DRP successfully predicts effect of 4 Breast Cancer drugs for Personalized Medicine

2017-01-24

Hoersholm, Denmark, January 24th, 2017 - Medical Prognosis Institute A/S (MPI.ST) (Denmark and Phoenix, AZ, USA) today announced that its Drug Response Predictor DRP(TM) tool was studied as a tool for Personalized Medicine - Patient Response Prediction - PRP(TM). MPI's vision is to develop a tool in the form of a report over drugs that are most likely to be effective for the individual cancer patient. As a part of the strategy for carrying out this vision a study was set up in collaboration with Breast Cancer Experts at Danish oncology departments. The database for hosting the clinical data on approximately 800 metastatic breast cancer patients was investigated for the PRPs ability to predict whether a patient would respond or not to anticancer treatments given during their disease.

Data for epirubicin, fulvestrant, anastrazole and exemestan demonstrated with statistical significant values that the PRP could predict whether the individual patients responded on the treatment with the mentioned drugs or not. As there is a high number of active anticancer agents for Breast Cancer and this approach has been very fruitful we will continue to broaden the database and the data mining to increase the number of products where our technology can bring value to the choice of therapy. MPI's vision is to develop a tool in the form of a report over drugs that are most likely to be effective for the individual cancer patient.

Epirubicin is cornerstone in the treatment of all types of metastatic breast cancer and fulvestrant, anastrazole and exemestan are fundamentals in the adjuvant and metastatic treatment of estrogen receptor positive (ER+) breast cancer patients. Numbers from 2008* show that 2/3 of newly diagnosed early stage Breast Cancer receives adjuvant chemo therapy and or adjuvant antihormone therapy indicating a huge marked potential for the MPI PRP. In the current study, metastatic breast cancer was the subject - but the products are used in the adjuvant setting as well.

The DRP analysis were performed on Formalin Fixed Paraffin Embedded (FFPE) biopsies from the time of the diagnosis of the patients. To our pleasant surprise, data was strong on the FFPE biopsies even though half of the material was more than 10 years old. This is highly valuable for MPI's technology and business model as screening can be performed with the patients consent but without having call in the patient for a new puncture for a biopsy.
This successful study is also very supportive for the DRP tool used in Oncology Venture for drug development as it builds on the same technology platform.

"The objective of the MPI study was to evaluate whether the PRP in practice could predict drug sensitivity to some of the most widely used drugs in the treatment of patients with metastatic breast cancer. Together with Danish breast cancer experts we found that the PRP with a strong statistical significance can tell whether a patient should be treated with epirubicin, fulvestrant, anastrazole and exemestan or not," says Peter Buhl Jensen, M.D., CEO of MPI. "I believe that these data form the first breakthrough for MPIs technology as Personalized Medicine and that these data indicate a great potential and value for breast cancer patients. The aim is that patients should receive the best treatment every time - as they have no time to waste and should avoid any side effects related to drugs with no efficacy potential," Buhl Jensen further comments.

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 January 24th 2017.

About MPI's multiple biomarker called Drug Response Predictor - DRP(TM)
MPI's DRP(TM) is a tool for developing tumor-derived genetic signatures to predict which cancer patients are high likely to respond 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) 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) is a Big Data tool based on messenger RNA.
The DRP(TM) platform can be used in all cancer types, and has been patented for more than 70 anti-cancer drugs in the US.

More about tumor biopsies
The pathologist evaluates biopsies to see if it is cancer. At the operational theatre, the surgeon places the biopsy in formalin and submits the specimen to the pathology department. Here a technician embeds the tumor biopsy in a paraffin block to allow the cutting of very fine slices of the specimen. The slices are put on glass slides and stained with various dyes and finally evaluated by the pathologist. The tumor in formalin and paraffin are stored. The biopsy block belongs to the patient and follows her or him if she or he changes hospital. In Scandinavia, hospitals are mostly public and patients usually stick to their local hospital. The patient and her or his clinical data can be followed over years as well as CT scans and blood tests. Biopsy blocks can be reclaimed for tests. 
In MPIs and Oncology Ventures LiPlaCis study more than 1100 patients have agreed to allow the two companies to attain material from the paraffin embedded biopsies and to measure the gene expression on the material and relate it to treatment outcome. Gene expression is a measurement of the activity of the genes. Some are very active some are not active. There are 20000 (twenty thousand) genes in normal tissue and in cancer and modern gene expression technology allows the measurement all the genes in one step on a single chip. MPI uses the commercially available Affymetrix chip for this purpose. MPI has developed and validated a link between gene expression and the efficacy of a range of anticancer drugs. This press release informs about a validation of the method by use of biopsy material and clinical data on four anticancer agents used in daily practice for breast cancer treatment. The companies have worked together with the Danish Cooperative Group for Breast Cancer and breast cancer experts on 10 hospitals to attain the data. The study encompasses data from more than 800 patients with metastatic Breast Cancer receiving almost 2800 treatment lines or an average of 3.5 treatments per patient. Biopsies were from the original diagnosis of Breast Cancer i.e. at a time where the patient was evaluated as curable and most of the patients at then received so-called adjuvant therapy with chemotherapy, irradiation and antihormone therapy after surgery. On average the biopsies were 10 years old.

About MPI
Medical Prognosis Institis 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 1,000 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.

* Adjuvant systemic therapy in early breast cancer: impact of guideline changes and clinicopathological factors associated with nonadherence at a nation-wide level. A. M. F. Verschoor et al.  Published online: 12 August 2016 Springer Science+Business Media New York 2016

For further information, please contact:
CEO, Peter Buhl Jensen, Adjunct Professor, MD, Ph.D.                              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

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