Enterologics Comments On Increased Number Of Clinical Trials Involving Probiotics
SAINT PAUL, Minn., June 11, 2012 /PRNewswire/ — Enterologics, Inc (OTCBB: ELGO) commented today on the remarkable increase in numbers of scientific publications related to probiotics over the past 5 years. Probiotics are being studied for their potentially beneficial role in human health and disease. A review of the scientific literature over the past two decades provides striking evidence for this trend. PubMed searches of the National Library of Medicine journal database, using the terms “probiotics” and “human” and limiting publication type to “randomized clinical trials”, generated the following statistics:
5-Year Period Randomized Clinical Trial Reports 1986 through 1990 0 1991 through 1995 1 1996 through 2000 32 2001 through 2005 190 2006 through 2010 498 2011 through May 2012 114
These numbers indicate that interest in probiotics continues to grow within the scientific community. Because clinical trials tend to be more expensive and time-consuming than studies in laboratory animals, increasing numbers of clinical trial reports demonstrate an expanding commitment to fund clinical testing of probiotics by industry, government agencies, foundations and other non-governmental organizations.
“Probiotics, in the form of fermented foods and yogurt, have been present in our diet for centuries. Despite their time-honored use, they were virtually unknown in the medical literature before 1995 and not taken seriously by the medical establishment until very recently, as these publication statistics confirm,” said Dr. Bob Hoerr, President of Enterologics. “New techniques in molecular biology are making it feasible to better understand how probiotics interact with our bodies and the mechanisms through which they exert their effects. We believe that Probactrix®, our E. coli M17 probiotic, likewise holds great promise and look forward to demonstrating its potential role for treating specific disease conditions through clinical trials.”
The ages of subjects involved in the clinical trial reports, published over the 20+ year period from 1991 through the present, range from the very young to elderly individuals:
Age Group Randomized Clinical Trial Reports (1991 through June 2012) 0 through 23 months 239 0 through 18 years 386 19 and older 495 65 and older 192
The multiple trials involving infants and children under two years of age are noteworthy due to the challenges of studying new treatments in this age group. The trials investigated use of probiotics to prevent and treat multiple diseases ranging from diarrheal infections to skin and respiratory disorders. Trials involving older individuals examined potential effects of probiotics on aging-related changes in body function, such as decreases in immune response, and on diseases that affect older individuals, such as diverticular disease and other bowel disorders, post-surgical infections, and side effects associated with cancer chemotherapy and radiation. These trends also confirm that investigators are focused on quantifying benefits of probiotics not only on health maintenance but also on determining their therapeutic value for specific disease indications.
Separately, the Company reports that the press release issued on June 5, 2012 continues to be newsworthy to its shareholders but was previously disseminated to the public on April 15, 2011 and was inadvertently issued as a release on June 5th.
Enterologics, Inc (ELGO) is a biotechnology company that is developing probiotics as biologic drugs for specific gastrointestinal disease indications. Probiotics are live microorganisms, in most cases, bacteria, that are similar to or derived from beneficial microorganisms that are found in the human gut (e.g. for more information see Introduction to Probiotics). They are also called “friendly bacteria” or “good bacteria.” Enterologics intends to develop unique probiotic strains for specific medical conditions, obtain regulatory approval and market these probiotics products as FDA-approved prescription drugs for specific label indications. The first probiotic product in its portfolio is E. coli M17, which is being developed for specific gastrointestinal indications.
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Key Words: probiotics, biologics, biotechnology, gastrointestinal diseases
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Important factors that, in our view, could cause actual results to differ materially from those discussed in the forward-looking statements include our ability to identify and in-license and the ability to adequately fund such targeted acquisitions. Risks and uncertainties are further described in reports filed by Enterologics, Inc with the U.S. Securities and Exchange Commission.
SOURCE Enterologics, Inc