- 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.
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.
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.
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).
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 (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.
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.
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
Frage: My first question is does the recent decision that FDA decision not to grant you the orphan drug designation have any impact whatsoever on the regulatory review timeframe?
Antwort: Yes, this is Tony. In terms of the orphan drug designation, we were a little disappointed that they did not grant us orphan drug designation. But if you go back a little bit, we actually applied for orphan drug designation with the combination trial in mind and had not negotiated the actual conclusion of monotherapy trial with the FDA at that time. So, we were quite pleased that we were able to have the FDA agreed to move forward with the protocol from monotherapy. And so consequently, after accepting reviewing and approving the monotherapy protocol, I suspect the FDA went back and felt that providing us with orphan drug designation for the combination therapy was not appropriate. So, to specifically answer your question, the denial of orphan drug has virtually no impact on timeline related to completing the combination therapy and then moving forward and completing the monotherapy which would be a second approval.
... announces that in a meeting held on October 12, 2017, the U.S. Food and Drug Administration (FDA) confirmed the number and type of evaluable patients required for submission of a Biologics License Application (BLA) for PRO 140 as a combination therapy. ...
On November 1, 2017, CytoDyn, Inc., a Delaware corporation (the “Company”), held a special meeting of stockholders at which the stockholders approved a proposal to effect a reverse stock split at a ratio of any whole number between one-for-two and one-for-fifteen, as determined by the board of directors, and a simultaneous reduction in the total number of authorized shares of common stock to 200,000,000 at any time before August 24, 2018, if and as determined by the board of directors.
The stockholders also approved an adjournment of the special meeting, if it had been necessary to solicit additional proxies, had there been insufficient votes to approve the reverse stock split.
The final results for each proposal are set forth below. A more detailed description of each proposal is set forth in the Company’s definitive proxy statement filed with the Securities and Exchange Commission on October 2, 2017.
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