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Data from 10 Patients with Stage Four Cancer Treated with Leronlimab for Nearly One Year Will Serve as Basis for Pre-Breakthrough Therapy Designation Meeting with FDA
Download as PDFMay 03, 2021 9:02am EDT
VANCOUVER, Washington, May 03, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company" , a late-stage biotechnology company developing leronlimab (Vyrologix or PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it is preparing a request for a pre-Breakthrough Therapy designation (BTD) meeting ahead of preparing a Phase 3 clinical trial protocol for 22 solid tumor cancer indications. The Company is extremely encouraged about the prospects of a Phase 3 trial and BTD based on preliminary indications of patients in the Company’s current Phase 2 basket trial, compassionate use study and a patient treated under an eIND, which may support a smaller trial.

Scott Kelly, M.D., CytoDyn’s Chief Medical Officer, stated, “We are very encouraged by leronlimab’s potential to control metastasis by blocking CCR5 overexpression in cells that undergo malignant transformation. We also believe in the potential of leronlimab in the tumor microenvironment, including decreased angiogenesis, macrophage polarization, and blocking T regulatory cells that turn off the immune system’s ability to fight cancer.”

Dr. Kelly recently presented “The Role of Leronlimab to Treat TNBC” at the Triple Negative Breast Cancer Drug Development Digital Summit 2021 and added, “We appreciate the warm reception of our oncology colleagues at the TNBC digital summit, and the recognition of the potential of leronlimab’s role in the future of immunotherapy.”

Nader Pourhassan, Ph.D., President and Chief Executive Officer, commented, “Our multi-pathway approach to exploring all potential indications for leronlimab is proving to be very encouraging. We look forward to accelerating our efforts in the oncology field with leronlimab. We are equally excited to update our stockholders on Wednesday, especially concerning the potential use of leronlimab in treating COVID-19 in severe, critical, and long-hauler populations.”

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