22nd Century Group (XXII) Receives Guidance from FDA on Phase III Clinical Trials for Prescription-Based Smoking Cessation Product

June 22, 2017 9:56 AM EDT

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22nd Century Group, Inc. (NYSE: XXII), a plant biotechnology company that is a leader in tobacco harm reduction, announced today that on June 20, 2017, the Company and its wholly owned subsidiary, Heracles Pharmaceuticals, participated in a meeting with the multi-discipline review team in the Division of Anesthesia, Analgesia, and Addiction Products at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) regarding the Company’s Investigational New Drug Application (IND) for 22nd Century’s X-22 prescription-based smoking cessation product in development so that it may become available for doctors to prescribe to help their patients to stop smoking. The meeting with the FDA/CDER was very positive and productive. FDA/CDER and the Company will work to reach agreement on the Company’s design and implementation of two parallel, Phase III clinical trials to be conducted by the Company in various parts of the United States to show that the Company’s X-22 prescription-based smoking cessation product will result in a more robust quit rate in smoking as compared to existing smoking cessation products that are already in the market in the U.S. The Company believes that it will be able to achieve such robust results.

Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group, stated, “The mission of our Company is to reduce the harm caused by smoking and we believe that we can help smokers to successfully stop smoking through the use of our novel X-22 smoking cessation product in development. We look forward to working collaboratively and closely with the FDA during 2017 regarding the approval of important aspects of the two parallel, Phase III clinical trials on X-22 that we intend to commence in the first half of 2018, subject to our determination of whether we will use funds from a third-party or Company funds to conduct such clinical trials. The public health implications of a smoking cessation product that is more robust in effectiveness than other existing smoking cessation products is enormous. We look forward to continuing to work closely with the FDA on this very important public health matter.”



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