TOKYO--(BUSINESS WIRE)--R-Tech Ueno (JASDAQ: 4573)
R-Tech Ueno, Ltd. has announced plans to conduct collaborative research with Autonomous University of Barcelona (UAB) and Vall d’Hebron Institute of Research (VHIR), in Catalonia (Spain) to develop a novel VAP-1 inhibitor (Development code: RTU-009) for treatment of cerebral infarction.
RTU-009 is a novel VAP-1 inhibitor, having an anti-inflammatory and
neuroprotective effect. It is confirmed that RTU-009 has a
neuroprotective effect similar to Edaravone (Radicut®), the
brain protective agent, and a cerebral dysfunction improving effect when
applied in combination with t-PA treatment in animal stroke models. It
is currently undergoing non-clinical studies to proceed to Phase I
clinical trials. Though an oral VAP-1 inhibitor named RTU-1096 is under
development, RTU-009 is the novel VAP-1 inhibitor that has been
developed as an injection agent targeting for treatment of acute
cerebral infarction.
To explore the possibility of the clinical
application of RTU-009 for treating cerebral infarction as a POC (Proof
of Concept) trials (Early Phase II clinical trials), we started
collaborative research using stroke animal models with the group led by
Professor Unzeta of the Institute of Neuroscience, UAB, and the group
led by Dr. Montaner, MD, of the Neurovascular Research Laboratory of
Vall d’Hebron Institute of Research, the research centre of the
UAB-affiliated Vall d'Hebron University Hospital, who are active in the
front line of clinical as well as research activity.
Going forward,
we will proceed with the development of RTU-009 as a combination with
t-PA treatment for acute cerebral infarction as the top priority target.
These initiatives, including early clinical trials, will be conducted in
collaboration with academia.
Yukihiko Mashima, MD, PhD, President of the company, has stated as
follows:
"The number of stroke patients is estimated to reach 3
million people in 2020, and once a stroke has occurred, patients are
likely to suffer from related aftereffects. Considering the policy to
extend a healthy life, as stated by the Ministry of Health, Labour and
Welfare in Japan, as well as from the perspective of the medical
economy, it is necessary to proceed with the strategy to suppress the
increasing population of patients suffering from the aftereffects of
stroke.
For the acute stage of cerebral infarction, thrombolytic
treatment using t-PA is the first-line therapy; however, t-PA can only
be used for patients within 4.5 hours from the onset of stroke,
considering the risk of brain hemorrhage. Therefore, it is extremely
important to develop a new treatment method that reduces the risk of
brain hemorrhage and enlarges the range of target patients. According to
some reports, the recovery rate, representing the rate of patients who
recover to the level of self-reliance, with t-PA treatment is 40-50% in
Japan. Further enhancement of the recovery rate and expansion of the
4.5-hour time window for treatment are strongly desired in clinical
practice, and we may achieve such goals by utilizing RTU-009 as
combination with t-PA treatment. In addition, it was recently reported
that removing the thrombus in treatable patients within 6 hours of
stroke onset via endovascular treatment (mechanical thrombus collection
therapy or endovascular thrombectomy) improves treatment results as
compared with conventional treatments. Based on this report, we would
like to also explore a new treatment utilizing RTU-009, which has an
anti-inflammatory effect, in combination with endovascular treatment.
Professor
Unzeta is the leading researcher for the VAP-1 study, and she is
targeting the diseases of cerebral infarction and Alzheimer disease now.
Dr. Montaner plays a central role in clinical trials related to stroke
in Spain. He conducted colaboration studies with Professor Unzeta on
acute cerebral infarction treatment utilizing VAP-1 inhibitors in the
animal models. By collaborative research with Professor Unzeta and Dr.
Montaner this time, R-Tech Ueno attempts to rapidly proceed with
clinical trials of RTU-009. Vall d'Hebron University Hospital had
established systems to conduct Phase I trials and POC trials under the
direction of Dr. Montaner. By taking advantage of this framework, we
plan to promote the development of RTU-009 as a new treatment to be used
in combination with t-PA through collaboration with academia."
The above venture will not contribute to any revisions to the earnings forecasts of the second cumulative quarter and the full year previously announced on May 14, 2015.
For full details of the press release, please visit:
http://www.rtechueno.com/en/investor/press/documents/150608_pr_en.pdf