The 5/30/24 Webcast Says So
Quote:Dr. Lalezari 10:13: mCRC trial, Inflammation trial,
Now thank you Tyler and I just want to say in the most heartfelt way that it has been a particular pleasure to work alongside Tyler and Mitch on the management team. These last few months, as we have started writing a new chapter to the CytoDyn story. And next, I'd like to provide an update on CytoDyn's overall corporate strategy going forward. So, as we noted in our recent shareholder letter, over the next six months, we expect to commence at least one and potentially two clinical trials.
Those prospective trials in order of priority are first, a phase two study of leronlimab in patients, with relapsed refractory, micro satellite stable, Colorectal cancer. Basically, third line colon cancer and a second study a phase two study exploring leronlimab's effect on inflammation. The company's priority will be the oncology trial, which, if it is successful, will put us on track towards a commercial approval of leronlimab in that indication.
So, the oncology study of leronlimab will involve patients with relapsed colorectal cancer. Colon cancer is among the most common and deadly forms of cancer and unfortunately appears to be increasing in incidence especially among younger people for reasons that are unknown.
Our protocol built on the published pre-clinical work of Dr. Dan Linder at the Cleveland Clinic, who demonstrated that leronlimab inhibited metastasis in a humanized Mouse model of colon cancer. As well as the unpublished, clinical observation that four of six patients with colon cancer in our prior basket trial, had either stable, or partially responsive disease up to 11 months after starting leronlimab.
Dr. Lalezari 12:15:
So, that's the basis and rationale for the study and the proposed clinical study will evaluate leronlimab in patients with colorectal cancer who have received at least one, but no more than two previous lines of treatment. The study will pair leronlimab with an established Salvage regimen and compare both 350 and 700 milligram dose levels.
CytoDyn is currently in the process of discussing the proposed protocol design with the FDA. We're conducting related budgeting and planning our related fundraising efforts and I look forward to providing further details on this study as we confirm our clinical investigators and finalize the clinical protocol of the next several months. As previously noted, starting the oncology study and related fundraising is a top priority of the company at this time.
Dr. Lalezari 13:14: hsCRP, new HIV protocol Inflammation
Our second priority is the inflammation study. Following the company's recent Communications with the FDA, I believe there are two foundational leronlimab questions that CytoDyn needs to address. The first question, after discussing, with our KOLs, key opinion leaders, we need to clarify the specific effect of blocking CCR5 with leronlimab on downstream signaling and biomarkers of inflammation. And second, we need to determine what is the optimal dose of leronlimab to use in the non-HIV and non-antiviral settings. I believe that addressing these questions will provide a framework for the FDA to understand any future clinical efficacy claims CytoDyn makes and help the company accelerate the advancement of leronlimab.
To provide a rationale for the inflammation study, we reviewed data from CytoDyn's prior, NASH, MASH study, where we looked at the effect of leronlimab in the subgroup of patients that entered that study, with inflammation as indicated by elevated levels of C-reactive protein CRP at baseline.
Elevated levels of C-reactive protein or CRP is widely understood to be a key marker of chronic inflammation and associated with heart attacks strokes and other inflammatory illnesses. The re-analysis of our data indicated a very important dose-dependent reduction in C-reactive protein, CRP when leronlimab was dosed at both 350 and 700 mg compared to Placebo. Indeed, the main goal of our inflammation study will be to statistically confirm that leronlimab lowers levels of C-Reactive Protein, as well as other key markers of inflammation.
So, follow in consultation with industry experts and mindful of the FDA's prior feedback, we further revised the inflammation protocol. The study will now enroll 90 HIV positive subjects, who have chronic inflammation as demonstrated by an elevated level of high sensitivity, hsCRP at a pre-screening visit, confirmed at a screening visit at least two weeks apart. These study participants will be treated for six months with weekly subcutaneous leronlimab at either 350 or 700 milligrams or Placebo. And as just mentioned, the primary endpoint will be reduction in C-Reactive Protein with a host of other inflammatory biomarkers evaluated, as secondary endpoints.
Dr. Otto Yang from UCLA has kindly agreed to be the lead investigator for the trial. And the revised protocol will be submitted to the FDA in the next several weeks, which in turn will start a 30-day review, period.
As noted in the recent shareholder letter, I believe it is imperative that the company generate unassailable results in the clinic, and I believe the above two trials can accomplish this.
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