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NASH Phase 2 Trial Open-Label Portion Demonstrates Average 80 msec cT1 Reduction in 50% of Patients and Reduction of Nearly 50 msec in 80% of Patients
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.”
New ProActive Video: CytoDyn updates on Brazil and US COVID-19 trial progress, files expanded use for HIV MDR patients
https://www.proactiveinvestors.com/companies/news/968811/cytodyn-updates-on-brazil-and-us-covid-19-trial-progress-files-expanded-use-for-hiv-mdr-patients-968811.html
CytoDyn Submits Protocol with the FDA for Phase 3 Registrational Trial of Leronlimab for Critically Ill COVID-19 Population
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 Files for Expanded Access Use of Leronlimab for Multi-Drug Resistance HIV Patients
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.”
https://www.cytodyn.com/newsroom/press-releases/detail/586/cytodyn-files-for-expanded-access-use-of-leronlimab-for
CytoDyn’s CRO in Brazil Met with ANVISA to Modify CD16 Trial for Critically Ill COVID-19 Patients to Expedite Interim Analysis After 51 Patients, Potentially in 1Q2022
DSMB to meet after 15 patients to evaluate safety of Leronlimab
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 its CRO in Brazil (Academic Research Organization (ARO) Albert Einstein Israelite Hospital (AEIH)) met with the Brazilian Health Regulatory Agency (ANVISA) and received its agreement to modify the CD16 trial for critically ill COVID-19 patients. ANVISA has authorized CytoDyn to submit the requested changes. CytoDyn will submit the revised protocol for CD16 providing for a reduction in total enrollment from 330 to 126 patients, with interim efficacy analysis by DSMB after 40% of patients (51 patients) are enrolled and have completed follow-up to Day 28.
In this trial, patients will be randomized in a 1:1 ratio to receive up to four weekly doses of 700 mg of leronlimab or placebo via IV infusion. By comparison, in the previous CD12 trial (a phase 3 trial for COVID-19 severe-to-critical ill patients) in the USA, patients received only two weekly doses of 700 mg of leronlimab via sub-cutaneous injections.
The subgroup analyses of 62 critically ill patients in the CD12 trial showed an 82% survival benefit at Day 14 after two doses of leronlimab on Day 0 and Day 7 (Odds Ratio 0.09 (CI 0.01, 0.72), p-value 0.0233) vs. standard-of-care plus placebo. The survival benefit fell from 82% after 2 more weeks to 30% after four weeks. The survival rate on Day 28 could be much better with four 700mg, IV doses of leronlimab administered on Day 0, 7, 14, and 21.
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “We are optimistic that our CRO in Brazil will be able to enroll 51 patients and conduct an interim analysis of the results in 1Q2022, with the potential for meeting the primary endpoint at the time of interim analysis. The primary endpoint in this study was based on the valuable information we had generated from the past CD12 trial. The p-value for length of hospital stay for the critically ill patients who were on invasive mechanical ventilator or ECMO was 0.005. The primary endpoint of the CD16 trial in Brazil is Time to Recovery, which is similar to this endpoint. Due to this past result from CD12 which was obtained with two sub-cutaneous doses of leronlimab, we believe four doses via IV will give us an excellent chance of success.”
So, you're saying Sheikh is a paid 13-D basher, too?
So the ~1,500 people whose lives have been saved by LL are paid by CYDY?? LMAO
Wrong. We disagree on both.
Is Jeffrey Beaty, the head mod on Reddit's CYDY board, a paid pumper? If you don't know the answer, perhaps we should check with Phil Harrison who was a paid basher for the 13-D gang. But, then again, I heard he's "clueless", so maybe not.
Send it to npourhassan@cytodyn.com and skelly@cytodyn.com. They're very good about helping those who need LL. They'll probably suggest that his doctor request it via Right to Try.
GLTU and your brother.
Please feel free to share the names of those "other drug candidates" and "competitors". Links would be appreciated.
If they continue to get very good results from the interim data, they won't need a BTD because it's well known that BP will either partner or purchase LL - they can't afford to sit on the sidelines for long.
Show me a drug that has as good or better results for NASH. It doesn't exist, which is why BP can't afford to ignore these results.
WRONG!!! Nobody can argue with these results. The numbers are INCREDIBLY GOOD and EVERYONE can see them. LMAO!!!
Ummm...the DATA IS DEFINITELY THERE as everyone can clearly see. The interim results are FANTASTIC and there are NO OTHER drugs that come close to treating NASH like LL. And BTW, Sidley is their attorney, not their Chief Medical Officer.
WHAT??? So, the FDA will reject a BLA if the drug has no side effects??? LMAO!!!
WHAT??? LMAO!!!
LMAO!!! A drug must have side effects or it will not work??? So, a drug's effectiveness is determined by the side effects??? LMAO!!!
CytoDyn Submits CMC (Manufacturing) Section of HIV BLA to FDA Under Previously Authorized Rolling Review; Last (Clinical) Section Will Complete Full BLA Submission
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 it has completed submission of all the major sections of CMC modules to FDA, some remaining supporting documentation will be submitted under Regional Information before the end of this week. CMC is a critical part of CytoDyn’s Biologics License Application (“BLA”) for HIV. This submission was made under rolling review consistent with guidance from the U.S. Food and Drug Administration (“FDA”). Only the clinical section remains to be submitted.
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “We are pleased to get close to completion of our HIV full BLA submission. We have only one more section (from the main three sections) to submit. With our resubmission of the non-clinical and CMC sections behind us, we are very excited to have our HIV and other activities back on track after the difficulties we experienced with our previous CRO. Our CD15, Long-Hauler’s trial for COVID-19, was submitted for peer review yesterday, and we are also very close to submitting our manuscript of HIV CD02, Phase 3, data to a peer reviewed journal. We are extremely excited about both submissions. Also, in light of recent news about multi-drug resistance (MDR) HIV patients having problems with durable viral suppression, we are working on making a request to the FDA for approval of expanded use of leronlimab in the HIV, MDR population. We are grateful to CytoDyn’s new BLA team, under the supervision of Dr. Nitya Ray and his team, and previously Dr. Chris Recknor, for their excellent work in helping us to reach these milestones. We believe this will lead to a very successful 2022 for CytoDyn.”
Nitya Ray, Ph.D., CytoDyn’s Chief Operating and Technology Officer, commented, “We are grateful for the excellent job that the CytoDyn’s dynamic CMC team has done working relentlessly alongside CytoDyn’s consultants and Dunn Regulatory Associates. In this submission we have included data of leronlimab manufacturing at Samsung Biologics. We are also grateful for the invaluable support we have received from Samsung’s Development, Manufacturing and Regulatory groups.”
"US WILL ban travel from EIGHT African countries in bid to stop spread of new COVID variant Omicron: Fauci overruled within hours over ‘most infectious, vaccine resistant’ mutant"
"Dow logs worst day of 2021; new COVID variant rocks market"
Not sure I follow you. So, if the mTNBC BTD gets approved and/or the NASH results are very good and the sp doubles or triples within the next 4-6 weeks, you're saying that's "not a catalyst because the CEO is at the helm"??? Well, I'd say that's the true definition of a "catalyst". LMAO
mTNBC BTD is not a "thought" nor are the NASH results.
ANYTHING that can double or triple the sp is a "catalyst". LMAO
No near-term catalysts??? LMAO
There are more near-term catalysts than we can count. What about mTNBC BTD and the results from the NASH trial at 700mg? Both of these alone are due within the next 4-6 weeks, and could easily double or triple the sp to the dismay of the failed 13D gang of miscreants.
Who is Mike Sheikh? Sounds like he's related to that long term paid 13D basher, Phil Harrison, but at least Sheihk won't be eating crow tonight like the failed 13D gang of miscreants.
From CytoDyn's latest 8-K filed yesterday:
What would be the share count to satisfy current obligations if we hadn't received approval to increase the authorized shares?
Shareholders approved all four proposals up for consideration at the Annual Meeting, including:
1) The election of six directors to serve on the Board of Directors until the 2022 Annual Meeting of Stockholders, including Scott A. Kelly, M.D., Nader Z. Pourhassan, Ph.D., Jordan G. Naydenov, Lishomwa C. Ndhlovu, M.D., Ph.D., Harish Seethamraju, M.D. and Tanya Durkee Urbach.
2) The ratification, on an advisory basis, of the selection of Warren Averett, LLC as the Company’s independent registered public accounting firm for the fiscal year ending May 31, 2022.
3) The approval, on an advisory basis, of the Company’s named executive officer compensation.
4) The approval of a proposal to amend the Company’s Certificate of Incorporation to increase the total number of authorized shares of common stock from 800,000,000 to 1,000,000,000.
Shareholders approved the additional 200m authorized shares, so the former 13Disgruntled gang must be very frustrated (again)! LMAO
Most CYDY shareholders are NOT going to share their personal information with Jeffrey Beatty who is one of the head 13Der's who just failed at their hostile takeover and preventing the company from increasing the authorized share count that's needed to fund the company.
And this is EXACTLY why every shareholder should vote YES to the 200m share request. The failed 13D case smelled worse than limburger cheese and got thrown out with a public spanking by the Delaware courts. Most shareholders are wise enough to know the company needs to get approval for the additional 200m shares in order to fund future progress, but the failed 13D(irtbags) continue to try to turn shareholders to join them on the Dark side. Very pathetic!
Yes, Publishers are not the same as scientific peer reviewers. LOL
CytoDyn Research Paper on Leronlimab Published in FRONTIERS in Immunology Journal
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 its research paper entitled “CCR5 receptor occupancy analysis reveals increased peripheral blood CCR5+CD4+ T cells following treatment with the anti-CCR5 antibody Leronlimab” has been accepted by Frontiers in Immunology, a leading journal in its field publishing rigorously peer-reviewed research across basic, translational and clinical immunology.
The article can be found here: http://journal.frontiersin.org/article/10.3389/fimmu.2021.794638/full?&utm_source=Email_to_authors_&utm_medium=Email&utm_content=T1_11.5e1_author&utm_campaign=Email_publication&field=&journalName=Frontiers_in_Immunology&id=794638
Importantly, the results of the study outlined in the research paper:
Establish two CCR5 receptor occupancy calculation methods for longitudinal monitoring of anti-CCR5 therapeutic antibody blockade efficacy in both macaques and humans;
Demonstrate that CCR5+CD4+ T cell levels temporarily increase with leronlimab treatment; and
Facilitate future detailed investigations into the immunological impacts of CCR5 inhibition in multiple pathophysiological processes.
“We are thrilled that the Frontiers in Immunology journal has published this important paper to inform further the scientific community of these exciting developments with leronlimab,” said CytoDyn’s Chief Medical Officer, Scott A. Kelly M.D. “We will relentlessly pursue the various indications for leronlimab to realize its full therapeutic potential. Our continued work on the mechanism of action of leronlimab continues to lay the foundation for more exciting opportunities of leronlimab for patients and our shareholders.”
Apple
And it can't be that idiot Tony Caracciolo. We all know how that turned out.
CITIBANK COVERAGE
Sharing from another site:
[1] Citibank is one of the biggest investment banks and they came out with a Buy rating on CYDY on 11/16/21.
[2] It’s hard to interpret the report because there is no analyst assigned to it or any context to the positive rating.
[3] Following OTC stocks is not something Citibank would do without a reason. It’s very likely that they want to broker a deal between CYDY and big pharma and if the stock were to dip below $1.00 it could throw a wrinkle in their plans which explains the timing of their rating.
[4]. There also seems to be some significant speculation in the media that CYDY is a potential joint venture partner in COVID-19 or even a buyout candidate. That chatter is hard to ignore when it’s real. Investors know Merck is in trouble with their COVID-19 pipeline and prepping the fields. Those types of deals would likely mean a double digit stock price for CYDY. Adding to the speculation is the fact that CytoDyn isn’t shying away from admitting that they are in talks. They cannot discuss the extent of the discussions due to confidentiality.
[5]. This Citibank coverage could also be due to the large retail following of the stock.
[6]. Regardless of the reason, what is certain is that Citibank has a top notch compliance and due diligence team that wouldn’t even dream of touching a company that has a DOJ or SEC investigation waiting in the wings—they only want to work with and cover the cream of the crop.
[7]. This coverage may finally give the longs something to crow about to debunk the shorts ideas that the DOJ was coming after the company when in reality they may have actually been investigating the 13-D group and their admitted violations. Citigroup (NYSE: C) has incredible access when it comes to these types of situations and it’s rare that they would step on a landmine.
Agree. Speaking of "idiots", this is why they got rid of Tony Caracciolo and brought back NP to mop up the mess Tony C. left behind.
Yes. He's much more reliable than Tony C. What a fiasco that was. And NP is actually getting things done to the dismay of the shorts.
Actually I said quite the opposite. The investment community easily saw the value of the PR and the enormous future potential of breaking into the Canadian market, not to mention that the PR only strengthens CytoDyn's application for the mTNBC BTD. This 6-15% increase today will be a blip on the radar compared to what it's going to look like if we get FDA approval on the BTD. Everyone knows that, and it's driving the shorts nuts that NP gets FULL CREDIT for moving the mTNBC BTD forward! NP has accomplished more this month than Tony C. did during his entire tenure at CYDY.
Apparently the market disagrees.
"Here is the real story of the Canadian Cancer Patient. She has been taking Leronlimab since September 2020. She started on Leronlimab as part of a trial and when the trial ended she and her oncologist had to apply for the Canadian Special Access Program to stay on Leronlimab. If she was in the US the application would have been under Right to Try. The approval for the SAP was granted one month ago. She has been on Leronlimab for 14 months and she has seen No Evidence of Disease - NED for exactly one year now. This is the first time Leronlimab has received this type of approval in Canada. This does potentially open the door for other cancer patients to apply under the same legislation as the first approval is definitely the hardest. It took Health Canada 6 weeks to make the decision. I know these are the facts because I know her personally."