St. Paul, MN, April 15, 2011 --(PR.com
)-- Enterologics, Inc., a biotechnology company, is dedicated to the development of live biotherapeutic products for gastrointestinal (GI) disorders, that it believes are poorly addressed by current therapies. Key examples include pouchitis, irritable bowel syndrome (IBS), Crohn’s disease, ulcerative colitis and Clostridium difficile infections.
Enterologics intends to license or acquire technology to build a product pipeline based on producing probiotic bacteria in novel, shelf-stable, high potency formulations that are delivered orally. Unlike probiotic bacteria that are sold over-the-counter as dietary supplements or in food products such as yogurt, they intend to develop products to meet the exacting standards necessary to gain FDA approval as prescription drugs and biologics, with demonstrated safety and clinical benefits for specific GI indications.
Bob Hoerr, Co-founder and President stated, “We recently announced that the Company has optioned and has the right of first refusal to enter into a license agreement with Universal Stabilization Technologies, Inc., a Delaware company ('UST') for a unique preservation/stabilization bacterial vitrification process. We believe UST’s breakthrough approach will prove superior to conventional freeze-drying techniques and can be applied to a wide variety of bacterial strains, rendering them in a state of 'suspended animation' and extending viability throughout a long shelf life, with demonstrated potency at the time they are administered. Over-the-counter probiotic products provide little assurance that they are delivering live, functional bacteria, leading to uncertainty on the part of the consumer and physician about product potency.
“We believe that commercializing a shelf-stable product that meets FDA standards for clinical efficacy will offer a competitive advantage in the market,” Dr. Hoerr continued. “We have identified a series of candidate probiotics that we will be transforming into proprietary, live biotherapeutic products. Each product follows a rigorous development template that includes comprehensive bacterial strain characterization, full genomic sequencing and dosage form optimization.”
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." Probiotics are available in foods such as yogurt and as dietary supplements (for example, capsules, tablets, and powders). Brand names that imply wellness or regularity in bowel function, coupled with ambiguous marketing claims to promote health, create interest but also confusion for consumers and physicians as to the real benefit of the specific product.
Most probiotics are bacteria similar to those naturally found in people's guts, especially in those of breastfed infants (who have natural protection against many diseases). Most often, the bacteria come from two groups, Lactobacillus or Bifidobacterium. Within each group, there are different species (for example, Lactobacillus acidophilus and Bifidobacterium bifidus), and within each species, different strains (or varieties). Other bacterial groups in which probiotic strains have been identified include Bacillus, E. coli, Enterococcus, and Streptococcus. A few common probiotics, such as Saccharomyces boulardii, are yeasts, which are different from bacteria.
Probiotics generally have a very short life-span. Water, acid and oxygen are harmful to probiotics and most die or cease to function after a short period of time after extraction from the source. A reduction in levels of beneficial bacteria that naturally live in our gastrointestinal tracts can occur. Poor eating habits, stress, or the use of antibiotic drugs or other factors may disrupt the natural balance of bacterial populations within the GI tract. Disturbances in this equilibrium are thought to contribute to a variety of abdominal ailments and an overall decrease in the function of the immune system.
Probiotics are now sold in the United States as dietary supplements or as components of conventional food products, such as yogurt. There are many hurdles to developing probiotics as prescription drugs, including meet 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. FDA staff have termed such products “live biotherapeutics” in their scientific publications, 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.
Enterologics believes that broader medical use of probiotics will follow convincing clinical tests of the type used to obtain regulatory approval for drugs and biologics to treat specific conditions. The Company intends to identify, in-license and 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. Predictable product potency is a critical feature of a live biotherapeutic.
Subject to UST’s technology meeting the Company’s specifications and their funding resources, they intend to license UST’s bacterial vitrification process, which they believe is far superior to other drying techniques and which they believe will enable them to meet the high potency standards necessary for prescription drug approval. This technology will be used to create highly stable dosage forms of their probiotic candidate products.
Enterologics will pursue its business plan to develop prescription biologics and drugs for treating various gastrointestinal disorders, subject to the availability of funding. They intend to finance the development of their business, including their prescription drug development efforts, from outside sources including through the sale of equity, debt or convertible securities, third party financing and strategic partnering. Their goal is secure sufficient financing to acquire and move a pipeline of products forward in clinical development as efficiently as possible.
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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.