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I don't know who does the intro, but we are still under review.
https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/authorization/applications.html
From the press release:
An abstract of the pivotal Phase 2b/3 study is expected to be available online after the conference concludes.
The abstract that you are reading is from the last ASM Microbe conference in June of 2016. The new abstract will be posted after the June 3rd presentation.
From post #1044
If I remember right, Progenics sold PRO140 to Cytodyn becuase at the time PRO140 was being made for HIV patients that abused their meds and it would only generate $50 million a year in sales. Progenics wanted to focus more on their cancer drugs.
When Cytodyn first received PRO140, Nader got a group of people together called KOL (Key Opinion Leaders). They started brainstorming on PRO140. They came up with treatment subtitution which is now the ongoing Phase 2b trail which 11 patients have past 18 months off their HARRT therapy.
Plus 2 Phase 3 trails. One for Monotheraphy which they believe will bring in over a $1 billion in sales.
Another Phase 2 trail for GvHD which could add $500 million in sales. Plus they are exploring the possibilities for cancer(prostate and breast). Plus other immunotherapies.
Do you think Cytodyn will file for compassionate use protocol for patients to stay on Pro 140 after the two week trial?
Prostate Cancer too
Charlie Sheen to be on the Today show on Monday
http://www.today.com/popculture/charlie-sheen-will-return-today-his-first-visit-hiv-announcement-t97536
After four weeks of PRO 140 monotherapy, no patient experienced virologic failure.
Half the patients maintained suppressed viral loads after 8 weeks of monotherapy.
Five patients, however, experienced virologic failures. The first of these 'failures' was documented to be a patient qualification screen failure rather than a drug failure. The Company believes that this is a likely cause in the other failures.
Virologic failures occurred as follows: three patients failed after 5 weeks of monotherapy, one failed after 6 weeks of monotherapy and one patient failure occurred after 7 weeks of monotherapy.
One inclusion criterion for this study required each patient to have an undetectable viral load for the 12 months prior to enrollment. As only HIV patients who have R5 virus exclusively can benefit from PRO 140, each patient is required to take a DNA Trofile test prior to enrollment in the study. However, this test is only about 50% accurate in patients with an undetectable viral load. Therefore, the Company expected to observe a number of viral rebounds due to inaccurate trofile screening as observed thus far. Of the five patients who demonstrated a rebound in their viral load, one patient has been retested and the test results concluded the patient had a "Dual/Mixed Tropic" HIV-1 virus and should have been excluded from the study. The other four patients have been retested for the qualifying R5 exclusive virus and results are expected shortly. CytoDyn is currently investigating the possibility of developing a more accurate screening test for R5 exclusive virus among patients with undetectable virus.
http://www.cytodyn.com/media/press-releases/detail/144/cytodyn-announces-positive-interim-results-from-its
They didn't have the R5 HIV, so they failed. Most of them made it 4 weeks. So Cytodyn developed a better Tropism test to see what type of the virus people have. Check out this link: http://content.equisolve.net/cytodyn/media/a142a8575db88331c0585a336ca2ebfd.pdf look at slide 11. The patients with the R5 are the ones that are still on it. Also look at slide 12.
Agreed, 10% market share would be great. I was just trying show that PRO140 had great potential even when and if Ibalizumab is approved. There is room for both of these.
PRO140
1. There is about 800,000 people in the US with R5 HIV. If you include Europe the number goes to 2.2 Million.
2. About 99% of all new HIV cases are the R5, About 50,000 new cases a year.
3. If the R5 is under control would it mutate to the X4?
4. Less Toxic
5. SC injections once a week, possible every two weeks and maybe once a month.
6. GvHD
7. May have another 12+ uses for
Even if PRO140 had 50% market share, 50% of $16 billion HIV revenue is still $8 billion.
I think Dec. 2015
I believe if you take Maraviroc you still have to take your HARRT medicine and PRO140 you don't.
The press conference back in November, Nader stated that about 800,000 people have the CCR5 type HIV and 99% of all new HIV patients have the CCR5 in the US alone. If you add in Europe it is closer to 2.2 million with the CCR5.
The results for the 11 patients that are left must be good if the FDA is allowing Cytodyn to proceed with the two Phase 3 trails.
Most of them dropped out because they did not have the CCR5. They have improved the testing for CCR5 since them.
Cytodyn's chairman of the board is an ex Gilead senior vice president for manufacturing and operations.
If I remember right, Progenics sold PRO140 to Cytodyn beacuase at the time PRO140 was being made for HIV patients that abused their meds and it would only generate $50 million a year in sales. Progenics wanted to focus more on their cancer drugs.
When Cytodyn first received PRO140, Nader got a group of people together called KOL (Key Opinion Leaders). They started brainstorming on PRO140. They came up with treatment subtitution which is now the ongoing Phase 2b trail which 11 patients have past 18 months off their HARRT therapy.
Plus 2 Phase 3 trails. One for Monotheraphy which they believe will bring in over a $1 billion in sales.
Another Phase 2 trail for GvHD which could add $500 million in sales. Plus they are exploring the possibilities for cancer(prostate and breast). Plus other immunotherapies.
Here is a good article from March 14
http://www.thesuitmagazine.com/health/medicine/22755-charlie-sheen-on-the-brink.html
Here is another article: https://www.poz.com/article/charlie-sheen-pining-wrong-clinical-trial-longacting-hiv-meds
It is from Cytodyns website. cytodyn.com
Investor Presentation:
http://content.equisolve.net/cytodyn/media/a142a8575db88331c0585a336ca2ebfd.pdf
There is about 1.2 million people in U.S. with HIV, and of those 800,000 have the R5. If I remember right. If you include Europe there is over 2.2 million people with the R5 HIV.
It looks like it takes 2-3 weeks to for Tropism test to see if one has the R5 or R4. So we have about another week or so to see if Charlie Sheen qualifies.
http://ltd.aruplab.com/tests/pub/2004747
Orphan Drug is 90 days and Breakthrough Therapy is 60 days. So hopefully end of March for both.
If PRO140 gets Breakthrough Therapy Designation status, Would it speed up the trail any? I'm not really sure what BTD does for a drug.
Maybe Nader's comments are based on if Cytodyn gets Breakthrough Therapy Designation status.
If Charlie S test results come back positive, I believe he would be enrolled in Phase 3 trail that is now ongoing. Cytodyn has not filled for Phase 3 Monotherpy yet and they are not accepting patients.
Well hopefully after this show airs we get a nice bump up. Maybe enough to get listed to NASDAQ. and no more talks of r/s.
This is exciting. I watched the video and that is Nader sitting next to Charlie. Charlie Sheen is back to set the record straight about that experimental HIV treatment he tried and responds to the controversial doctor who told him he was cured. Charlie also opens up about a new, game-changing HIV treatment he’s excited about.
This could be big.
The Chairman of the board for Cytodyn use to be a Senior Vice President, Manufacturing and Operations and was a senior member of Gilead's executive committe. So I could see a buyout from Gilead, maybe.
By the end of March we should know if PRO140 will be approved for BTD for HIV and Orphan Drug for GvHD. It could be an interesting month.
In my opinion. Let them sell their shares. I will be buying more when it dips down below $.80, if it gets that low again. PRO-140 is going to take market share from Gilead and other big Pharma companies with HIV drugs once and if it goes to market. How much are is Big Pharma willing to pay for PRO-140? I'm going to wait and find out and whoever else does shall be rewarded, IMO. It may be 2 months from now or a year. I have been waiting 5 years so whats any year.
During the last press conference Nader pointed that out to a shareholder that asked "what is Cytodyn going to do get the share price up? It sounded like they were going to let it organically rise on its own. When or if PRO-140 gets BTD the share price may take care of itself.