By Ludwig Burger
FRANKFURT, Aug 28 (Reuters) - Bayer BAYGn.DE said an
experimental stem cell therapy developed by its U.S. subsidiary
BlueRock had shown signs of easing Parkinson’s disease symptoms
in an early 12-patient trial.
The German drugmaker announced the trial had succeeded in a
brief summary in June, saying it was a first for a stem-cell
Parkinson's therapy, but held back details for a medical
conference.
In a statement on Monday it said that one year after the
treatment, the seven participants on a high dose had 2.16 hours
longer on average with well-controlled symptoms per day and the
time of worsening symptoms was 1.91 hours shorter per day for
them.
The five participants on a lower dose experienced 0.72 hours
longer per day with well-controlled symptoms on average and the
time of worsening symptoms was 0.75 hours shorter per day for
them.
The treatment was well tolerated with no major safety
issues.
“The positive outcome of this Phase I clinical trial is
a clear step forward," said Christian Rommel, Bayer's head of
drug research and development.
For BlueRock's experimental therapy, the researchers took
human pluripotent embryonic stem cells and transformed them into
dopamine-producing nerve cells. They were implanted into the
brain to restore neural networks destroyed by Parkinson's.
Drugs to prevent the immune system from attacking the new
cells were also given.
The results were presented at the International Congress of
Parkinson's Disease and Movement Disorders in Copenhagen,
Denmark.
The hunt for a treatment of Parkinson's, which causes a lack
of the molecule dopamine which helps regulate several basic
brain functions, has seen many setbacks over decades.
A slew of research projects around the globe, including
Bayer's, have recently honed in on the approach to transplant
modified cells to restore a dopamine-producing area of the
brain.
Some of this work is being done by Britain's' Cambridge
University, South Korea's Bundang CHA Hospital, International
Stem Cell Corp's ISCO.PK Cyto Therapeutics in Australia, the
Chinese Academy of Sciences, Harvard University in the United
States and Japan's Kyoto University Hospital.
Bayer reiterated it would advance testing on humans to the
second of three stages. Patient enrolment, also for a
comparative group that will not receive the treatment, would
start in the first half of 2024.
Parkinson's, for which there is no cure and which affects
more than 10 million people worldwide, causes progressive brain
damage. Common symptoms are loss of muscle control, tremors and
muscle rigidity while dementia is seen in some patients.
(Reporting by Ludwig Burger; Editing by Susan Fenton)
((ludwig.burger@thomsonreuters.com; +49 30 220133634;))