Commercialization of an MRI contrast agent for differential diagnosis ofprostate cancer.

Contact PD PILiYajuan AbstractParent GrantProstate cancer is a highly heterogeneous disease and the second most cause of cancer death of men in the USCurrent methods to assess prostate cancer risk combine prostate specific antigenPSAscreening and random prostate biopsyUnfortunatelythis strategy fails to reveal the lesion s location and does not accurately differentiate between aggressive and non aggressive prostate cancersAs a resultmost patients will receive unnecessary active treatment for low risk prostate cancer in order to avoid under treatmentActive treatment involves surgery or radiationoften causing long term side effects such as urinary incontinenceerectile dysfunctionor bowel urgencyThusdevelopment of non invasive and accurate diagnostic imaging technology to localize and differentiate high risk prostate cancer offer a new tool to assist physicians in risk stratification and decision making and to spare millions patients with lowrisk cancer from unnecessary aggressive treatmentThe mission of Molecular Theranosticsfka Prostate Theranosticsis to commercialize a novel molecular imaging approach that targets an oncoprotein associated with epithelial to mesenchymal transitionEMTcancer cell stemnessangiogenesisproliferationand metastasisThe oncoprotein has a high expression in the tumor extracellular matrix of high risk prostate cancerlow in low grade tumornone in normal tissuesThe goal of this project is to commercialize a safe and effective targeted contrast agent for accurate early detectionlocalizationand differential diagnosis of high risk prostate cancer with MRIIn phase Iwe have optimized and identified a lead targeted MRI contrast agent for clinical translationAll of the milestones in Phase I of the project have been achievedThe agent possesses the superior ability of robust specific contrast enhancement in high risk prostate cancernot in slow growing low risk tumors in animal modelsand has the potential to visualize and differentiate high risk prostate cancers with MRIThe objectives of this SBIR Phase II are to develop a lead formulation of the contrast agentto perform FDA required eIND enabling studiesand to commercialize the agent for clinical imaging prostate cancerThe specific aims areto scale up the synthesis of the targeted contrast agent and develop a lead product formulation for pre clinical study and clinical trialsto validate the effectiveness of the formulation for prostate cancer imaging on a clinical MRI scanner and to determine its minimally effective doseto perform eIND enabling pharmacokinetics and safety studies in rodentsNon invasive accurate detection of prostate cancer is an unmet clinical need for prostate cancer managementClinical trials will be initiated as soon as the eIND is approved by the FDASuccessful development of our imaging technology has the potential to accurately detectlocalizeand diagnose prostate cancerreplace invasive prostate biopsyand improve decision making in clinical management of prostate cancerIt also has the potential for non invasive active surveillance of prostate cancer and timely monitoring of disease progressionas well as image guided therapyProject Summary Abstract PageContact PD PILiYajuan Project NarrativeParent Grant Although the detection of prostate cancer is criticalclinicians still need to know where the cancer is located and most importantly if the cancer is aggressiveOur targeted MRI contrast agent binds a protein found in high risk prostate cancer and has demonstrated the ability for non invasive visualization and differentiation of prostate cancer with MRIThe commercialization of such a contrast agent offers an innovative approach to the risk stratification and treatment of prostate cancerProject Narrative Page