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NCI,
CvergenX to partner on radiosensitivity assay
04-10-2013
EDIT CONNECT
SHARING OPTIONS:
TAMPA, Fla.—CvergenX, Inc. has announced
an agreement with
the National Cancer Institute (NCI) to develop a
new assay for radiation
therapy. CvergenX is developing a molecular signature index technology into a
radiosensitivity test in conjunction with the
NCI's Clinical Assay Development
Program. The technology, InterveneXRT, was selected by the NCI for further
development and validation as part of a
commercial collaboration agreement in
hopes of getting the assay ready for clinical trials and U.S. Food and Drug
Administration approval.
CvergenX acquired the exclusive rights to the InterveneXRT
technology platform in a previous licensing
agreement with the Moffitt Cancer
Center. No
financial details were disclosed. Additional research collaborations
between the companies have demonstrated the product candidate's efficacy in
trials for patients with breast, rectal, esophageal and head and neck cancers.
"We are the first
commercial enterprise to develop a
companion diagnostic to radiation therapy, joining a growing group of
personalized medicine companies that are
applying genomics-based analysis to
clinical practice," Mary Del Brady, chairman and CEO of CvergenX, said in a
press release. "Our goal is to have a
validated test with proven clinical
utility in the marketplace within the next three years. The test will provide
more information, and far greater
accuracy, than oncologists have ever had,
enabling them to adjust their clinical management for better outcomes for their
patients."
The initial development of this molecular signature was
based on gene expression for 10 specific genes as well as
a linear regression
algorithm. It was developed in 48 cancer cell lines using a systems-biology
strategy that focused on the identification of
biomarkers for cellular
radiosensitivity.
"Developing a radiosensitivity predictive assay has
been a
goal of radiation biology for decades," commented Javier F. Torres-Roca, M.D.,
a member of the Radiation Oncology, Chemical Biology and
Molecular Medicine
Programs at Moffitt and co-founder and chief scientific officer of CvergenX.
"This effort supports the emphasis on personalized
medicine, where the goal is
to use molecular signatures to guide therapeutic decisions."
Torres-Roca noted that approximately 60 percent of all cancer
patients receive radiotherapy at some point in their treatment, but so far no
diagnostics or biomarkers have been developed to help weigh radiosensitivity,
the state of the cancer and possible benefits.
Rectal cancer will be the initial focus, as it represents a
disease group in which preoperative radiotherapy is
considered the standard of
care for patients with Stage 2 or 3 cancer and yet roughly 40 percent of
patients display no clinical response. The Clinical
Assay Development Network,
a nationwide network of CLIA-certified laboratories, placed a bid with the NCI
for this project and will perform the
necessary work. Financing, labor and
expertise for the development of the assay will be provided by the NCI.
SOURCE: CvergenX press release Code: E04101301 Back |
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