March 31, 2015

Another Success for Parkinson’s Vaccine Development

Just over a week ago, we learned some interesting news from the Irish biotech company Prothena: the vaccine they produced to slow the progress of Parkinson’s disease (PD) had passed its Phase I trial -- the initial testing of a drug on a small group of people to evaluate its safety, determine a safe dosage range, and identify side effects.

This new Prothena vaccine in development introduces an antibody (PRX002) directly into the body. That particular antibody works to unclump the build-up of alpha-synuclein protein in the brain, and those accumulations are now convincingly linked to Parkinson’s disease.

The vaccine also apparently prevents continuing protein clumping in the brain, thereby protecting it from further degradation of neurons, a breakdown associated with the development and progress of PD.

Positive Findings from Phase I Trial
To establish the vaccine’s Phase I success in the clinical trial, the Prothena researchers tested it on 40 healthy volunteers. Not only did those study subjects tolerate the drug without incident, their average levels of alpha-synuclein -- the suspect protein that clumps – was reduced.

Dr. Gene Kinney, Prothena’s chief scientific officer and head of research and development, said:
We look forward to building upon these data with results from the on-going, multiple ascending dose study in patients with Parkinson's disease expected in the first half of 2016, where we will also be measuring levels of PRX002 in the cerebrospinal fluid and assessing additional biochemical, imaging and clinical biomarker endpoints.

Having shown its vaccine’s safety generally, Prothena is now recruiting people with PD for another Phase I trial.

Earlier Positive Vaccine Results from Austria 
This recent report from Ireland adds punch to news last summer from Austria, where biotech company AFFiRiS had similar Phase I success with its vaccine PD01A. The Austrian researchers administered two different doses of its vaccine, both of which proved safe and tolerable.

Though the Prothena and AFFiRiS vaccines are immunotherapy drugs, they work a bit differently to prevent the protein accumulations. The Prothena vaccine injects the the alpha-synuclein antibody directly. On the other hand, PD01A -- the AFFiRiS vaccine -- prompts the body to produce that antibody.    

The Michael J. Fox Foundation (MJFF) ponied up nearly $2M to test the AFFiRiS vaccine, the first drug targeting alpha-synuclein to reach clinical testing.

The Quest Continues
This coming September, AFFiRiS will begin a Phase II trial to assess the vaccine's efficacy and confirm the safety of an additional “booster vaccination.” The MJFF will support that trial, too.

Said MJFF CEO Todd Sherer, PhD:
A treatment that could slow or stop Parkinson’s progression would be a game changer for the five million worldwide living with this disease and the many more who will become at risk as our population ages. This trial is one of the most promising efforts toward that goal.

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The MJJF maintains what it calls a “robust alpha-synuclein portfolio,” confirming the foundation’s commitment to this line of attack against PD. From the foundation's "Foxfeed" blog: A Few Ways We May Stop Parkinson's.

In this video, AFFiRiS CEO Walter Schmidt discusses the "first-of-its-kind" Parkinson's disease vaccine.

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