CCR5 receptor antagonist

CytoDyn Receives Clearance from Brazil’s ANVISA to Commence Phase 3 Trial for Severe COVID-19 Patients

Retrieved on: 
Tuesday, August 3, 2021
Biotechnology, FDA, Health, Clinical trials, Health sciences, Leronlimab, Health, Drugs, COVID-19, Long Covid, PASC, CCR5 receptor antagonist, Leronlimab, CytoDyn, LERONLIMAB, CYTODYN

This Phase 3 trial will be conducted in up to 35 clinical sites with 612 patients who are hospitalized and in need of oxygenation support.

Key Points: 
  • This Phase 3 trial will be conducted in up to 35 clinical sites with 612 patients who are hospitalized and in need of oxygenation support.
  • Additionally, ANVISA is reviewing another protocol submitted for a second clinical trial for 316 critically ill COVID-19 patients.
  • After completing two clinical trials with COVID-19 patients (a Phase 2 and a Phase 3), CytoDyn initiated a Phase 2 investigative trial for post-acute sequelae of SARS COV-2 (PASC), also known as COVID-19 Long-Haulers.
  • CytoDyn also completed a Phase 2b/3 investigative trial with leronlimab used as a once-weekly monotherapy for HIV-infected patients.

CytoDyn Announces Preliminary Results from 30 mTNBC Patients Treated with Leronlimab. Decreases in CAMLs after 4 Doses of Leronlimab were Identified in Over 70% of Patients and were Associated with a 450% Significant Increase in Overall Survival at 12-Mon

Retrieved on: 
Monday, July 19, 2021
Leronlimab, Indication, Medicine, Health care, CCR5 receptor antagonist, Health

Based on leronlimabs mechanism of action, we believe these results may provide tangible hope for patients suffering from mTNBC, and potentially other forms of cancer.

Key Points: 
  • Based on leronlimabs mechanism of action, we believe these results may provide tangible hope for patients suffering from mTNBC, and potentially other forms of cancer.
  • As we have said previously, we believe CytoDyn will evolve into an oncology-focused company as well as other potential indications.
  • Nader Pourhassan, Ph.D., CytoDyns President and Chief Executive Officer, added, Todays results validate the strategic decision by CytoDyn to pursue leronlimabs potential cancer indications.
  • We have built a team that is now advancing leronlimab towards potential marketing approval across many indications and therapeutic areas.

CytoDyn’s Trial for Metastatic Triple-Negative Breast Cancer Demonstrates Safety with 350 mg, 525 mg and 700 mg Dosages; Officially Advances to Phase 2 from Phase 1b

Retrieved on: 
Monday, July 12, 2021
Leronlimab, Drugs, Breast cancer, Triple-negative breast cancer, Health, Medical specialties, Management of HIV/AIDS, Cancer, CCR5 receptor antagonist

We believe these safety findings are a tremendous step forward for CytoDyns oncology program for all tumors that have the potential to be treated with leronlimab.

Key Points: 
  • We believe these safety findings are a tremendous step forward for CytoDyns oncology program for all tumors that have the potential to be treated with leronlimab.
  • Physicians and patients have shared their experiences with us supporting their belief that leronlimab has prolonged lives.
  • It is an honor to be entrusted with this mission and we will redouble our efforts to achieve the best outcome possible for leronlimab.
  • The first indication is combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC).

CytoDyn Submits Dose Justification Report to FDA to Begin Overcoming Deficiencies in its BLA for HIV

Retrieved on: 
Thursday, July 1, 2021
Leronlimab, Health, HIV/AIDS, HIV, Food and Drug Administration, CCR5 receptor antagonist

The dose justification report is a key component for the BLA and includes receptor occupancy analysis, among other factors, to determine the optimal marketed dose for leronlimab.

Key Points: 
  • The dose justification report is a key component for the BLA and includes receptor occupancy analysis, among other factors, to determine the optimal marketed dose for leronlimab.
  • Following FDA feedback on this critical step, CytoDyn will begin submission of BLA modules by specified timelines in accordance with FDA guidance and approval.This update is consistent with our intent and commitment to keep CytoDyn investors informed of critical developments.
  • We have a great molecule with many opportunities being evaluated in parallel to the BLA, including COVID, NASH and Oncology.
  • Leronlimab does not work on other strains of HIV (for example X4), however, R5 is the most dominant strain of HIV.

Nature Communications Publishes Study of CytoDyn’s Leronlimab Preventing HIV Infection in Primates

Retrieved on: 
Monday, June 7, 2021
Medicine, Clinical medicine, Health, Leronlimab, Prevention of HIV/AIDS, HIV/AIDS, Pre-exposure prophylaxis, HIV, CCR5 receptor antagonist

Sacha and Ndhlovu for their contributions to this important study and very much look forward to the future PrEP trial to prevent human infection of the AIDs virus.

Key Points: 
  • Sacha and Ndhlovu for their contributions to this important study and very much look forward to the future PrEP trial to prevent human infection of the AIDs virus.
  • PrEP drugs currently available can lead to adverse side effects such as kidney and bone problems, side effects we have not seen with leronlimab.
  • The potential use of leronlimab in multiple therapeutic indications is exciting (i.e., HIV, NASH, cancer, COVID-19).
  • Leronlimab does not work on other strains of HIV (for example X4), however R5 is the most dominant strain of HIV.

CytoDyn and Philippine Airlines Work Together to Provide Filipinos with the Best Possible Treatment Options In the Fight Against Covid-19

Retrieved on: 
Tuesday, June 1, 2021
Leronlimab, Retroviridae, Prevention of HIV/AIDS, HIV/AIDS, Drugs, Sexually transmitted diseases and infections, Medical specialties, Management of HIV/AIDS, HIV, Triple-negative breast cancer, CCR5 receptor antagonist

Philippine Airlines (PAL) has stepped up to help with one of the main challenges, the long delivery time from the USA to the Philippines.

Key Points: 
  • Philippine Airlines (PAL) has stepped up to help with one of the main challenges, the long delivery time from the USA to the Philippines.
  • Filipinos can get more information on how to access leronlimab in the Philippines by contacting CytoDyns local distribution partner Chiral Pharma Corporation.
  • The first indication is combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC).
  • Leronlimab does not work on other strains of HIV (for example X4), however R5 is the most dominant strain of HIV.

CytoDyn Receives First Purchase Order from Chiral Pharma Corporation for Use of Leronlimab Under CSP for COVID-19 Patients in the Philippines

Retrieved on: 
Tuesday, June 1, 2021
Leronlimab, HIV/AIDS, Drugs, Triple-negative breast cancer, Hepatotoxins, Management of HIV/AIDS, Medical specialties, CCR5 receptor antagonist

The Company expects to recognize revenues related to this purchase order upon fulfillment of the purchase order and the terms of the agreement.

Key Points: 
  • The Company expects to recognize revenues related to this purchase order upon fulfillment of the purchase order and the terms of the agreement.
  • The first indication is combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC).
  • There have been no strong safety signals identified in patients administered leronlimab in multiple disease spectrums, including patients with HIV, COVID-19 and oncology.
  • CytoDyn also completed a Phase 2b/3 investigative trial with leronlimab used as a once-weekly monotherapy for HIV-infected patients.

Biomm S.A. Announces Plans to Submit Authorization to Conduct Phase 3 Clinical Studies of Leronlimab with ANVISA in Brazil in the Next Few Days

Retrieved on: 
Thursday, May 27, 2021
Leronlimab, Drugs, Hepatotoxins, Medical specialties, Health, Prevention of HIV/AIDS, CCR5 receptor antagonist

Once approved by ANVISA, the Phase 3 trials will be conducted by Albert Einstein Israelite Hospital, an Academic Research Organization in Brazil.

Key Points: 
  • Once approved by ANVISA, the Phase 3 trials will be conducted by Albert Einstein Israelite Hospital, an Academic Research Organization in Brazil.
  • The COVID-19 trials in Brazil are intended to provide ANVISA with the requisite data to consider advancing the availability of leronlimab to thousands of Brazilians infected with COVID-19.
  • CytoDyn is also conducting a Phase 2 clinical trial for NASH to evaluate the effect of leronlimab on liver steatosis and fibrosis.
  • CytoDyn successfully completed a Phase 3 pivotal trial using leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients.

CytoDyn to Submit Newly Completed Topline Report of CD12 Trial Results to Regulatory Agencies in Multiple Countries including India and Philippines

Retrieved on: 
Tuesday, May 18, 2021
Branches of biology, Leronlimab, Breast cancer, Biology, Drugs, Triple-negative breast cancer, Prevention of HIV/AIDS, HIV/AIDS, Biomarker, Management of HIV/AIDS, CCR5 receptor antagonist

We are very excited for the opportunity to receive our first approval in multiple countries in great need of leronlimab.

Key Points: 
  • We are very excited for the opportunity to receive our first approval in multiple countries in great need of leronlimab.
  • The first indication is combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC).
  • This trial will evaluate the effect of leronlimab on clinical symptoms and laboratory biomarkers to further understand the pathophysiology of PASC.
  • CytoDyn has already completed two trial in COVID-19 patients (a Phase 2 and a Phase 3).

CytoDyn HIV Indication Update: Leronlimab HIV Extension Arm Nearing 7 Years with Continued Excellent Safety Results

Retrieved on: 
Monday, May 3, 2021
HIV/AIDS, Health sciences, Health, Retroviridae, Leronlimab, Sexually transmitted diseases and infections, Clinical trial, HIV, CCR5 receptor antagonist

Clinical results from multiple trials show that Vyrologix can significantly reduce the viral burden in people infected with HIV.

Key Points: 
  • Clinical results from multiple trials show that Vyrologix can significantly reduce the viral burden in people infected with HIV.
  • CytoDyn has gained tremendous insight in the safety of Vyrologix through extension of their three core HIV trials.
  • There have been 66 patients from the original trials still receiving Vyrologix in an open label design with an exposure range of 4-7 years.
  • Nine clinical trials have demonstrated leronlimab could significantly reduce or control HIV viral load in humans.