Importance Of The Foundational Manuscripts
Greetings to All of You, Welcome Here. Thank you in advance.
Folks, we need those manuscripts. Those manuscripts lead us forward, they point the way, the direction. They provide for guidance, Gems of information, hidden even, here and there, and the assembling of them all, brings understanding.
The study of the manuscripts can illuminate the course setting. So, I seek these manuscripts out.
Let's take a look at what was said about the proposed manuscripts.
From the 12/14/2023 Webcast:
"00:32:24, Dr. Jacob Lalezari:
The other, so getting this protocol finalized, coming off hold, that's all going to happen, I think, in the very short term. I mentioned the priority of getting manuscripts published*. CytoDyn is sitting on some very provocative clinical data. And the world mostly doesn't know about it. So that's a top priority.*
The CD02 study (HIV-MDR), I believe, has been tentatively accepted, pending release of the clinical hold. So we expect to be able to move forward with that very quickly. I'm obviously someone who's been very interested in the COVID data. And we're going to make a priority of getting CD10 and CD12 published*.*
00:33:19, Dr. Jacob Lalezari:
I've also recently reviewed the cancer data. And it is urgent that we get CD07 (mTNBC) published for that, again, provocative single benefit. So publications, are getting a protocol finalized, off hold, begin the process to implement, get these publications, including the NASH study, the long COVID study, submitted for peer review. I had talked to folks at NIH some years ago about our COVID data in the ICU population. They've been waiting to see the data in a peer reviewed format. And so that's a huge priority for me. And then at the same time, there's no reason why we cannot aggressively pursue partnerships to extend the research platform for leronlimab. And I will commit to that wherever that makes sense. So those are the significant events that, you know, I'll be looking for over the next, you know, two to six months."
From the 3/5/2024 Webcast:
"7:07: Turning now to the commitment to prioritize publications of our existing clinical data. I am pleased to announce that we are moving forward with the submission of (4) manuscripts in the coming weeks including (2) papers with 8 of 10 women with triple negative breast cancer. A paper in patients with multi-drug resistant HIV and a paper in patients with Mild to Moderate Covid-19.
7:40: The 1st publication will report on the observations that 8 of 10 women on the 3rd line therapies for triple negative breast cancer had either stable disease or a partial response after 6 months of combined treatment of leronlimab with a chemotherapy agent called carboplatin*. This result compares favorably with historical controls.*
8:09: The 2nd publication will report (2) further observations that suggests that leronlimab may have a role in the treatment of triple negative breast cancer*. First, in the pooled analysis of 28 patients, there appeared to be a signal on the dose response. The patients on the higher 525mg dose of leronlimab, had a modestly increased progression free and overall survival compared to the 350mg dose.*
Second, I think most provocatively, the pooled analysis showed that after receiving an initial dose of leronlimab, patients divided into one of two categories. About 25% of the patients had an increase in Circulating Tumor Cells, these are cells that are measured in the blood and can be referred to as CTCs. While about 75% of the patients had a decrease or absence of these CTCs in the weeks following the first dose of leronlimab.
9:17: That differentiation in CTC response in turn appeared to identify which patients subsequently responded to leronlimab with improved progression free and overall survival. Indeed, I believe the data on CTC response, is perhaps the most compelling part of the leronlimab story in triple negative breast cancer and could provide the basis for a screening test to identify which patients are most likely to respond from leronlimab in a follow up study.
9:53: Turning to our other manuscripts, we are pleased to announce that our Phase II-III study of leronlimab, in a population of patients with HIV and multi-drug resistant environments*, will also shortly be submitted for review. This study did achieve a* significant p-value for its Primary Endpoint demonstrating the Efficacy of leronlimab in the multi-drug resistant population*. So, we are choosing to prioritize other applications at this time. This study could support the pursuit of leronlimab as an HIV anti-viral should that opportunity once again make sense.*
10:37: Finally, I'm pleased to announce that the manuscript in our study of patients in mild to moderate Covid-19 will be submitted for peer review in the coming weeks. Although this study did not achieve its Primary or Secondary Endpoints, in a post-hoc analysis, the study did show marked improvement on a metric called the National Early Warning Score or NEWS for leronlimab compared with placebo*. That score combines measures of heart rate, blood pressure, O2 levels, and other clinical measurements and then having risked with it, which Covid patients are at the highest risk for subsequent pulmonary collapse.*
11:22: In retrospect, the real value of this Covid study, may have been to help define the more advanced population needed for a study of a proposed immune modulator such as leronlimab in patients with acute Covid 19. Indeed, the results of our studies in such patients in severe and critical Covid, should be ready for submission in our next wave of manuscripts. That wave should also include a manuscript to our NASH/MASH study, and a manuscript highlighting the critical endpoints of CytoDyn's long haulers Covid study.**"
From the 5/30/2024 Webcast:
"... CytoDyn is also continuing to aggressively pursue publication of our clinical data for peer review.
Importantly, the clinical endpoint data from the CD15 Long COVID trial was recently published in the Journal of Infection*. That study enrolled. 56 patients, with long COVID who were treated for eight weeks with either leronlimab or Placebo and the study results showed clinical improvement in 19 of the 24 endpoints that were evaluated.*
So that data is now posted on our website and has been brought to the attention of colleagues at the RECOVER program at NIH, overseeing studies in long COVID.
In addition to that. now published data, we have two manuscripts from our studies of patients with triple negative breast cancer, a manuscript from our study of HIV positive patients with multi-drug resistant virus, and a manuscript from our study of patients with mild to moderate COVID-19 that have all been submitted from publication and are currently undergoing peer review. In addition, a manuscript detailing results from both our pre-clinical and clinical studies of leronlimab in MASH is undergoing final internal review and will be submitted shortly.**"
Lastly, from the September 2024 Letter To Shareholders:
"CytoDyn has also continued to pursue publication of our existing clinical data. The CD10 manuscript describing the leronlimab trial of patients with mild to moderate Covid-19 was recently accepted for publication by Clinical Therapeutics. The CD02 HIV paper, the CD12 manuscript on severe/critical Covid, the twin papers on the TNBC study results, and the MASH manuscript are all pending either final author review or final data confirmation prior to submission*. All published research will be available on the Company’s website, soon after publication."*
So, the preceding is the company telling us that these manuscripts shall be forthcoming. So far, they have delivered on two of them. The manuscript on LongHauler's PASC is on the website. The manuscript on CD10 is not yet on the website, but can be found here.
Can these manuscripts buy CytoDyn less confrontation by the regulating body? Can the nominated Head of Health and Human Services be much less confrontational to CytoDyn simply as a result of his much more favorable policies towards safe drugs? Soon, someone is going to be put into power that is extremely influential to the Drug Regulating Authority's future, to the future of the NIH and to the future of the CDC. Those governing bodies, but most especially the FDA, are thinking twice now, as a result.
No matter how you look at it, CytoDyn is winning. The pace will be picking up soon. We are headed towards the end of year and things should be happening by the end of year. The two main items we should be excited about are the Results of the GlioBlastoma Multiforme Murine Study conducted by Albert Einstein / Montefiore Medical Center and the beginning of the mCRC Clinical Trial, the enrollment of the trial should begin by end of year or shortly into the beginning of the next year.
Max and Melissa, recently arriving at CytoDyn should be making statements. Definitely Max, but Melissa might be some time from now. Max's real purpose should be revealed with that statement, but it seems to me that he will do what he needs to do to get the job done. What job? Partnership with GSK is my answer to that. Why with GSK? Because Max took a massive Reverse Step from SVP at ViiV to SVP at CytoDyn. Nobody does that unless there is a solid motive backing the move. Yes, GSK has CytoDyn's back IMHO.
"“I am deeply enthusiastic to welcome Dr. Lataillade to the CytoDyn team. I have had several opportunities to collaborate with him over the past ten years and I believe his accomplishments in the industry and his skillset will help us progress our development pipeline,” said Dr. Jacob Lalezari, CEO. “I look forward to working with Dr. Lataillade to capitalize on both early and continued clinical results, and to help drive further success for the Company.”
Dr. Lataillade added, “I am ready to leverage my experience and background to pursue strategic development opportunities and advance CytoDyn’s clinical pipeline. By further developing leronlimab, I believe CytoDyn is poised to provide material benefits to patients suffering from a number of serious conditions. I look forward to working with Dr. Lalezari to drive the Company’s clinical development.”"
I see Max's hire as GSK's hooks into CytoDyn, leading to partnership with GSK which happens at any time, just like the lift of the hold happened, at any time, but CytoDyn worked towards that and they achieved it. So they also work towards partnership, with the writing and publishing of the manuscripts, which are coming soon. To achieve partnership with GSK seals CytoDyn's fate indefinitely. Therefore, at the root of it all, partnership with GSK, really is the main goal, just not stated. All of CytoDyn's enemies fall prostrate, flat on their faces with such an announcement. CytoDyn is winning.
What do the manuscripts provide? They prove leronlimab's efficacy and safety. Yes, our knowledge of leronlimab's efficacy and safety is not world renown, but these manuscripts do help in making that known at least to BP. It is going to be an amazing thing when mTNBC patients become aware that their disease may be treated better and with less side effects than SOC.
These manuscripts will defang, will take away the power of CytoDyn's enemies, of the scoffers, the bashers, the twats. They shall help CytoDyn defeat their enemies, greatest of which is G, rendering them powerless, especially, now with the new and Influential Helping Head of Health and Human Services coming on board January 20, 2025. CytoDyn is focused and there is no stopping it, especially with Max and Melissa, led by Dr. Lalezari. Winning with a strong defense got the hold lifted and propagates the IP with excellent and protective patent law. Winning by an offensive push with Sidley Austin brought in what was necessary to initiate the coming trials. Winning by establishing by peer-reviewed published manuscripts, leronlimab's effectiveness and safety.
When will it be understood throughout BP that leronlimab is effective and that it is safe? Soon, once all the manuscripts are out. Wouldn't that make GSK's shareholders more at ease to know they are collaborating with a perfectly safe drug with incredible effectiveness in a sheer array of possible billion dollar indications? What are the first signs of this? When leronlimab is mentioned by name in future research articles as a CCR5 blockade with fine potential. Currently, maraviroc is really only mentioned as it is the CCR5 which has found FDA approval, but leronlimab shall be discussed more and more now that it is off hold and that these manuscripts are becoming published proving its efficacy and safety. You never know what that next research article might just say. Hidden nuggets passed to those who need to know those gems of golden information.
Posted Nov 17, 2024, 3:36 PM UTC