Abstracts for European Society of Medical Oncology (ESMO) available online on Wednesday, 28th September 2016 12.00 (CET)

Hoersholm; September 28th, 2016 – Medical Prognosis Institute A/S (MPI.ST) (Denmark and Phoenix, AZ, USA) today announced that Cisplatin and APO010 abstracts accepted for poster presentation at ESMO Annual Congress 2016 in Copenhagen, Denmark will be available online on the ESMO website www.esmo.org on Wednesday, September 28th 2016 at 12.00 (CET).  Below are the two abstracts in English.

ESMO is the leading European professional organization for medical oncology. Comprising more than 13,000 oncology professionals from over 130 countries. ESMO is the society of reference for oncology education and information.

“Combining APO010 with DRP analysis will add a precision medicine element to immuno-oncology treatment of Multiple Myeloma. The DRP method will enable us to identify patients with high likelihood of response and thereby facilitate focused future trial design and patient recruitment to achieve clinical success. I look very much forward to the presentation of the prediction method at the largest oncology congress in Europe,” Said Adjunct Professor Peter Buhl Jensen, M.D., CEO of MPI.
Cisplatin is one of the most used chemotherapies in the world and there is a need for biomarkers to predict efficacy of the drug. Oncology Venture is running a Proof of Concept clinical trial with LiPlaCis, a liposomal formulation of cisplatin, in breast cancer and I expect the data to be presented for the DRP in lung cancer at this years’ ESMO is supportive for the Breast Cancer study as well.” Buhl Jensen further commented.

ESMO venue: Bella Center, Center Boulevard 5, 2300 Copenhagen, Denmark

Poster # 1187P:
Multigene expression profile for predicting efficacy of cisplatin and vinorelbine in non-small cell lung cancer
will be presented in Hall E, October 8th 2016 at 13-14 CET

Poster # 134P:
APO010 sensitivity in relapsed Multiple Myeloma patients
will be presented in Hall E, October 10th 2016 at 13-14 CET.

For further information, please contact:
CEO, Peter Buhl Jensen, Adjunct Professor, MD, PhD                              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

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 28th 2016.

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Multigene expression profile for predicting efficacy of cisplatin and vinorelbine in non-small cell lung cancer

Ida Kappel Buhl1,2, Ib Jarle Christensen3, Eric Santoni-Rugiu4, Jesper Ravn5, Anker Hansen2, Thomas Jensen2, Jon Askaa2, Peter Buhl Jensen2, Steen Knudsen6, Jens Benn Sørensen7

1 Section for Molecular Disease Biology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; 2Medical Prognosis Institute, Hoersholm, Denmark; 3Department of Gastroenterology, Hvidovre Hospital, Hvidovre, Denmark, 4Department of Pathology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; 5Department of Thoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; 6Medical Prognosis Institute Inc, Scottsdale, Arizona 85258, USA;  7Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

There is a need for biomarkers to predict efficacy of adjuvant chemotherapy in resected non-small cell lung cancer (NSCLC). Presented is a combined cisplatin and vinorelbine marker from a previously validated model system [1] tested in two cohorts.

The profiles consist of correlated in vitro cytotoxicity of cisplatin and vinorelbine and mRNA expressions. Then each profile is correlated to mRNA expression of 3500 tumors.
The cohorts are 1) a publically available dataset with 133 completely resected stage Ib-II NSCLC patients, 71 of whom received adjuvant cisplatin and vinorelbine (ACT) and 62 patients who had no adjuvant treatment (OBS) [2] and 2) 95 stage Ib-IIIb completely resected NSCLC patients who all received adjuvant cisplatin and vinorelbine [3].

Endpoint is cancer specific survival.

The combined cisplatin and vinorelbine profiles scored as a continuous covariate showed 1) a Hazard Ratio (HR) of 0.265 ((95% CI:0.079-0.889), p=0.032) in the ACT cohort (sensitive versus resistant), and no significant discrimination in the OBS cohort (HR=1.328 (95% CI:0.46-3.835), p=0.60). A multivariate model adjusted for stage demonstrated significance for ACT (HR=0.284 (95% CI:0.086-0.944), p=0.040) but not for OBS (HR=1.702 (95% CI: 0.575-5.036), p=0.34).
The combined profiles resulted in 2) a significant prediction for up to 3 years from surgery (HR=0.143 (95% CI:0.038-0.542), p=0.004, scored as a continuous covariate). A multivariate model adjusting for stage showed that the predictor remained significant (HR=0.123 (95% CI:0.030-0.512), p=0.004).

A pooled analysis of the two treated cohorts resulted in a significant prediction (HR=0.187, (95% CI:0.069-0.508), p=0.001) up to 3 years from surgery using a random effects model.

The combined profiles demonstrate that NSCLC patients who benefit from cisplatin and vinorelbine can be identified. The profiles did not discriminate patients in the untreated arm. This holds promise for a predictive effect of the profiles and it is currently being validated in a prospective study [4].
[1] PLoS ONE 2016, 11(2): e0148070.

[2] Zhu et al JCO 2010;28:4417-4424.
[3] ASCO 2016 abstract e20007.
[4] AACR 2016 Abstract CT154.

APO010 sensitivity in relapsed Multiple Myeloma patients

A.J. Vangsted1, P.B. Jensen2, M.W. Madsen2, P. Gimsing1, T. Jensen3, A. Hansen3, A. Rasmussen2, A. Nielsen2, U. Buhl2, H. Jandu2, N. Brunner2, B. Pratt2, U.C. Frølund4, C. Helleberg5, N. Abildgaard6, S. Knudsen2

1Haematology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, DK, 2Oncology, Oncology Venture, Hørsholm, DK, 3Biology, Medical Prognosis, Scottsdale, AZ, US, 4Haematology, Roskilde Hospital, Roskilde, DK, 5Oncology, University Hospital Herlev, Herlev, DK, 6Haematology, Odense University Hospital, Odense C, DK

Multiple Myeloma is the next most common hematological malignancy and represents a continuous medical challenge since all patients eventually progress despite of many new drugs approved lately. The incidence of Multiple Myeloma is about 6 to 8 out of 100.000 in Western Countries. APO010 (a hexameric FAS-ligand) is an immune-oncology drug, which mimics cytotoxic T-lymphocyte signaling to induce apoptosis and could therefore be a new effective drug for Multiple Myeloma as these cells express CD95 (FAS-receptor).

Using a previously validated method by Medical Prognosis Insttute A/S (MPI), we have developed an APO010 response predictor (APO010-DRPTM), which is based on gene expression cluster obtained by comparing associations between gene expression profiles and growth inhibition by APO010 in a panel of cell lines. A second step has included filtering the identified gene expression profile against mRNA expression from a collection of 3200 human tumors, thereby making a predictive profile for APO010 responsiveness. We have initiated to screen relapsed/refractory Multiple Myeloma patients by isolating CD138 positive myeloma cells from the bone marrow and perform APO010-DRPTM in order to select the patients with the highest likelihood of benefit from APO010 treatment.

Using the APO010-DRPTM analysis demonstrated Multiple Myeloma to be sensitive to APO010 compared to most solid tumors except breast cancer, which also appeared to be sensitive. First results from Multiple Myeloma patient screening will be presented at ESMO 2016.

Combining APO010 with DRPTM analysis will add a precision medicine element to immune-oncology treatment of Multiple Myeloma. This will enable us to identify patients with high likelihood of response and thereby facilitate focused future trial design and patient recruitment to achieve clinical success.

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.

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 1,100 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.

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