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Last updated on April 23, 2014 at 1:22 EDT

Adaptimmune Selects SCiAN Services’ EDC(PRO) Solution to Support a Series of Clinical Trials Starting in 2013

February 12, 2013

TORONTO, Feb. 12, 2013 /PRNewswire/ – SCiAN Services, Inc., a North American
Clinical Data Management – Biostatistics CRO and EDC solution provider
announces that Adaptimmune has selected SCiAN’s EDC(PRO) platform to manage its clinical trials starting in 2013.  Following a
review of several EDC vendors and CROs a services agreement was
executed with SCiAN to deliver a comprehensive systems and services
solution for Web-based data capture and data management, including
pharmacovigilance using the SAE(PRO) module and integrated electronic record management of trial master
files (TMF) using the EDMS extension.

SCiAN’s systems will support Adaptimmune’s novel T cell therapy clinical
trials by providing a comprehensive EDC, data management,
pharmacovigilance and TMF solution.  “In addition to the SCiAN staff’s
responsiveness and knowledge in oncology, Adaptimmune’s Clinical Team
was impressed by the user-friendly interface of EDC(PRO) compared to other EDC systems evaluated. We were especially pleased
with the ability to dynamically update and control user views and
upload 3(rd) party data, such as lab data and site documentation – Word and PDF
documents – as well as the ability of the standard and ad hoc reporting module, which is a real asset for both data management and
site monitoring activities,” said Dr. Gwen Binder-Scholl, Executive
Vice President, Adaptimmune, LLC. She added, “SAE(PRO) and SCiAN’s services for pharmacovigilance were also essential elements
in the decision and will allow us to seamlessly record and report data
to regulatory authorities.”

EDC(PRO) has elevated the scope of what is now possible within EDC trials. “With
EDC(PRO), Adaptimmune will have complete control over their data, principally
due to the rigorous communications, tracking and control features that
have garnered praise among our user base”, said St. Clare Chung,
Director, Biostatistics and Data Management.  She went on to add,
“Investors and drug developers today are extremely risk averse when it
comes to their clinical development programs and partners.  The
transparent functionality and data quality analytical tools that are
resident in EDC(PRO) are just two key features that enable sponsor oversight to maintain
data quality and integrity and prevent cost overruns and loss of time.”

About Adaptimmune

Adaptimmune is focused on the use of T cell therapy to treat HIV and
cancer. It aims to utilize the body’s own machinery – the T lymphocyte
cell – to target and destroy cancerous or infected cells.

Established in July 2008 with a research base in Oxford, UK and clinical
base in Philadelphia, US, Adaptimmune was set up to a develop unique T
cell receptor engineering technology for adoptive T cell therapy
exclusively licensed from Immunocore Ltd (formerly Avidex/MediGene).
Specifically, Adaptimmune makes use of the body’s ability to recognize
infected or cancerous cells by enhancing the power of the T cell
receptor (TCR) on killer T cells. All cells, including cancerous cells,
will typically present small parts or peptides of internal proteins on
their surface as part of the natural protein processing pathway. This
offers a “molecular fingerprint” of the protein called an epitope for
killer T-cells from the immune system to identify and destroy. However,
since cancer proteins are usually derived from self proteins against
which naturally selected TCRs in the body do not respond, the
Adaptimmune technology uniquely enhances the natural TCR affinity to
these cancer-specific epitopes enabling targeted killing of the cancer
cells.

Adaptimmune has undertaken significant preclinical development with a
number of pipeline TCRs to demonstrate their potency and specificity in
vitro. The TCR in the current myeloma study specifically recognizes two
cancer testis antigen targets: NY-ESO-1 (157-165) and LAGE-1 (HLA A2; SLLMWITQC), and was engineered using Adaptimmune’s
proprietary TCR engineering platform. Myeloma is the lead indication
for the therapy, with related trials in melanoma and sarcoma also
recruiting patients and further trials in ovarian and hepatic cancer
scheduled to open in 2013. http://www.adaptimmune.com

About SCiAN

SCiAN Services is a North American leading Clinical Data Management -
Biostatistics – Pharmacovigilance CRO and EDC solution provider.  Drug
developers (Biotech/Biopharma, and pharmaceutical companies) rely on
SCiAN’s 27 years of experience in IND stage clinical trials phases
I-III. SCiAN’s therapeutic area expertise developed in over 650
clinical trials includes oncology, CNS, infectious diseases,
inflammatory / autoimmune diseases, diabetes, etc. The company’s
service depth is further backed by its industry renowned EDC(PRO) platform, custom developed for small to medium size drug development
companies and their CROs.

SOURCE SCiAN Services, Inc.


Source: PR Newswire