Karyopharm and Medidata Expand Clinical Trial Partnership

NEW YORK–(BUSINESS WIRE)– Medidata (NASDAQ:MDSO) and clinical-stage pharmaceutical company Karyopharm
Therapeutics (NASDAQ:KPTI) today announced an expanded partnership
to bring novel machine-learning technology and targeted risk-based
monitoring (RBM) techniques to clinical oncology trials.

In addition to renewing its use of the Medidata
Clinical Cloud^® platform—including key capabilities
within Medidata’s study conduct and site support suites—Karyopharm is
adopting Medidata
CSA (Centralized Statistical Analytics) and Medidata
TSDV (Targeted Source Document Verification) to enhance its data
review process and incorporate modern risk assessment practices into its
drug development programs.

« As we advance our most promising cancer therapies, it is vital that
Karyopharm embraces the latest technologies and evolving trends in the
clinical trials space. Adopting Medidata’s machine-learning capabilities
for centralized monitoring will not only put us in line with the updated
ICH E6 R2 guidelines, but will also allow us to view clinical
information at a more holistic level, better prioritize trial resources,
and maintain data quality and integrity,” said Ran Frenkel, chief
development operations officer at Karyopharm. “Medidata is more than our
technology provider of choice—they are a valued partner that is helping
us reach our scientific goals sooner. »

A Medidata customer since 2014, Karyopharm has been using Medidata’s
industry-leading electronic data capture (EDC) and management system, Medidata
Rave^®, as well as integrated capabilities that plug into
Rave—including randomization
and trial supply management, medical
coding, adverse
event reporting and clinical
trial management—to advance its pipeline of oncology-focused
therapies. Together, these unified applications have streamlined
Karyopharm’s clinical trial processes: reducing electronic case report
form (eCRF) design times by 74%, improving data entry time by 64%, and
reducing the cycle time to open, answer and close queries by 41%.

Now, Karyopharm will realize more value from the Medidata platform by
leveraging Medidata CSA and Medidata TSDV, two integral capabilities
within Medidata’s Strategic Monitoring solution. CSA’s machine-learning
capabilities help to identify unusual clinical trial data anomalies
within a study, enabling better prioritization of resources around data
quality and integrity, as well as patient safety. Medidata CSA
simplifies the site monitoring process, making it easier for teams to
detect and track critical data errors throughout a clinical trial, while
Medidata TSDV optimizes the data verification process by enabling
sponsors to configure study-specific and site-specific SDV plans.

“Karyopharm is on the front line of cancer research, pursuing novel,
first-in-class drugs to accelerate hope for patients, and we’re proud to
be a strategic partner in that effort,” said Mike Capone, Medidata’s
chief operating officer. “Our collective teams understand the power of
utilizing pioneering technologies and innovative R&D approaches to push
the envelope in scientific discovery. By combining our agile,
machine-learning tools with Karyopharm’s therapeutic excellence, we look
forward to driving meaningful and efficient clinical research for those
who need it most.”

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About Karyopharm Therapeutics

Karyopharm Therapeutics Inc. (Nasdaq:KPTI) is a clinical-stage
pharmaceutical company focused on the discovery and development of novel
first-in-class drugs directed against nuclear transport and related
targets for the treatment of cancer and other major diseases.
Karyopharm’s SINE™ compounds function by binding with and inhibiting the
nuclear export protein XPO1 (or CRM1). The Company’s initial focus is on
seeking regulatory approval and commercialization of its lead drug
candidate, oral selinexor (KPT-330). To date, over 1,900 patients have
been treated with selinexor and it is currently being evaluated in
several mid- and later-phase clinical trials across multiple cancer
indications, including multiple myeloma in combination with low-dose
dexamethasone (STORM) and backbone therapies (STOMP), diffuse large
B-cell lymphoma (SADAL), and liposarcoma (SEAL), among others.
Karyopharm plans to initiate a pivotal randomized Phase 3 study of
selinexor in combination with bortezomib (Velcade^®) and
low-dose dexamethasone (BOSTON) in patients with multiple myeloma in
early 2017. In addition to single-agent and combination activity against
a variety of human cancers, SINE™ compounds have also shown biological
activity in models of neurodegeneration, inflammation, autoimmune
disease, certain viruses and wound-healing. Karyopharm, which was
founded by Dr. Sharon Shacham, currently has five investigational
programs in clinical or preclinical development. For more information,
please visit www.karyopharm.com.

About Medidata

Medidata
is reinventing global drug and medical device development by creating
the industry’s leading cloud-based solutions for clinical research.
Through our advanced applications and intelligent data analytics,
Medidata helps advance the scientific goals of life sciences customers
worldwide, including nearly 850 global pharmaceutical companies,
biotech, diagnostic and device firms, leading academic medical centers,
and contract research organizations.

The Medidata Clinical Cloud^® brings a new level of quality
and efficiency to clinical trials that empower our customers to make
more informed decisions earlier and faster. Our unparalleled clinical
trial data assets provide deep insights that pave the way for future
growth. The Medidata Clinical Cloud is the primary technology solution
powering clinical trials for 17 of the world’s top 25 global
pharmaceutical companies and is used by 16 of the top 20 medical device
developers—from study design and planning through execution, management
and reporting.

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