Replies to post #8803 on Cytodyn Inc (CYDY)

[jboatswain]

Yes, we have discussed this before...multiple times...and with the same poster(s).

Whatever you guys discussed was NOT helpful at all. Just don't write off as a short, whenever someone questions the data critically. Dr Pourhassen has provided the answer yesterday for the question I, Pears and goldfish had. It is one thing to say that one doesn't know the answer, quite another thing to call others integrity into question when people have questions about resistance.

http://seekingalpha.com/article/4034678-cytodyns-ceo-dr-nader-pourhassan-presents-investment-community-conference-transcript?page=3

Now I must discuss an interesting and potentially very positive new development pertaining to the non-responders to PRO 140 by some patients with R5 strain in our Phase 2 monotherapy trial that could have implication for our Phase 3 monotherapy trial. So just to remind you, some patient did not respond more than few weeks to monotherapy in our previous Phase 2b trial, while others did, and as you know some are now have passed two years of treatment.

At the FDA’s suggestion we reviewed published data indicating that HIV patients can have widely varying density of CCR5 under cell surface. According to this data that number could exceed the previous acknowledged level of CCR5 by factor exceeding 100 folds.

What does this mean? Well, as we all know, PRO 140 works by blocking the CCR5 receptor that allows HIV to infect cells. This means that those patients who didn't respond to PRO 140 in Phase 2 monotherapy trial might have had a high density of CCR5, which means they could have had more CCR5 under surface of their cell than others, which could indicate that they needed more PRO 140 than others.

We know that only 21 of 39 of the original enrolled patient completed 12-week monotherapy trial. Among the 18 non-responders, eight were treated for infection, which is a non-response issue that could be independent of PRO 140. By excluding these patients 21 of 31 patients or about 70% were responders.

So to put this in a simple language, the lack of response to PRO 140 monotherapy by the other 10 patients in the trial may have been due to an insufficient dose of PRO 140 to address the high CCR5 density. This is encouraging as it may provide insights into why some patients with R5 strain responded, while others did not, like this is not the case."

Another paper that deals with the same issue:
https://www.ncbi.nlm.nih.gov/pubmed/10720514