PETERSBURG, Va., Sept. 22 /PRNewswire-FirstCall/ -- Star Scientific, Inc. 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.
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 found in several nicotine replacement therapy products (NRT) as reported by a University of Minnesota research team in December, 2007.
The company also formally nominated Dr. Wright for a position on the Scientific Advisory Committee that has been established by the FDA under the new legislation. In a letter submitted to the agency on September 21, the company pointed out that “Dr. Wright has an enormous breadth of experience in the area of addictive substances, and eight years of his career were spent at the Food & Drug Administration. . .Dr. Wright can contribute not only as a scientist, but also as an executive with significant industry experience. “
Although the Company believes the expectations reflected in such forward-looking statements are based on reasonable assumptions, it can give no assurance that the expectations will be attained or that any deviation will not be material. See additional discussion under “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2008, as filed with the SEC on March 16, 2009, and other factors detailed from time to time in the Company’s other filings with the SEC, available at www.sec.gov. All information in this release is current as of this date, and the Company undertakes no obligation to update or advise upon any such forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.
About Rock Creek Pharmaceuticals
Rock Creek Pharmaceuticals develops pharmaceutical products for treatment of addiction and other neurological disorders. The company supports third-party academic, educational and therapeutic advances in both these areas of research. Rock Creek has scientific and research offices in Gloucester, MA.
Photo: http://www.newscom.com/cgi-bin/prnh/20090317/STARSCIENTIFICLOGO
http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.comStar Scientific, Inc.
