PI3k Drug in COVID-19 FDA Ph2 Trial

US Company Verastem, Inc. has commenced an FDA Clinical Trial for their PI3k drug Duvelisib, to treat COVID...........There are only 4 such cancer drugs approved by the FDA, but none of them cross the Blood Brain Barrier - unlike KZA PI3k Inhibitor Paxalisib.  Link at very bottom. With results in Oct 2020.

Duvelisib is exactly the same type of Pi3k pathway drug as KZA Pi3k Paxalisib......except as mentioned, it does not cross the BBB.

Verastem  does not enter the brain (see COVID and the Brain info below). This is a big story on a big day. FDA does not allow Clinical Trials like this on a whim....so a situation with COVID and Paxalisib to watch closely.


---------------
From Verastem :-

"The exceedingly high mortality rates of severe and critical COVID-19 warrant the identification and evaluation of novel therapies that could potentially mitigate the advanced disease manifestations. Based on preclinical data from this institution and others, the investigators hypothesize that PI3K inhibition with duvelisib could potentially quell aberrant hyperactivtation of the innate immune system, preferentially polarize macrophages, reduce pulmonary inflammation, and limit viral persistence, thereby improving patient outcomes."
--------------------
https://www.hopkinsmedicine.org/hea...navirus/how-does-coronavirus-affect-the-brain
Patients with COVID-19 are experiencing an array of effects on the brain, ranging in severity from confusion to loss of smell and taste to life-threatening strokes. Younger patients in their 30s and 40s are suffering possibly life-changing neurological issues due to strokes. Although researchers don’t have answers yet as to why the brain may be harmed, they have several theories.

Critical care physician and neurointensivist Robert Stevens, M.D., who is the associate director of the Johns Hopkins Precision Medicine Center of Excellence for Neurocritical Care, has been tracking cases at Johns Hopkins in which patients with COVID-19 also have neurological problems. And, thanks to a new research consortium of more than 20 institutions, including the University of Pittsburgh Medical Center, New York University, Johns Hopkins and health systems in Europe, researchers, including Stevens, are using imaging and tests of blood and spinal fluid to understand how the coronavirus operates so they can prevent and treat effects on the brain.
Stevens explains some of the prevailing scientific theories.
Q: In what ways does the coronavirus affect the brain?

A: Cases around the world show that patients with COVID-19 can have a variety of conditions related to the brain, including:

• Confusion
• Loss of consciousness
• Seizures
• Stroke
• Loss of smell and taste
• Headaches
• Trouble focusing
• Changes in behavior

Patients are also having peripheral nerve issues, such as Guillain-Barré syndrome, which can lead to paralysis and respiratory failure. I estimate that at least half of the patients I’m seeing in the COVID-19 units have neurological symptoms.



https://clinicaltrials.gov/ct2/show/NCT04372602