Nativis awarded patents in Japan, China, India for drug signal technology

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Nativis, Inc., a La Jolla, Calif.-based life science company, has been issued patents in Japan, China and India for its innovative technology that captures the unique signals of approved drugs at the atomic level and then delivers the signal in a solution to treat serious illnesses. The technology, which also has U.S., Canadian and Australian patents, promises to transform the treatment of diseases, including those for which there are no known cures, such as brain cancer.

“Through our global patent strategy, which now includes five U.S. and eight foreign patents, plus filings in 34 countries, Nativis has perfected its intellectual property portfolio for drug signal technology, the drug signal and related processes for transduction to biological systems”

"Through our global patent strategy, which now includes five U.S. and eight foreign patents, plus filings in 34 countries, Nativis has perfected its intellectual property portfolio for drug signal technology, the drug signal and related processes for transduction to biological systems," said John Butters, chief executive officer, and co-founder of Nativis. "We are particularly pleased to have been issued patents in Japan, which is known for its lengthy and rigorous process."

A drug signal is captured from existing drug molecules using Nativis' patented technology. The resulting signal can be replicated and delivered in solution. It has been shown in animal studies to provide the same therapeutic impact of the "chemical" drug while overcoming the physical hurdles that limit the effectiveness of traditionally administered drugs, such as the ability to cross all physiological barriers (e.g., blood-brain, blood-tumor, blood-bone). These barriers protect the brain and other organs and glands from common infections but also hinder the delivery of diagnostic and therapeutic agents. The new technology also has the promise of replacing the current process of producing drug compounds in traditional manufacturing plants, which would reduce the environmental footprint by eliminating waste and conserving energy.

The first application of the Nativis technology will be a drug signal therapeutic called Digitax™, used to target glioblastoma, the most aggressive form of brain cancer and one of the most difficult to treat. Delivered orally in a water-based solution, it is effective in safely crossing the blood-brain and other barriers and has been proven in preclinical studies to reduce and eliminate tumor growth.

Following additional preclinical studies, Nativis anticipates filing an investigative new drug (IND) application for Digitax with the Food and Drug Administration (FDA) in fall 2010. Clinical studies will be conducted at two major cancer research centers on the west coast.

The company is also in early stages of RNAi research, capturing the signal a siRNA molecule called PCSK9 and using the PCSK9 drug signal to lower LDL (bad) cholesterol while not affecting HDL (good) cholesterol. Early preclinical work shows a significant reduction in LDL levels using the PCSK9 drug signal. The PCSK9 drug signal is administered orally.

Foreign and U.S. Patent Information:

Australia Patent No. 2003230950 - Title: System and method for sample detections based on low-frequency spectral components. Filed: April 18, 2003. Issued: February 22, 2007.

Australia Patent No. 2003231978 - Title: System and method for characterizing a sample by low-frequency spectra. Filed: March 28, 2003. Issued: June 2, 2005.

Australia Patent No. 2004280998 - Title: Characterizing a sample by low-frequency spectra. Filed: October 8, 2004. Issued: July 24, 2008.

Canada Patent No. 2,460,794 - Title: System and method for sample detection based on low-frequency spectra. Filed: April 18, 2003. Issued: February 8, 2005.

China Patent No. ZL200480029490.2 - Title: System and method for characterizing a sample by low-frequency spectra. Filed: October 8, 2004. Issued: November 15, 2006.

India Patent No. 229893 - Title: An apparatus and method for interrogating a sample that exhibits molecular rotation. Filed: March 28, 2003. Issued: February 24, 2009.

India Patent No. 237823 - Title: System and method for characterizing a sample by low-frequency spectra. Filed: August 10, 2004. Issued: January 8, 2010.

Japan Patent No. 4425639 - Title: System and method for characterizing a sample by low-frequency spectra. Filed: March 28, 2003. Issued: December 18, 2009.

Japan Patent No. 4425922 - Title: System and method for characterizing a sample by low-frequency spectra. Filed: October 8, 2004. Issued: December 18, 2009.

United States Patent No. 6,724,188 - Title: Apparatus and method for measuring molecular electromagnetic signals with a SQUID device and stochastic resonance to measure low-threshold signals. Filed: March 29, 2002. Issued: April 20, 2004.

United States Patent No. 6,952,652 - Title: System and method for sample detection based on low-frequency spectral components. Filed: March 19, 2004. Issued: October 4, 2005.

United States Patent No. 6,995,558 - Title: System and method for characterizing a sample by low-frequency spectra. Filed: October 9, 2003. Issued: February 7, 2006.

United States Patent No. 7,081,747 - Title: System and method for characterizing a sample by low-frequency spectral components. Filed: August 20, 2004. Issued: July 25, 2006.

United States Patent No. 7,412,340 - Title: System and method for sample detection based on low-frequency spectral components. Filed: April 1, 2005. Issued: August 12, 2008.

United States Patent No. 7,575,934 - Title: Oriented magnetic particle-fluorescence detectable moiety compositions and methods of making and using the same. Filed: July 3, 2007. Issued: August 18, 2009.

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