Piramal Imaging and AC Immune present first
clinical data for tau PET-imaging tracer PI-2620 at the
International Conference on Alzheimer's and Parkinson's Diseases
and Related Neurological Disorders (AD/PD)
New Data provides research community with
insights on the preclinical properties, human dosimetry and tracer
binding in AD and PSP subjects
Berlin, Germany and Lausanne, Switzerland,
April 3, 2017 - Piramal Imaging and AC Immune SA (Nasdaq: ACIU)
today presented the pre-clinical profile and first clinical data of
the investigational next generation tau PET-imaging tracer PI-2620
at the International conference on Alzheimer's and Parkinson's
Diseases and Related Neurological Disorders (AD/PD) , in Vienna,
Austria. These results are an important step in Piramal Imaging's
mission to develop molecular imaging innovations for an earlier and
more accurate diagnosis of Alzheimer's disease and other
neurodegenerative disorders. PI-2620 is the result of a research
collaboration between the two companies.
First results of the ongoing clinical program
confirmed the favorable potential of PI-2620. In contrast to first
generation tau tracers, PI-2620 did not exhibit an increased tracer
uptake in choroid plexus, striatum, amygdala or other regions of
non-demented control subjects. In Alzheimer's disease (AD)
subjects, however, the PI-2620 tau PET-scan showed a clear pattern
of high uptake particularly in the lateral temporal and frontal
lobes, consistent with the expected tau pathology. Uptake in
substantia nigra and globus pallidus of Progressive Supranuclear
Palsy (PSP) subjects was strong.
"We are excited by the progress of this joint
tau research program and are looking forward to moving PI-2620 into
larger clinical trials." Said Dr. Ludger Dinkelborg, Director of
the Board of Piramal Imaging. "A non-invasive, early and
precise measurement of tau will lead to improved patient management
and is critical for the successful development of disease modifying
drugs."
Dr. Andreas Muhs, CSO of AC Immune
commented: "We are very pleased with the excellent selectivity and
capability of this novel tau PET imaging tracer to detect tau in
several neurodegenerative diseases. The importance of such tau PET
imaging agents was emphasized in recent ground-breaking AD
publication(1). Researchers showed that having knowledge about tau
pathology for baseline selection of Alzheimer's patients could
dramatically improve the power of clinical trials and the
counseling of patients regarding disease progression."
(1) JAMA Neurol.
doi:10.1001/jamaneurol.2016.5953
Tau deposits, in conjunction with beta-amyloid,
represent a critical pathology in AD and play an important role in
non-AD neurodegenerative diseases, e.g. Frontotemporal Dementia
(FTD), Progressive Supranuclear Palsy (PSP), and chronic Traumatic
Brain Injury (cTBI). The spreading of tau neurofibrillary tangles
across defined brain regions is associated with cognitive decline.
In recent years positron emission tomography (PET) has evolved as
an important tool for the detection of misfolded protein aggregates
such as beta-amyloid and tau in the brain)
Abstracts presented at AD/PD
conferenceThe pre-clinical characterization and first clinical
data of PI-2620 were presented in two abstracts during the AD/PD
2017 meeting.
- John Seibyl et al.: First in human characterization of PI-2620,
a next generation PET tracer for assessing tau in Alzheimer's
disease and other tauopathies. Poster Talk: Wed 29 Mar 2017 //
15:55-16:00 Hall E2, Poster Presentation: Wed 29 Mar 2017 //
8:00-18:00 Galleria.
- Andrew Stephens et al.: Characterization of novel PET tracers
for the assessment of tau pathology in Alzheimer's disease and
other tauopathies. Oral Presentation: Fri 31 Mar 2017 //
16:15-16:30 Hall C.
PI-2620 is a promising new tau PET imaging
tracer with favorable properties and is currently being validated
in further clinical studies. PI-2620 shows high affinity to tau in
AD and non-AD pathologies (e.g. PSP, Pick's disease) and high
selectivity over other targets in the brain (e.g. beta-amyloid,
monoamine oxidases A and B). Pharmacokinetic studies in mice and
non-human primates confirmed favorable brain penetration, rapid
washout from non-target regions and overall low-background
binding.
About the research collaborationPI-2620
was discovered in a research collaboration between Piramal Imaging
and AC Immune, a Swiss-based clinical stage biopharmaceutical
company focused on neurodegenerative diseases. Piramal Imaging
obtained the exclusive, world-wide license for research,
development and commercialization of all tau PET tracers generated
within the discovery program. First-in-man clinical studies were
performed at Molecular Neuroimaging, a division of Invicro, New
Haven, Connecticut.
About Piramal Imaging SAPiramal Imaging SA, a division of
Piramal Enterprises, Ltd., was created in 2012 with the acquisition
of the molecular imaging research and development portfolio of
Bayer AG. By developing novel PET tracers for molecular imaging,
Piramal Imaging is focusing on a key field of modern medicine.
Piramal Imaging strives to be a Molecular Imaging leader by
developing innovative products that improve early detection and
characterization of chronic and life threatening diseases, leading
to better therapeutic outcomes and improved quality of life. For
more information, please go to www.piramal.com/imaging.
About AC Immune SAAC Immune is a clinical
stage Swiss-based biopharmaceutical company focused on
neurodegenerative diseases with four product candidates in clinical
trials. The Company designs, discovers and develops therapeutic and
diagnostic products intended to prevent and modify diseases caused
by misfolding proteins. AC Immune's two proprietary technology
platforms create antibodies, small molecules and vaccines designed
to address a broad spectrum of neurodegenerative indications, such
as Alzheimer's disease. The Company's pipeline features seven
therapeutic and three diagnostic product candidates. The most
advanced of these is Crenezumab, an anti-Abeta antibody in Phase 3
clinical studies that is being advanced by the collaboration
partner Genentech, Inc., a member of the Roche Group. Other
business partners include Biogen, Janssen Pharmaceuticals, Nestlé
Institute of Health Sciences and Piramal Imaging.
Piramal DisclaimerPiramal Imaging
cautions that statements included in this press release that are
not a description of historical facts are forward-looking
statements that involve risks, uncertainties, assumptions and other
factors which, if they do not materialize or prove correct, could
cause Piramal's results to differ materially from historical
results or those expressed or implied by such forward-looking
statements. Such statements are based on management's beliefs as
well as assumptions made by and information currently available to
Piramal. The potential risks and uncertainties, many of which are
beyond Piramal's control, could contribute to the uncertain nature
of these statements and include, among others, risks associated
with acceptance of the Piramal's products by its customers, the
outcome of any clinical trial, regulatory approval of any product,
development and acceptance of new products or product enhancements,
operations and business interruptions or strategic changes,
expansion of our networks, and the other risks and uncertainties
described in Piramal's press releases and periodic filings with
appropriate regulatory agencies. Piramal assumes no obligation to
update any forward looking statement to reflect events or
circumstances arising after the date on which it was made.
AC Immune forward looking statementThis
press release contains statements that constitute "forward-looking
statements" within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934.
Forward-looking statements are statements other than historical
fact and may include statements that address future operating,
financial or business performance or AC Immune's strategies or
expectations. In some cases, you can identify these statements by
forward-looking words such as "may," "might," "will," "should,"
"expects," "plans," "anticipates," "believes," "estimates,"
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other comparable terminology. Forward-looking statements are based
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significant risks and uncertainties that could cause actual
results, developments and business decisions to differ materially
from those contemplated by these statements. These risks and
uncertainties include those described under the captions "Item 3.
Key Information-Risk Factors" and "Item 5. Operating and Financial
Review and Prospects" in AC Immune's Annual Report on Form 20-F and
other filings with the Securities and Exchange Commission.
Forward-looking statements speak only as of the date they are made,
and AC Immune does not undertake any obligation to update them in
light of new information, future developments or otherwise, except
as may be required under applicable law. All forward-looking
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statement.
For further information please contact:AC
Immune
Prof. Andrea PfeiferChief Executive OfficerPhone: +41-21-345 91
21E-mail:andrea.pfeifer@acimmune.com |
Eva SchierCorporate Communications ManagerPhone: +41-21-345 91
34Mobile: +41 79 926 66 03E-mail: eva.schier@acimmune.com
|
Nick Miles/ Toomas Kull Cabinet Privé de Conseils Phone : +41
22 321 45 40E-mail : miles@cpc-pr.com kull@cpc-pr.com
|
In the USTed AgneThe Communications Strategy Group
Inc.Phone: +1 781 631 3117E-mail: edagne@comstratgroup.com
|
Piramal Enterprises
Investor Relations:Hitesh Dhaddha / Bhavna SinyalContact:
+91 22 3046 6444 / +91 22 3046 6570Email:
investor.relations@piramal.com |
Corporate Communications:Dimple Kapur Contact: +91 22
3351 4269 Email:dimple.kapur@piramal.com |
Piramal Imaging: Nicole Fletcher Contact: 1+ (857)
202-1122Email: nicole.fletcher@piramal.com |
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