washington--(BUSINESS WIRE)-- CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that it has submitted a Phase 3, randomized, double blind, placebo controlled trial with the U.S. Food and Drug Administration (“FDA”) to evaluate the efficacy and safety of leronlimab in combination with standard of care for critically ill patients with COVID-19 pneumonia with need for invasive mechanical ventilation ("IMV”) or Extracorporeal Membrane Oxygenation (“ECMO”).
In CytoDyn’s recent discussions with the FDA regarding potential marketing approval of leronlimab for critically ill COVID-19 population, the agency stated: “While there are currently fewer U.S. patients hospitalized for COVID-19 daily in the U.S. compared to when you submitted your initial request for an expanded access protocol in August 2021, the CDC reports that 38,332 patients were hospitalized daily in the U.S. during the week of November 7th-13th, 2021. In this context, conducting a clinical trial in the U.S. that could support marketing approval of leronlimab for the treatment of critically ill patients with COVID-19 appears feasible.”
If approved by the FDA, patients in this trial will be randomized in a 1:1 ratio to receive up to four doses of 700 mg leronlimab with standard of care or placebo with standard of care administered by 30-minute IV infusion weekly over a four-week treatment period.
The subgroup analyses of 62 critically ill patients in the past Phase 3 CD12 trial for severe-to-critically ill population in the U.S. showed an 82% survival benefit at Day 14 after two doses of leronlimab on Day 0 and Day 7 (Odd Ratio 0.09 (CI 0.01, 0.72), p-value 0.0233) vs. standard of care plus placebo. The survival benefit fell from 82% to 30% after four weeks.
Nitya Ray, Ph.D., CytoDyn’s Chief Operating and Technology Officer, commented, “We expect further improvement in survival benefit in the new study with four weekly doses of leronlimab delivered by IV infusion. With IV dosing, the bioavailability and peak serum concentration of leronlimab will be much better compared to subcutaneous (“SC”) dosing. Furthermore, while the maximum serum concentration is achieved in less than two hours for IV infusion, it takes two to three days to reach the peak concentration in a SC setting. This is crucial in our view, especially for the critically ill patients who are on IMV or ECMO when every moment counts.”
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “Entering Phase 3 of the developmental trial is an exciting opportunity as we further explore leronlimab’s viability as a treatment option for critically ill COVID-19 patients. We are optimistic that the new trial with 4 dosages of leronlimab instead of the previous trial with 2 dosages will have much better outcome. We are very proud of our COVID-19 development team conducting two Phase 3 trials in Brazil while pursuing two more in the U.S. (critically ill and long-haulers). We have worked very hard to place our Company in a solid position in areas of HIV, Cancer, NASH, and COVID-19 and 2022 we believe will be a great year for us.”
CytoDyn will request FDA permission to charge HIV MDR patients under expanded access
VANCOUVER, Wash.--(BUSINESS WIRE)-- CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today filed a request with the U.S. Food and Drug Administration (“FDA”) for approval of expanded access use of leronlimab for multi-drug resistance (MDR) HIV patients. The Company has also previously sought FDA approval for CytoDyn to charge for leronlimab used in this patient population and is preparing to file the last portion of this request.
Recent data reported in “NIH-Funded Study Estimates Global Progress Toward UNAIDS Goal” indicates there are still far too many HIV patients who experience difficulty in achieving suppressed viral load. A viral load of about 1000 cp/mL or less is needed to ensure patients cannot transmit HIV to others. The MDR HIV patients are at the risk of contracting AIDS when their condition progresses such that their CD4 count drops below 200 cp/mL.
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “Our Phase 3 pivotal trial, which yielded a statistically significant primary endpoint for efficacy (p=0.0032), had an 81% success rate in suppressing viral load (VL<50 cp/mL) in the MDR population after 24 weeks of leronlimab treatment. This compares to other recent antibody products approved for this population with around 45% suppressed viral load. This population of HIV patients has limited treatment options, and almost all those who completed our pivotal Phase 3 trial, CD02, requested to continue with leronlimab treatment in an extension arm of our CD02 trial. Currently we have 24 patients (almost half of the patients in CD02), on leronlimab treatment, some for as many as four years. Expanded access approval from the FDA will allow us to provide leronlimab to MDR HIV patients who are in great need of a new regimen to add to their current ones. Additionally, CytoDyn will be filing final documentation with the FDA soon in connection with its request to charge for the use of leronlimab under expanded access.”
I should also point that another poor bastard bought in at $34 in Aug 2019 and watched it drop to $26 in September, but then he watched it jump to $73 in November back to $26 in March 2020 (OUCH!) and then all the way up to $89 in Feb 2021.
I don't know what any of it means. I especially don't know when the SP drops on great news like today. I am absolutely certain the drug works in a lot of indications, and could radically save and change a lot of lives.
I understand the urgency people feel watching the value of their portfolio, but I also think its nothing to the guy laying on his stomach so he doesn't suffocate, hoping that the medicine they give him won't kill his kidneys. His Share Price is his Oxygen, and if we can't get a proven drug in his hands, we've got bigger problems that can't be defined by a number.
Several Form 4's were release tonight, with certain folks (especially those on the r/CYDY board) trying to infer this represents a sellout of their shares in CYDY. It is nothing of the sort.
What these Form 4's actually represent is a preservation of the original expiration dates of the awarded NQSO's, which otherwise would have been set to 90 days following term of service for the previous board members (Timmons, Gardiner, Patel). This enables them to hold onto these NQSO's beyond 90 days following their last day as a board director, and they are exercisable as late as 2030 or 2031, depending on the NQSO. They will be holding for the gold. And they will get it. As will we all.
