CLINUVEL to Trial Innovative Drug in Stroke

Acute Ischaemic Stroke

A clot in the brain vessel of a stroke patient leads to instant death of brain tissue closest to the clot, shown in dark pink. The larger area surrounding the core (shaded) is characterised as the penumbra, tissue which can still be rescued.
A clot in the brain vessel of a stroke patient leads to instant death of brain tissue closest to the clot, shown in dark pink. The larger area surrounding the core (shaded) is characterised as the penumbra, tissue which can still be rescued.
A clot in the brain vessel of a stroke patient leads to instant death of brain tissue closest to the clot, shown in dark pink. The larger area surrounding the core (shaded) is characterised as the penumbra, tissue which can still be rescued.

MELBOURNE, Australia, Oct. 28, 2020 (GLOBE NEWSWIRE) — The drug afamelanotide will be used for the first time in patients with acute stroke. The study will evaluate the safety and efficacy of afamelanotide, developed by Australian company CLINUVEL, in arterial ischaemic stroke (AIS). The aim is to offer a treatment for patients suffering a stroke who are unable to receive treatment to dissolve or remove the underlying blood clot. AIS accounts for approximately 85% of the 15 million strokes suffered worldwide each year.

“Stroke is most commonly caused by a clot in a patient’s brain which starves surrounding tissue of blood and essential oxygen, causing the destruction of brain cells,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said. “This brain damage can have an irreversible effect on a patient’s ability to speak, move, and function, and tragically leads to an early death for more than 5.5 million people per annum. It is our aim to show that treatment with afamelanotide can safely reduce and prevent brain damage in the majority of stroke patients who cannot be offered standard therapy.”

Strokes cause death of brain tissue at the site of the clot and lead to a shortage of oxygen in a larger area of the brain, known as the penumbra, which is salvageable brain tissue if treated quickly. The longer the delay in a stroke patient receiving treatment, the greater the potential threat to their life and overall prognosis as tissue within the penumbra becomes irreversibly damaged.

Current stroke therapies rely on early intervention to restore blood flow to the brain by either chemically dissolving or physically removing the clot. In Europe, no treatment can be offered to over 85% AIS patients due to a critical delay between the start of the stroke and presentation of the patient to a hospital. Additionally, the location of the clot within the artery is also an important factor impacting the possibility to offer treatment.

Research has indicated that afamelanotide – which is approved in Europe and the USA for patients with a rare metabolic disorder called EPP1 – may rapidly exert its effects to protect brain tissue, act on blood vessels to optimise blood flow, and reduce the size of swelling in the brain following a stroke. More than 10,000 doses of afamelanotide have been administered to over 1,400 individuals during its development and use across a period of nearly two decades.

The pilot Phase IIa clinical study (CUV801) will be conducted

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Leronlimab Shows Early, but Promising Clinical Responses in First Two Patients Recovering from Stroke

VANCOUVER, Washington, Oct. 26, 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 two patients have demonstrated noticeable signs of improvement following treatment with leronlimab (PRO 140) 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.”

Scott A. Kelly, M.D., CytoDyn Chairman of the Board, Chief Medical Officer and Head of Business Development, commented, “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. 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.”

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.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “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. In addition to moving forward rapidly to complete our Biologics License Application for HIV, in multiple countries, our 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 of the world.”

About Leronlimab’s Ability to Cross BloodBrain Barrier
The blood-brain barrier (BBB) mediates the communication between the periphery and the central nervous system (CNS). The BBB separates the circulation from the brain. It is a highly selective permeable border

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‘Weekend Effect’ Affects Survival Odds for Rural Stroke Patients | Health News

By Robert Preidt, HealthDay Reporter

(HealthDay)

WEDNESDAY, Oct. 21, 2020 (HealthDay News) — Stroke patients have a higher risk of death if they’re admitted to a rural hospital on the weekend, a new study finds.

University of Georgia researchers analyzed 2016 data on stroke deaths at U.S. hospitals to learn whether the so-called “weekend effect” influenced stroke outcomes.

“The weekend effect is the phenomenon where the risk of bad or adverse outcomes, such as mortality in our study, increases for those who are admitted to the hospital over the weekend as opposed to a weekday,” said lead author Birook Mekonnen, who was a graduate student in the College of Public Health when the research was conducted.

There was evidence to support the weekend effect in all hospitals. But outcomes were especially poor for rural patients who had hemorrhagic (bleeding) strokes on a weekend, as opposed to ischemic strokes (ones caused by blocked blood flow to the brain).

But the time of week may be just one factor in unfavorable outcomes for rural stroke patients, according to study co-author Donglan Zhang, an assistant professor of health policy and management in public health.

Zhang noted that rural hospitals tend to have fewer resources, including stroke specialists and equipment for particularly severe cases. They also serve a wider area and it’s not uncommon for rural patients to be more than an hour’s drive from the nearest hospital.

The researchers said one way to protect stroke patients from the weekend effect is to invest in telemedicine. They noted that more rural hospitals are joining telestroke care networks, enabling them to connect with specialists and collaborate on treatment for stroke patients.

Mekonnen advised people who are at risk for stroke or other major health problems to look into the telemedicine options available to them. “This may be the new norm,” he said in a university news release.

The findings were published in the October issue of the Journal of Stroke & Cerebrovascular Diseases.

The American Academy of Family Physicians has more on stroke.

Copyright © 2020 HealthDay. All rights reserved.

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Stroke After TIA: Risk Remains High

The incidence of stroke following a transient ischemic attack (TIA) has decreased somewhat over the past 50 years but hardly at all during the past decade, a new meta-analysis shows.

“This systematic review and meta-analysis found that transient ischemic attack continues to be associated with a high risk of early stroke. However, the rate of post-TIA stroke might have decreased slightly during the past 2 decades,” the authors conclude.



Dr Ramin Zand

“In recent years, there has been a lot of advancement in the treatment of stroke but not so much improvement for TIA,” senior author Ramin Zand, MD, Geisinger Neuroscience Institute, Danville, Pennsylvania, told Medscape Medical News.

“Many strokes happen in the first few days after a TIA, so it is of utmost importance to evaluate these patients quickly and get preventative treatments on board as soon as possible. Unfortunately, this does not always happen,” he said.

“Speedy diagnosis and treatment of TIA is possibly even more important than for stroke, as no brain damage has yet occurred in TIA patients and we have the opportunity to stop such damage from occurring,” Zand added.

The meta-analysis of all published studies of TIA outcomes from 1971 to 2019 was published online in JAMA Neurology on October 12. A total of 68 studies involving 206,455 patients were included.

The rate of subsequent ischemic stroke after TIA over the whole time span was estimated to be 2.4% within 2 days, 3.8% within 7 days, 4.1% within 30 days, and 4.7% within 90 days.

The authors evaluated the population with respect to three periods ― before 1999 (group A), from 1999 to 2007 (group B), and after 2007 (group C). These periods were chosen on the basis of changes to the guidelines on TIA made in 1999 and two important publications on TIA in 2007.

Results showed that there was a significant reduction in stroke following TIA after the change in the guidelines in 1999.

For the 2 days after TIA, stroke rates fell from 3.4% in group A (before 1999) to 2.1% in groups B and C.

Similarly, stroke rates within 7 days of TIA went from 5.5% before 1999 to 3.2% during the period 1999–2007 and to 2.9% after 2007.

For the period within 30 days of a TIA, stroke rates dropped from 6.3% pre-1999 to 3.4% in 1999–2207 and 2.9% after 2007.

Within 90 days of TIA, stroke rates were 7.4% pre-1999 and 3.9% in both 1999–2007 and after 2007.

Zand explained that some changes were made to the guidelines regarding TIA treatment in 1999, and in 2007, a couple of landmark publications on risk for stroke following TIA appeared.

“We thought these may have had an effect on subsequent stroke rates by raising awareness,” he added.

“In 1999, after the guidelines changed, we did see a reduction in stroke after TIA,” he said.

They were hoping to see another reduction after the publication of the landmark studies, which confirmed the high risk for stroke after TIA and the

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