Rock, I sent these statements that you made to Nader and Scott Kelly -
>> 30% of the American public has NAFLD..30-65% of HIV patients have NAFLD..!!!
If we were to do an MRI-PDFF on the Patient’s currently in our HIV trial..WE COULD SEE WHETHER LERONLIMAB WORKS..FOR NAFLD..!!!
This data alone could get us a Phase 2/3 NASH study approved by the FDA..!!! FOR BIOPSY PROVEN RESOLUTION OF NASH..!!!
An MRI-PDFF dependent study of a Phase 2. NASH Study...Will lead to a Phase 3 MRI-PDFF Study of the same..This if successful will lead to a BIOPSY PROVEN PHASE 2 and then 3 Study of NASH..Total time to get thru this abomination..3-5 years..!!! If lucky..!!!
WE CANNOT GET APPROVAL FOR NASH..WITHOUT A BIOPSY BACKED STUDY..PERIOD..!!!
Could someone..Anyone..Make OUR Team realize this..!!! <<
>> All our HIV patients are near a facility that harbors a MRI. !!! You have to get a software costing a 180,000 to be able to do a PDFF on it..Instead ..If you use PHANTOMS..Costing a dollar a study..You do it for a dollar on ANY MRI IN THE US..!!!
Doing this on OUR HIV PATIENTS SAVES US A FEW MILLION DOLLARS ON OUR PHASE 2 STUDIES...AND 5 YEARS OF TIME..!!! <<
".If HIV patients on Leronlimab..Show 0% NAFLD.. Compared to 30-65% Acknowledged prevalence in the HIV community ..It provides a very strong case for further evaluation via a BIOPSY CENTERED APPROACH ..!!!"
Scott Kelly responded -
John,
Please see below. This is a quote from Dr. Ken Sherman of University of Cincinnati regarding CCR5 and NASH.
"Medications that people take for HIV treatment sometimes cause fatty liver, and other forms of liver injury," says Sherman. "Following infection with HIV, the gut bacteria leak into the circulation, a process known as bacterial translocation. One of the liver's jobs is to clean bacterial toxins before they get to the rest of the body. Unfortunately, the liver itself is sometimes injured following exposure to bacterial breakdown products, causing injury and scarring.
"We don't have agents that protect the liver from non-specific injury at this time. If CCR5 and CCR2 are central to the pathways that lead to liver scarring then perhaps that injury can be modulated through CCR5 and CCR2 blockade," says Sherman. "It is possible that someday all patients with HIV may be treated with a blocking agent as part of their HIV drug cocktail designed to protect the liver and regain and maintain liver health."
I spoke with Dr. Sherman and he feels CCR5 is the key receptor. We believe we have a tremendous opportunity in both the general population and the HIV population. Thank you for the input.
Best,
Scott A. Kelly, M.D.
