AMEBAGONE INC — Department of Health and Human Services SBIR Phase II: N

Description

Project Summary Abstract Bacterial keratitisBKis an infection of the cornea thatif left untreatedcan cause blindnessStaphylococcus aureusSaStreptococcus pneumoniaeSpand Pseudomonas aeruginosaPaare three major causes of BK in North AmericaSymptoms of BK include painrednessinflammationand opacity of the affected cornea and loss of visual acuityAmebaGone IncAGpartnered with UW Madison Department of Ophthalmology to develop a novel biocontrol method to treat BKAG holds issued patents and has expert knowledge related to use of Dictyostelid cellsDCa benignsoildwelling organism known to destroy pathogenic bacteria through the phagocytosisIssued patents broadly cover the use of DC to eat biofilm enmeshed and free livingplanktonicbacteriaTherapeutic Ameba and Uses ThereofUSPTO granted patentand follow up patent USA patent covering countries of the European Union has been filed and the firm has licensed rights to more thanDC strains fromworldwide collections occupying diverse natural habitatsBenign DC diverged from aquatic amoebasome of which are pathogenicoverbillion years agoIn Phase I workAG identifiedDicty strains capable of efficiently killingrtlogreduction in bacterial titersSa at eye temperatureOf these strainsAG identifiedDC strains that reproducibly germinated to high levels and developed a gel formulation that increased the maximum recovery time fromtohoursAdditionallyAG tested safety of these DC strains and found no increase in corneal pathology or discomfort compared to the vehicle controlIn the Phase II project AG proposes toExpand the target of DC from singular action against Sa to additional causative agents of BKPa and SpDevelop effective formulation and assess DC stability thereinConduct in vivo safety and basic biology testing of DC treatment in the eyeandQuantify efficacy of DC cocktails in treating murine cornea infected with SaPaor Sp in vivoThe data generated in these studies will position us to prepare an Investigational New DrugINDapplication for the Food and Drug AdministrationFDA