Management of HIV/AIDS

CytoDyn to Present at Wall Street Reporter’s “NEXT SUPER STOCK” Livestream Event on April 17, 2020 at 12:30 pm ET / 9:30 am PT

Retrieved on: 
Thursday, April 16, 2020
Life sciences, Articles, Medical specialties, HIV/AIDS, Monoclonal antibodies, Biopharmaceutical, Biotechnology, Pharmacy, PRO 140, CCR5 receptor antagonist, Management of HIV/AIDS, CCR5

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.

Key Points: 
  • 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.
  • 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 April 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.

First Patient Treated with Leronlimab in Phase 2b/3 Trial for COVID-19

Retrieved on: 
Wednesday, April 15, 2020
Health, Medical specialties, Medicine, Hepatotoxins, Clinical research, Design of experiments, Management of HIV/AIDS, Prevention of HIV/AIDS, Clinical trial, Zidovudine, Graft-versus-host disease, Randomized controlled trial

Concurrently, the Company has about 15 patients enrolled in its Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S.

Key Points: 
  • Concurrently, the Company has about 15 patients enrolled in its Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S.
  • Thus far, over 30 COVID-19 patients have been treated with leronlimab in hospitals and clinics throughout the country.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.
  • 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.

CytoDyn Collaborating with U.K.’s Department of Health to Provide Emergency Access to Leronlimab for Severe and Critically Ill COVID-19 Patients

Retrieved on: 
Tuesday, April 7, 2020
Health, Medicine, Hepatotoxins, Clinical research, HIV/AIDS, RTT, Zidovudine, Management of HIV/AIDS, Clinical trial, Placebo, PRO 140, CCR5 receptor antagonist

The FDA recently cleared the Company to initiate a Phase 2b/3 clinical trial for severe and critically ill COVID-19 patients for which enrollment is now underway.

Key Points: 
  • The FDA recently cleared the Company to initiate a Phase 2b/3 clinical trial for severe and critically ill COVID-19 patients for which enrollment is now underway.
  • The Phase 2b/3 trial for severe and critically ill COVID-19 patients is for 390 patients, double blinded with 2:1 ratio (active drug to placebo ratio).
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.
  • CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients.

Treatment with CytoDyn's Leronlimab Indicates Significant Trend Toward Immunological Restoration in Severely Ill COVID-19 Patients

Retrieved on: 
Thursday, April 2, 2020
Medical specialties, Medicine, Hepatotoxins, Branches of biology, Immunology, Management of HIV/AIDS, Prevention of HIV/AIDS, HIV/AIDS, Zidovudine, Cytokine, HIV, CD4+/CD8+ ratio

Patient test data reveals improvement in cytokines, IL-6, and a trend toward the normalization of the CD4/CD8 ratio.

Key Points: 
  • Patient test data reveals improvement in cytokines, IL-6, and a trend toward the normalization of the CD4/CD8 ratio.
  • The current data suggests a trend toward the restoration of immune function and mitigation of the cytokine storm.
  • This is consistent with prior laboratory results in the first four patients treated for COVID-19 with leronlimab.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.

CytoDyn Files a Clinical Trial Protocol with the FDA to Treat Severely Ill COVID-19 Patients with Leronlimab where the Primary Endpoint is Mortality Rate at Two Weeks

Retrieved on: 
Wednesday, April 1, 2020
Health, Hepatotoxins, Medicine, Clinical pharmacology, Management of HIV/AIDS, Prevention of HIV/AIDS, Zidovudine, Clinical trial, PRO 140, CCR5 receptor antagonist

This trial will be conducted under the same FDA-approved IND as the Companys recently initiated Phase 2 clinical trial to treat COVID-19 patients with mild-to-moderate indications.

Key Points: 
  • This trial will be conducted under the same FDA-approved IND as the Companys recently initiated Phase 2 clinical trial to treat COVID-19 patients with mild-to-moderate indications.
  • The new protocol for Severely Ill COVID-19 patients is for 342 patients, double blinded with 2:1 ratio.
  • Patients enrolled in this trial are expected to be administered leronlimab for two weeks with the primary endpoint being the mortality rate at 14 days.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.

“Next Super Stocks” in News:  CYDY: Coronavirus Treatment Progress.  FBNK: fuboTV ($223 million run rate) Merger = Streaming Powerhouse. NEXCF: Remote Work/Learning Acquisition, Revenues Accelerating.

Retrieved on: 
Tuesday, March 31, 2020
FuboTV, Management of HIV/AIDS

FaceBank Group (OTC: FBNK) a featured presenter at Wall Street Reporters NEXT SUPER STOCK conference series, is merging with fuboTV, direct-to-consumer live TV streaming platform with a current revenue run rate of $223 million.

Key Points: 
  • FaceBank Group (OTC: FBNK) a featured presenter at Wall Street Reporters NEXT SUPER STOCK conference series, is merging with fuboTV, direct-to-consumer live TV streaming platform with a current revenue run rate of $223 million.
  • fuboTV plans to leverage FaceBanks IP sharing relationships with leading celebrities and other digital technologies to enhance its sports and entertainment offerings.
  • Watch FBNK NEXT SUPER STOCK livestream video:
    NexTech AR Solutions (OTC: NEXCF) (CSE: NTAR) Revenues Accelerating with New Social Trends Driving E-Commerce, AR adoption.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.

CytoDyn Completes Non-dilutive $15 Million Convertible Note Financing with Conversion Rate at $4.50 Per Share without Warrants

Retrieved on: 
Tuesday, March 31, 2020
Hepatotoxins, Drugs, Prevention of HIV/AIDS, RTT, HIV/AIDS, Medical specialties, Management of HIV/AIDS, Zidovudine, PRO 140, CCR5 receptor antagonist

The note, has a two-year maturity, bears interest at the rate of 10% per annum and is secured by all assets of the Company, excluding its intellectual property.

Key Points: 
  • The note, has a two-year maturity, bears interest at the rate of 10% per annum and is secured by all assets of the Company, excluding its intellectual property.
  • The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.
  • CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients.

FDA Clears CytoDyn’s Phase 2 Randomized Trial to Treat Mild-to-Moderately Ill Coronavirus Patients with Leronlimab; Enrollment to Begin Immediately

Retrieved on: 
Tuesday, March 31, 2020
Viruses, Hepatotoxins, Medical specialties, Health, HIV/AIDS, Azides, RTT, Zidovudine, Severe acute respiratory syndrome, Management of HIV/AIDS, HIV, PRO 140

Patients enrolled in the trial are expected to have a treatment window of approximately 6 weeks.

Key Points: 
  • Patients enrolled in the trial are expected to have a treatment window of approximately 6 weeks.
  • SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.
  • CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients.

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

Retrieved on: 
Friday, March 27, 2020
Hepatotoxins, Chemical substances, Management of HIV/AIDS, Prevention of HIV/AIDS, Zidovudine, Chemical compounds, Medical specialties, HIV/AIDS

We will now also immediately file a second trial protocol, per the FDAs suggestion, for severely ill COVID-19 patients.

Key Points: 
  • We will now also immediately file a second trial protocol, per the FDAs suggestion, for severely ill COVID-19 patients.
  • COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact.
  • The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.

U.S. Food and Drug Administration (FDA) Grants Emergency IND for Two Coronavirus Patients Treated in New York with CytoDyn’s Leronlimab

Retrieved on: 
Thursday, March 19, 2020
Hepatotoxins, Medical specialties, Branches of biology, Regulatory T cell, Medicine, HIV/AIDS, Zidovudine, Management of HIV/AIDS, PRO 140, Tuberculosis in relation to HIV

The treatment was administered at a leading medical center in the New York City area under an emergency Investigational New Drug (IND) recently granted by the U.S. Food and Drug Administration (FDA).

Key Points: 
  • The treatment was administered at a leading medical center in the New York City area under an emergency Investigational New Drug (IND) recently granted by the U.S. Food and Drug Administration (FDA).
  • Leronlimab is intended to serve as a therapy for patients who experience respiratory illness as a result of contracting the Coronavirus Disease 2019 (COVID-19).
  • In addition, leronlimab can block Regulatory T cells (Tregs), which can inhibit the innate immune response against pathogens, into areas of inflammation.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients.