Hoersholm, Denmark; August 23rd, 2016 - Medical Prognosis Institute A/S (MPI:ST) announces that the first patient with metastatic Breast Cancer included in the extension - proof of concept part of the LiPlaCis trial, has obtained a confirmed Partial Remission (ie >30% reduction of her tumor). LiPlaCis is the lead drug of Oncology Venture a spinout of MPI that used the Drug Response Predictor in clinical trials. The patient has - in addition to surgery and adjuvant treatment received five prior medical treatments of her disease. The best response obtained has been Stable Disease (i.e. no change in the overall measurement of the tumor burden) and is this a patient with a hard to treat tumor.
The patient is the first out of 12-15 patients whose tumor tissue has been screened for genomic expression by the Drug Response Predictor - DRP and found to be in the top 10% of patients who have the highest likelihood of response to LiPlaCis treatment.
The DRP is designed to enable a high response rate and give Breast Cancer patients a new effective personalized treatment opportunity.
The extension PoC phase will take approximately 12 months, with interim data expected during this period.
More than 1100 patients have had their tumors DRP-screened beforehand. The included patients in the LiPlaCis proof of concept study will be in the top 10% of high likely responders according to the DRP, by which patients' individual biopsies are analyzed for sensitivity (effect) to LiPlaCis. Using a conservative cut off of top 10% is to demonstrate the ability of the DRP to select sensitive patients. Later, the cut off is expected to be less conservative, as the relevant patient population is expected to be at a cut off around 30-40%.
"Knowing that this is one patient out of up to 15 and therefore not sufficient data, to promise that LiPlaCis will be approved, I am however happy every time OVs drug and Professor Knudsen's Drug Response Predictor technology makes a difference for a patient. LiPlaCis - OV's lead product - is the first prospective study which is set up to demonstrate that MPI's DRP can select those patients who will benefit from the treatment", said Adjunct Professor Peter Buhl Jensen, MD, PhD and CEO of MPI. "The hope is that we can keep delivering good results in the study and develop a new, effective personalized treatment option for Breast Cancer patients with metastatic disease. We believe the future lies in personalized treatment, and that DRP(TM) technology is at the forefront", Dr. Buhl Jensen further commented.
Medical Prognosis is a publicly traded international company specialized in improving cancer patients lives by developing Personalized Medicine using its unique DRP 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 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.
About MPI's multiple biomarker called Drug Response Predictor - DRP
MPI's DRP 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 has been tested in 37 trials, where 29 trials showed that drug-specific DRP Biomarkers could predict which patients responded well to the treatment. The DRP platform has amongst others been externally validated and published in collaboration with leading statisticians at the MD Anderson Cancer Center. The DRP 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 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 is a Big Data tool based on messenger RNA.
The DRP platform can be used in all cancer types, and has been patented for more than 60 anti-cancer drugs in the US.
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 approximtely 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.
More About LiPlaCis and the Clinical Testing
The Phase 1 study to evaluate the safety and tolerability of LiPlaCis in patients with advanced tumours has been conducted at two Oncology sites at University Hospitals in Copenhagen and has included 20 patients in the dose escalation part of a phase 1 study in solid tumors. The LiPlaCis program has now moved into the extension proof of concept phase, which is part of the phase 1 application where patients with a specific disease - here metastatic Breast Cancer - are included to investigate early Proof of Concept, i.e. effect of the drug. 75mg LiPlaCis/patient is administered intravenously in weekly cycles on day 1 and day 8. Upon the investigator's judgement, the patient may continue treatment for more than three cycles when benefiting from the study drug.
For further information, please contact:
CEO, Peter Buhl Jensen, Adjunct Professor, MD, PhD Ulla Hald Buhl, IR & Communication
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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 23rd august 2016.
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