Hoersholm; September 14th, 2016 - Medical Prognosis Institute A/S (MPI.ST) (Denmark and Phoenix, AZ, USA) today announced that its Personalized Response Predictor PRP(TM) is to be studied in collaboration with Breast Cancer Experts at Danish oncology departments. The collaboration will last until further notice. The database for hosting the data on approximately 800 metastatic breast cancer patients has obtained approval from the Datatilsynet (Data Protection Agency) as well as from the Ethics Committee. The patients' tumors to be investigated are selected from a data set of > 1100 Danish Breast Cancer patients. The aim of the study is to investigate the PRPs ability to predict whether a patient would respond or not to anticancer treatments given during their disease. This will be investigated by using the PRP tool to analyze the patients' tumors genetic profile in the biopsy taken at the time of the diagnosis - and the clinical response results documented in hospital charts. A statistical analysis plan has been prepared ahead to demonstrate the expected strength of the Personalized Response Predictors ability to predict individual patients' treatment outcome. If the PRP with statistical significance can predict treatment outcome for the individual cancer patient the potential benefit for patients, treating physicians and financial savings are huge.
"The objective of the study is to evaluate whether the PRP in practice can predict drug sensitivity to Fulvestrant, epirubicin and vinorelbine + trastuzumab in patients with metastatic breast cancer by comparing the results of the PRPs with the patient's clinical response to a particular drug", says Adjunct Professor Peter Buhl Jensen, M.D., CEO of MPI. "Systems to match a patient and a drug are eagerly awaited and preferably each patient's tumor should be evaluated in order to single out the drugs most likely to have an effect in the individual patients. MPI has in 29 out of 37 studies demonstrated an ability to predict response correctly in different tumor types and drugs. The aim is to develop the PRP in collaborations all the way to market." Buhl Jensen further commented.
The objective of the study is to evaluate whether the PRP in practice can predict drug sensitivity in patients with locally advanced or metastatic breast cancer by comparing the respective PRP with the patient's clinical response to a particular drug. The cancer drug signatures to be evaluated are initially Fulvestrant, epirubicin and vinorelbine + trastuzumab. The primary endpoint is time to progression and secondary endpoints are overall survival (OS) and response. Allowance from the authorities have also been given to include analysis of docetaxel, capecitabine, eribulin, lapatinib, tamoxifen, gemcitabine, paclitaxel and trastuzumab which will be analyzed later.
About MPI's multiple biomarker called Drug Response Predictor - DRP(TM) and Personalized Response Predictor - PRP(TM) MPI's DRP(TM) and PRP(TM)are tools for developing tumor-derived genetic signatures to predict which cancer patients will respond with a high likelihood to a given anti-cancer product. The DRP(TM) has been tested in 37 trials, where 29 trials showed that drug-specific DRP(TM) Biomarkers could predict which patients responded well to the treatment. The DRP(TM) platform has amongst others been externally validated and published in collaboration with leading statisticians at the MD Anderson Cancer Center. The DRP(TM) method can be used to design the Clinical Development Plan, i.e. to select which indications are relevant for a given anti-cancer drug. In addition to this, the individual genetic patterns of patients can be analyzed as part of a screening procedure for a clinical trial to ensure inclusion of patients with a high likelihood of response to the drug. DRP(TM) and PRP(TM) builds on comparison between sensitive and resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and clinical correlates in a systems biology network. The DRP(TM) and PRP(TM) are Big Data tools based on messenger RNA. The DRP(TM) platform i.e. the DRP(TM) and the PRP(TM) tools can be used in all cancer types, and is patented for more than 60 anti-cancer drugs in the US. The DRP(TM) is used in Oncology Venture - a spinout from MPI - for drug development. The PRP(TM) is used by MPI for Personalized Medicine.
About MPI Medical Prognosis Institute A/S is a publicly traded international company specialized in improving cancer patients lives by developing Personalized Medicine using its unique DRP(TM) technology. MPI's exceptional opportunity to personalize cancer treatment - begins with Breast Cancer moving on to Multiple Myeloma and Prostate Cancer as the first steps. MPI's DRP(TM) tool has shown its ability to separate patients who benefit and who do not benefit from a specific cancer treatment. This has been shown in as many as 29 out of 37 trials, and covers more than 80 anti-cancer treatments in a wide range of cancer indications. MPI has built a significant large database with over 1,100 screened breast cancer patients and is building up a database in Multiple Myeloma to be followed by Prostate cancer in collaboration with oncologists and hematologists throughout Denmark.
For further information, please contact: CEO, Peter Buhl Jensen, Adjunct Professor, MD, PhD Ulla Hald Buhl, IR & Communication E-mail: pbj@medical-prognosis.com E-mail: uhb@medical-prognosis.com Telephone: +45 21 60 89 22 Telephone +45 21 70 10 49
This information is information that Medical Prognosis Institute A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on September 14 2016.
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