Clinical Development
LACTIN-V Clinical Development Plan
Osel has been advised on its Clinical Development Plan for LACTIN-V by its Clinical Advisory Board (CAB), members of which are among the leading clinical experts in the field. This CAB consists of Dr. Stamm, an expert in infectious disease and RUTI, University of Washington; and Dr. Gary Schoolnik, Osel’s co-founder, and former head of the infectious disease specialty at Stanford University. In 2004-5, Osel successfully completed two Phase I safety trials evaluating LACTIN-V gelatin capsules for the indications of BV and RUTI. Results demonstrated the product to have an excellent safety profile and that it was well accepted and tolerated by women. Following these initial studies, Osel conducted two randomized, double-blinded, placebo controlled Phase II trials for the prevention of recurrent BV and UTIs. These trials continued to demonstrate product safety and acceptability, and suggested potential efficacy in the prevention of BV and UTIs in women with effective colonization. From these studies further improvements were made in the product formulation and dosage form to improve the vaginal colonization rates. In 2007-8, a Phase I dose-escalation study in healthy women using the new formulation in a novel vaginal applicator delivery system showed that high dose LACTIN-V could be safely delivered by a vaginal applicator. Recently, a Phase IIa trial was initiated among women following treatment for BV to evaluate the efficiency of vaginal colonization as a biologic surrogate of efficacy. In addition, the effect of LACTIN-V on vaginal microflora, safety, and acceptability will be assessed. With positive results from this colonization trial and the ongoing Phase II trial for the prevention of RUTI, Osel will be poised to initiate licensure-driven Phase III efficacy trials for both indications. Osel enjoys a strategic development advantage that by the nature of Osel's products, and the indications for which they are designed to address, small trials of relatively brief duration will enable a shorter time to market compared to most all other products.
CBM588 Clinical Development Plan
CBM588 has been safely used in Japan for over 30 years as a non-antibiotic treatment option for antibiotic-associated diarrhea (AAD) as well as other conditions characterized by disturbances of the gastrointestinal flora, including Clostridium difficile associated disease (CDAD) and irritable bowel syndrome (IBS). In 2005-6, following Osel's in-licensure of this product, a Phase II randomized, double-blinded, placebo controlled study was undertaken among healthy outpatient adults receiving oral antibiotics to evaluate the safety and potential efficacy of CBM588 in preventing AAD. Results showed that the product could be safely used in an American population and suggested a trend for efficacy. Osel will be pursuing these promising results with initiation of a new Phase II trial in 2009 to evaluate the therapeutic effect of CBM588 in hospitalized patients with AAD and CDAD, as well as its effect on the prevention of CDAD. In addition, Osel is also planning to evaluate CBM588's therapeutic effect in IBS. As CDAD is currently increasing in rates nation wide and accounts for more deaths than all other gastrointestinal infections combined, Osel will vigorously pursue a Phase III efficacy trial through fast-track licensure with the FDA.