Business Wire

Phase III Study using 22nd Century’s SPECTRUM® Research Cigarettes Demonstrates Immediate Reduction to Very Low Nicotine is Most Likely to Lead to Less Harm

Del

22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology company that is focused on tobacco harm reduction, announced today that Dr. Dorothy Hatsukami, at the Vermont Center on Behavior and Health’s 5th Annual Conference on Tobacco Regulatory Science, revealed the fundamental findings of a highly anticipated 1,250-patient, 20-week study that compared smokers who were assigned to: i) an immediate reduction to Very Low Nicotine cigarettes; ii) gradual reduction in reduced nicotine content cigarettes; or iii) normal nicotine content cigarettes. Designed to determine which approach produces the most optimal outcomes for smokers, the announcement of the results of the seminal phase III study comes only weeks after the United States Food and Drug Administration (FDA) announced that the Agency is exercising its authority under the Family Smoking Prevention and Tobacco Control Act to mandate lower nicotine – at non-addictive levels – in all combustible cigarettes sold in the United States.

This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171006005223/en/

22nd Century’s proprietary SPECTRUM® research cigarettes facilitate independent studies on nicotine  ...

22nd Century’s proprietary SPECTRUM® research cigarettes facilitate independent studies on nicotine reduction strategies. The FDA plans to mandate lower nicotine – at non-addictive levels – in all cigarettes sold in the United States. (Photo: Business Wire)

Dr. Hatsukami, who is the Co-Director of the Center for the Evaluation of Nicotine in Cigarettes and Professor of Psychiatry and Director of the Tobacco Research Programs at the University of Minnesota, led the ground-breaking phase III study that was conducted in 10 cities across the United States and included participants from all demographics.

22nd Century was the exclusive provider of the Very Low Nicotine and other SPECTRUM research cigarettes that were used in Dr. Hatsukami’s 1,250-participant trial and in more than 16 other clinical trials. In fact, 22nd Century is the only company in the world capable of growing tobacco with nicotine levels of just 0.4mg per gram of tobacco, which is more than a 95% reduction in nicotine as compared to tobacco in conventional cigarettes. Many scientists around the world believe that tobacco with this very low level of nicotine is minimally or non-addictive.

Though the details of Dr. Hatsukami’s phase III study are still under peer review, Dr. Hatsukami divulged the answer to the study’s core question of whether an immediate or a gradual reduction in nicotine is the best approach. Dr. Hatsukami clearly and confidently declared in her panel presentation at the Vermont Conference that “an immediate approach [to nicotine reduction] is most likely to lead to less harm.” Further, Dr. Hatsukami pointed out that the study data indicates compensatory smoking is less likely to occur with an immediate reduction in nicotine, and that the there was a “greater likelihood of more rapid smoking cessation” with the immediate approach to nicotine reduction.

Following Dr. Hatsukami’s discussion, Dr. Stephen T. Higgins, Director of the University of Vermont Tobacco Center of Regulatory Science took the podium and announced to the conference attendees: “I will present evidence that reducing nicotine content lowers the addiction potential of smoking among those with psychiatric conditions or socioeconomic disadvantage consistent with prior evidence in samples from the general adult smoker population.” In addition to finding reduced evidence of addiction in smokers of 22nd Century’s Very Low Nicotine Content (VLNC) cigarettes, Dr. Higgins found that: “VLNCs did not produce evidence of compensatory smoking.” [emphasis added]

Dr. Jonathan Foulds of Penn State College of Medicine also delivered a powerful call to action at the conference, challenging the attending scientists to deny the tobacco industry any diversions or strategies that could be used to delay the FDA’s planned mandate to reduce nicotine in cigarettes to very low, non-addictive levels. Dr. Foulds then pointed out the stakes involved: “Such a move [by FDA to reduce nicotine content of cigarettes] could result in one of the largest single improvements in public health ever [seen] in this country.”

“Considering the results of numerous phase II and phase III studies that have been conducted with VLN cigarettes, there is now compelling and conclusive evidence that Very Low Nicotine cigarettes decrease cigarette dependence, reduce the number of cigarettes smoked per day, and increase smokers’ quit attempts,” explained Henry Sicignano III, President and CEO of 22nd Century Group. “With the power to save millions of lives and to prevent a new generation of young people from becoming dependent on tobacco, minimally or non-addictive Very Low Nicotine cigarettes are the ultimate harm reduction strategy.”

About 22nd Century Group, Inc.

22nd Century is a plant biotechnology company focused on genetic engineering and plant breeding which allows the increase or decrease of the level of nicotine in tobacco plants and the level of cannabinoids in cannabis plants. The Company’s primary mission in tobacco is to reduce the harm caused by smoking. The Company’s primary mission in cannabis is to develop proprietary hemp/cannabis strains for important new medicines and agricultural crops. Visit www.xxiicentury.com and www.botanicalgenetics.com for more information.

Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking information, including all statements that are not statements of historical fact regarding the intent, belief or current expectations of 22nd Century Group, Inc., its directors or its officers with respect to the contents of this press release, including but not limited to our future revenue expectations. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements. We cannot guarantee future results, levels of activity or performance. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances, or to reflect the occurrence of unanticipated events. You should carefully review and consider the various disclosures made by us in our annual report on Form 10-K for the fiscal year ended December 31, 2016, filed on March 8, 2017, including the section entitled “Risk Factors,” and our other reports filed with the U.S. Securities and Exchange Commission which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected.

Contact information

22nd Century Group
James Vail, 716-270-1523
Director of Communications
jvail@xxiicentury.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Zonoville Investments Limited Announces Agreement on Acquisition of RUSAL Shares19.2.2018 18:19Pressemelding

Zonoville Investments Limited, a consortium of investors led by Renova Group and Access Industries, announced today that it had reached an agreement with Onexim Group to purchase its 6% stake in the United Company RUSAL Plc. Following completion of the purchase, Zonoville Investments Limited and its associate SUAL Partners Limited will hold, in aggregate, approximately a 26.5% interest in United Company RUSAL Plc. About Renova Renova Group of companies (www.renova.ru) is a major private Russian business group which owns and manages assets in metallurgy, mining, chemical, construction, transport, energy, telecommunications, high-tech engineering, public utilities, medicine and financial sectors in Russia and abroad (CIS, Switzerland, Italy, South Africa and the United States of America). Renova’s largest assets include its interests in UC Rusal, T Plus Group, OCTO Telematics and Swiss-based technology concerns Schmolz+Bickenbach, OC Oerlikon, and Sulzer. About Access Industries Founded

The Digital Health Technology Show: The Leading Show for Healthcare Innovation Comes to London19.2.2018 18:05Pressemelding

Medical innovation will take centre stage for 2018, at the largest wearables and disruptive health technology event in the world, with never before-seen devices and applications and a raft of industry-leading speakers. The Digital Health Technology Show returns to London on the 13th & 14th March 2018 at London’s Excel, gathering together more than 6,000 attendees and over 100 exhibitors. The 2018 Conference programme boasts three tracks, with over 100 hours of content programmed. Attendees can choose to attend talks on the Digital Health Disrupt Stage – covering global innovation in healthcare, the Leadership Theatre – where senior healthcare figures in the UK will discuss and debate the challenges ahead, or the Patient Engagement Stage – delivering insights into how technology is being used in the real world. There will also be demonstrations of the latest medical innovations on the Innovation Stage, which will also host a start up competition – The Health Innovation Award. Over 200 s

World Patient Safety Summit is Sold Out But Space is Available at the Breakout Sessions, Held the Day after the World Summit, at the Royal Society in London19.2.2018 13:00Pressemelding

The latest advances in vaccine safety, reducing unnecessary C-sections and person & patient engagement will be among the varied breakout sessions offered the day after the 6th Annual World Patient Safety, Science & Technology Summit in London by the Patient Safety Movement Foundation. The breakout sessions will convene on Sunday, February 25, 2018 at the prestigious Royal Society, the independent scientific academy of the United Kingdom and the Commonwealth, dedicated to promoting excellence in science. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180219005119/en/ Limited Space available to participate with experts at the 6th Annual World Patient Safety, Science & Technology Summit Break Out Sessions at the Royal Society in London (Photo: Business Wire) The breakout sessions are full-day working meetings structured for shared learning on existing Actionable Patient Safety Solutions (APSS) – collaborative, evidence-based pro

Tampere Attracts AV Productions with a New Incentive19.2.2018 12:41Pressemelding

One of the City of Tampere’s strategic goals is to be an international meeting place for creativity and innovation. The development of the experience economy is an essential focus of the city’s business policy. The incentive system is being used to attract more local, national and international productions to the Tampere region. The goal is to promote the development of the industry and to increase the number of jobs and the turnover of commercial productions in Tampere. Through the incentive system, an audiovisual production may recover some of the costs it has spent on wages and service purchases in the Tampere region. A production meeting the incentive criteria may be refunded 10–15 per cent of the accepted costs accrued in the region. Professional productions that utilise the Tampere region as their location or use expertise from the area may apply for the incentive. Thanks to the growing number of productions, Tampere will become more visible in films and TV shows, which will add

Tempo Grows Revenue by 38% in 2017 to $17.9 Million19.2.2018 11:14Pressemelding

Tempo, creator of efficiency-enhancing project management software solutions for Atlassian’s Jira platform, announced strong results for its 2017 fiscal year ending December 31, 2017. “2017 marks another productive and successful year for Tempo, with December our highest grossing month ever and sales across our product range exceeding expectations,” commented Agust Einarsson, CEO, “The completion of our new cloud infrastructure and successful migration of our entire customer base to Amazon Web Services (AWS) marks a strategic milestone, empowering Tempo with a more scalable underlying platform and enabling us to deploy products to customers faster.” Highlights for 2017 include: Revenue grew 38% year-over-year to US$17.9 million Almost 2,000 new customers were acquired Launched our new cloud infrastructure Expanded product footprint beyond the Atlassian environment with Tempo for Slack North American operations continued to grow More than 120 partners worldwide Celebrated our 10-year an

Morrow Sodali Announces Appointment of David Shammai as Corporate Governance Director - Cross Border19.2.2018 10:05Pressemelding

Morrow Sodali today announced that David Shammai has joined the firm as Corporate Governance Director - Cross Border. David joins from APG Asset Management, the Dutch pension fund manager, where in his role as senior corporate governance specialist he was involved in voting, policy, and engagement. Based in the London office, David will focus on the firm’s growing corporate governance activities across its European offices. Together with Morrow Sodali’s expanding team of corporate governance professionals, David will work to further develop the firm’s governance services – ranging from benchmarking and assessments of governance practice to board advisory on engagement with investors. “At Morrow Sodali we recognise that today many of our clients face growing needs for an in-depth and meaningful dialogue with their investors on a broadening range of topics. Having David onboard - from one of the world’s largest fiduciary asset managers - demonstrates our reinforced commitment to helping