MOMO'S BREAKOUT BOARD

[dude iligence]

CYDY $1.37 +46% today alerted last week at $1. A lot more to this company than meets the eye at first glance. Read closely pay attention to the bold.



initial run .30 to $1.7ish 5.5 bagger. Second leg a 5 bagger from $1 is $5
$1.17 breakout above 50ma($1.10) on Huge news! CytoDyn Files FDA-Suggested Modifications to IND and Protocol for Phase 2 Clinical Trial for COVID-19 Patients with Mild to Moderate Indications and a Second Randomized Protocol for All COVID-19 Patients in Severe Condition Will be Filed Next Week per FDA Recommendation
https://finance.yahoo.com/news/leronlimab-used-seven-patients-severe-100010810.html

GlobeNewswire GlobeNewswire•March 27, 2020
VANCOUVER, Washington, March 27, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that, at the suggestion of the U.S. Food and Drug Administration (FDA), the Company filed another round of modifications to its IND and protocol for a Phase 2 clinical trial with leronlimab (PRO 140). In addition, the FDA suggested the Company file a second randomized protocol for all COVID-19 patients in severe condition, so as to preclude each physician from filing an emergency IND for every patient to be treated with leronlimab.

The treatment with leronlimab is targeted as a therapy for patients who experience respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19). Leronlimab is believed to provide therapeutic benefit by enhancing the immune response while mitigating the “cytokine storm” that leads to morbidity and mortality in these patients.

The first Phase 2 clinical trial that was filed on March 26 is a randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of leronlimab in patients with mild to moderate documented COVID-19 illness and calls for 75 planned patients in up to 10 centers in the United States. Patients enrolled in the trial are expected to have a treatment window of approximately 6 weeks.

Jacob Lalezari, M.D., Interim Chief Medical Officer for CytoDyn, said, “We are grateful for the responsiveness of the FDA and very pleased that the same New York medical center currently treating severely ill COVID-19 patients with leronlimab under emergency access has agreed to take the lead on initiating this randomized Phase 2 trial in patients with mild to moderate illness."

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, “On behalf of all COVID-19 patients, we are thankful for the FDA’s responsiveness and their ability to provide timely guidance in order to collaboratively finalize our Phase 2 trial protocols. We will now also immediately file a second trial protocol, per the FDA’s suggestion, for severely ill COVID-19 patient

About Leronlimab (PRO 140)
The FDA has granted a “Fast Track” designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).










Leronlimab Used in Seven Patients with Severe COVID-19 Demonstrated Promise with Two Intubated Patients in ICU, Removed from ICU and Extubated with Reduced Pulmonary Inflammation
GlobeNewswire GlobeNewswire•March 27, 2020
IncellDx’s evaluation of test results from the first four patients suggests immunological benefit within three days following treatment with leronlimab on all four patients and lower level of cytokine storm, especially IL-6 and TNF-a, which were reduced significantly

VANCOUVER, Washington, March 27, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the three-day results post-leronlimab treatment of the first four patients under an Emergency Investigational New Drug (EIND) granted by the U.S. Food and Drug Administration (FDA). A total of seven patients have been enrolled thus far under EIND in the same leading medical center in the New York City area.

The treatment with leronlimab is targeted as a therapy for patients who experience respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19). Leronlimab is believed to provide therapeutic benefit by enhancing the immune response while mitigating the “cytokine storm” that leads to morbidity and mortality in these patients.

Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, said, “IncellDx has developed specific companion diagnostic tests to determine the efficacy and dosing of leronlimab in these severe cases of COVID-19. We found that patients with severe COVID-19 disease are in the midst of immunologic chaos which includes the cytokine storm. Our companion diagnostics showed that after three days of therapy, the immune profile in these patients approached normal levels and the levels of cytokines involved in the cytokine storm were much improved.”

Jacob Lalezari, M.D., Interim Chief Medical Officer of CytoDyn, commented, “These preliminary results give hope that leronlimab may help hospitalized patients with COVID-19 recover from the pulmonary inflammation that drives mortality and the need for ventilators. A leading medical center in the heart of the New York City epidemic was instrumental in giving the preliminary data.”

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said: “We are extremely pleased for the coronavirus patients under the care of the treating medical team and that the FDA is so responsive to advance our Phase 2 clinical trial. I am very hopeful that leronlimab can help to reduce the rate of mortality among COVID-19 patients with severe symptoms of ARDS and to assist our government to fight this battle.”

About Coronavirus Disease 2019
SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140)
The FDA has granted a “Fast Track” designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted “orphan drug” designation to leronlimab for the prevention of GvHD.

About CytoDyn
CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in the first quarter of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at www.cytodyn.com.



Time to connect the dots.
leronlimab is in clinical trials for treatment of HIV patients and Cancer Metastatic Breast cancer. It limits the Cancer to one area so it can be dealt with. For HIV patients

leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years

Right now its being fast tracked for use in Covid 19 patients to fight lung cytokine storm (inflammation which kills them).

Best case senario for shareholders

1. leronlimab is proven to save covid 19 patients lives, HUGE NEWS!
2. leronlimab gets massive media spotlight
3. leronlimab clinical trials for HIV and Cancer treatment prove effective.
4. Skys the limit.