Cervical injuries only, eh?Originally Posted by niallel
Bummer.
Cervical injuries only, eh?
Bummer.
T3 complete since Sept 2015.
https://www.prnewswire.com/news-rele...300871144.html
https://www.clinicaltrials.gov/ct2/s...3989440&rank=1
Recruitment will begin immediately for the Phase 1 first-in-human trial of AXER-204 for the treatment of chronic spinal cord injury (SCI). The "RESET" Trial will assess safety, tolerability, pharmacokinetics, and efficacy in patients at leading SCI treatment centers across the U.S. An estimated 300,000 people are currently living with chronic SCI in the U.S., and there is currently no approved therapeutic to restore sensory or motor function after injury. An effective therapeutic to promote recovery of function after damage would be the first of its kind to address a significant and completely unmet medical need.
I wasn't able to determine if/how they will exercise patients.
I don't think they're adding any rehabilitation arm to this trial by the way the brief summary reads... It seems to be testing just the medication itself.
Brief Summary:
This two-part trial will assess the safety, tolerability, pharmacokinetics, and efficacy of AXER-204 administered by lumbar puncture and slow bolus infusion. Part 1 will evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of AXER-204. Part 2 will evaluate the safety, tolerability, pharmacokinetics, and efficacy of repeated doses AXER-204 in comparison to placebo.
It's a phase 1 trial so safety is the main aim. Don't know if rehab is going to part of the next phases though.
The reasoning I was given was:
I was told Phase 4 for Thoracic injuries - but as we know that doesn't mean anything in terms of timelines.The reason for focusing on cervical patients with some residual hand function is that it is possible to measure changes resulting from the treatment. As you know, the muscles and dermatomes in the thoracic region are difficult to assess and therefore it would be more difficult to achieve conclusive results. Of course, patients with thoracic injuries could also benefit from such treatments but their inclusion would be further in the future.
Last edited by niallel; 06-19-2019 at 03:46 PM. Reason: removed some spacing
All of the secondary outcome measures are return of function, which is not likely to happen without intense rehab. If the drug proves to be safe but the subjects don't recover, I hope they continue with a trial that includes intense rehab.
Our trials definitively showed that without intense rehab, the patients do not recover.
ReNetX Bio, Inc. Announces U.S. FDA Authorization to Proceed for IND Application to Treat Patients with Chronic Spinal Cord Injury
NEWS PROVIDED BYSHARE THIS ARTICLE
ReNetX Bio, Inc. Jun 19, 2019, 09:18 ET
NEW HAVEN, Conn., June 19, 2019 /PRNewswire/ -- ReNetX Bio, Inc., a leading biotechnology company committed to reversing disease and damage for patients suffering from central nervous system disorders, has announced that the U.S. Food and Drug Administration (FDA) has allowed the Company's Investigational New Drug (IND) application for its lead drug candidate, fusion protein AXER-204.
Recruitment will begin immediately for the Phase 1 first-in-human trial of AXER-204 for the treatment of chronic spinal cord injury (SCI). The "RESET" Trial will assess safety, tolerability, pharmacokinetics, and efficacy in patients at leading SCI treatment centers across the U.S. An estimated 300,000 people are currently living with chronic SCI in the U.S., and there is currently no approved therapeutic to restore sensory or motor function after injury. An effective therapeutic to promote recovery of function after damage would be the first of its kind to address a significant and completely unmet medical need.
Axonal loss is a common, yet unaddressed pathology, in a broad range of chronic and acute diseases of the central and ocular nervous systems. The Company's technology relies on blocking inhibitory proteins to promote regrowth of neurons and was developed by ReNetX Founder and Scientific Advisor Stephen Strittmatter, MD, PhD, Vincent Coates Professor of Neurology at Yale University. Three proteins were identified as key inhibitors preventing neural regrowth due to binding with NgR1 (Nogo Pathway). In preclinical studies with AXER-204, these inhibitors are blocked and neural plasticity as well as new axonal growth is triggered. These new neural connections enable rewiring and reversal of damage in the central nervous system.
AXER-204 has generated positive results in numerous preclinical disease models which have been independently validated in leading academic and industrial labs. Studies have indicated that treatment with ReNetX's proprietary therapeutic AXER-204 resulted in significant regrowth of nerve fibers and increased functionality? including axonal regeneration, axonal sprouting, and synaptic plasticity ? even many months after injury or damage. In addition, the therapy has been shown to be safe with no toxicological findings.
The company has received major support from leading organizations across the world, including in a collaboration with the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH ) through the BrIDGs Program (Bridging Interventional Development Gaps), and from the Wings for Life Spinal Cord Research Foundation to advance the program into the clinic. "We recognize the unmet need, we are encouraged by the success our therapeutic has shown to date, and we hope that AXER-204 will deliver a much-needed therapeutic option for patients," says Dr. Strittmatter.
"We are grateful for the partners that have supported our efforts to achieve this major milestone and are excited to advance an entirely new approach for patients to restore function to damaged nerve fibers in the central nervous system," says ReNetX CEO, Erika R. Smith. "This breakthrough therapy has the potential to reverse conditions that, until now, were considered untreatable," adds the company's lead investor Gregory P. Ho, President, Spring Mountain Capital.
More information about the study is available at www.clinicaltrials.gov under the identifier NCT03989440.
About ReNetX Bio, Inc. For more information, please visit www.renetx.com
About Spring Mountain Capital, LP For more information, please visit www.springmountaincapital.com
Contact Information: Gregory P. Ho, 212-292-8310, gh@smcinvest.com
SOURCE ReNetX Bio, Inc.
https://www.prnewswire.com/news-rele...300871144.html
C-5, 6 SCI. Took about 6 months to walk. Walking full time. Without any assistance since Nov. 2003 and will make a full recovery
Let us hope this has been taken into consideration for the future phases of any funded trials.
The study states that they will be doing a lumbar puncture which is where the drug would be administered. Can that area help with cervical injuries and hand improvements. I would think that a lumbar puncture would be more directed towards improving leg function. Thanks for any input.
A lumbar puncture (LP) is the insertion of a needle into the spinal canal to collect and examine the fluid that surrounds the brain and spinal cord (cerebral spinal fluid). It is termed a "lumbar puncture" because the needle is placed in the lumbar portion of the back and used to puncture through tissues to enter the spinal canal. Other names for a lumbar puncture (an LP) include spinal tap, spinal puncture, thecal puncture, and rachiocentesis.
An LP can also be done to treat diseases, as a way of administering antibiotics, cancer drugs, or anesthetic agents into the spinal canal fluid.
https://www.medicinenet.com/lumbar_p...ar_puncture_lp
Thanks Grammy as always for your insight and vast array of knowledge
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