Star Scientific Announces Successful Completion of Product Satisfaction Study - Results Show Potential for Development and Manuf
07 January 2009 - 12:00AM
PR Newswire (US)
PETERSBURG, Va., Jan. 6 /PRNewswire-FirstCall/ -- Star Scientific
(NASDAQ :STSI) announced today that its subsidiary, Rock Creek
Pharmaceuticals, Inc., in conjunction with its Star Tobacco, Inc.
subsidiary, recently completed a study to determine the ability of
Stonewall(R) dissolvable smokeless tobacco to relieve cigarette
withdrawal symptoms when compared to an over-the-counter nicotine
replacement product (NRT). The study, which included 49 cigarette
smokers, was designed to measure 1) nicotine's effects and 2)
relief from smoking withdrawal symptoms, using a 4mg NRT product
and a 4mg Stonewall piece, along with placebos of each product. The
NRT, Stonewall product and the two placebos were administered over
the course of four sessions. Both the nicotine replacement product
and the 4mg Stonewall product were much more effective than their
placebos in reducing nicotine craving, confirming the preliminary
results published in 2007 in the journal Tobacco Control. These
results are important because they confirm the "proof of concept"
hypothesis that is the basis of Rock Creek's focus on developing
and manufacturing a low-cost, botanical-based NRT product to
compete with NRT products now on the market. Rock Creek
Pharmaceutical's strategies include the exploration, development
and manufacturing of novel cessation and therapy products to change
the current "status-quo" in smoking cessation and harm reduction
strategies. Dr. Curtis Wright, Chief Medical Officer of Rock Creek,
commented, "Recent scientific and clinical studies, in addition to
Rock Creek's completed product satisfaction study, strongly suggest
the value of pursuing the development of a low-cost botanical-based
NRT product for both smoking and smokeless tobacco cessation. We
have to move beyond the current situation that makes NRT more
expensive than continuing to use tobacco." Dr. Wright further
commented that Rock Creek intends to apply to have the results of
the recent study included in an abstract submission at the Society
for Research in Nicotine and Tobacco (SRNT) - Europe Conference to
be held in Dublin, Ireland in April 2009. Dr. Wright also stated
that based on the recent study results, there are good reasons to
consider bioequivalence testing of this class of product. Depending
on results of this testing, Rock Creek plans to seek FDA review for
a botanical-based tobacco cessation product for use by adult
tobacco users who smoke and/or use smokeless tobacco products. The
company anticipates using the name CigRX(TM) as the trade name.
There currently is no FDA-approved pharmaceutical product for
smokeless tobacco cessation. Rock Creek Pharmaceuticals has a
central focus on the development and manufacturing of a low-cost
NRT pharmaceutical cessation products. The company will continue to
explore at the same time development of other pharmaceutical
products with clinical claims, as well as a "relapse prevention
product" to assist smokers during nicotine withdrawal. The goal is
to achieve higher quit and long-term abstinence rates for dependent
smokers for whom conventional NRT smoking cessation products have
not been successful. Rock Creek is dedicated to developing an array
of pharmaceutical and related products that promote the concept
that "smoking is not an option." Paul L. Perito, Rock Creek
Pharmaceutical's Chairman and CEO, commented that Star Scientific
is fortunate to have a respected medical and scientific
professional like Dr. Wright, with extensive prior FDA and
pharmaceutical company experience, to lead this vital drug
development effort. Mr. Perito further noted that depending on
results from the bioequivalence study, and parallel work that will
be done by Rock Creek with a contract research organization or
academic institution, the company expects to move forward with the
FDA approval process as soon as practicable. This press release
contains certain forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. Star
Scientific, Inc. and its consolidated subsidiaries ( collectively,
"The Company") has tried, whenever possible, to identify these
forward-looking statements using words such as "anticipates",
"believes", "estimates", "expects", "plans", "intends" and similar
expressions. These statements reflect the Company's current beliefs
and are based upon information currently available to it.
Accordingly, such forward-looking statements involve known and
unknown risks, uncertainties and other factors which could cause
the Company's actual results, performance or achievements to differ
materially from those expressed in, or implied by, such statements.
These risks, uncertainties and contingencies include, without
limitation, the challenges inherent in new product development
initiatives, the uncertainties inherent in the progress of
scientific research, the Company's ability to raise additional
capital in the future necessary to maintain its business, potential
disputes concerning the Company's intellectual property, risks
associated with litigation regarding such intellectual property,
potential delays in obtaining any necessary government approvals of
the Company's low-TSNA tobacco products, market acceptance of the
Company's new smokeless tobacco products, competition from
companies with greater resources than the Company, the Company's
decision not to join the Master Settlement Agreement ("MSA"), the
effect of state statutes adopted under the MSA, and the Company's
dependence on key employees and on its strategic relationships with
Brown & Williamson Tobacco Corporation in light of its
combination with RJ Reynolds Tobacco Company, Inc. The impact of
potential litigation, if initiated against or by individual states
that have adopted the MSA, could be materially adverse to the
Company. See additional discussion under "Risk Factors" in the
Company's Annual Report on Form 10-K for the year ended December
31, 2007, as filed with the SEC on March 17, 2008, and other
factors detailed from time to time in the Company's other filings
with the SEC, available at http://www.sec.gov/. 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. About Star Scientific Star Scientific is
a technology-oriented tobacco company with a toxin reduction
mission. It is engaged in the development of dissolvable smokeless
tobacco products that deliver fewer carcinogenic toxins
(principally tobacco specific nitrosamines, or TSNAs), through the
utilization of the innovative StarCured(R) tobacco curing
technology, and in sublicensing that technology to others. Star
Scientific has a Corporate and Sales Office in Petersburg, VA, an
Executive, Scientific & Regulatory Affairs office in Bethesda,
MD, and manufacturing facilities in Chase City, VA. See Star's
website at: http://www.starscientific.com/ DATASOURCE: Star
Scientific CONTACT: Sara Troy Machir, Vice President,
Communications & Investor, of Relations, Star Scientific,
+1-301-654-8300, Web Site: http://www.starscientific.com/
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