New Clinical Trial Starting: A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD) (REGENERATE-PD)

[Canddy]

Here is a link to the trial on clinicaltrials.gov

clinicaltrials.gov/study/NC...

Below is an excerpt from a news article about the trial:

A new Phase II trial, REGENERATE-PD, will study AB-1005, an adeno-associated virus 2 (AAV2) glial cell line-derived neurotrophic factor (GDNF) gene therapy for the treatment of moderate-stage Parkinson’s disease.

The trial will include an estimated 87 subjects with study sites located in the US, UK and Europe.

In January, AskBio announced that the Phase Ib trial of AB-1005 met its primary endpoint, which was to evaluate the safety of a one-time bilateral delivery of AB-1005 directly to the putamen.

The investigational gene therapy for the treatment of Parkinson’s disease was well tolerated with no serious adverse events that were considered related to AB-1005 in all 11 patients at 18 months.

“By enhancing levels of a naturally occurring growth factor, glial cell line-derived neurotrophic factor (GDNF) gene therapy is intended to promote the survival and functioning of vulnerable brain cells that degenerate in Parkinson’s disease,” said Alan Whone, Consultant Senior Lecturer in Movement Disorder, Bristol Medical School, and Honorary Consultant Neurologist at North Bristol Trust, UK.

“The advancement of AB-1005 is a significant milestone in the development of a gene therapy for Parkinson’s disease and has the potential to bring an effective treatment one step closer to patients.”

A “transformative impact” in Parkinson’s

“Following the encouraging results from the Phase Ib study and the presentation of 18-month data at the American Association of Neurology (AAN) meeting in April, we are excited to be progressing AB-1005 to this larger, Phase II study,” said Krystof Bankiewicz, Scientific Chair, Parkinson’s and MSA, AskBio. “This latest advancement highlights our confidence in the potential of AB-1005 to provide a transformative impact for patients with Parkinson’s disease.”

[Bluebell2022]

link not working

[Canddy in reply to Bluebell2022]

clinicaltrials.gov/study/NC...

try this

[scotta in reply to Bluebell2022]

This is weird... I cannot access clinicaltrials.gov in Firefox but Chrome works fine.

[Canddy in reply to scotta]

Glad you got the link to work...

[ZebraDoodle]

Think this is the same trial? bayer.com/media/en-us/askbi...

Anyone found any UK Phase 2 trials details yet?

[jeffreyn]

AB-1005 gene therapy placed on fast track by regulators in US, UK

parkinsonsnewstoday.com/new...

[ZebraDoodle]

Does anyone have any views on the wisdom of upping GDNF levels re: cancer risk? I’ve heard GDNF described a brain fertiliser - does this make better conditions for cancer cells too? Is the argument that this is targeted, (in an area with low GDNF?) Or does it just make no difference?