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CytoDyn says leronlimab shows early, but promising clinical responses in first two stroke patients

A physician in Mississippi requested leronlimab, which was given to him under Mississippi’s “Right to Try” statute, and he has been feeling better

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CytoDyn CEO Nader Pourhassan said “leronlimab’s ability to cross the blood-brain barrier potentially presents numerous opportunities for the treatment of patients suffering from diseases related to the central nervous system"

CytoDyn Inc (OTCQB:CYDY), a biotechnology company developing leronlimab (PRO 140) for multiple indications, revealed on Monday that two patients have demonstrated noticeable signs of improvement following treatment with leronlimab in helping their recovery from stroke.

The most recent stroke patient, a physician in Mississippi, requested leronlimab, which was administered to him under Mississippi’s recently expanded “Right to Try” statute. The physician’s son, commenting on his father, stated, “He is doing good. Yesterday, he received his second treatment. He said he has been feeling better, and he thinks it is working. He said parts of his body and face that have been numb are starting to change/wake up.”

In a statement, CytoDyn chairman and chief medical officer Scott A. Kelly, said: “We are encouraged by leronlimab’s potential to help patients recover from stroke and traumatic brain injury. Independent research has concluded CCR5 is upregulated in neurons after stroke, blocking CCR5 induces motor recovery after stroke, and CCR5 antagonism may enhance learning, memory, and plasticity.”

READ: CytoDyn wins positive DSMC recommendation after interim analysis of leronlimab in Phase 2b/3 COVID-19 trial

“CCR5 is rapidly becoming an important target for neural repair in stroke and traumatic brain injury. Our recent data that leronlimab crosses the blood-brain barrier with 70-75% receptor occupancy of the CCR5 receptors in the brain (Macaque model) is encouraging for the potential to enhance recovery in stroke and traumatic brain injury and explore a variety of central nervous system pathology," Kelly added.

The company said a second stroke patient was receiving treatment with leronlimab as part of her therapy for breast cancer. "The treating physician noted her partial paralysis was mitigated relatively quickly, which may have been causally related to the posited role of CCR5 in stroke,” it added.

CytoDyn CEO Nader Pourhassan commented: “Leronlimab’s ability to cross the blood-brain barrier potentially presents numerous opportunities for the treatment of patients suffering from diseases related to the central nervous system.”

“Therefore, we are accelerating the filing of a Phase 2 protocol to evaluate leronlimab’s potential as a therapeutic for stroke recovery. We continue to focus our energies on our most important task of enrolling more patients in our severe-to-critical COVID-19 Phase 3 trial as quickly as possible.”

Dr Pourhassan said that in addition to moving “forward rapidly” to complete the Biologics License Application for HIV, in multiple countries, the company’s “extensive plan” includes filing a protocol and IND for Phase 2 clinical trials for both stroke and Long Haulers COVID-19 indications.

“We continue to strongly believe leronlimab has the potential to provide therapeutic benefit to patients suffering from a variety of diseases, and this incredible prospect drives our management team every day. CytoDyn is committed to fulfilling this obligation to patients,” he added.

The US Food and Drug Administration has granted Fast Track designation to Vancouver, Washington-based CytoDyn for a combination therapy with HAART for HIV-infected patients and metastatic triple-negative breast cancer.

Contact the author Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive

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