TAMPA, Fla.--(BUSINESS WIRE)--Oragenics, Inc. (OTCBB:ORNI) announced that a recently completed randomized, double-blind, placebo-controlled, human clinical study with 32 enrolled subjects resulted in a statistically and clinically significant reduction in body weight when healthy, overweight and mildly obese adult volunteers were given daily supplementation of Oragenics’ Weight Loss Agent LPT3-04 over a twelve-week period. This study, sponsored by Oragenics, was conducted at the Miami Research Associates (MRA) clinical research facilities in Miami, Florida. MRA investigators also confirmed that there were no safety concerns with daily supplementation of LPT3-04 over the 12-week duration of the trial, and that no reports of serious adverse events, including depression, occurred during this trial. This human study result confirms the extensive results obtained from animal safety and efficacy studies completed to date by Oragenics, and suggests that LPT3-04, a natural occurring dietary substance with an excellent safety and tolerance profile, can support weight loss in overweight men and women.
The World Health Organization estimated that by 2015, there will be more than 1.5 billion overweight consumers. Further, according to a 2012 healthcare market research report published by Markets and Markets, the total global weight loss market is expected to be worth US$586.3 billion by 2014, with a compound annual growth rate of 10.9% from 2009 to 2014. These reports suggest that the opportunities for a scientifically-substantiated weight management product are impressive.
“We are delighted with the results of this well-designed human study. The reported weight loss appears to relate to LPT3-04’s ability to increase programmed cell death (apoptosis) of white fat cells. The Company is currently seeking partners to further develop this technology and commercialize food and beverage products that encourage the weight management of both humans and companion pets,” stated John N. Bonfiglio, Ph.D., Chief Executive Officer of Oragenics.
About Oragenics, Inc.
Oragenics is a leading nutraceutical company focused on oral care probiotics for humans and companion pets. The Company’s proprietary products Evora and ProBiora3® are currently sold in the United States and international markets. In addition, Oragenics has an exciting pipeline of therapeutic products targeting infectious diseases.
About Miami Research Associates
Miami Research Associates (MRA) is a multi-specialty clinical research facility in operation since 1996. Our expert staff consists of more than 16 board-certified physician investigators and more than 38 ACRP certified clinical research coordinators. We are industry leaders at the execution of Phase I-IV clinical trials and pride ourselves on accuracy, integrity and quality data.
Safe Harbor Statement: Under the Private Securities Litigation Reform Act of 1995: This release includes forward-looking statements that reflect the Company’s current views with respect to future events and financial performance. These forward-looking statements are based on management’s beliefs and assumptions and information currently available. The words “believe,” “expect,” “anticipate,” “intend,” “estimate,” “project” and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to our ability to raise additional capital to sustain our operations beyond March 31, 2012 and those set forth in our most recently filed annual report on Form 10-K and quarterly report on Form 10-Q, and other factors detailed from time to time in filings with the U.S. Securities and Exchange Commission. We expressly disclaim any responsibility to update forward-looking statements.
Linda Loren, 813-527-1020
Cooper Global Communications, LLC
Jennifer K. Zimmons, Ph.D., 212-209-7360