Timing? Something happening behind the scenes?
Post# of 148189
Organization of clinical trials. We are in the season. Welcome all of you here.
Jonah Sacha in 12/7/22 R & D Update :
"1:25:47: So what that means is that with a single dose, we were able to get coverage of about a 3-month window where individuals would be protected from sexual transmission. And these Prep studies are ongoing. I've recently presented these data actually on Monday at the HIV DART meeting in Cabo St. Lucas, and we'll also be presenting these results next week at the Miami Reservoirs meeting. So these are really breaking data that is very exciting for both us and the field."
"1:26:58: And so really looking forward to where this -- where the field is going. This is in vivo gene therapy. And currently, the state-of-the-art is AAV vectors or adeno-associated virus. And what you can do is you can actually take leronlimab in sequence. You can put it into this vector, you can then inject that into the muscle. And these myocytes, muscle cells will pick up the AAV vector, and they will then turn into a little antibody factories and produce leronlimab for the rest of your life*.*"
"1:29:20: And so this is why we are so optimistic about the future of leronlimab long-acting for HIV prevention and cure. So we think a long-acting molecule like this where a patient could, at home, subcutaneously dose themselves once every 3 months or perhaps even longer*, will have very high uptake and will be very attractive to patients. And for* functional cure*, by that, I mean, control of viremia, the goal here is to develop something where you could just go in,* get a single shot*. And you have coverage of --* your own body will make leronlimab*. And this is only possible because* leronlimab appears to be very well tolerated in patients and also in our preclinical studies."
Cyrus introducing Scott Hansen in 4/11/23 Webcast.
"12:56: Additionally, we have also firmly established Dr. Scott Hansen as our Head of Research and Basic Science*. Dr. Hansen is currently an Associate Professor at OHSU. and within this newly formalized role, Dr. Hansen will support our clinical development activities, related to biomarker and assay development for* future clinical trials*, as well as supporting and leading some of our earlier staged efforts, geared* towards the development of longer acting molecules targeted to CCR5*.*
13:33: As a part of those efforts, we have also recently entered into a joint development agreement with a 3rd party Research and Development Bio-Tech company to develop long acting or more longer acting molecule CCR5 blocking*. So, in addition to potentially leading to a improved or modified therapeutic, that, we believe that has greater acceptance by those patients and physicians and this could help to yield extended intellectual property section that would increase the underlying value of our patent portfolio."*
"14:33 Scott Hansen: Thank you Cyrus. I have about 25 years of experience in the fields of virology, oncology and immunology. At OHSU, I currently lead one of the largest and prominent, non-human primate research labs in the country. My laboratory covers a remarkable breadth of work including research projects on malaria, numerous viral and bacterial diseases, immunology and cancer*. As you all know, many of these research areas, that I'm studying are* relavant to CytoDyn's own development plans*. However, what* I am most known for, is developing Cytomegalo Virus or CMV as a next generation vaccine platform*. Based on this technology, I helped cofound a small BioTech company,* preserved the IP around the new vector platform, and take it through the clinical development process*. Till I took the new clinical development process for the CMV vector platform...*"
Scott Hansen closes with: "I think one of the big questions people may be wondering, is if I will be leaving OHSU? and the answer is No*. At least, not at this time. CytoDyn does not currently have the necessary laboratory space for me to be effective and in position and provide research, support for mechanism of action in* upcoming clinical trials*. I basically need a laboratory.* OHSU and CytoDyn already have a strong relationship*. Our* work is supported by ongoing sponsored research agreements and at this time, will continue with the arrangement. Thank you again Cyrus, for the opportunity and I look forward to working with everybody in the company in a more formal capacity and basically getting the job done*.*"
A potential combination drug for HIV-Prep is VIR-1388 which is a pre-clinical subcutaneously administered HIV T cell vaccine based on HCMV that has been designed to elicit abundant T cells that recognize HIV epitopes in a way that differs from prior HIV vaccines. It is slated for Phase I clinical trials in the coming months. This drug itself does NOT block CCR5. All it does is reduce HIV in the body by upregulating T cells and CD8 cytotoxic cells. By adding Leronlimab to the 3 - month Prep treatment, they will achieve 100% Receptor Occupancy on CCR5. Vir would do very well by adding LL to that HIV Prep product.
Here you can see why it is so important to block CCR5.
Jonah Sacha, PhD Scientific Advisory Board Expert speaking on CURE for HIV.
Please check out Multiple Trunks as it ties in beautifully as to what I will be saying here concerning Oncology and NASH.
Why are all the Pharmaceuticals so afraid to see the results of CytoDyn's coming trials? Are they so very worried as to what they shall produce? There are other pharmaceuticals that really need CytoDyn's help, and LL is slated to be tested in combination with them to provide them that assist. But efforts to prevent this very thing from happening continue to persist and even strengthen. Amarex was their attempt to put us out completely, but that turned into a shit show for them and for Amarex, so now, they must look elsewhere.
The day they lose, is the day the hold lifts. But when we have such a grand day, they too, will raise their ugly head and pronounce for themselves a king over them to guide them now, within a world which permits Leronlimab and sees it as safe. They pledge their allegiance to this new found ruler to obey his/her every command. He/She shall be given great power through multiple proxies. He/She shall announce that power following the lift of the hold but He/She shall quickly learn to co-exist with CytoDyn, and agree to have no control over CytoDyn. Those in control now, won't be once the hold lifts.
Come on, bring it on already! A new alliance is forming and you are not included. No longer can you be trusted. You have been forsaken. Once you've provided that safe haven, but your services are no longer needed. The hold will be lifted. Zero doubt.
Stage is set, but the curtains are open. Transitions between Acts takes place with the curtains open. We are transitioning between Act 1 and Act 2, but the curtains are open and we can see everything. In the last scene of Act 1, the hold is lifted. But I can see the forces of opposition aligning and getting ready to elevate up their Master to be introduced in Act 2.
But CytoDyn is already keenly aware of what shall take place and has already been taking the appropriate steps, measures and precautions to ward off any attack. Cyrus, President has the Independent Board he selected and the Scientific Advisory Board of Experts who have been preparing the clinical trials for the New Era. Already, the Board has put into place Melissa Palmer, MD Interim CMO and Salah Kivlighn, PhD Clinical And Strategic Advisor who are both very experienced with Clinical Trials. Prior to that, they brought on Scott Hansen, PhD Head of Research and Basic Science as well as Jane Conlon Werner, Executive Director of Quality and they too are experienced in Clinical Trials. Key to getting the clinical hold lifted are Bernie Cunningham, PhD, MRPharmS, PMP Vice President of Operations and Joseph Meidling, Senior Director of Clinical Operations. As for the Arbitration , Sidley Austin is on top of it, need I say more?
CytoDyn is protected and shall be given the go ahead on the 3 trials mentioned at the beginning. Oncology, HIV and NASH. Regardless of what happens in the world of Big Pharma, CytoDyn's works continue un-impeded, shielded, un-abated and un-deterred. Our trial work hides from the forefront, from the media, from the news, but the results shall be broadcast and made known everywhere. They, who are now in opposition and aligned against us shall soon have no power over us any more, in clandestine fashion, our work proceeds, strategically accomplishing our mission. Everyone else aligned in our opposition remain exposed and controlled by who they are aligned to, by who they elected as their king, but CytoDyn ensures its own governance, and its protection is agreed upon and it remains left alone to carry out its mission. All shall kiss our ass.
Let's get to the point. On multiple fronts, something great is happening. Hopefully, your eyes and ears are opened. Time is near and Cyrus' illness threw us for a loop, but we are still on track. CytoDyn shall not be herded in with the rest of them, nor shall it be controlled as the rest are submitted to. Rather, CytoDyn shall fulfill its mission.
"So before we begin I want to remind everyone of CytoDyn mission which I think is particularly relevant given the nature of the topics that we're going to be discussing today.
3:22: We believe that we have a moral obligation to generate therapies to improve people's lives. We achieve this through a focused and disciplined development strategy and in doing so, it creates a value generating path resulting in economic returns for our investors."
Through this FOCUSED and DISCIPLINED development strategy, CytoDyn shall get there and they too shall know it, accept it, allow it and they shall let it be and learn to live with it. A new era is coming and this can not be denied.