Thank you misiu. Maybe they will respond. Here is the total numbers I just looked up.
On new slides,
Enrollment closed after reaching 565 patients.
On Jan presentation,
Numbers
325mg 229
500mg 115
700mg 45
The first ~150 eligible subjects were enrolled to receive PRO 140 (leronlimab) 350mg SC weekly injection in a single-arm study. Subsequently, next ~150 subjects were randomized 1:1 to PRO 140 (leronlimab) 350mg (Group A) or PRO 140 (leronlimab) 525mg (Group
. An additional ~200 subjects will be randomized 1:1 to PRO 140 (leronlimab) 525mg (Group or PRO 140 (leronlimab) 700mg (Group C)
June presentation numbers didn’t state the numbers of 325mg, but did gave 525mg and 700mg.
195 on 525mg
124 on 700mg
But 229 (at 350mg from Jan) + 195 (525mg from June) + 124 (700mg from June) = 548 which is just a few shy of the 565 total.
So I think first enrollment of ~150 on 350mg only happened until early 2018
The sebsequent enrollment ~150 on 350mg vs 525mg randomly assigned happened until July 2018
The final ~ 250 enrollment 525mg vs 700mg randomly assigned started in August 2018-June 2019, they had ~100 in Jan 2019, but increased rapidly after the fda requested safety data on 700mg.
So I don’t believe any patients on 350mg were enrolled past July 2018 and the extra overlap started early 2019.
July 30, 2018 PR
https://www.cytodyn.com/newsroom/press-releas...se-rate-at
CytoDyn initiated the trial treating patients with weekly PRO 140 at 350 mg and found that approximately 40% were able to maintain suppressed HIV viral load. Following treatment of the first 150 patients, the protocol was revised to increase the weekly dose of PRO 140 to 525 mg. Patients who were non-responders to PRO 140 at the 350 mg dose were given the opportunity to switch to the higher 525 mg dose, and a majority were able to re-suppress with the higher dose.
“We were pleased that more than 20 patients achieved re-suppressed HIV viral load on PRO 140 525 mg dose after failing the lower PRO 140 350 mg dose and were able to continue in the trial,” said Dr. Pourhassan. “Also of note, patients who achieve suppressed HIV viral load after 10 weeks tend to maintain suppressed viral load. Interestingly, some patients in our Phase 2b extension study are now achieving suppressed HIV viral load for nearly four years with PRO 140 as a single agent.”
“This IRB decision is exciting for patients, our Company and our shareholders, given the potential for a higher patient response rate with PRO 140 as a single agent at the 700 mg dose level,” said Nader Pourhassan, Ph.D., CytoDyn’s president and chief executive officer. “Approximately 70% of trial participants who started with PRO 140 at the 525 mg dose and have been treated between one and nine months are achieving HIV viral load suppression. This response rate is very promising and we are excited to evaluate PRO 140 at an even a higher dose.”
On new slides,
Enrollment closed after reaching 565 patients.
On Jan presentation,
Numbers
325mg 229
500mg 115
700mg 45
The first ~150 eligible subjects were enrolled to receive PRO 140 (leronlimab) 350mg SC weekly injection in a single-arm study. Subsequently, next ~150 subjects were randomized 1:1 to PRO 140 (leronlimab) 350mg (Group A) or PRO 140 (leronlimab) 525mg (Group
. An additional ~200 subjects will be randomized 1:1 to PRO 140 (leronlimab) 525mg (Group or PRO 140 (leronlimab) 700mg (Group C) June presentation numbers didn’t state the numbers of 325mg, but did gave 525mg and 700mg.
195 on 525mg
124 on 700mg
But 229 (at 350mg from Jan) + 195 (525mg from June) + 124 (700mg from June) = 548 which is just a few shy of the 565 total.
So I think first enrollment of ~150 on 350mg only happened until early 2018
The sebsequent enrollment ~150 on 350mg vs 525mg randomly assigned happened until July 2018
The final ~ 250 enrollment 525mg vs 700mg randomly assigned started in August 2018-June 2019, they had ~100 in Jan 2019, but increased rapidly after the fda requested safety data on 700mg.
So I don’t believe any patients on 350mg were enrolled past July 2018 and the extra overlap started early 2019.
July 30, 2018 PR
https://www.cytodyn.com/newsroom/press-releas...se-rate-at
CytoDyn initiated the trial treating patients with weekly PRO 140 at 350 mg and found that approximately 40% were able to maintain suppressed HIV viral load. Following treatment of the first 150 patients, the protocol was revised to increase the weekly dose of PRO 140 to 525 mg. Patients who were non-responders to PRO 140 at the 350 mg dose were given the opportunity to switch to the higher 525 mg dose, and a majority were able to re-suppress with the higher dose.
“We were pleased that more than 20 patients achieved re-suppressed HIV viral load on PRO 140 525 mg dose after failing the lower PRO 140 350 mg dose and were able to continue in the trial,” said Dr. Pourhassan. “Also of note, patients who achieve suppressed HIV viral load after 10 weeks tend to maintain suppressed viral load. Interestingly, some patients in our Phase 2b extension study are now achieving suppressed HIV viral load for nearly four years with PRO 140 as a single agent.”
“This IRB decision is exciting for patients, our Company and our shareholders, given the potential for a higher patient response rate with PRO 140 as a single agent at the 700 mg dose level,” said Nader Pourhassan, Ph.D., CytoDyn’s president and chief executive officer. “Approximately 70% of trial participants who started with PRO 140 at the 525 mg dose and have been treated between one and nine months are achieving HIV viral load suppression. This response rate is very promising and we are excited to evaluate PRO 140 at an even a higher dose.”
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