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Osel, Inc. Receives National Institutes of Health (NIH) Award Under Partnerships For Topical Microbicides

10/19/2005 5:08:52 PM

SANTA CLARA, Calif., June 9 /PRNewswire/-- Osel, Inc., the Bacterio-Therapeutics company, announced award of a multiple-year grant from the NIAID, NIH towards development of an encapsulated MucoCept Lactobacillus strain for therapeutic prevention of bacterial vaginosis (BV) and HIV infection under support of the Partnerships for Topical Microbicides.

The scale of the AIDS crisis now surpasses even the worst-case scenarios of a decade ago. Around the world, approximately 40 million people are living with HIV/AIDS. The predominant mode of HIV transmission worldwide is via heterosexual contact, and women appear to be at greatest risk for HIV infection. The need to develop a simple, cost-effective, female-controlled preventative against heterosexual transmission of HIV in women is urgently recognized by both the WHO and NIH.

Osel, Inc. is pursuing an innovative and women-initiated strategy to prevent the heterosexual transmission of HIV worldwide. This strategy is based on Osel's therapeutic platform technology, known as MucoCept. The MucoCept approach involves the use of proprietary technology designed to harness the natural Lactobacillus flora and its associated biofilm on the mucosal surface -- the site of HIV entry -- to neutralize HIV particles before infection of the host. The MucoCept bacterium, a genetically enhanced human vaginal isolate of Lactobacillus jensenii, is designed to colonize the vaginal mucosa and prevent bacterial vaginosis (BV) and associated sexually transmitted infections (STIs) through production of lactic acid and hydrogen peroxide, and in addition, to further prevent HIV transmission by secreting potent protein-based microbicides into the mucosal environment. Over the past several years, under the support of multiple NIH grants, Osel has made substantial progress towards design and development of this novel topical microbicide. An expression cassette has been stably integrated into the bacterial chromosome with retention of wild-type phenotype of the host bacteria. "We are moving ahead with our business plan to develop genetically enhanced lactobacilli as a delivery vehicle for protein-based microbicides to complement our product candidates utilizing naturally occurring mucosal bacteria." said Dr. Peter P. Lee, the inventor of the MucoCept concept and a co-founder of Osel, Inc.

Osel's MucoCept technology and approaches offer a unique means of generating a topical therapeutic barrier to HIV transmission. Though a number of substantial tasks remain in the development of MucoCept HIV for human clinical testing, Dr. Qiang Xu, Principal Investigator of the funded study and Director of MucoCept Research at Osel, Inc., said "my thanks and gratitude at this announcement must go to our project team and scientists at multiple institutions for jointly advancing the development of our MucoCept bacteria as a potential topical microbicide."

The microbicide field has built significant momentum in recent years, with the introduction of the Microbicides Development Act in the U.S. Senate on March 8, 2005 and several first-generation candidates entering large-scale human clinical trials around the world. To be used globally, microbicides need to be inexpensive to manufacture, safe, and effective at reducing the transmission of HIV.

BV is a common syndrome that afflicts over 16 million women every year, in the U.S. and EU alone. It is characterized by a depletion of vaginal hydrogen peroxide-producing lactobacilli and a dramatic increase in organisms associated with BV. A deficiency of hydrogen peroxide-producing lactobacilli has been associated with an increased risk of STIs, including HIV and Herpes Simplex Virus-2 (HSV-2).

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 technologies are focused on harnessing the mucosal microflora in two complementary ways. First, we identify the most appropriate naturally occurring bacteria to treat and prevent diseases caused by disruptions in the protective microflora. Second, we develop technologies to genetically enhance the capabilities of these bacteria to combat disease-causing organisms, represented by the MucoCept line of second-generation products. Osel is conducting two Phase II clinical trials of LACTIN-V (a vaginal capsule containing a natural human Lactobacillus crispatus), one for the treatment of recurrent urinary tract infection (RUTI), and a second for recurrent bacterial vaginosis (RBV). Osel is also preparing to take to the clinic its in-licensed CDACTIN-O bacterial product candidate for the prevention of antibiotic associated diarrhea (AAD).

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

Osel, Inc.

CONTACT: Ralph Levy President of Osel Inc., +1-408-986-0012, ext. 206, orcell, +1-415-699-0135, or

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