Okay, I added, I will delete the old ones to remov
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Posted On: 12/20/2019 9:45:24 AM
Okay, I added, I will delete the old ones to remove clutter from the board.
CytoDyn Cliff Notes
Feel free to give input or correct
Drug in clinical development: Leronlimab
Science Advisors: Dr Sacha/OSHU, Dr. Patterson/IncellDx, Dr. Lindner/ Cleveland Clinic, Dr. Dennis Burger/ex-CSO CYDY, also CEO of several nasdaq bio, Dr. Maddon (inventor or leronlimab and discovered CD4/HIV connection)
Clinical: Dr Dhody/Amarex Clinical Research, Dr Dolezal/Pacific Hematoloty, Dr. Lalezari/Quest Clinical Research
Manufacturing: AGC & Samsung Biologics
Potential benifits: fewer side effects, ZERO Serious Adverse Events in over 850 patients, low toxicity, weekly dosing, high resistance barrier, low food/drug interaction
HIV:
Combo: Unmet Need R5 Population. Fast Track Designation, Completed Phase3 with BLA submission December/January, BLA rolling review
Mono: R5 Population suppressed V.: In Phase 2b/3 investigatory trial. Phase 3 pivotal could start 2020 with FDA approval,
5 patients on mono for over 4 years; over 150 patients on mono for over 1 year
PrEP: Coordinating with Thai Red Cross/Dr Sacha funding for 1200 patient study, one arm monthly dosing
Potential partner US Army, talks with US Senators with funding, first goal BTD submission
Licensing: Vyera US/HIV only, 50% net sales & 87M milestone. Other global and US non-HIV still open.
FDA denied ODD stating population larger than 200k is a possibility
Cancer
Animal: 98% metastatic tumor burden reduction in tnbc mice model
TNBC— Fast Track Designation: Phase 1b/2: Patient 1 CTC reduced to zero in first eight weeks, matching similar results in animal model. Enrolling next two soon. Will Apply for BTD if similar results
Colon—Phase 2 approval, 30 patient with Regorafenib, enrollment not started
Compassionate use approved: melanoma, pancreatic, lung, liver, breast, and prostate
Basket trial with in works with melanoma, pancreatic, lung, liver, breast, and prostate
NASH
Animal: completely in a statistically significant manner inhibited lipid uptake, inhibited liver fibrosis and fatty liver development
Phase 2 approval, 60 patients, random, double blind-enrollment not started
Brenden Rae, “ we expect there to be a significant interest from industry stakeholders in the development of leronlimab for the treatment of NASH.”
GvHD: Orphan Drug Designation
Animal: 100% survival with leronlimab vs 0 without
Phase 2 approval 60 patient, enrollment not started
MS
Phase 2 IND submission coming early 2020
Possible other ccr5 connections:
Stroke, COPD, Alzheimer's Disease, Atherosclerosis, Diabetes, HCV, Inflammatory Bowel, Pulmonary Diseases
CytoDyn Cliff Notes
Feel free to give input or correct
Drug in clinical development: Leronlimab
Science Advisors: Dr Sacha/OSHU, Dr. Patterson/IncellDx, Dr. Lindner/ Cleveland Clinic, Dr. Dennis Burger/ex-CSO CYDY, also CEO of several nasdaq bio, Dr. Maddon (inventor or leronlimab and discovered CD4/HIV connection)
Clinical: Dr Dhody/Amarex Clinical Research, Dr Dolezal/Pacific Hematoloty, Dr. Lalezari/Quest Clinical Research
Manufacturing: AGC & Samsung Biologics
Potential benifits: fewer side effects, ZERO Serious Adverse Events in over 850 patients, low toxicity, weekly dosing, high resistance barrier, low food/drug interaction
HIV:
Combo: Unmet Need R5 Population. Fast Track Designation, Completed Phase3 with BLA submission December/January, BLA rolling review
Mono: R5 Population suppressed V.: In Phase 2b/3 investigatory trial. Phase 3 pivotal could start 2020 with FDA approval,
5 patients on mono for over 4 years; over 150 patients on mono for over 1 year
PrEP: Coordinating with Thai Red Cross/Dr Sacha funding for 1200 patient study, one arm monthly dosing
Potential partner US Army, talks with US Senators with funding, first goal BTD submission
Licensing: Vyera US/HIV only, 50% net sales & 87M milestone. Other global and US non-HIV still open.
FDA denied ODD stating population larger than 200k is a possibility
Cancer
Animal: 98% metastatic tumor burden reduction in tnbc mice model
TNBC— Fast Track Designation: Phase 1b/2: Patient 1 CTC reduced to zero in first eight weeks, matching similar results in animal model. Enrolling next two soon. Will Apply for BTD if similar results
Colon—Phase 2 approval, 30 patient with Regorafenib, enrollment not started
Compassionate use approved: melanoma, pancreatic, lung, liver, breast, and prostate
Basket trial with in works with melanoma, pancreatic, lung, liver, breast, and prostate
NASH
Animal: completely in a statistically significant manner inhibited lipid uptake, inhibited liver fibrosis and fatty liver development
Phase 2 approval, 60 patients, random, double blind-enrollment not started
Brenden Rae, “ we expect there to be a significant interest from industry stakeholders in the development of leronlimab for the treatment of NASH.”
GvHD: Orphan Drug Designation
Animal: 100% survival with leronlimab vs 0 without
Phase 2 approval 60 patient, enrollment not started
MS
Phase 2 IND submission coming early 2020
Possible other ccr5 connections:
Stroke, COPD, Alzheimer's Disease, Atherosclerosis, Diabetes, HCV, Inflammatory Bowel, Pulmonary Diseases
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