Deans' stroke musings: FDA removes hold on investigational new drug application for ischemic stroke therapy

Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Wednesday, June 28, 2023

FDA removes hold on investigational new drug application for ischemic stroke therapy

Do your doctors and hospital even know about this?

Do you prefer your doctor and hospital incompetence NOT KNOWING? OR NOT DOING?

FDA removes hold on investigational new drug application for ischemic stroke therapy

The FDA has removed the clinical hold on the investigational new drug application for the phase 2/3 ReMEDy2 trial of DM199 for acute ischemic stroke, DiaMedica Therapeutics announced in a press release.

“We are pleased that the FDA has fully lifted the clinical hold,” DiaMedica President and CEO Rick Pauls, MBA, said in the release. “DM199 represents a novel approach to treating [acute ischemic stroke] patients, principally aimed at enhancing collateral blood flow in the brain tissues affected by the stroke.”

Source: Adobe Stock. — The FDA removed a hold on DiaMedica’s IND application for a phase 2/3 clinical trial of a novel therapy for acute ischemic stroke. *Image: Adobe Stock*

According to the release, DM199 is a synthetic form of human tissue kallikrein-1, a serine protease involved in several physiological processes, including blood flow, inflammation, fibrosis, oxidative stress and neurogenesis. Deficiency of the protein may play a role in vascular disease such as stroke and vascular dementia.

The company plans to resume its ReMEDy2 trial as soon as possible and aims to enroll approximately 350 individuals at 75 sites in the U.S. Participants will receive DM199 or placebo for 3 weeks, beginning within 24 hours of acute ischemic stroke symptoms, with the final follow-up scheduled for 90 days.

“We look forward to re-engaging with our study sites and stroke expert principal investigators as we resume our ReMEDy2 trial, as there is continued unmet need of new potential therapeutics for patients who have had an ischemic stroke,” Kirsten Gruis, MD, DiaMedica’s chief medical officer, said in the release.