Hoersholm; September 20th, 2016 - Medical Prognosis Institute A/S (MPI.ST) (Denmark and Phoenix, AZ, USA) today announced that its spinout Oncology Venture Sweden AB (OV:ST) has entered a co-development agreement with Cadila Pharmaceuticals Ltd. to develop the anticancer product LiPlaCis® in combination with its Drug Response Predictor - DRP(TM). LiPlaCis® is the lead product in Oncology Ventures pipeline, and the agreement with Cadila secures the in-kind funding of several phase 2 and phase 3 trials using the Drug Response Predictor, DRP(TM). Cadila Pharmaceuticals is one of the largest privately held pharmaceutical companies in India.
Cadila Pharmaceuticals will finance in kind and conduct the studies with a total of 310 cancer patients with the highest likelihood of success from the LiPlaCis® treatment.
In accordance with the agreement more than 1 250 metastatic breast cancer patients will be screened by the use of the LiPlaCis-DRP(TM) of to identify 250 patients with high likelihood to respond to LiPlaCis treatment and perform a randomized phase 3 trial in these 250 patients comparing standard therapy with LiPlaCis.
Through Cadilas strong network and Cadilas CRO four (4) clinical Phase 2 trials in 20 patients (out of 100 screened) with Head & Neck cancer, 20 prostate cancer patients (out of 100 screened), and 10 skin cancer patients and 10 esophagus cancer patients are planned. The two latter indications are in a high frequency sensitive to cisplatin - of which LiPlaCis® is an improved formulation - why the patients will not be screened.
Please refer to Oncology Ventures press release of today (www.oncologyventure.com)
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 LiPlaCis Cisplatin is one of the most widely used drugs in the treatment of cancer due to its documented efficacy in a number of tumor types. Cisplatin is used in the treatment of large indications such as Lung Cancer (EU+US approximately 480,000 new cases annually), Head and Neck Cancer (500,000 cases annually worldwide) Bladder Cancer (EU+US approximately 170,000 annually) and Ovarian Cancer (EU+US approximately 71,000 annually). The lipid formulation LiPlaCis is the answer to a well-established need for improving cisplatin therapy and the formulation of the drug, so that a more selective up-take of cisplatin takes place at the site of the tumor.
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 20th 2016.
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