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Star Scientific Breaks New Ground, Plans FDA Filing for Approval of First 'Modified Risk' Tobacco Product; Nominates Curtis Wright, MD, MPH for FDA Advisory Committee
Date:9/22/2009

PETERSBURG, Va., Sept. 22 /PRNewswire-FirstCall/ -- Star Scientific, Inc. (Nasdaq: STSI) makers of low-nitrosamine smokeless tobacco products, announced today that the company will utilize a novel, patented method for cultivation, curing and preparation of tobacco to formulate dissolvable smokeless tobacco products. This new curing process was the subject of a patent application filed in December, 2008. Its use has resulted in tobacco leaf with significantly lower levels of tobacco-specific nitrosamines (TSNAs) than previously achieved using the StarCured(R) curing process: the International Agency for Research on Cancer previously has reported on the low levels of nitrosamines in Star's products. The company believes that this novel process, as reflected in its patent application, will enable the company to achieve the lowest toxin levels anywhere in the world. Star plans to submit the products to the FDA for approval to market as "modified risk" tobacco products, under Section 911 of the new Family Smoking Prevention and Tobacco Control Act, once formulation and testing of the new product is completed in early 2010.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090317/STARSCIENTIFICLOGO )

Curtis Wright, MD, MPH, Chief Medical Officer for Rock Creek Pharmaceuticals, Star Scientific's pharmaceutical division, commented, "I am excited to see how low the nitrosamine content of this new material will be once it is processed and formulated." Laboratory testing of some of the tobacco leaf samples after curing has revealed levels for NNN and NNK, the most lethal forms of TSNAs, below ten parts per billion. These values are comparable to NNN and NNK levels
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SOURCE Star Scientific, Inc.
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