Replies to post #14474 on Cytodyn Inc (CYDY)

[Amatuer17]

Don't know much about it but it clearly is serious competition - also they will be years ahead compared to CYDY

PRO-140 has 52 week trial but they had 24 weeks P3 - so why CYDY went for 52 weeks for monotherapy?

"The ibalizumab BLA is based on data from the phase III TMB-301 study, a single arm, 24-week study of ibalizumab plus an optimized background regimen (OBR) in treatment-experienced patients infected with MDR HIV-1. Full results from the trial were recently presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2017."

[misiu143]

Titan V--Ibalizumab will be live saving for patients CCR5 negative , with resistance to HAART.

It is CD4 inhibitor , and most probably sooner on the market than Pro 140 , but IMO not a very big competition to it.
It is giving as an IV injection every two wks. So patients need to go to clinic or hospital every 2 weeks for IV infusion.

From TaiMed web....."Phase 1/2 clinical trial of SC and IM injection started in 2012 in Taiwan for HIV positive and HIV negative patients.The current available
UN- AUDITED data show tremendous antivirus activity "

All together studies are done as an adjunct treatment only.

I exchanged few e-mails in the past with Dr Chen from TaiMed , and according to him they not planning monotherapy for HIV positive patients.
Monotherapy they doing study only with HIV negative , high risk patients as a prevention.

With adjunct phase 3 ( 30 patients total ) they have 36% patients
accomplished <50 copies/mil viral load.
If we looking at Pro 140 , even without adjusting the dose 62.5% patients on monotherapy did very well , with many patients <1copy/mill viral load.
With adjunct I expect even better.
One patient stop Ibalizumab because developed some immune problems . This is not happening with Pro 140.

For those reasons IMO Pro 140 is superior with CCR5 positive patients.