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The Nanotechnology Characterization Laboratory Selects Luna's MRI Contrast Agent Candidate
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 Incorporated
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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Luna Innovations Incorporated
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