Charlie Sheen: Kein HIV mehr im Blut nachweisbar

Bei Charlie Sheen hat offenbar das von Cytoyn entwickelte Pro-140 gewirkt. Obwohl noch keine Daten zur aktuell laufenden Studie (Phase III) veröffentlicht wurden, ist der Fall Sheen ggf. stark indikativ für die Wirksamkeit von Pro-140.
Link: https://www.welt.de/vermischtes/article159939879/...-nachweisbar.html

Kurs hat gestern schon etwas angezogen.

Meinungen?

Natürlich keine Kauf- oder Verkaufsempfehlung von mir..  

aktienkurs auf watchlist :-)  

https://www.poz.com/article/...ong-clinical-trial-longacting-hiv-meds

Auch der Kurs hatte diesbezüglich bereits reagiert, wie man am Chart deutlich ablesen kann. Ist aber nun auch wieder zurück gekommen.

Gibt wohl reichlich Warrants etc. für $ 0,75, wenn man die Filings unter SEC liest. ;-)

http://ir.cytodyn.com/all-sec-filings  

...warum sich der Kurs nun um die $ 0,75 bzw. 0,70 Euro herum aufhält. Drunter lohnt sich das Tauschen von Warrants oder Convertibles  eben nicht, gelle ? ;-)

"For such claims about recent research into PRO 140, the public only has CytoDyn’s word. Fourteen months after the official completion of the Phase IIb trial of PRO 140, results have neither been published in a peer-reviewed journal nor presented at a medical conference."

"The 2016 Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, a major annual meeting focusing heavily on HIV science, made no mention of PRO 140. Instead, the non-daily HIV treatment that made a big splash was long-acting cabotegravir/Edurant. "

https://www.poz.com/article/...ong-clinical-trial-longacting-hiv-meds

Meine Meinung.  

Die News spricht sich rum.
Wie hoch geht es hier noch?  

...so weit über pari war, haben einige sicherlich gern gesehen. Man konnte dann später erneut günstig einkaufen gehen. ;-)

http://www.ariva.de/cytodyn-aktie/historische_kurse

In US war im times&sales wieder gut zu sehen, dass da noch immer reichlich verkauft wird. S.a. #3...

Höher gehen dürfte es wohl erst, sobald nun endlich einmal interessante Daten zu Pro-140 Anklang fänden, also nach dem 7. Dezember vielleicht:

http://www.cytodyn.com/media/press-releases/...in-event-on-december-7  

Ich hab mal bissl gesucht was in der Konferenz vom 06.12 so gesagt wurde.
Das einzige was ich finden konnte ist jetzt das Forum von yahoo wo einer bissl berichtet.
Nicht groß aber doch interessant.

https://finance.yahoo.com/quote/CYDY/community?p=CYDY

Auszug:
Finally got to listen to the conference call in it's entirety. P3 Mono has been cleared and patients will be dosed any day now..along with a waiting list. P3 adjunct still on track and Autoimmune first dose Q1 2017...these are the clarifications and confirmations I was hoping to hear. I suspect that we will get the formal Mono PR within the next 10 to 15 days. Consider the Conference validation a chance to get in with cheap shares prior to the masses via..formal PR! Also, with fast tract and AA designation, PRO 140 could be approved early if Mono safety data is reassuring. I think MONO will fill the clinics fast. Nader said patient have had to be turned away..we have a waiting list and a pent up demand . Celebrities are going to help this cause even more.  

meinte natürlich 7 Dezember, nicht den 6ten  

https://www.sec.gov/Archives/edgar/data/1175680/...186/d309639d8k.htm

Auszug:
On December 12, 2016, the Company announced the first several patients have been treated in the Company’s Phase 3 clinical trial with PRO 140 as a single-agent maintenance therapy in virally suppressed subjects with HIV.

und nochmal detailierter:
http://seekingalpha.com/news/...ance-therapy-hiv?source=feed_news_all

interessanter Auszug:
PRO 140 will compete against the only other CCR5 antagonist approved for the treatment of HIV infection, ViiV Healthcare's (NYSE:GSK)(NYSE:PFE)(OTCPK:SGIOY) Selzentry (maraviroc). PRO 140's value proposition compared to Selzentry (and HAART) is less toxicity, fewer side effects and once-weekly administration versus daily.  

CytoDyn Reports Treatment of First Several Patients With PRO 140 in Its Phase 3 Monotherapy Trial for HIV
https://www.bloomberg.com/press-releases/...monotherapy-trial-for-hiv  

https://www.sec.gov/Archives/edgar/data/1175680/.../d511999dex991.htm

Auszug:

- We are on track to reach a major clinical and business inflection point and expect to report initial efficacy results from our pivotal Phase 3 trial with PRO 140 as a combination therapy during the first half of 2017;

- We are encouraged by the interest shown by clinicians and patients alike in our Phase 3 clinical trial with PRO 140 as a monotherapy and anticipate rapid enrollment in this trial;

- We expect to treat the first patient in our Phase 2 trial with PRO 140 in graft versus host disease (GvHD); and

- We are encouraged by recent developments in evaluating PRO 140 for autoimmune diseases and cancer.  

CytoDyn's CEO Dr. Nader Pourhassan Presents Investment Community Conference (Transcript)
http://seekingalpha.com/article/...ranscript?source=feed_all_articles


kleiner Auszug:

Specifically, we overcame many difficult obstacles and undertook many tough challenges, and here we are, two Phase 3 clinical trials and the potential to submit a BLA, Biologic Licensing Agreement for final approval in this year 2017. As you know, we have a clear regulatory path for U.S. approval of PRO 140 for treating HIV patients.

Important milestones for 2017 for our HIV program are; regard to our Phase 3 pivotal trial, now this is the trial we will use to get our first approval for PRO 140. We are on track to reach a major clinical and business inflection point by the end of March by reporting efficacy results from our pivotal Phase 3 trial with PRO 140 as a combination therapy.  

Aus der Konferenz noch kleiner Zusatz:

Turning now to corporate development update number five. We entered 2017 with the strengthened balance sheet, having raised $13 million late last year in support of advancing the development of PRO 140. We are proud to have raised more than $32 million in all of 2016 and more than 70 million since I became CEO in 2012. Obviously, under my leadership we never failed to deliver on this important task.  

CytoDyn Files for Breakthrough Therapy Designation With the FDA for PRO 140 in HIV Therapy
https://www.bloomberg.com/press-releases/...or-pro-140-in-hiv-therapy

Auszug:
CytoDyn Inc.
(OTC.QB:CYDY), a biotechnology company focused on the development of new
therapies for combating human immunodeficiency virus (HIV) infection, today
announced the Company filed a request for Breakthrough Therapy Designation
with the FDA for PRO 140 as a treatment for HIV-1 infection in
treatment-experienced patients with virologic failure.

While the standard of care for HIV infection has been a combination of
medications from different antiretroviral classes that interfere with
different steps of the HIV lifecycle, there is now a significant number of
long-term survivors who are facing issues of drug resistance and need new
treatment options. The Company believes this request for Breakthrough Therapy
Designation addresses this unmet need for novel therapies for the growing
number of heavily treatment-experienced HIV patients.

Based on results from four completed and ongoing clinical trials, the Company
believes the PRO 140 treatment option addresses the unmet medical need for
therapy options for HIV-1 infected patients with uncontrolled viral load,
despite conventional Antiretroviral Therapy (ART).
 

eigentlich poste ich ja nicht unbedingt personalien,
aber wenn ichs richtig lese gehts auch langsam um die vermarktung von Pro140
(man möge mich gerne berichtigen)

CytoDyn Strengthens Executive Management With Appointment of Anthony D. Caracciolo as Executive Chairman
https://www.bloomberg.com/press-releases/...olo-as-executive-chairman

Auszug:
CytoDyn Inc.
(OTC.QB:CYDY), a biotechnology company focused on the development of new
antibody therapies for combating human immunodeficiency virus (HIV) infection,
announces the appointment of Anthony D. Caracciolo as Executive Chairman of
CytoDyn effective immediately.  In this new capacity, Mr. Caracciolo will
assume an active leadership role in the Company’s strategic planning, business
development and operations.  Nader Pourhassan, Ph.D., will continue to serve
as President and Chief Executive Officer, and Mr. Caracciolo will retain his
position as Chairman of the Board.

“We are committed to increasing shareholder value and this appointment is
aimed at strengthening our management team and driving our corporate
strategy,” said Dr. Pourhassan. “Mr. Caracciolo’s significant industry and
operational experience is expected to be highly valuable in directing our
ongoing clinical trials and enhancing business development efforts as we
pursue broader strategic opportunities for our late-stage PRO 140 technology
to increase the franchise value of our pipeline.”  

CytoDyn commences $1.2M direct capital raise; shares ease 3%
http://seekingalpha.com/news/...s-ease-3-percent?source=feed_news_all


- CytoDyn (OTCQB:CYDY -3.3%) inks agreements with certain investors for the direct placement of 1,534,999 shares of common stock at $0.75/share. Buyers will also receive five-year warrants to purchase 767,498 shares of common at $1.

- Net proceeds of ~$1M will fund clinical trials and general corporate purposes. Closing date is today.

- Yesterday's close was $0.73.
 

Two-Year Update From CytoDyn’s PRO 140 Monotherapy Study in HIV to be Featured in Two Events at CROI 2017
https://www.bloomberg.com/press-releases/...n-two-events-at-croi-2017

Auszug:
CytoDyn  Inc.
(OTC.QB:CYDY), a  biotechnology  company focused  on  the development  of  new
antibody therapies for combating human immunodeficiency virus (HIV) infection,
announces that data from its ongoing Phase 2b extension study with PRO 140  as
a monotherapy for the treatment of  HIV-infected patients will be the  subject
of a poster  presentation on  February 15  and will  be featured  in a  Themed
Discussion on February 16 at the Conference on Retroviruses and  Opportunistic
Infections (CROI) being  held in  Seattle.  Dr. Kush  Dhody, Senior  Director,
Clinical Operations at  Amarex Clinical Research,  will make the  presentation
and participate in the discussion on behalf of CytoDyn.

denke mal wird bei uns dann auf die nacht zum donnerstag sein.
da ich donnerstags trainier werd ich eventuell erst freitag erfahren wies ausschaut.
aber vielleicht kann ja einer der stillen mitleser schon eher was einstellen zu den daten.  

Data Presented at CROI Show CytoDyn’s Pro 140 as a Single Agent Provided Maximal Virologic Suppression in HIV Patients for Ne
https://www.bloomberg.com/press-releases/...on-in-hiv-patients-for-ne

2 hervorzuhebende Sätze:
"It is indeed an honor to present this data to attendees at CROI 2017.”
und
“We are excited about both Phase 3 trials with PRO 140,”

so weit ichs versteh sind da wirklich paar gute Neuigkeiten bei.  

Nachrichten sind nicht so wichtig schau auf den Kurs der sagt alles
Gestern +8%
bleibt abzuwarten ob und wie viel  jemand bereit ist auf den Tisch zu Legen
der CEO spricht von Goldenen Jahr

http://seekingalpha.com/article/...nt-community-conference-transcript

Hoffe auch für uns Kleinanleger ;-))
ciao  

bei guten News/Fortschritten sind die leute eher bereit geld aufn tisch zu legen ;)  

Die Leute
Ich glaube Gilead , Glaxo oder sonst wer kennen schon die News/Fortschritte
was bleibt
A-es gibt schon Verhandlungen
B- alle warten ab je weiter Fortgeschritten um so Sicherer
C-es ich doch nicht so Toll
es gibt Gerüchte Gilead hätte schon Leute drin bei Cyto Dyn
ciao
 

Pro140 Präsentation wurde aktualisiert

Filling:
https://www.sec.gov/Archives/edgar/data/1175680/...953/d541270d8k.htm

Kopie der Präsentation:
https://www.sec.gov/Archives/edgar/data/1175680/.../d541270dex991.htm  

SHAREHOLDER ALERT: Purcell Julie & Lefkowitz LLP Is Investigating CytoDyn Inc. for Potential Breaches Of Fiduciary Duty By Its Board of Directors
https://www.bloomberg.com/press-releases/...-of-fiduciary-duty-by-its

wasn da los????  

10-Q
https://www.sec.gov/Archives/edgar/data/1175680/...00/d353531d10q.htm
 

Potential for CytoDyn’s PRO 140 for Treating HIV Patients Deemed Too Broad for Orphan Drug Designation by the FDA
https://www.bloomberg.com/press-releases/...ug-designation-by-the-fda

wenns ichs richtig les hat FDA abgelehnt weil se mehr potential in Pro140 sehen???