MPI's DRP used in the first prospective study

2016-05-31

Hoersholm, Denmark; May 31st, 2016 - Medical Prognosis Institute A/S announces that the first patient has been dosed in the first prospective study using the DRP(TM). The DRP(TM) will be used in the LiPlaCis proof of concept extension phase study conducted by Oncology Venture, who has recently in licensed the LiPlaCis product. Oncology Venture is the drug development arm of MPI. By analyzing biopsies using the DRP(TM) - patients are screened for high likelihood of effect of the LiPlaCis(TM) drug before enrolled in the study. The study will enroll twelve to fifteen (12-15) screened patients with metastatic breast cancer (mBC) to demonstrate safety and efficacy. The extension PoC phase will take approximately 12 months, with interim data expected during this period. The DRP(TM) should enable a high response rate and give breast cancer patients a new effective personalized treatment opportunity.

More than 1000 patients have had their tumors analyzed using the DRP(TM) technology beforehand. The patients that will be included in the proof of concept study will be in the top 10% of high likely responders according to the DRP(TM). Using a conservative cut off of top 10% is to demonstrate the ability of the DRP(TM) to select sensitive patients.

"I am very excited that our DRP(TM) will now be tested in this first prospective study of LiPlaCis in metastatic breast cancer patients. If the DRP(TM) successfully can identify those patients who benefits from LiPlaCis, the drug and its DRP companion diagnostic will address a huge medical need and offer these hard to treat patients have a new personalized treatment option.", Said Adjunct Professor Peter Buhl Jensen, MD, PhD and CEO of MPI. "The DRP(TM) method has been extensively validated through testing in a blinded setting of 37 trials whereof the DRP(TM) in 29 could successfully predict who would benefit from the drug tested. I look forward to the first results in this first prospective testing of the DRP", Dr. Buhl Jensen further commented.

About MPI
Medical Prognosis 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 1,000 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.

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. MicroRNA is used on certain products whereas the messengerRNA is more broadly useable and more validated. The DRP(TM) platform can be used in all cancer types, and has been patented for more than 60 anti-cancer drugs in the US.

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@oncologyventure.com
Phone: +45 21 60 89 22                                                                        Telephone +45 21 70 10 49

Certified Advisor: Carsten Yde Hemme, PricewaterhouseCoopers, Strandvejen 44, 2900 Hellerup, Denmark