Operations are picking up at Osel Inc., a company looking to develop bacteria-based therapeutics.

The Santa Clara, Calif.-based company added a top executive and scientific advisers over the past couple of months. It also moved its lead product into clinical testing during the same period: In June, Lactin-V entered a Phase I study for bacterial vaginosis, and within the next month it is expected to move into a Phase I trial for recurring urinary tract infections. The product stems from a naturally occurring Lactobacillus cristatus bacteria, and is designed to act on vaginal mucosa to inhibit disease.

"The bacteria helps to re-establish the natural flora," Ralph Levy, Osel's recently appointed president, told BioWorld Today. "It produces hydrogen peroxide and lactic acid that fight off the offending bacteria - E. coli and others - and we intend to use it for both acute indications and prophylaxis to prevent recurring situations. And between the U.S. and Europe, the two conditions together affect some 15 million patients."

The conditions commonly are treated with antibiotics, which can kill the natural flora and cause resistance. Levy, who has 30 years of drug development industry experience, said both Lactin-V programs would run in parallel, followed by short Phase II and Phase III studies, with an eye toward commercialization in 2007.

The bacterial vaginosis trial is being conducted at the University of Pittsburgh under the watch of Sharon Hillier, while the recurring urinary tract infection study will be held at the University of Washington in Seattle under Walter Stamm. Both were recently added to Osel's clinical advisory board.

Down the road, the 10-employee company plans to test the product's use for in vitro fertilization. Levy said patients looking to undergo the procedure often have E. coli and other bacteria, while lacking normal levels of Lactobacillus.

Osel gained its rights to Lactin-V from The Medicines Co., of Parsippany, N.J., and Levy said it soon expects to acquire another bacteria product for an unnamed general hospital indication.

"It's along the same lines," he said, adding that it's also a natural bacteria. "It will go through the same type of brief clinical trials, and it [targets] a worldwide indication."

Other future plans include out-licensing sales rights to large pharmaceutical partners, after Osel develops its products internally through Phase III testing.

The company was founded in 1998 by Peter Lee, a cancer immunologist who remains chairman, to exploit a platform called the Mucocept technology, designed to genetically engineer bacteria to produce proteins and antibodies in vivo. Applying the technology to Lactobacillus jensenii, it since has produced second-generation HIV inhibitors, CD4 and cinovarin-N. An eventual product from the inhibitors would be delivered as a suppository for women to block the virus from entering a vagina's mucosal wall.

"It acts through a totally different mechanism than anything else that's either available or being developed," Lee told BioWorld Today. "For instance, vaccines require the host to mount an immune response, and they act after the virus has already entered the body. But this is basically acting at the door - it stops the virus from entering in the first place."

He added that the HIV product is being developed for both stand-alone use or in combination with vaccines, can be produced inexpensively, remains stable for more than a year when stocked and will remain in place for about a week after application.

An assistant professor of medicine at Stanford University in Palo Alto, Calif., Lee said he has evaluated genetically engineered Lactobacillus for about 10 years. Levy added that Osel recently received a $5 million grant from the National Institutes of Health in Bethesda, Md., to continue the technology's development. The early stage research has yet to be tested in animals, though Levy noted that a study would soon get under way.

In the meantime, Osel is working to advance Lactin-V, a bacterial product borne of similar principle.

"We see Lactin-V as a first-generation product," Lee said, "a highly selected, carefully chosen, human isolated lactobacilli. And the second generation will be genetically modified. A lot of the formulation and clinical trial design issues are very similar, so we see Lactin-V and Mucocept as quite synergistic."

He added that Osel also aims to engineer Lactobacillus that inhibits other sexually transmitted pathogens. To that end, the company has generated engineered bacteria for herpes simplex virus and papillomavirus. A manufacturing site in Colorado, also acquired from The Medicines Co., produces Lactin-V and also will be used for future products.

Osel's funding to date includes about $7 million in grants, a figure that comprises the latest NIH award, and about $5 million from private investors. In the near term, Levy expects to seek added financing through either venture capital investments or a round with industrial or corporate investors.

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