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Comprehensive Study by AstraZeneca and Genentech Confirms Superiority of InSphero Human Liver Microtissues for Prediction of Drug-Induced Liver Injury

ID: 1511683
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(Thomson Reuters ONE) -
InSphero AG /
Comprehensive Study by AstraZeneca and Genentech Confirms Superiority of
InSphero Human Liver Microtissues for Prediction of Drug-Induced Liver Injury
. Processed and transmitted by Nasdaq Corporate Solutions.
The issuer is solely responsible for the content of this announcement.

Archives of Toxicology publication reveals microtissues are twice as sensitive
as 2D primary human hepatocytes (PHH) for predicting hepatotoxicity of 110
clinically defined DILI compounds.

Schlieren, Switzerland, June 29, 2017 (GLOBE NEWSWIRE) -- In the most
comprehensive evaluation of 3D spheroid hepatic cultures conducted to date, a
publication co-authored by lead toxicologists and drug safety experts at
AstraZeneca and Genentech revealed InSphero 3D InSight(TM) Human Liver
Microtissues to be a more sensitive and highly specific in vitromodel for
predicting drug-induced liver injury (DILI) compared to 2D models. The study
entitled, "Utility of spherical human liver microtissues for prediction of
clinical drug-induced liver injury," was published online Tuesday, June 13 in
the journal Archives of Toxicology. Dr. William Proctor, Head of Investigative
Toxicology at Genentech, and Alison Foster, Senior Scientist in the Drug Safety
and Metabolism group at AstraZeneca, were co-first authors on the publication.

2D PHH assays have been the "gold-standard" model used for DILI testing, yet
DILI still remains one of the leading sources for drug attrition, black box
warnings, and post-market withdrawal of drugs. Thus, there is a growing need for
better predictive tools to assess liver injury earlier in the drug development
process. The authors note in the paper that, "3D models have shown promise in
small sets of DILI compounds, but a more comprehensive retrospective study of
DILI positive and negative drugs to test the predictive power of 3D models head


to head with 2D PHH assays had not been performed."

The study determined that regardless of the threshold used, "Human Liver
Microtissues demonstrated increased sensitivity in identifying known
hepatotoxicants versus PHH, while specificity was consistent across both
assays." Microtissues also, "outperformed PHH in correctly classifying
hepatotoxicants from different pharmacological classes of molecules."
Furthermore, the authors found that 3D microtissues displayed sufficient
structural and functional characteristics to warrant exploratory studies to see
if novel biomarkers used in the clinic could also be detected in vitro. Findings
revealed that despite each microtissue consisting of ~1000 cells, the
mechanistic and exploratory hepatotoxicity biomarkers miR-122, HMGB1, and alpha-
GST could be detected in the culture supernatants, demonstrating that, "3D liver
microtissues have the potential to recapitulate in vivo findings in vitro."

"This landmark study provides convincing, independent evidence that InSphero
liver microtissues can help identify hepatotoxic drugs with greater sensitivity
without sacrificing specificity, says InSphero Chief Executive Officer and Co-
founder Dr. Jan Lichtenberg. "Having two of the world''s leading pharmaceutical
companies collaborate to produce this thorough validation further confirms that
our 3D models not only better reflect in vivo biology, but also deliver the
reproducibility and scalability required to meet the early stage screening
demands of large pharma. Our assay-ready 3D InSight(TM) models offer a cost-
effective, turnkey solution that gives toxicologists greater confidence when
characterizing risk in lead compound sets."

3D InSight(TM) Human Liver Microtissues are a standardized primary human liver
model developed by InSphero that display enhanced liver phenotype, metabolic
activity, and stability over 28 days in culture, enabling long-term drug
exposure studies not attainable with 2D hepatic models.

For more information about InSphero 3D InSight(TM) Liver Microtissues and
applications, visit www.insphero.com

####



About InSphero

InSphero sets the standard for in vitro testing of novel drugs in the
pharmaceutical and biotechnology industry with comprehensive solutions that
provide greater confidence in decision making. Its robust and highly
physiologically relevant suite of 3D InSight(TM) Microtissues and Services are
used by major pharmaceutical companies worldwide to increase efficiency in drug
discovery and safety testing. InSphero patent-pending technologies and methods
enable large-scale, reproducible production of scaffold-free 3D microtissues
driven solely by cellular self-assembly. The company specializes in delivering
assay-ready and custom 3D models derived from liver, pancreas, and tumor
tissues, to provide unrivalled biological insight into liver toxicology,
metabolic diseases (e.g., diabetes and liver diseases), and oncology (with a
focus on immuno-oncology). All InSphero microtissues are thoroughly validated to
ensure the highest quality, certified for use in a variety of assays, and
shipped globally to customers in a patented, easy-to-use spheroid-optimized
platform, ready for research. Field application scientists and research staff
with expertise in working with 3D models help ensure efficient integration and
onsite training as needed. For customers who prefer an outsourcing strategy with
fast turnaround, InSphero also offers contract research services utilizing their
3D microtissue models.

InSphero 3D InSight(TM) solutions drive significant findings in peer-reviewed
journals, through collaborative industry initiatives such as EU-
ToxRisk and HeCaToS, and have gained validation in the world''s largest
government institutions and pharmaceutical, chemical and cosmetics companies.

Founded in 2009, the privately held company is headquartered in Switzerland,
with subsidiaries in the United States and Germany. It has been recognized for
its scientific and commercial achievements with several national and
international awards.

Follow us on Twitter and LinkedIn.

Attachments:

A photo accompanying this announcement is available
at http://www.globenewswire.com/NewsRoom/AttachmentNg/49b63be5-b99c-
4789-82ec-255febd1bef4

Attachments:

A photo accompanying this announcement is available
at http://www.globenewswire.com/NewsRoom/AttachmentNg/cd947eeb-
93b5-4005-9072-76223d78942a

Attachments:

A photo accompanying this announcement is available
at http://www.globenewswire.com/NewsRoom/AttachmentNg/6f21ed8c-d6f6-4bd2-bf0e-
f6e0e46ea6ff

Randy Strube
InSphero AG
+1 800-779-7558
randy.strube(at)insphero.com

Jan Lichtenberg
InSphero AG
+41 44 515 0490
jan.lichtenberg(at)insphero.com




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: InSphero AG via GlobeNewswire






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Date: 06/29/2017 - 14:00
Language: English
News-ID 1511683
Character count: 2738
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Firma: InSphero AG
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Stadt: Schlieren
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