Hoersholm, Denmark (Press Release) – Medical Prognosis Institute A/S (MPI.CO) (Denmark and Phoenix, AZ, USA) today announced that the first patient has been in­cluded in the APO010 Screening Protocol for Multiple Myeloma by MPI's spinout OV. This patient has entered the study at the first out of four planned participating Danish hematology sites. Approximately 150 patients will be screened using MPI's DRP(TM) (Drug Response Predictor), out-licensed to Oncology Venture. The DRP(TM) uses genomic in­­for­ma­tion from the individual cancer patient's tumor. The screen­ing will identify 15 patients with the highest likelihood to benefit from treat­ment with APO010. These 15 multiple myeloma patients will then be in­cluded in a focused phase 2 multi-center study. The phase 2 study is ex­pec­ted to start Q2-Q3 2016, if the prod­uct already in stock is approved. APO010 is a first-in-class FAS-ligand anticancer prod­uct in the immuno-oncology field.

I 'm very happy that the first patient has been in­cluded in the screen­ing for APO010 sensitivity in multiple myeloma patients. Fifteen of the highest likely sensitive patients will be in­cluded in a proof-of-concept phase 2 trial with this first in class immuno on­col­ogy prod­uct", says Adjunct Professor Peter Buhl Jensen, M.D., CEO of MPI. MPI has already screened more than 1000 metastatic breast cancer patients and the multiple myeloma screen­ing is the next step in build­ing the personalized medicine tool." Peter Buhl Jensen further commented.

About MPI's multiple bio­­marker called Drug Response Predictor - DRP(TM)

MPI's lead prod­uct, the DRP(TM) Diagnostic Platform, 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.

About Multiple Myeloma

Multiple myeloma is a systemic malig­nan­cy in the blood accumulating plasma cells in the bone marrow. The introduction of high-dose ther­apy with au­tol­o­gous stem cell sup­port, and introduction of new ther­a­pies like the pro­te­a­some inhibitor bor­tez­o­mib and IMIDs (thalidomide and lena­lido­mide) has im­proved the out­come. In spite of this, eventually all patients will ex­peri­ence progressive disease and con­tinue into second and sub­se­quent lines of treat­ment. OV will ap­proach this important clin­i­cal issue by introducing a novel systemic chemotherapeutic treat­ment together with a predictive bio­­marker test. Based on DRP(TM), APO010 will be developed for use in treat­ment of multiple myeloma, a market with a turnover of seven billion USD in 2014.

About APO010

APO010 is a multimeric form of FAS-ligand for immuno-cancer ther­apy with a unique mech­a­nism of action. APO010 acts through the FAS-receptor leading to apop­tosis of the malignant cells. APO010 is ex­pec­ted to act in synergy with other cancer immunology agents such as ipilimumab and PD1-PD-L1 inhibitors. The drug can­di­date is complemented by a companion diagnostic tech­nology (APO010 DRP(TM)) for enrichment of the patient pop­u­la­tion. APO010 was tested in 25 patients with solid tumors in a phase 1 study. The drug was well tolerated. Pre-clinical studies have revealed that APO010 is highly efficient in Multiple Myeloma. Therefore, a phase 2 trial will be conducted in patients with Multiple Myeloma that have been pre-screened for sensitivity using the APO010 DRP(TM) tech­nology.

There is a great need for effective treat­ment against multiple myeloma, and the market value was over 7 billion USD during 2014. Researchers esti­mate the value of the cancer immuno­therapy market to 35 billion USD by 2023 (Citi GPS).

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.

Source: Medical Prognosis Institute.