Expanding the Market and Success Rates for Myeloablative Cancer Treatments Using PUL an Innate Immune Stimulant

Pulmotect Inc was founded in to translate discoveries that induce innate immune resistance in the lung into therapeutics that will provide protection from inhaled pathogens Our technology platform is a direct result of basic research by our founders on the mechanisms of microbial resistance in the lung epithelium We have developed an inhaled therapeutic PUL that provides immediate protection against a broad spectrum of respiratory pathogens PUL is a clinical stage specific combination of two well characterized synthetic molecules a lipopeptide Pam CSK and an oligodeoxynucleotide ODN M that act as agonists of the Toll like Receptors TLR and TLR respectively This unique proprietary combination of molecules synergizes to rapidly and powerfully stimulate the body s natural defenses The response is localized and specific to the site of administration In mice treatment before and after exposure with aerosolized PUL results in increased survival rates to pathogens including multiple Gram and Gram bacteria three of which are Class A bioterror agents the fungus Aspergillus fumigatus and the Sendai and influenza viruses In each case increased survival is associated with a reduction of lung pathogen burden not simply increased tolerance to the pathogen by the host which indicates a resistance mechanism of action Pulmotectandapos s long term strategy is to leverage its technology across a wide array of important threats from inhaled pathogens by limiting the pathogen burden and transmission of disease The range of applications for PUL currently in development includes use in immunosuppressed patients pandemic influenza asthma exacerbations associated with viral infections and manmade bioterror threats as well as naturally emerging viruses While this broad spectrum technology is not envisioned to replace traditional vaccine approaches its value and differentiation reside in the ability to confer immediate host based protection that is not limited by the identity of the pathogen The potential indications that lie outside the scope of this proposal are synergistic building on experimental methods that we established since our earliest research in this field The scientific basis of boosting the innate immune system in the lungs is rapidly expanding as we better understand the underlying mechanism of action The primary goal of this proposal is to complete a Phase II clinical trial in immunosuppressed cancer patients This will be a multi center randomized double blind trial that will compare PUL against placebo on the overall incidence and severity of pneumonia specifically on those who have been screened to have a parainfluenza infection prior to enrollment The three objectives of the trial are described below Primary objective to determine the safety and tolerability of PUL inhalation solution in patients with documented parainfluenza infection Secondary objective to determine the efficacy of PUL inhalation solution to prevent the progression of documented parainfluenza infection to clinically documented lower respiratory tract infection Exploratory objectives evaluate the effect of PUL on parainfluenza viral titers and neutralizing antibodies evaluate the effect of PUL over time on the microbiome and virome in nasal washes in the study population and determine whether PUL induces neutralizing antibodies against PUL components The successful achievement of these objectives will demonstrate proof of concept in man and further validate the technology for market use With secured matching funds already in place this NIH proposal is designed to help move the project to the end goal rather than provide the initial seed funds to start the process The Company would be well positioned to advance existing collaborations partnerships and discussions with leading large pharma and biotechnology organizations accelerating the path to the market to address the serious unmet needs that many patients are currently facing Pulmotect Inc is developing novel therapeutics that stimulate the innate immune system to protect against infectious diseases even in cases of severely compromised immunity Proof of concept data has shown that this technology effectively protects against a broad range of inhaled pathogens including viral challenges that often cause asthma exacerbations Early clinical studies have shown the drug to safe in humans up to the expected therapeutic dose This project aims to further advance the clinical development of this technology by completing a proof of concept Phase II clinical trial in immunosuppressed cancer patients