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CytoDyn Inc (OTCMKTS:CYDY) Leronlimab; One Molecule Multiple Opportunities

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CytoDyn Inc (OTCMKTS:CYDY) has been making big moves in recent days including filing a protocol with the FDA) for a Phase 2 clinical trial for leronlimab as a treatment for COVID-19 patients suffering from long-hauler symptoms entitled: ”A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab in Patients Experiencing Prolonged Coronavirus Disease 2019 (COVID-19) Symptoms [Long-Haulers]. The Company also reported Health Canada has cleared CytoDyn to file its Biologics License Application (BLA) for leronlimab as a combination therapy for multi-drug resistance HIV patients in Canada. CytoDyn said in a statement, the Company looks forward to filing its BLA in the very near future.

The Company also reported 9 of its trademark applications to register the VYROLOGIX mark have now successfully passed through formal examination. In summary, the U.S. and E.U. applications have been allowed, applications in Hong Kong, China and Russia have registered, and the Company’s applications in Australia, Israel, New Zealand and Singapore will each proceed to registration once they have passed through the opposition period unopposed.

CytoDyn Inc (OTCMKTS: CYDY) is a biotech focused on developing innovative treatments for multiple therapeutic indications. Its lead candidate Leronlimab (PRO 140) belongs to a new class of therapeutics called viral-entry inhibitors and is one of the most advanced experimental monoclonal antibodies for HIV treatment, GVHD, NASH, stroke recovery, multiple sclerosis, Parkinson’s disease, metastatic cancer and coronavirus. Leronlimab, the Company’s CCR5 antagonist, a once a week, subcutaneous injection. One molecule with multiple opportunities.

Leronlimab is showing considerable value in potentially mitigating the “cytokine storm” believed to play an integral role in the development of acute respiratory distress syndrome (ARDS) in those affected by COVID-19. Chemokines and chemokine receptors play a critical role in the recruitment, activation, and coordination of leukocytes in the pathophysiology of lung inflammation. The acute respiratory distress syndrome (ARDS) of COVID-19 results from the accumulation of neutrophils within the pulmonary circulation and alveolar spaces. Leronlimab (PRO 140) inhibits the migration of Tregs into areas of inflammation, which can inhibit the innate immune response against pathogens and, most importantly, the migration of macrophages and release of pro-inflammatory cytokines in lungs.

Recent laboratory data for patients treated with leronlimab for COVID-19 infection has shown increases in the profoundly decreased CD8 T-lymphocyte percentages by Day 3, normalization of CD4/CD8 ratios, and resolving cytokine production including reduced IL-6 correlating with patient improvement. The current data suggests a trend toward the restoration of immune function by day 7. Restoration of the immune function is critical in COVID-19 patients to prevent opportunistic infections.

Leronlimab has been administered to fifteen severely ill COVID-19 patients at four hospitals, ten patients treated at a leading medical center in the New York City area, and five patients at three other hospitals. Each patient received treatment under an emergency investigational new drug (EIND), which was granted by the U.S. Food and Drug Administration (FDA) for each patient. The evaluation of leronlimab for patients with mild-moderate COVID-19 indications will be conducted under the Company’s Phase 2 randomized clinical trial. Also, CytoDyn has the approval to proceed with a Phase 2b/3 trial for 390 severely ill COVID-19 patients. This study is a double-blinded study with a 2:1 ratio (a drug to placebo ratio). Patients enrolled in this trial are expected to be administered leronlimab for two weeks, with the primary endpoint being the mortality rate at 28 days and a secondary endpoint of the mortality rate of 14 days. The Company will perform an interim analysis of the data from 50 patients following two weeks of leronlimab therapy.

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Health Canada recently cleared CytoDyn to file its Biologics License Application (BLA) for leronlimab as a combination therapy for multi-drug resistance HIV patients in Canada. CytoDyn said in a statement, the Company looks forward to filing its BLA in the very near future. Health Canada’s decision validates the opportunity for leronlimab as a treatment for HIV patients around the world. The Company also updated health Canada on its COVID-19 trials and plans to simultaneously file its BLA for leronlimab as a combination therapy for HIV with the MHRA in the U.K. and Health Canada.”

Nine of CytoDyns trademark applications to register the VYROLOGIX mark have now successfully passed through formal examination. In summary, the U.S. and E.U. applications have been allowed, applications in Hong Kong, China and Russia have registered, and the Company’s applications in Australia, Israel, New Zealand and Singapore will each proceed to registration once they have passed through the opposition period unopposed. The name Vyrologix as the proprietary name for leronlimab is conditional on FDA approval of the Company’s Biologics License Application and new drug application.

On November 17 CytoDyn announced it has filed a protocol with the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical trial for leronlimab as a treatment for COVID-19 patients suffering from long-hauler symptoms. According to a recent article from The Journal of the American Medical Association and a study done by British scientists, researchers estimate about 10% of COVID-19 patients become long-haulers. CytoDyn’s protocol for its Phase 2 COVID-19 long-haulers trial is entitled:”A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab in Patients Experiencing Prolonged Coronavirus Disease 2019 (COVID-19) Symptoms [Long-Haulers].” The planned number of patients is 102 to be enrolled in up to 10 sites. The study will have an interim analysis after half of the patients are enrolled and will allow CytoDyn to report the results.

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Cytodyn is among the first biotechs to have a drug that is proving to be effective in the global fight against coronavirus COVID-19 world epidemic. Leronlimab (PRO 140) belongs to a new class of therapeutics called viral-entry inhibitors and is one of the most advanced experimental monoclonal antibodies for HIV treatment and is proving to be effecting in GVHD, NASH, stroke recovery, multiple sclerosis, Parkinson’s disease, metastatic cancer and coronavirus. Leronlimab can potentially mitigate the cytokine storm which plays an integral role in the development of acute respiratory distress syndrome (ARDS) in those affected by COVID-19. Leronlimab inhibits the migration of Tregs into areas of inflammation, which can inhibit the innate immune response against pathogens and, most importantly, the migration of macrophages and release of pro-inflammatory cytokines in lungs. Recent laboratory data for patients treated with leronlimab for COVID-19 infection has shown increases in the profoundly decreased CD8 T-lymphocyte percentages by Day 3, normalization of CD4/CD8 ratios, and resolving cytokine production including reduced IL-6 correlating with patient improvement. The current data suggests a trend toward the restoration of immune function by day 7. For more on CytoDyn Subscribe Right now by entering your email below. MicroCapdaily has been reporting on Cytodyn since it was pennies.

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Disclosure: we hold no position in CYDY either long or short and we have not been compensated for this article.

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1 Comment

  1. #Why doesn’t Cytodyn go back to “Emergency Care dosage”. at least it could be saving some lives
    doing this resurgence of the virus. I would think that would be a suggestion of the FDA if they are serious about saving lives.

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