LACTIN-V - Clinical Plans for LACTIN-V
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. Walter Stamm, an infectious disease and RUTI expert, University of Washington; and Dr. Gary Schoolnik, Osel’s co-founder, and former head of the infectious disease specialty at Stanford University. In 2004, Osel successfully completed two Phase I safety trials utilizing LACTIN-V, for BV and RUTI, which resulted in showing that the product candidate is safe and well tolerated. As such, in mid 2005 Osel initiated two randomized, double-blinded, placebo controlled Phase II trials, one each for the prevention of recurring UTIs and recurring BV infections. The current Clinical Development Plan calls for the completion of the Phase II studies of LACTIN-V in the RBV and RUTI indications in late 2005. This clinical plan will position Osel to file an NDA for use of LACTIN-V in the prevention of RUTI and RBV by the end of 2006 and allow the company to supplement the NDA with claims to treatment in IVF by mid-2007, and to file for EU Marketing Authorizations six months thereafter. The nature of Osel’s products and the indications for which they are designed to address, enable a short time to market, by utilizing Clinical trials of short duration, for approval of first treatment indications, to be followed by additional trials for prophylaxis indications.
CDACTIN-O Clinical Development Plan
Because of the extensive amount of safety data available from clinical use in Japan, Osel plans, in late 2005, to conduct a pivotal Phase 2/3 randomized, double-blinded, placebo controlled clinical study to assess safety and efficacy in an adult population receiving antibiotics (beta lactams and cephalosporins) for the treatment of infection. The ultimate goal of the clinical development program is to show that CDACTIN-O is safe and efficacious in the prevention of Antibiotic Associated Diarrhea, in patients receiving oral antibiotics as outpatient treatment for infections. CDACTIN-O is to be administered orally and treatment initiated with the start of oral antibiotics. The study is designed to show incidence rate and efficacy by antibiotic class. This study will also yield information regarding the prevention of Clostridium difficile. The formulation and dose to be investigated in the proposed study is identical to that authorized for clinical administration in Japan, and will be manufactured in the same facility and by the same validated processes. In future clinical development Osel may specifically investigate the ability of CDACTIN-O to prevent and possibly treat Clostridium difficile infection, especially in high risk populations.
