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February 24, 2020

CytoDyn gets IRB approval for leronlimab’s Phase II basket trial

CytoDyn has received approved from the Institutional Review Board (IRB) to conduct its Phase II basket trial of leronlimab in patients with various solid tumour types.

CytoDyn has received approved from the Institutional Review Board (IRB) to conduct its Phase II basket trial of leronlimab in patients with various solid tumour types.

Leronlimab is an investigational antagonist of C-C chemokine receptor type 5 (CCR5) receptor.

A basket trial design involves the evaluation of one drug or a combination in different cancer populations.

The overall response rate is measured as the primary endpoint. An adequate response signal in a sub-study may enable expansion to gather data for a marketing approval submission.

The company’s Phase II basket trial will enrol 30 patients with CCR5+ locally advanced or metastatic solid tumours. It will investigate a 350mg, subcutaneous weekly dose of leronlimab and participants will be able to continue the standard-of-care chemotherapy.

CytoDyn will enrol patients with 22 different solid tumours, including glioblastoma, melanoma, lung, breast, ovarian, pancreas and bladder cancers.

The primary endpoint of the US-based Phase II study is progression-free survival. Preliminary data from each participant is expected within three to four weeks following the initial administration of leronlimab.

CytoDyn president and CEO Nader Pourhassan said that more than 70 patients are currently interested in participating and the first subject will be injected within approximately ten days.

Overall enrolment is expected to be completed within one to two months.

Pourhassan added: “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.”

CytoDyn submitted the Phase II trial protocol to the US Food and Drug Administration (FDA) earlier this month.

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