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Osel, Inc. Begins Phase 2/3 Clinical Study For Prevention Of AAD


10/19/2005 5:13:19 PM

SANTA CLARA, Calif., Oct. 11 /PRNewswire/ -- Osel Inc., the Bacterio- Therapeutics Company, has enrolled the first subjects into its Phase 2/3 clinical study for the prevention of Antibiotic Associated Diarrhea (AAD). The initial Phase 2 part of this Phase 2/3 study is a randomized, double-blinded, placebo controlled study to be conducted at 12 U.S. study sites, and will enroll 600 subjects requiring antibiotic therapy for the treatment of infection. The study is designed to show efficacy and safety of Osel's CDACTIN-O therapeutic product. CDACTIN-O was in-licensed from Miyarisan Pharmaceutical Company, Ltd. of Japan, where it is marketed under the name MIYA-BM(R) as an oral therapeutic drug product. Osel has exclusive rights to commercialize the product in North America and Europe.

MIYA-BM(R), an oral tablet, was approved by the Japanese Ministry of Health, Labor and Welfare, and is used for the indications of C. difficile associated disease (CDAD) and the larger market of antibiotic associate diarrhea (AAD). "Osel, with our partner Miyarisan, has worked quickly and effectively with the FDA to get to this point in our development program in only five months. We have a uniquely effective working relationship, between our two companies located on two continents, like none I have seen in my 30 plus years in this industry" said Osel President, Ralph Levy.

"This product complements our current portfolio of drug product candidates as it is also a commensal live bacterial product for the treatment of infections for which no optimal treatment exists today. Billions of dollars are expended in the treatment of, and extended hospital stays resulting from, these infections," reiterated Mr. Levy.

The active ingredient of CDACTIN-O is a specific, proprietary strain of C. butyricum, which has been shown to prevent as well as treat the antibiotic- induced gastrointestinal disorders, AAD and CDAD. It has been used safely and effectively in thousands of patients, from pediatric to geriatric, for these indications for years in other countries, including Japan. The product is manufactured by a proprietary process at Miyarisan's state-of-the-art biological manufacturing facility located in Nagano, Japan.

The study will examine efficacy and safety of CDACTIN-O when given to outpatients undergoing antibiotic therapy regimens of beta-lactams or cephalosporins for the treatment of infection. Our goal is to show that CDACTIN-O prevents AAD, including the more severe CDAD. Osel will follow this Phase 2 part of the study with parallel Phase 3 studies, one in patients treated with beta-lactams, and the other with cephalosporins.

Mr. Levy also said, "I am pleased to state that not only did Osel's current investors increase their funding of the company for this trial, but our partner Miyarisan also made an equity investment in Osel, which further confirms the promise of the work we are doing, and the continued support for it." Masayuki Uchida, Miyarisan's president said, "I am delighted to hear that Osel has entered into the Phase 2 part as planned, and we promise to make our best efforts continuously to support them toward our shared goal. I truly look forward to further developing our fine relationship, which has worked very effectively, to the mutual benefit of our organizations."

The incidence of AAD ranges from 15-25% of subjects receiving the antibiotic families to be utilized in this study. The more severe form of AAD, CDAD, typically extends patients' hospital stays 8 to 20 days, resulting in higher medical care costs and a higher risk of acquiring other types of nosocomial infections. Treatment for AAD is limited because there are no approved therapies available apart from discontinuation of the inciting antibiotic and supportive care. Discontinuation of antibiotic therapy is effective in only 15% of patients. Toxigenic C. difficile is responsible for 20% to 30% of AAD cases. This organism is the causative agent for pseudomembranous colitis, a potentially life threatening condition, and the most common intestinal tract infection in adult hospitalized patients. Diarrhea and colitis of CDAD are mediated by two toxins produced by toxigenic C. difficile strains. CDAD is currently treated with metronidazole or vancomycin. Although these antibiotics effectively kill C. difficile, they also disrupt the protective gut flora, leading to relapses. Recurrence of CDAD from re-infection with C. difficile is a major medical problem in the hospital setting (Osel's next venue for studies), and occurs in 15% to 20% of patients within 30 days of discontinuing antibiotic therapy.

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 currently has its LACTIN-V product candidate in Phase 2 trial in the U.S. for recurrent bacterial vaginosis (RBV)and RUTI indications. 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, orcell, +1-415-699-0135, or rlevy@oselinc.com



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