Stem cell therapy heals injured mouse brain

NIH

Animal study examines method for restoring brain cells killed by stroke or other neurological diseasesPR Brain

Scientists and clinicians have long dreamed of helping the injured brain repair itself by creating new neurons, and an innovative NIH-funded study published today in Nature Medicine may bring this goal much closer to reality. A team of researchers has developed a therapeutic technique that dramatically increases the production of nerve cells in mice with stroke-induced brain damage.

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ZZ Biotech’s regenerative bio drugs manufactured in Brisbane with support of Biopharmaceuticals Australia

ZZ Biotech was awarded a $250,000 grant by BPA to support clinical development of its lead drug product, 3K3A-APC. The drug was manufactured at Patheon’s state-of-the-art contract manufacturing located in Brisbane, and will be used in animal studies and Phase 2 clinical trials targeting ischemic stroke and diabetic foot ulcers.

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ZZ Biotech Acquires Bioatrix

In December 2015, US company ZZ Biotech LLC completed the acquisition of Bioatrix Pty Ltd. Based in Houston, ZZ Biotech is in a Phase 2 trial with 3K3A-Activated Protein C (‘3K3A-APC’) in acute ischemic stroke patients, supported by a grant from the National Institute for Neurological Disease and Stroke.

ZZ Biotech’s Australian subsidiary is presently manufacturing 3K3A-APC at Patheon Biologics in Brisbane and it has secured Queensland Government grant funding to facilitate the manufacture.

The Australian subsidiary will pursue a Phase 2 trial with 3K3A-APC in chronic wounds in 2016, and ZZ Biotech will undertake further trials of 3K3A-APC in stroke.

$8 Million NIH Grant Will Fund Multicenter Clinical Trial of Stroke Intervention Drug

Award to Cedars-Sinai Stroke Intervention Researchers Supports Collaborative Study Involving National Institute of Neurological Disorders and Stroke

LOS ANGELES (April 22, 2014) – Cedars-Sinai stroke intervention researchers have been informed that the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, will award an $8 million grant to fund a multicenter Phase II clinical trial of an experimental drug for stroke.

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ZZ Biotech Announces Phase 2 Trial with 3K3A-APC in Stroke

ZZ Biotech Announces Phase 2 Trial with 3K3A-APC in Stroke; Funds Will Be Provided by NIH and Broadview Ventures

HOUSTON, April 22, 2014—ZZ Biotech today announced that the National Institutes of Health will support a multicenter Phase 2 clinical trial of its experimental drug, 3K3A-APC, in patients suffering from acute ischemic stroke.

The Phase 2 study will evaluate safety, tolerability and activity of ZZ Biotech’s 3K3A-APC when given after tissue plasminogen activator, or tPA, in patients who have experienced moderately severe ischemic stroke. The drug will be given intravenously as a 15-minute infusion every 12 hours for up to five treatments, and four dose levels will be evaluated. About 100 participants, ages 18 to 80, will be followed for 90 days.

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Experimental stroke therapeutic developed at Keck Medicine of USC also shows promise for people with Lou Gehrig’s disease (ALS)

New research finds vascular damage in mice with ALS contributes to early development of the neurodegenerative disease, while repairing damage delays disease progression

LOS ANGELES, March 3, 2014Keck School of Medicine of USC neuroscientists have unlocked a piece of the puzzle in the fight against Lou Gehrig’s disease, a debilitating neurological disorder that robs people of their motor skills. Their findings appear in the March 3, 2014, online edition of the Proceedings of the National Academy of Sciences of the United States of America, the official scientific journal of the U.S. National Academy of Sciences.

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Experimental drug reduces brain damage, eliminates brain hemorrhaging in rodents afflicted by stroke

Multi-site phase 2 clinical trials anticipated to begin recruiting patients in 2014

LOS ANGELES, October 24, 2013 — An experimental drug called 3K3A-APC appears to reduce brain damage, eliminate brain hemorrhaging and improve motor skills in older stroke-afflicted mice and stroke-afflicted rats with comorbid conditions such as hypertension, according to a new study from Keck Medicine of the University of Southern California (USC).

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Clinical Trials Start for Stroke Drug Developed by Scripps Research Institute, USC, and ZZ Biotech

Experimental drug may extend window for effective stroke treatment

LA JOLLA, CA, August 8, 2012 — Clinical trials start this week for a stroke drug initially created by a team led by scientists at The Scripps Research Institute and the University of Southern California (USC) and further developed by biotech company ZZ Biotech.

The clinical trials will test the safety in humans of the experimental drug 3K3A-APC, which has been shown in animal models to reduce brain damage and improve motor skills after stroke when given in conjunction with a federally approved clot-busting therapy.

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ZZ Biotech Initiates Phase 1 Study with 3K3A-APC for the Treatment of Acute Ischemic Stroke

HOUSTON, Texas, August 8, 2012—ZZ Biotech, LLC today announced that it has commenced dosing healthy volunteers in a Phase 1 clinical study with 3K3A-APC, a recombinant variant of human activated protein C (APC), being developed for the treatment of acute ischemic stroke.

The Phase 1 study is a randomized, double-blind, placebo-controlled, single-center trial that will investigate the safety and pharmacokinetics of single and multiple ascending doses of 3K3A-APC in healthy adult volunteers. Approximately 62 eligible adult subjects will be assigned sequentially to 1 of 10 cohorts, at successively higher single doses, followed by successively higher multiple doses. Results of the study are anticipated in the first quarter of 2013.

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