CytoDyn Files a Phase 2 Basket Trial with Leronlimab (PRO 140) for Treatment of All Solid Tumor Cancers
Download as PDFFebruary 06, 2020 6:00am EST
VANCOUVER, Washington, Feb. 06, 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 Phase 2 protocol for a basket trial with the U.S. Food and Drug Administration (FDA) under its cancer IND. The Company can immediately initiate enrollment in this Phase 2 clinical trial for the treatment of approximately 22 different solid tumor cancers, including melanoma, brain-glioblastoma, throat, lung, stomach, colon carcinoma, breast, testicular, ovarian, uterine, pancreas, bladder, among other indications. The Company expects to receive preliminary results on each patient within 3 to 4 weeks after the initial treatment with leronlimab. The Company will continue to enroll patients in its metastatic breast cancer trials.
The basket trial is a Phase 2 study with 30 patients with CCR5+ locally advanced or metastatic solid tumors. Leronlimab will be administered subcutaneously as a weekly dose of 350 mg. Subjects participating in this study will be allowed to receive and continue the standard-of-care chemotherapy as determined by the treating physician.
Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner and an advisor to CytoDyn commented, “The results so far in breast cancer patients have remarkably demonstrated the shrinking of primary tumors, the shrinking or elimination of metastatic lesions, and the reduction of CTCs to zero which has remained stable over weeks. In other studies, we have seen CTC levels in this cancer >5 and some as high as 20 per 4 mL of blood. Further, these data help define the relationship between CCR5 on immune cell infiltrates and response as we analyze these responding patients.”
“If leronlimab proves to be as effective in this basket trial as we have seen in the first 4 patients in our MBC trials, we believe we will be able to file for another breakthrough therapy designation (BTD) for the multiple cancer indications evaluated in this basket trial, which could cover approximately 22 different forms of cancers,” said Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn. “Since we started our cancer trials for mTNBC and compassionate use and expanded access for MBC, we have received requests from patients in the U.S. and overseas. More than 50 patients have requested to use leronlimab and our current basket trial will be able to quickly screen all these patients.”
Download as PDFFebruary 06, 2020 6:00am EST
VANCOUVER, Washington, Feb. 06, 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 Phase 2 protocol for a basket trial with the U.S. Food and Drug Administration (FDA) under its cancer IND. The Company can immediately initiate enrollment in this Phase 2 clinical trial for the treatment of approximately 22 different solid tumor cancers, including melanoma, brain-glioblastoma, throat, lung, stomach, colon carcinoma, breast, testicular, ovarian, uterine, pancreas, bladder, among other indications. The Company expects to receive preliminary results on each patient within 3 to 4 weeks after the initial treatment with leronlimab. The Company will continue to enroll patients in its metastatic breast cancer trials.
The basket trial is a Phase 2 study with 30 patients with CCR5+ locally advanced or metastatic solid tumors. Leronlimab will be administered subcutaneously as a weekly dose of 350 mg. Subjects participating in this study will be allowed to receive and continue the standard-of-care chemotherapy as determined by the treating physician.
Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner and an advisor to CytoDyn commented, “The results so far in breast cancer patients have remarkably demonstrated the shrinking of primary tumors, the shrinking or elimination of metastatic lesions, and the reduction of CTCs to zero which has remained stable over weeks. In other studies, we have seen CTC levels in this cancer >5 and some as high as 20 per 4 mL of blood. Further, these data help define the relationship between CCR5 on immune cell infiltrates and response as we analyze these responding patients.”
“If leronlimab proves to be as effective in this basket trial as we have seen in the first 4 patients in our MBC trials, we believe we will be able to file for another breakthrough therapy designation (BTD) for the multiple cancer indications evaluated in this basket trial, which could cover approximately 22 different forms of cancers,” said Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn. “Since we started our cancer trials for mTNBC and compassionate use and expanded access for MBC, we have received requests from patients in the U.S. and overseas. More than 50 patients have requested to use leronlimab and our current basket trial will be able to quickly screen all these patients.”
3
