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Osel, Inc. Initiates Two Phase II Trials For LACTIN-V


10/19/2005 5:13:15 PM

SANTA CLARA, Calif., April 12 /PRNewswire/ -- Osel, Inc., the Bacterio-Therapeutics company, announced the initiation of two Phase II clinical trials of LACTIN-V, one for the treatment of recurrent urinary tract infection (RUTI), and a second for recurrent bacterial vaginosis (RBV).

LACTIN-V, a vaginal capsule containing a natural human bacterial organism, will be studied in a total of eight centers for RUTI and for RBV under the clinical direction of Lynn Conrad, MD, University of Tennessee Health Science Center, Memphis (RUTI), and Benson Horowitz, MD, University of Connecticut (RBV). "We are moving ahead with our business plan to develop products utilizing naturally occurring mucosal bacteria. We are continuing to successfully meet our clinical trials milestones for the evaluation of LACTIN-V for treatment of RUTI and RBV, two conditions which plague 15 million women a year in the U.S. and Europe," said Osel president, Ralph Levy.

Urinary tract infections (UTI) account for almost 11 million physician visits each year in the U.S., and an equal number in Europe. Up to 33% of women with UTIs develop recurrent infections (>2 per year). While a routine UTI is easily treated with a short course of oral antibiotics, treatment of recurrent UTI (RUTI) with multiple courses of antibiotics may lead to resistant strains, diarrhea, and vaginal yeast infections. Thus, there is significant interest amongst women who suffer from RUTI for novel non-antibiotic therapies. Bacterial vaginosis (BV) afflicts over 16 million women every year worldwide, and is the most common reason that women seek medical help, after vaginal yeast infections.

Osel's first product, LACTIN-V, is directed at recurrent urinary tract infections (RUTI), and recurrent bacterial vaginosis (RBV). Both diseases result from deficiencies in the normal lactobacillus-dominated microflora within the reproductive and urinary tracts of susceptible women. LACTIN-V contains a natural human bacterium, Lactobacillus crispatus, which has been carefully selected based upon detailed scientific findings that demonstrate its unique ability to colonize the vaginal mucosa and to secrete substances that inhibit the growth of microbial pathogens. LACTIN-V has been optimally formulated to restore the protective vaginal microflora to combat infections and is expected to fill this unmet medical need.

About Osel

Osel, Inc. is the leading company in the emerging field of Bacterio-Therapeutics. The company's business is based on exploiting recent scientific discoveries demonstrating the central role of naturally occurring mucosal bacteria in the maintenance of health and the prevention of disease. Osel's mission is to harness the protective properties of these specialized non-pathogenic bacteria as a basis for a series of innovative products initially targeted for the prevention and treatment of diseases of the genitourinary and gastrointestinal tracts.

Contact: Ralph Levy President, Osel Inc. Phone: 408-986-0012 ext. 206 Cell : 415-699-0135 Email: rlevy@oselinc.com

Osel, Inc.

CONTACT: Ralph Levy President of Osel Inc., +1-408-986-0012, ext. 206,or cell, +1-415-699-0135, or rlevy@oselinc.com


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