Luna Innovations Plans Preclinical Studies and Collaboration with National Cancer Institute
09 Abril 2008 - 12:28PM
Business Wire
Luna Innovations Incorporated (NASDAQ:LUNA) announces the National
Cancer Institute has selected Luna�s magnetic resonance imaging
(MRI) contrast agent candidate for preclinical characterization by
the Nanotechnology Characterization Laboratory (NCL), a national
resource and knowledge base for cancer researchers. The NCL was
established to perform and standardize the preclinical
characterization of nanomaterials intended for therapeutics and
diagnostics. Luna�s contrast agent for MRI is a modified fullerene
compound with the potential to provide a completely new approach to
enhancing contrast during MRI procedures. Luna�s technology may
also prevent the toxicity currently associated with gadolinium, a
contrast substance frequently used in MRI which has been associated
with health problems. �The core of Luna�s commercialization
strategy is to develop technologies in alliances with valued
partners, including federal labs, universities, and other
businesses. In this collaboration with the NCL, we will be working
together to perform preliminary studies, which will further develop
our nanotechnology strategy towards application and provide
preliminary characterization data. The data can be used to aid the
regulatory process and in the transition to commercialization,�
said Luna Chairman and CEO, Dr. Kent Murphy. �We are pleased to
have been selected for this program, which can help to accelerate
the development of our nanomaterials-based contrast agent and we
believe will improve contrast, while using less agent and improving
upon safety.� The U.S. Food and Drug Administration (FDA) and the
National Institute of Standards and Technology (NIST) are partners
of the NCL with its intent to accelerate the transition of basic
nano-biotech research into clinical applications. A panel
consisting of scientists from the NCL, the NCI, the pharmaceutical
industry, the NIST, the FDA and the nanotechnology industry
evaluate and select proposal applications from a large number of
potential nanomaterials candidates. Nanomaterials selected for
characterization are based on their projected impact on clinical
cancer applications and/or furthering nanotechnology�s
compatibility with biological systems. Studies of Luna�s MRI
candidate will include characterization of its physical attributes,
its in vitro biological properties and its in vivo compatibility
using animal models. Critical parameters related to distribution,
metabolism, elimination and toxicity will be examined. The time to
characterize a nanomaterial through the NCL, from receipt through
the in vivo phase, is anticipated to be one year. �The outcome of
this characterization study is the report necessary for an IND, or
Investigational New Drug, application,� commented Dr. Chris Kepley,
nanoImmuminology Group Leader at Luna and Principal Investigator of
this study. �The process of getting a new drug to market can be a
lengthy one, however with the NCL behind us we hope to move forward
more quickly bringing to market a next-generation solution for MRI
contrast agents.� About Luna Innovations: Luna Innovations
Incorporated (www.lunainnovations.com) develops and manufactures
new-generation products for the healthcare, telecommunications,
energy and defense markets. Luna�s products are used to measure,
monitor, protect and improve critical processes. Through its
disciplined commercialization business model, Luna has become a
recognized leader in transitioning science to solutions. Luna
nanoWorks (www.lunananoworks.com) is a division of Luna
Innovations, developing products empowered by nanomaterials with
applications in diagnostics, therapeutics, and organic solar cells.
Forward Looking / Safe Harbor Statement under the Private
Securities Litigation Reform Act of 1995: This press release
includes information that constitutes �forward-looking statements�
made pursuant to the safe harbor provision of the Private
Securities Litigation Reform Act of 1995, including but not limited
to the development of nanomaterials-based contrast agents, the
safety from such agents, nanotechnology�s projected impact on
clinical cancer applications, nanotechnology�s compatibility with
biological systems, the time to characterize a nanomaterial through
the NCL and the timeline of bringing any new drugs based on
nanomaterials to market. The company attempts, whenever possible,
to identify forward-looking statements by words such as �intends,�
�will,� �plans,� �anticipates,� �expects,� �may,� �estimates,�
�believes,� �should,� �projects,� or �continue,� or the negative of
those words and other comparable words. Similarly, statements that
describe the company�s business strategy, goals, prospects,
opportunities, outlook, objectives, plans or intentions are also
forward-looking statements. Actual events or results may differ
materially from the expectations expressed in such forward-looking
statements as a result of various factors, including risks and
uncertainties, many of which are beyond the company�s control.
Factors that could cause actual results to differ materially from
the expectations expressed in such forward-looking statements
include, but are not limited to: the company�s ability to
successfully identify market needs for new products; the potential
adverse effects of nanotechnology, whether real or perceived; and
the potential limitations of regulatory requirements in obtaining
clearance by the U.S. Food and Drug Administration or other
regulatory agencies for the company�s products. Additional factors
that may affect the future results of the company are set forth in
the company�s quarterly and annual reports on Form 10-Q and Form
10-K, respectively, and other filings with the Securities and
Exchange Commission (�SEC�), which are available at the SEC�s
website at http://www.sec.gov, and at the Company�s website at
http://www.lunainnovations.com. These risk factors are updated from
time to time through the filing of periodic reports with the SEC.
The statements made in this press release are based on information
available to the company as of the date of this release and Luna
Innovations undertakes no obligation to update any of the
forward-looking statements herein after the date of this press
release.
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