PAI LIFE SCIENCES INC — Department of Health and Human Services SBIR Phase I: NIAID

Description

DESCRIPTION provided by applicant Tuberculosis TB a disease caused by Mycobacterium tuberculosis Mtb is an ongoing threat to public health Globally approximately two billion people are infected with TB with nine million newly diagnosed cases of active TB each year causing million deaths Furthermore mismanagement or inappropriate treatments for TB infections can result in the development of drug resistant TB cases for which treatments are difficult and expensive Drug resistant strains of Mtb are not treatable with frontline therapy and require months of complex second and third line antibiotics In addition TDR totally drug resistant strains exist which cannot be treated with any available antibiotics The current proposal is designed to develop a novel synergistic combination chemo immunotherapeutic regimen for the treatment of infections caused by Mtb including multi extremely and totally drug resistant strains An effective treatment that reduces bacterial loads and shortens therapy to less than six months would play an important role in dramatically reducing the impact of this pathogen This application is an extension of our systematic and methodical approach towards developing vaccines for TB Over the last twenty years we have applied this strategy towards developing M AS E currently in Phase II clinical trials and ID GLA SE into viable vaccine candidates At present to our knowledge ID GLA SE is the sole TB vaccine candidate that has been tested for prevention and therapy in multiple animal models of TB Our candidate vaccine has three protective effects significantly reduces pulmonary bacterial loads reduces disseminated Mtb infection after aerosol challenge and post exposure immunotherapeutic protection Funding this application will help our continuing efforts to develop an adjuvanted ID vaccine towards for future human clinical trials ultimately resulting in an approved post exposure TB vaccine PUBLIC HEALTH RELEVANCE Mycobacterium tuberculosis is a global pathogen of extreme concern requiring months of treatment with multiple antibiotics for drug resistant forms of tuberculosis By defining and validating a shorter and more effective combination regimen comprised of two or more antibiotics to prevent bacterial growth and an immunotherapeutic vaccine to stimulate the immune system to clear the bacteria from the body we intend to progress towards an immune chemotherapeutic product leading to an improvement in global health