CytoDyn Receives Institutional Review Board Approval to Initiate Phase 2 Basket Trial for 22 Solid Tumor Cancers
Results from mTNBC and MBC studies continues to be positive with the first patient now at almost five months of treatment showing zero CTC, EMT and CAML. Seven patients have been enrolled to date
https://www.cytodyn.com/newsroom/press-releas...pproval-to
VANCOUVER, Washington, Feb. 21, 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, reported that it has received Institutional Review Board (IRB) approval to begin its 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.
Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn, stated, “We currently have more than 70 patients eagerly waiting to participate in this basket trial and expect the first patient injection to take place within approximately ten days. Furthermore, overall enrollment of the trial could be completed in as little as 30 to 60 days, as this is a 30-patient trial.”
This basket trial is a 30 patient, CCR5+ Phase 2 study with locally advanced or metastatic solid tumors. Leronlimab will be administered subcutaneously as a weekly dose of 350 mg. Patients participating in this study will be allowed to receive and continue the standard-of-care chemotherapy as determined by the treating physician.
The clinical trial will take place at multiple sites across the U.S., with preliminary results on each patient expected within three to four weeks after the initial treatment with leronlimab. The primary endpoint of the basket trial is progression-free survival.
“Peripheral blood sampling from Patient #1 in the mTNBC trial, who has been on leronlimab for approximately five months, revealed no cancer cells or cancer associated cells (0 CTC, 0 EMT and 0 CAML). In addition, Patient #2, who has been on leronlimab for almost 3 months in the MBC study, with brain metastasis, continues to show in the latest CT scan, stable lesions that are now described as scar-like suggesting repair in the metastatic tumors,” added Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner and an advisor to CytoDyn. “These data are substantiating the relationship between CCR5 and immune cell infiltrates and response which supports the current basket trial.”
“Our current basket trial focuses on method of action (MOA) rather than a specific cancer type,” continued Dr. Pourhassan. “We are extremely pleased the central IRB provided approval to proceed with the trial in a matter of weeks. This process can often take two months or more. If leronlimab proves to be as effective in this basket trial, as we have seen in our mTNBC and MBC patients, this opens up a strong potential for CytoDyn to file for another Breakthrough Therapy designation (BTD) for the 22 cancer indications being evaluated in this trial.”
About Basket Trials
A basket trial involves a single investigational drug or drug combination that is studied across multiple cancer populations defined by disease stage, histology, number of prior therapies, genetic or other biomarkers, or demographic characteristics. It is usually designed as a single-arm, activity-estimating trial with overall response rate as the primary endpoint. A strong response signal seen in a sub-study may allow for expansion to generate data that could potentially support a marketing approval.1
CONTACTS
Investors:
Dave Gentry, CEO
RedChip Companies
Office: 1.800.RED.CHIP (733.2447)
Cell: 407.491.4498
dave@redchip.com
https://www.fda.gov/drugs/cder-small-business...2019-issue
Results from mTNBC and MBC studies continues to be positive with the first patient now at almost five months of treatment showing zero CTC, EMT and CAML. Seven patients have been enrolled to date
https://www.cytodyn.com/newsroom/press-releas...pproval-to
VANCOUVER, Washington, Feb. 21, 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, reported that it has received Institutional Review Board (IRB) approval to begin its 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.
Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn, stated, “We currently have more than 70 patients eagerly waiting to participate in this basket trial and expect the first patient injection to take place within approximately ten days. Furthermore, overall enrollment of the trial could be completed in as little as 30 to 60 days, as this is a 30-patient trial.”
This basket trial is a 30 patient, CCR5+ Phase 2 study with locally advanced or metastatic solid tumors. Leronlimab will be administered subcutaneously as a weekly dose of 350 mg. Patients participating in this study will be allowed to receive and continue the standard-of-care chemotherapy as determined by the treating physician.
The clinical trial will take place at multiple sites across the U.S., with preliminary results on each patient expected within three to four weeks after the initial treatment with leronlimab. The primary endpoint of the basket trial is progression-free survival.
“Peripheral blood sampling from Patient #1 in the mTNBC trial, who has been on leronlimab for approximately five months, revealed no cancer cells or cancer associated cells (0 CTC, 0 EMT and 0 CAML). In addition, Patient #2, who has been on leronlimab for almost 3 months in the MBC study, with brain metastasis, continues to show in the latest CT scan, stable lesions that are now described as scar-like suggesting repair in the metastatic tumors,” added Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner and an advisor to CytoDyn. “These data are substantiating the relationship between CCR5 and immune cell infiltrates and response which supports the current basket trial.”
“Our current basket trial focuses on method of action (MOA) rather than a specific cancer type,” continued Dr. Pourhassan. “We are extremely pleased the central IRB provided approval to proceed with the trial in a matter of weeks. This process can often take two months or more. If leronlimab proves to be as effective in this basket trial, as we have seen in our mTNBC and MBC patients, this opens up a strong potential for CytoDyn to file for another Breakthrough Therapy designation (BTD) for the 22 cancer indications being evaluated in this trial.”
About Basket Trials
A basket trial involves a single investigational drug or drug combination that is studied across multiple cancer populations defined by disease stage, histology, number of prior therapies, genetic or other biomarkers, or demographic characteristics. It is usually designed as a single-arm, activity-estimating trial with overall response rate as the primary endpoint. A strong response signal seen in a sub-study may allow for expansion to generate data that could potentially support a marketing approval.1
CONTACTS
Investors:
Dave Gentry, CEO
RedChip Companies
Office: 1.800.RED.CHIP (733.2447)
Cell: 407.491.4498
dave@redchip.com
https://www.fda.gov/drugs/cder-small-business...2019-issue
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