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Last updated on April 24, 2014 at 21:24 EDT

Enterologics Comments On Increased Number Of Clinical Trials Involving Probiotics

June 11, 2012

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.

About Enterologics

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.

Contact Information

For further information, contact ir@enterologics.com or visit www.enterologics.com.

Key Words: probiotics, biologics, biotechnology, gastrointestinal diseases

Forward-Looking Statement
Matters discussed in this release may constitute forward-looking statements. The U.S. Private Securities Litigation Reform Act of 1995 provides safe harbor protections for forward-looking statements in order to encourage companies to provide prospective information about their business. The Company desires to take advantage of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and is including this cautionary statement in connection with this safe harbor legislation.

Forward-looking statements reflect our current views with respect to future events and financial performance and may include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements, which are other than statements of historical facts. The words “believe,” “intend,” “better,” “estimate,” “project,” “promise,” “plan,” “potential,” “may,” “should,” “expect” and similar expressions identify forward-looking statements.

The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions, including without limitation, the consummation of the acquisition described above, the ability to obtain regulatory approval and market its products, availability of capital, management’s examination of historical operating trends, data contained in our records and other data available from third parties. Although we believe that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond our control, we cannot assure you that it will achieve or accomplish these expectations, beliefs or projections.

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


Source: PR Newswire