CytoDyn Files Request with FDA for Preliminary Meeting for Breakthrough Therapy Designation for Leronlimab in the Treatment of Cancer
Download as PDFApril 03, 2020 6:15am EDT
The Company’s pursuit of a Breakthrough Therapy designation is further strengthened by continued strong clinical indications from mTNBC and MBC patient data
VANCOUVER, Washington, April 03, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: 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 it has filed a request with the U.S. Food and Drug Administration (FDA) for a preliminary meeting to discuss new clinical data which the Company believes further supports its objective to obtain Breakthrough Therapy designation (BTD) for leronlimab in the treatment of metastatic triple-negative breast cancer (mTNBC). The FDA had previously granted Fast Track designation to leronlimab for the treatment of mTNBC. Last month, the Company reported that the FDA had recommended such a meeting to provide preliminary advice prior to resubmission of a Breakthrough Therapy designation request. Concurrent with the Company’s Phase 1b/2 trial for mTNBC and expanded access studies for MBC, it is also conducting a Phase 2 trial with leronlimab for 22 solid cancer tumors.
Metastatic triple-negative breast cancer (mTNBC), an aggressive histological subtype, has a poor prognosis. In addition, metastatic breast cancer (MBC) is breast cancer that has spread beyond the breast and lymph nodes to other organs in the body (typically the bones, liver, lungs, or brain). Both types of cancer pose significant challenges for patients due to their aggressiveness and limited treatment options.
The Company’s Phase 1b/2 study involves monitoring of circulating tumor cells (CTC), epithelial mesenchymal transition in tumor metastasis (EMT), and cancer-associated microphages like cells (CAML) every 21 days during the treatment phase.
Nader Pourhassan, Ph.D., President and Chief Executive officer of CytoDyn, commented, “We are extremely encouraged by the test results from these patients and continue to keep the FDA current on therapeutic benefit demonstrated by leronlimab for multiple cancer indications.”
Download as PDFApril 03, 2020 6:15am EDT
The Company’s pursuit of a Breakthrough Therapy designation is further strengthened by continued strong clinical indications from mTNBC and MBC patient data
VANCOUVER, Washington, April 03, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: 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 it has filed a request with the U.S. Food and Drug Administration (FDA) for a preliminary meeting to discuss new clinical data which the Company believes further supports its objective to obtain Breakthrough Therapy designation (BTD) for leronlimab in the treatment of metastatic triple-negative breast cancer (mTNBC). The FDA had previously granted Fast Track designation to leronlimab for the treatment of mTNBC. Last month, the Company reported that the FDA had recommended such a meeting to provide preliminary advice prior to resubmission of a Breakthrough Therapy designation request. Concurrent with the Company’s Phase 1b/2 trial for mTNBC and expanded access studies for MBC, it is also conducting a Phase 2 trial with leronlimab for 22 solid cancer tumors. Metastatic triple-negative breast cancer (mTNBC), an aggressive histological subtype, has a poor prognosis. In addition, metastatic breast cancer (MBC) is breast cancer that has spread beyond the breast and lymph nodes to other organs in the body (typically the bones, liver, lungs, or brain). Both types of cancer pose significant challenges for patients due to their aggressiveness and limited treatment options.
The Company’s Phase 1b/2 study involves monitoring of circulating tumor cells (CTC), epithelial mesenchymal transition in tumor metastasis (EMT), and cancer-associated microphages like cells (CAML) every 21 days during the treatment phase.
Nader Pourhassan, Ph.D., President and Chief Executive officer of CytoDyn, commented, “We are extremely encouraged by the test results from these patients and continue to keep the FDA current on therapeutic benefit demonstrated by leronlimab for multiple cancer indications.”
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