SILBIOTECH, INC. — Department of Health and Human Services SBIR Phase II: 102

Description

PROJECT SUMMARY ABSTRACT This SBIR direct Phase II project is on developing a multimarker based technology for precisely selecting candidates for prophylactic treatments and preventing sporadic breast cancers The patient population addressed here for selecting candidates is among subjects diagnosed with proliferative precancerous breast tumors that include atypias papillomas sclerosing adenosis and usual hyperplasias Numerous clinical studies have established that diagnosis of above tumors is a risk factor and of atypical and of non atypical groups subsequently develop cancer in or more years Because of the increased risk patients diagnosed with above tumors are offered standard prophylactic therapies such as Tamoxifen Raloxifen AIs or mastectomies However due to lack of any tools that precisely separate the of high risk candidates oncologists are faced with an uncertainty in precisely predicting cancer risk and dilemma in selecting candidates for the treatments As a result patients are either under or over treated and those who have low risk are unnecessarily subjected to side effects of drugs or undergoing mastectomies The high risk candidates who opt out to avoid side effects are not getting the benefit of prophylactic treatments We have conducted a preliminary study to test the feasibility of stratifying the high risk subjects by exploiting the differences in the biology of tumors from patients with and without the history of subsequent cancer development We have derived putative markers that could predict cancer risk by gene expression approach and tested selected cancer markers in a limited number of tumor tissues Our data demonstrated the feasibility of stratifying those who develop cancer from the low risk group based on cancer marker expressions We have also shown the feasibility of translating multi marker data into a Cancer Risk Score for clinical utility Our overall objective here is to develop a Multimarker Technology that will provide comprehensive information on whether a subject will have the risk of developing cancer or low risk the future cancer will be ER or ER and how long it may take to develop cancer so that oncologists can make an informed decision in selecting candidates for treatments Our aims include screening tissues for selective markers from the to identify markers and develop algorithm that stratifies the high risk group with accuracy design a marker based algorithm that separates Cases into ER or ER cancer risk validate the developed algorithms in new sets of samples investigate an inverse correlation between marker derived risk scores and years to develop cancer after pre cancer diagnosis and finally develop a software program for implementing the technology The broader impact of the planned Technology will be precision medicine in administering prophylactic treatments and sparing low risk patients from unnecessary side effects of drugs or mastectomies The developed technology will also stratify high risk subjects into ER and ER groups for administering preventive endocrine therapies Finally the technology will become a standard tool in testing new drugs for preventing ER cancers PROJECT NARRATIVE The current proposal is on developing a biomarker based breast cancer risk prediction test The proposed test could be applied to screen and identify women who are at highest risk for developing breast cancer Once high risk women are identified using the planned test then they could be treated prophylactically and prevented from developing breast cancer Thus the planned research is highly relevant to reducing breast cancer one of the major public health problems in the USA