Hoersholm; January 9th, 2017 – Medical Prognosis Institute A/S (MPI.ST) (Denmark and Phoenix, AZ, USA) today announced that CE-marking for the in vitro diagnostic medical device (IVD); the Drug Response Predictor – DRP(TM) – has been technically validated and registered for Oncology Ventures lead drug candidate LiPlaCis® allowing the product to be marketed in EU.
Oncology Venture a spinout of MPI focusing on developing anticancer drugs and is utilizing MPI’s DRP to select high likely responding patients for its clinical trials. The LiPlaCis DRP(TM) is key in the selection of high likely responding patients and pivotal in OV’s clinical breast cancer trial in Denmark and also key for OV’s partner Cadila Pharmaceuticals Ltd. who is in the process of starting four phase 2 trials and one phase 3 trial with LiPlaCis® and LiPlaCis DRP(TM).
The LiPlaCis DRP(TM) uses a diagnostic sample of the patient’s tumor to determine response to treatment with LiPlaCis®. In that way, it can be avoided giving a patient a treatment that will be of no benefit.
CE-marking shows compliance with EU Directives and demonstrates that specific standards of performance, quality, safety, and efficacy for the LiPlaCis DRP(TM) has been met and enables commercialization in 32 European countries.
“The CE-mark registration in EU of LiPlaCis is an important milestone for MPI. LiPlaCis and its DRP-companion diagnostic is the first in a series of precision anti-cancer medicine to be co-develop by Oncology Venture with the Drug Response Predictor. The CE mark is also recognized in several ex-EU countries”, Said Adjunct Professor Peter Buhl Jensen, M.D., CEO of Medical Prognosis Institute.
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 9h 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 60 anti-cancer drugs in the US.
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.
For further information, please contact:
CEO, Peter Buhl Jensen, Adjunct Professor, MD, Ph.d. Ulla Hald Buhl, IR & Communication
E-mail: [email protected] E-mail: [email protected]
Telephone: +45 21 60 89 22 Telephone +45 21 70 10 49
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