SOURCE: Enterologics

April 18, 2011 16:51 ET

Enterologics, Inc. to Develop Probiotics as Biologic Drugs for Gastrointestinal Diseases

Enterologics, Inc. Announces Its Business Strategy to Develop a Pipeline of Specific Probiotic Strains as Biologic Drugs for Gastrointestinal Disease Conditions

SAINT PAUL, MN--(Marketwire - Apr 18, 2011) - Enterologics, Inc. (OTCBB: ELGO), a biotechnology company, unveiled its business strategy to build and develop a pipeline of probiotic biologics. The Company will license or acquire specific probiotic strains and develop these to meet the exacting standards necessary for FDA approval as prescription biologics for specific gastrointestinal (GI) indications. Many GI disorders are poorly addressed by current therapies, including pouchitis, irritable bowel syndrome (IBS), Crohn's disease, ulcerative colitis and Clostridium difficile infections.

"Today, most probiotic bacteria are sold over-the-counter as dietary supplements or in food products such as yogurt, with ambiguous benefits. Instead, Enterologics plans to commercialize our probiotic strains as biologics, each meeting FDA standards for clinical efficacy and approval for a specific indication. We believe that this will establish a unique and strong competitive position in the market," stated Bob Hoerr, Co-Founder and President.

"We have identified a series of candidate probiotic strains for potential licensing," Dr. Hoerr continued. "We intend to transform each strain into proprietary, live biotherapeutic products, together with a proprietary formulation process to preserve maximum biologic activity. Each product will follow a rigorous development template that includes comprehensive bacterial strain characterization, genomic sequencing and dosage form optimization. Our goal is to move as quickly as possible into clinical trials under an active Investigational New Drug (IND) application."

Probiotics are live microorganisms (in most cases, bacteria) that are similar to or derived from beneficial microorganisms found in the human gut. They are also called "friendly bacteria" or "good bacteria." The community of bacteria living in the gut, which differs in each individual, is the microflora. Poor eating habits, stress, or antibiotics and other drug treatments for various conditions can disrupt the microflora's natural balance. Disturbances in this equilibrium may occur in conjunction with various GI diseases and may even contribute to their cause.

There are many hurdles to developing probiotics as prescription drugs, including meeting the stringent requirements of the FDA for quality and demonstrated efficacy through clinical testing. However, this pathway does exist and at least one IND has been approved for a specific probiotic bacterial strain. In their publications, FDA scientists have termed such products "live biotherapeutics," contrasting these to other biologic products, many of which may have been produced by living organisms or cells, but are not in and of themselves capable of replicating and multiplying in the body.

Dr. Hoerr predicted that broader medical use will follow convincing clinical tests of the type used to obtain regulatory approval for drugs and biologics to treat specific conditions. Enterologics will pursue its business plan to develop prescription biologics and drugs for treating various gastrointestinal disorders, subject to the availability of funding. The Company plans to finance the development of its business from outside sources including through the sale of equity, debt or convertible securities, third party financing and strategic partnering. The goal is to secure sufficient financing to acquire and move a pipeline of products forward in clinical development as efficiently as possible.

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," "anticipate," "estimate," "project," "forecast," "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, 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.

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