Click here to close now.




















Welcome!

News Feed Item

Star Scientific, Inc./Rock Creek Pharmaceuticals Report Positive Initial Results of ASAP Human Thyroid Health Study Showing Benefits in Immune System Support

GLEN ALLEN, Va., Jan. 7, 2013 /PRNewswire/ -- Star Scientific, Inc. (NASDAQ: STSI) announced today the preliminary results of the Company's ASAP (Anatabloc Supplementation Autoimmune Prevention) Human Thyroid Study that analyzes the impact of anatabine dietary supplementation on thyroid health. 

(Logo: http://photos.prnewswire.com/prnh/20120301/NE62741LOGO )

The study is a three-month, five-visit, double-blind, placebo-controlled study of the impact of anatabine dietary supplementation in humans with autoimmune disease of the thyroid.  The study was conducted at nine sites and builds upon previous epidemiological and animal experimental studies.  Initial results for all study subjects suggest that dietary supplementation with anatabine ameliorates the immune system's targeting of the thyroid gland in autoimmune thyroiditis.

Subjects in the study were screened initially to establish the presence of active autoimmune thyroid inflammation.  Baseline thyroid sonography, thyroid antibody levels, and cytokine levels were collected from the subjects who were determined to have active autoimmune thyroid inflammation.  Thyroid function tests and routine safety monitoring were also done in these subjects.  Eligible subjects were enrolled in the study and then received weight-appropriate doses of anatabine or placebo, ranging from nine to twenty-four mg of the anatabine supplement or placebo per day.  Subjects received treatment for three months, returning at four-week intervals for repeat laboratory testing and/or sonography of the thyroid. 

One-hundred forty-eight subjects completed the study, of which one-hundred forty six complied with all treatment, visits and required tests.  The preliminary examination of the primary outcomes shows a clear and statistically significant difference in the treated group as compared to the placebo group by the end of the trial, with declines in anti-thyroglobulin antibody levels.  Anatabine subjects also tended toward a reduction in thyroid gland vascularity on ultrasound relative to placebo.

The full report of the study is still being completed and will soon be submitted for peer review.  Therefore, it is unavailable at this time.  However, these promising initial results prompted Curtis Wright, MD, MPH, Medical Director of Rock Creek Pharmaceuticals, to comment, "It is remarkable that dietary supplementation is able to help lower the thyroid antibody activity.  To see antibodies that may have been elevated for years beginning to come down in a significant way after three months of supplementation is exciting.  Given the rate of decline over three months, it is quite reasonable to expect that the effect may continue with longer use, which has already been observed in individual cases.  I look forward to following subjects over a longer period in order to establish how profound and clinically meaningful the effect is going to be.  The thyroglobulin levels in some patients returned entirely to normal in this three month study."

Dr. Paul Ladenson, senior endocrinological consultant for the study, stated, "Data from this rigorously conducted, placebo-controlled, double blind trial show that anatabine-treated subjects had progressive decreases in circulating thyroglobulin antibody levels, which became significant by the end of the trial.  Current treatment for autoimmune thyroiditis is limited to end-stage disease when irreversible gland damage necessitates lifelong thyroid hormone replacement.  The prospect of a novel nutritional or pharmaceutical intervention that could preserve thyroid health represents an encouraging advance.  Further clinical studies are now warranted." 

The title of the study is, "A Multi-Site, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety and Potential Effects of the Dietary Supplement Anatabine on Antithyroid Autoantibodies and Thyroid Function in Subjects with Autoimmune Thyroiditis".  The full study report will be available after all secondary analyses have been completed and is planned to be submitted for scientific presentation and publication later in the year.

Certain statements contained in this release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to statements identified by words such as "believes," "expects," "anticipates," "estimates," "intends," "plans," "targets," "projects" and similar expressions.  The statements in this release are based upon the current beliefs and expectations of our company's management and are subject to significant risks and uncertainties.  Actual results may differ from those set forth in the forward-looking statements.  Numerous factors could cause or contribute to such differences, including, but not limited to, results of clinical trials and/or other studies, the challenges inherent in new product development initiatives, including the continued development and market acceptance of our nutraceutical products, the effect of any competitive products, our ability to license and protect our intellectual property, our ability to raise additional capital in the future that is necessary to maintain our business, changes in government policy and/or regulation, as well as other risks discussed from time to time in our filings with the Securities and Exchange Commission, including, without limitation, our annual report on Form 10-K for the fiscal year ended December 31, 2011.  We undertake no duty to update any forward-looking statement or any information contained in this press release or in other public disclosures at any time.

About Star Scientific
Star Scientific, Inc. is a technology-oriented company with a mission to promote maintenance of a healthy metabolism and lifestyle.  Over the last several years, through its wholly owned subsidiary, Rock Creek Pharmaceuticals, Star Scientific has been engaged in the manufacturing, sale, and marketing of two nutraceutical dietary supplements, and the development of other nutraceuticals and pharmaceuticals.  The company also continues to pursue the licensing of the technology behind its proprietary StarCured® curing process and its related products. Rock Creek Pharmaceuticals has scientific and research offices in Gloucester, MA, and a regulatory office in Washington, DC.  Star Scientific has a Corporate and Sales Office in Glen Allen, VA, and an Executive, Scientific & Regulatory Affairs office in Washington, DC.

Contact:
Talhia T. Tuck
Vice President, Communications and Investor Relations
Star Scientific, Inc.
(202) 887-5100
[email protected]

SOURCE Star Scientific, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
"We've just seen a huge influx of new partners coming into our ecosystem, and partners building unique offerings on top of our API set," explained Seth Bostock, Chief Executive Officer at IndependenceIT, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
Mobile, social, Big Data, and cloud have fundamentally changed the way we live. “Anytime, anywhere” access to data and information is no longer a luxury; it’s a requirement, in both our personal and professional lives. For IT organizations, this means pressure has never been greater to deliver meaningful services to the business and customers.
Digital Transformation is the ultimate goal of cloud computing and related initiatives. The phrase is certainly not a precise one, and as subject to hand-waving and distortion as any high-falutin' terminology in the world of information technology. Yet it is an excellent choice of words to describe what enterprise IT—and by extension, organizations in general—should be working to achieve. Digital Transformation means: handling all the data types being found and created in the organizat...
SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
Chuck Piluso presented a study of cloud adoption trends and the power and flexibility of IBM Power and Pureflex cloud solutions. Prior to Secure Infrastructure and Services, Mr. Piluso founded North American Telecommunication Corporation, a facilities-based Competitive Local Exchange Carrier licensed by the Public Service Commission in 10 states, serving as the company's chairman and president from 1997 to 2000. Between 1990 and 1997, Mr. Piluso served as chairman & founder of International Te...
The Software Defined Data Center (SDDC), which enables organizations to seamlessly run in a hybrid cloud model (public + private cloud), is here to stay. IDC estimates that the software-defined networking market will be valued at $3.7 billion by 2016. Security is a key component and benefit of the SDDC, and offers an opportunity to build security 'from the ground up' and weave it into the environment from day one. In his session at 16th Cloud Expo, Reuven Harrison, CTO and Co-Founder of Tufin,...
Container technology is sending shock waves through the world of cloud computing. Heralded as the 'next big thing,' containers provide software owners a consistent way to package their software and dependencies while infrastructure operators benefit from a standard way to deploy and run them. Containers present new challenges for tracking usage due to their dynamic nature. They can also be deployed to bare metal, virtual machines and various cloud platforms. How do software owners track the usag...
SYS-CON Events announced today that MobiDev, a software development company, will exhibit at the 17th International Cloud Expo®, which will take place November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. MobiDev is a software development company with representative offices in Atlanta (US), Sheffield (UK) and Würzburg (Germany); and development centers in Ukraine. Since 2009 it has grown from a small group of passionate engineers and business managers to a full-scale mobi...
With SaaS use rampant across organizations, how can IT departments track company data and maintain security? More and more departments are commissioning their own solutions and bypassing IT. A cloud environment is amorphous and powerful, allowing you to set up solutions for all of your user needs: document sharing and collaboration, mobile access, e-mail, even industry-specific applications. In his session at 16th Cloud Expo, Shawn Mills, President and a founder of Green House Data, discussed h...
For IoT to grow as quickly as analyst firms’ project, a lot is going to fall on developers to quickly bring applications to market. But the lack of a standard development platform threatens to slow growth and make application development more time consuming and costly, much like we’ve seen in the mobile space. In his session at @ThingsExpo, Mike Weiner, Product Manager of the Omega DevCloud with KORE Telematics Inc., discussed the evolving requirements for developers as IoT matures and conducte...
There are many considerations when moving applications from on-premise to cloud. It is critical to understand the benefits and also challenges of this migration. A successful migration will result in lower Total Cost of Ownership, yet offer the same or higher level of robustness. In his session at 15th Cloud Expo, Michael Meiner, an Engineering Director at Oracle, Corporation, analyzed a range of cloud offerings (IaaS, PaaS, SaaS) and discussed the benefits/challenges of migrating to each offe...
One of the hottest areas in cloud right now is DRaaS and related offerings. In his session at 16th Cloud Expo, Dale Levesque, Disaster Recovery Product Manager with Windstream's Cloud and Data Center Marketing team, will discuss the benefits of the cloud model, which far outweigh the traditional approach, and how enterprises need to ensure that their needs are properly being met.
In their session at 17th Cloud Expo, Hal Schwartz, CEO of Secure Infrastructure & Services (SIAS), and Chuck Paolillo, CTO of Secure Infrastructure & Services (SIAS), provide a study of cloud adoption trends and the power and flexibility of IBM Power and Pureflex cloud solutions. In his role as CEO of Secure Infrastructure & Services (SIAS), Hal Schwartz provides leadership and direction for the company.
In a recent research, analyst firm IDC found that the average cost of a critical application failure is $500,000 to $1 million per hour and the average total cost of unplanned application downtime is $1.25 billion to $2.5 billion per year for Fortune 1000 companies. In addition to the findings on the cost of the downtime, the research also highlighted best practices for development, testing, application support, infrastructure, and operations teams.
The Internet of Everything (IoE) brings together people, process, data and things to make networked connections more relevant and valuable than ever before – transforming information into knowledge and knowledge into wisdom. IoE creates new capabilities, richer experiences, and unprecedented opportunities to improve business and government operations, decision making and mission support capabilities.