Please excuse "disgender" typo when should be "cisgender"
Anyway, was pulled away but here's a followup regarding what Dr. Lalezari further said including upcoming publications:
Please excuse any omission with a blank as I was not able to clearly make out what he said... hope I have all else as close to exact as possible.
Anyway, was pulled away but here's a followup regarding what Dr. Lalezari further said including upcoming publications:
Quote:Turning now to the commitment to prioritize publication of our existing clinical data:
I am pleased to announce that we are moving forward with the submission of four manuscripts in the coming weeks, including two papers with data from women with Triple Negative Breast Cancer, a paper in patients with Multi-Drug Resisting HIV and a paper in patients with mild to moderate Covid-19.
The first publication will report on the observation that eight of ten women with parablind therapy for Triple Negative Breast Cancer had either stable disease or a partial response after six months of combined treatment of Leronlimab with a chemotherapy agent called Carboplatin. This result compares favorably with historical controls.
The second publication will report two further observations suggesting Leronlimab may have a role in the treatment of Triple Negative Breast Cancer. First, in the pooled analyses of 28 patients, there appeared to be a signal of a dose response. The patients receiving the highest 5.5 mg dose of Leronlimab having modestly improved, progression free and overall survival compared to the 350 dose.
Second and I think most provocatively, the pooled analyses showed that after receiving an initial dose of Leronlimab, patients divided into one of two categories. About 25% of patients had an increase in circulating tumor cells through the cells that are measured in the blood and can be referred to as CPTs, while about 75% of patients had a decrease or absence of these CPTs in the weeks following the first dose of Leronlimab. That differentiation in CPT response ____ appeared to identify which patients subsequently responded to Leronlimab with improved, progression free and overall survival.
Indeed, I believe the data on CPT 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 to Leronlimab in a follow up study.
According to our other manuscripts, we are pleased to announce that our phase two-three study of Leronlimab, in a population of patients with HIV and multi-drug resistant (vitals?) 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 resistance population. While we are choosing to prioritize other applications at this time, this study could support the purusit of Leronlimab as an HIV antiviral should that opportunity once again make sense.
Finally, I'm pleased to announce that the manuscript for our study of patients with 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 talk analyses, the study did show a marked improvement on a method called the National All In One Store for Leronlimab compared to placebo. That score combines measures of heart rate,blood pressure, oxygen levels and other clinnical measurements and has been used to predict which Covid patients are at the highest risk for subsequent pulminary collapse. In restrospect, 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 study of such patients with severe and critical Covid, should be ready for submission in our next wave of manuscripts. That wave should also include a manuscript for our NASH/MASH study and a manuscript highlighting the clinical endpoint of CytoDyn's Longhauler Covid study.
In terms of partnerships, I'd like to affirm our ongoing commitment to pursue partnerships and give Leronlimab multiple shots on goal to prove itself. The Board and management are currently evaluating several options on how to proceed as pertains to Oncolgy, MASH and other potential indications. For example, we are acutely aware of the continuing and even growing interest in Long Covid and will continue our efforts to bring attention to Leronlimab as a possible partner in the Long Covid treatment strategies.
I would also like to note the growing body of evidence implicating the role of inflammation and specifically CCFI in the pathogenesis of Alzheimers Disease. This is obviously an area of enormous and urgent unmet need. And given the world's highest safety profile of Leronlimab to date, together with data from a recent preclinical study suggesting that blocking CCFI in mice can rescue memory deficits, I believe a pilot study in Alzheimer's Disease is now justified.
The challenge of course is that CytoDyn is just emerging from a two year clinical hold and doesn't have the resources to do everything we'd like. We're also keenly aware the need to stay focused and not try to do too much all at once. That said, the Board and management are working closely together to identify our priorities and the appropriate next steps to proceed. To that end, we will be taking steps to ensure the effective and efficient use of our resources while incorporating funding from third party sources wherever possible.
Please excuse any omission with a blank as I was not able to clearly make out what he said... hope I have all else as close to exact as possible.
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