Danish Breast Cancer Cooperative Group

Copenhagen, Denmark

Danish Breast Cancer Cooperative Group

Copenhagen, Denmark

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Hoersholm, Denmark, May 17th, 2017 - Medical Prognosis Institute A/S ("MPI") today announced that the previously warranted abstract with DRP data on epirubicin for breast cancer has been published electronically on the website of ASCO (American Society of Clinical Oncology). The title of the abstract is "Retrospective-prospective blinded evaluation predicting efficacy of epirubicin by a multigene assay in advanced breast cancer within a Danish Breast Cancer Cooperative Group (DBCG) cohort".  The DRP was significantly associated to Progression Free Survival (PFS) in a cohort of 137 metastatic breast cancer patients. PFS is a measure of the total time epirubicin can block tumor growth. The estimated median time to progression for a patient with a DRP value of 25% was 7 months versus 13 months for a patient with a DRP value of 75%. The result is of tremendous value to MPI as epirubicin response prediction is an important part of building a broader Patient Response Prediction (PRP(TM)) Compass for individual patients and also for Oncology Ventures spinout 2X Oncology Inc. in developing the GSH-liposomal- doxorubicin for breast and brain cancer with their in-licensed product 2X-111. MPI will own 10% of 2X Oncology Inc. after a successful series A financing. The poster including update of data will be presented on the 4th of June 2017 at the annual ASCO conference in Chicago, USA taking place from June 2-6 2017. Epirubicin - which is an anthracycline like doxorubicin - is a cornerstone in the treatment of primary and advanced breast cancer. Usually about 50% will benefit with a reduction in their tumor size. Until now there has been no method to find out who will benefit and who will not. The current study looked at 137 epirubicin treated patients to evaluate MPI's Epirubicin Drug Response Predictor (DRP(TM)). The DRP was significantly associated to Progression Free Survival (PFS) that measures the total time epirubicin can block tumor growth. The estimated median time to progression for a patient with a DRP value of 25% was 7 months versus 13 months for a patient with a DRP value of 75%. The result is of tremendous value to MPI as epirubicin response prediction is an important part of building a broader Patient Response Prediction (PRP(TM)) Compass for individual patients and also for Oncology Ventures spinout 2X Oncology Inc. in developing the GSH-liposomal- doxorubicin for breast and brain cancer with their in-licensed product 2X-111.  MPI will own 10% of 2X Oncology Inc. after a successful series A financing. "These data are of great importance to MPI as our patented Epirubicin DRP(TM) is now with statistically significance validated also in clinical practice. 2X Oncology Inc.'s product 2X-111 is very similar to epirubicin- and I am confident that by using the DRP(TM) to analyze the individual patient's tumor we can find those patients who are most likely to benefit from 2X-111. Anthracyclines are cornerstone products for treating breast cancer patients all over the world. Further to this the new published data strengthen MPI's Personalized Response Predictor - an oncology drug compass for the individual patient.", said Adjunct Professor Peter Buhl Jensen, M.D., CEO of MPI. "MPI  will own 10% of 2X Oncology Inc. after a successful series A financing," Peter Buhl Jensen further commented. Earlier this year (24th of January 2017) Medical Prognosis Institute and Oncology Venture published information on data based on more than 800 patients with metastatic breast cancer that demonstrated with statistical significant values that the Patient Response Predictor (PRP) could predict whether the individual patients would respond on the treatment with epirubicin (an anthracycline like doxorubicin), fulvestrant, anastrazole and exemestan or not. As there is a high number of active anticancer agents for Breast Cancer and this approach has been very fruitful, MPI and Oncology Venture will continue to broaden the database and the data mining to increase the number of products where our DRP technology can bring value to the choice of therapy. The abstract will be released by ASCO on May 17, 2017, at 5:00 PM EDT/23:00 CET on abstracts.asco.org An up-date on data from the abstract will be presented as a poster on the poster session Breast Cancer-Metastatic on the 4th of June 2017 at 8:00 AM-11:30 AM local time/15:00-18:30 CET. ASCO, American Society of Clinical Oncology, ANNUAL MEETING. McCormick Place, Chicago, Illinois, USA. Founded in 1964, the American Society of Clinical Oncology (ASCO) is committed to making a world of difference in cancer care. As the world's leading organization of its kind, ASCO represents more than 40,000 oncology professionals who care for people living with cancer. The ASCO Annual Meeting is considered the premiere international forum for the presentation of scientific research and state-of-the-art education in clinical oncology. The five-day event attracts 30,000 attendees from around the world. Clinical trial results and updates presented at ASCO's Annual Meeting represent the significant progress made each year in the fight against cancer. For further information on Oncology Venture please contact This information is that Oncology Venture Sweden AB 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 May 17th 2017. About the DRP(TM) Companion Diagnostic Developed by and in-licensed from Medical Prognosis Institute, the DRP(TM) screening platform utilizes messenger RNA (mRNA) gene expression signatures from patient biopsies to identify patients with a high likelihood of responding to specific cancer-fighting therapies. This DRP(TM) method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines, combined with clinical tumor biology and clinical correlates in a systems biology network. Specific DRP(TM)'s are developed for each pipeline product, which will enable us to identify and predict which patients are most likely to respond and thereby benefit from a given pipeline product.  This would enable likely responders to receive appropriate treatment while expediting the decision path for predicted non-responders, saving them critical time and money in their cancer fight. About Oncology Venture Sweden AB (OV) OV is engaged in the research and development of anti-cancer drugs via its wholly owned Danish subsidiary Oncology Venture ApS. Oncology Venture has a license to use Drug Response Prediction - DRP(TM) - in order to significantly increase the probability of success in clinical trials. DRP(TM) has proven its ability to provide a statistically significant prediction of clinical outcomes from drug treatment in cancer patients in 29 of the 37 clinical studies that were examined. The Company uses a model that alters the odds in comparison with traditional pharmaceutical development. Instead of treating all patients with a particular type of cancer, patients' tumors genes are screened first and only those who are most likely to respond to the treatment will be treated. Via a more well-defined patient group, the risk and costs are reduced while the development process becomes more efficient. The current product portfolio: LiPlaCis for Breast Cancer in collaboration with Cadila Pharmaceuticals, Irofulven developed from a fungus for prostate cancer and APO010 - an immuno-oncology product for Multiple Myeloma. Oncology Venture has spun out 2X Oncology Inc. a company focused on developing precision medicine for women's cancer with three anticancer products in pipeline and OV-SPV2 which will test and potentially develop an oral Tyrosine Kinase inhibitor from a Big Pharma the treatment of cancers. 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. 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 May 17th 2017.


Hoersholm, Denmark, May 17th, 2017 - Medical Prognosis Institute A/S ("MPI") today announced that the previously warranted abstract with DRP data on epirubicin for breast cancer has been published electronically on the website of ASCO (American Society of Clinical Oncology). The title of the abstract is "Retrospective-prospective blinded evaluation predicting efficacy of epirubicin by a multigene assay in advanced breast cancer within a Danish Breast Cancer Cooperative Group (DBCG) cohort".  The DRP was significantly associated to Progression Free Survival (PFS) in a cohort of 137 metastatic breast cancer patients. PFS is a measure of the total time epirubicin can block tumor growth. The estimated median time to progression for a patient with a DRP value of 25% was 7 months versus 13 months for a patient with a DRP value of 75%. The result is of tremendous value to MPI as epirubicin response prediction is an important part of building a broader Patient Response Prediction (PRP(TM)) Compass for individual patients and also for Oncology Ventures spinout 2X Oncology Inc. in developing the GSH-liposomal- doxorubicin for breast and brain cancer with their in-licensed product 2X-111. MPI will own 10% of 2X Oncology Inc. after a successful series A financing. The poster including update of data will be presented on the 4th of June 2017 at the annual ASCO conference in Chicago, USA taking place from June 2-6 2017. Epirubicin - which is an anthracycline like doxorubicin - is a cornerstone in the treatment of primary and advanced breast cancer. Usually about 50% will benefit with a reduction in their tumor size. Until now there has been no method to find out who will benefit and who will not. The current study looked at 137 epirubicin treated patients to evaluate MPI's Epirubicin Drug Response Predictor (DRP(TM)). The DRP was significantly associated to Progression Free Survival (PFS) that measures the total time epirubicin can block tumor growth. The estimated median time to progression for a patient with a DRP value of 25% was 7 months versus 13 months for a patient with a DRP value of 75%. The result is of tremendous value to MPI as epirubicin response prediction is an important part of building a broader Patient Response Prediction (PRP(TM)) Compass for individual patients and also for Oncology Ventures spinout 2X Oncology Inc. in developing the GSH-liposomal- doxorubicin for breast and brain cancer with their in-licensed product 2X-111.  MPI will own 10% of 2X Oncology Inc. after a successful series A financing. "These data are of great importance to MPI as our patented Epirubicin DRP(TM) is now with statistically significance validated also in clinical practice. 2X Oncology Inc.'s product 2X-111 is very similar to epirubicin- and I am confident that by using the DRP(TM) to analyze the individual patient's tumor we can find those patients who are most likely to benefit from 2X-111. Anthracyclines are cornerstone products for treating breast cancer patients all over the world. Further to this the new published data strengthen MPI's Personalized Response Predictor - an oncology drug compass for the individual patient.", said Adjunct Professor Peter Buhl Jensen, M.D., CEO of MPI. "MPI  will own 10% of 2X Oncology Inc. after a successful series A financing," Peter Buhl Jensen further commented. Earlier this year (24th of January 2017) Medical Prognosis Institute and Oncology Venture published information on data based on more than 800 patients with metastatic breast cancer that demonstrated with statistical significant values that the Patient Response Predictor (PRP) could predict whether the individual patients would respond on the treatment with epirubicin (an anthracycline like doxorubicin), fulvestrant, anastrazole and exemestan or not. As there is a high number of active anticancer agents for Breast Cancer and this approach has been very fruitful, MPI and Oncology Venture will continue to broaden the database and the data mining to increase the number of products where our DRP technology can bring value to the choice of therapy. The abstract will be released by ASCO on May 17, 2017, at 5:00 PM EDT/23:00 CET on abstracts.asco.org An up-date on data from the abstract will be presented as a poster on the poster session Breast Cancer-Metastatic on the 4th of June 2017 at 8:00 AM-11:30 AM local time/15:00-18:30 CET. ASCO, American Society of Clinical Oncology, ANNUAL MEETING. McCormick Place, Chicago, Illinois, USA. Founded in 1964, the American Society of Clinical Oncology (ASCO) is committed to making a world of difference in cancer care. As the world's leading organization of its kind, ASCO represents more than 40,000 oncology professionals who care for people living with cancer. The ASCO Annual Meeting is considered the premiere international forum for the presentation of scientific research and state-of-the-art education in clinical oncology. The five-day event attracts 30,000 attendees from around the world. Clinical trial results and updates presented at ASCO's Annual Meeting represent the significant progress made each year in the fight against cancer. For further information on Oncology Venture please contact This information is that Oncology Venture Sweden AB 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 May 17th 2017. About the DRP(TM) Companion Diagnostic Developed by and in-licensed from Medical Prognosis Institute, the DRP(TM) screening platform utilizes messenger RNA (mRNA) gene expression signatures from patient biopsies to identify patients with a high likelihood of responding to specific cancer-fighting therapies. This DRP(TM) method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines, combined with clinical tumor biology and clinical correlates in a systems biology network. Specific DRP(TM)'s are developed for each pipeline product, which will enable us to identify and predict which patients are most likely to respond and thereby benefit from a given pipeline product.  This would enable likely responders to receive appropriate treatment while expediting the decision path for predicted non-responders, saving them critical time and money in their cancer fight. About Oncology Venture Sweden AB (OV) OV is engaged in the research and development of anti-cancer drugs via its wholly owned Danish subsidiary Oncology Venture ApS. Oncology Venture has a license to use Drug Response Prediction - DRP(TM) - in order to significantly increase the probability of success in clinical trials. DRP(TM) has proven its ability to provide a statistically significant prediction of clinical outcomes from drug treatment in cancer patients in 29 of the 37 clinical studies that were examined. The Company uses a model that alters the odds in comparison with traditional pharmaceutical development. Instead of treating all patients with a particular type of cancer, patients' tumors genes are screened first and only those who are most likely to respond to the treatment will be treated. Via a more well-defined patient group, the risk and costs are reduced while the development process becomes more efficient. The current product portfolio: LiPlaCis for Breast Cancer in collaboration with Cadila Pharmaceuticals, Irofulven developed from a fungus for prostate cancer and APO010 - an immuno-oncology product for Multiple Myeloma. Oncology Venture has spun out 2X Oncology Inc. a company focused on developing precision medicine for women's cancer with three anticancer products in pipeline and OV-SPV2 which will test and potentially develop an oral Tyrosine Kinase inhibitor from a Big Pharma the treatment of cancers. 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. 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 May 17th 2017.


Hoersholm, Denmark, May 17th, 2017 - Medical Prognosis Institute A/S ("MPI") today announced that the previously warranted abstract with DRP data on epirubicin for breast cancer has been published electronically on the website of ASCO (American Society of Clinical Oncology). The title of the abstract is "Retrospective-prospective blinded evaluation predicting efficacy of epirubicin by a multigene assay in advanced breast cancer within a Danish Breast Cancer Cooperative Group (DBCG) cohort".  The DRP was significantly associated to Progression Free Survival (PFS) in a cohort of 137 metastatic breast cancer patients. PFS is a measure of the total time epirubicin can block tumor growth. The estimated median time to progression for a patient with a DRP value of 25% was 7 months versus 13 months for a patient with a DRP value of 75%. The result is of tremendous value to MPI as epirubicin response prediction is an important part of building a broader Patient Response Prediction (PRP(TM)) Compass for individual patients and also for Oncology Ventures spinout 2X Oncology Inc. in developing the GSH-liposomal- doxorubicin for breast and brain cancer with their in-licensed product 2X-111. MPI will own 10% of 2X Oncology Inc. after a successful series A financing. The poster including update of data will be presented on the 4th of June 2017 at the annual ASCO conference in Chicago, USA taking place from June 2-6 2017. Epirubicin - which is an anthracycline like doxorubicin - is a cornerstone in the treatment of primary and advanced breast cancer. Usually about 50% will benefit with a reduction in their tumor size. Until now there has been no method to find out who will benefit and who will not. The current study looked at 137 epirubicin treated patients to evaluate MPI's Epirubicin Drug Response Predictor (DRP(TM)). The DRP was significantly associated to Progression Free Survival (PFS) that measures the total time epirubicin can block tumor growth. The estimated median time to progression for a patient with a DRP value of 25% was 7 months versus 13 months for a patient with a DRP value of 75%. The result is of tremendous value to MPI as epirubicin response prediction is an important part of building a broader Patient Response Prediction (PRP(TM)) Compass for individual patients and also for Oncology Ventures spinout 2X Oncology Inc. in developing the GSH-liposomal- doxorubicin for breast and brain cancer with their in-licensed product 2X-111.  MPI will own 10% of 2X Oncology Inc. after a successful series A financing. "These data are of great importance to MPI as our patented Epirubicin DRP(TM) is now with statistically significance validated also in clinical practice. 2X Oncology Inc.'s product 2X-111 is very similar to epirubicin- and I am confident that by using the DRP(TM) to analyze the individual patient's tumor we can find those patients who are most likely to benefit from 2X-111. Anthracyclines are cornerstone products for treating breast cancer patients all over the world. Further to this the new published data strengthen MPI's Personalized Response Predictor - an oncology drug compass for the individual patient.", said Adjunct Professor Peter Buhl Jensen, M.D., CEO of MPI. "MPI  will own 10% of 2X Oncology Inc. after a successful series A financing," Peter Buhl Jensen further commented. Earlier this year (24th of January 2017) Medical Prognosis Institute and Oncology Venture published information on data based on more than 800 patients with metastatic breast cancer that demonstrated with statistical significant values that the Patient Response Predictor (PRP) could predict whether the individual patients would respond on the treatment with epirubicin (an anthracycline like doxorubicin), fulvestrant, anastrazole and exemestan or not. As there is a high number of active anticancer agents for Breast Cancer and this approach has been very fruitful, MPI and Oncology Venture will continue to broaden the database and the data mining to increase the number of products where our DRP technology can bring value to the choice of therapy. The abstract will be released by ASCO on May 17, 2017, at 5:00 PM EDT/23:00 CET on abstracts.asco.org An up-date on data from the abstract will be presented as a poster on the poster session Breast Cancer-Metastatic on the 4th of June 2017 at 8:00 AM-11:30 AM local time/15:00-18:30 CET. ASCO, American Society of Clinical Oncology, ANNUAL MEETING. McCormick Place, Chicago, Illinois, USA. Founded in 1964, the American Society of Clinical Oncology (ASCO) is committed to making a world of difference in cancer care. As the world's leading organization of its kind, ASCO represents more than 40,000 oncology professionals who care for people living with cancer. The ASCO Annual Meeting is considered the premiere international forum for the presentation of scientific research and state-of-the-art education in clinical oncology. The five-day event attracts 30,000 attendees from around the world. Clinical trial results and updates presented at ASCO's Annual Meeting represent the significant progress made each year in the fight against cancer. For further information on Oncology Venture please contact This information is that Oncology Venture Sweden AB 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 May 17th 2017. About the DRP(TM) Companion Diagnostic Developed by and in-licensed from Medical Prognosis Institute, the DRP(TM) screening platform utilizes messenger RNA (mRNA) gene expression signatures from patient biopsies to identify patients with a high likelihood of responding to specific cancer-fighting therapies. This DRP(TM) method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines, combined with clinical tumor biology and clinical correlates in a systems biology network. Specific DRP(TM)'s are developed for each pipeline product, which will enable us to identify and predict which patients are most likely to respond and thereby benefit from a given pipeline product.  This would enable likely responders to receive appropriate treatment while expediting the decision path for predicted non-responders, saving them critical time and money in their cancer fight. About Oncology Venture Sweden AB (OV) OV is engaged in the research and development of anti-cancer drugs via its wholly owned Danish subsidiary Oncology Venture ApS. Oncology Venture has a license to use Drug Response Prediction - DRP(TM) - in order to significantly increase the probability of success in clinical trials. DRP(TM) has proven its ability to provide a statistically significant prediction of clinical outcomes from drug treatment in cancer patients in 29 of the 37 clinical studies that were examined. The Company uses a model that alters the odds in comparison with traditional pharmaceutical development. Instead of treating all patients with a particular type of cancer, patients' tumors genes are screened first and only those who are most likely to respond to the treatment will be treated. Via a more well-defined patient group, the risk and costs are reduced while the development process becomes more efficient. The current product portfolio: LiPlaCis for Breast Cancer in collaboration with Cadila Pharmaceuticals, Irofulven developed from a fungus for prostate cancer and APO010 - an immuno-oncology product for Multiple Myeloma. Oncology Venture has spun out 2X Oncology Inc. a company focused on developing precision medicine for women's cancer with three anticancer products in pipeline and OV-SPV2 which will test and potentially develop an oral Tyrosine Kinase inhibitor from a Big Pharma the treatment of cancers. 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. 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 May 17th 2017.


Hoersholm, Denmark, May 17th, 2017 - Medical Prognosis Institute A/S ("MPI") today announced that the previously warranted abstract with DRP data on epirubicin for breast cancer has been published electronically on the website of ASCO (American Society of Clinical Oncology). The title of the abstract is "Retrospective-prospective blinded evaluation predicting efficacy of epirubicin by a multigene assay in advanced breast cancer within a Danish Breast Cancer Cooperative Group (DBCG) cohort".  The DRP was significantly associated to Progression Free Survival (PFS) in a cohort of 137 metastatic breast cancer patients. PFS is a measure of the total time epirubicin can block tumor growth. The estimated median time to progression for a patient with a DRP value of 25% was 7 months versus 13 months for a patient with a DRP value of 75%. The result is of tremendous value to MPI as epirubicin response prediction is an important part of building a broader Patient Response Prediction (PRP(TM)) Compass for individual patients and also for Oncology Ventures spinout 2X Oncology Inc. in developing the GSH-liposomal- doxorubicin for breast and brain cancer with their in-licensed product 2X-111. MPI will own 10% of 2X Oncology Inc. after a successful series A financing. The poster including update of data will be presented on the 4th of June 2017 at the annual ASCO conference in Chicago, USA taking place from June 2-6 2017. Epirubicin - which is an anthracycline like doxorubicin - is a cornerstone in the treatment of primary and advanced breast cancer. Usually about 50% will benefit with a reduction in their tumor size. Until now there has been no method to find out who will benefit and who will not. The current study looked at 137 epirubicin treated patients to evaluate MPI's Epirubicin Drug Response Predictor (DRP(TM)). The DRP was significantly associated to Progression Free Survival (PFS) that measures the total time epirubicin can block tumor growth. The estimated median time to progression for a patient with a DRP value of 25% was 7 months versus 13 months for a patient with a DRP value of 75%. The result is of tremendous value to MPI as epirubicin response prediction is an important part of building a broader Patient Response Prediction (PRP(TM)) Compass for individual patients and also for Oncology Ventures spinout 2X Oncology Inc. in developing the GSH-liposomal- doxorubicin for breast and brain cancer with their in-licensed product 2X-111.  MPI will own 10% of 2X Oncology Inc. after a successful series A financing. "These data are of great importance to MPI as our patented Epirubicin DRP(TM) is now with statistically significance validated also in clinical practice. 2X Oncology Inc.'s product 2X-111 is very similar to epirubicin- and I am confident that by using the DRP(TM) to analyze the individual patient's tumor we can find those patients who are most likely to benefit from 2X-111. Anthracyclines are cornerstone products for treating breast cancer patients all over the world. Further to this the new published data strengthen MPI's Personalized Response Predictor - an oncology drug compass for the individual patient.", said Adjunct Professor Peter Buhl Jensen, M.D., CEO of MPI. "MPI  will own 10% of 2X Oncology Inc. after a successful series A financing," Peter Buhl Jensen further commented. Earlier this year (24th of January 2017) Medical Prognosis Institute and Oncology Venture published information on data based on more than 800 patients with metastatic breast cancer that demonstrated with statistical significant values that the Patient Response Predictor (PRP) could predict whether the individual patients would respond on the treatment with epirubicin (an anthracycline like doxorubicin), fulvestrant, anastrazole and exemestan or not. As there is a high number of active anticancer agents for Breast Cancer and this approach has been very fruitful, MPI and Oncology Venture will continue to broaden the database and the data mining to increase the number of products where our DRP technology can bring value to the choice of therapy. The abstract will be released by ASCO on May 17, 2017, at 5:00 PM EDT/23:00 CET on abstracts.asco.org An up-date on data from the abstract will be presented as a poster on the poster session Breast Cancer-Metastatic on the 4th of June 2017 at 8:00 AM-11:30 AM local time/15:00-18:30 CET. ASCO, American Society of Clinical Oncology, ANNUAL MEETING. McCormick Place, Chicago, Illinois, USA. Founded in 1964, the American Society of Clinical Oncology (ASCO) is committed to making a world of difference in cancer care. As the world's leading organization of its kind, ASCO represents more than 40,000 oncology professionals who care for people living with cancer. The ASCO Annual Meeting is considered the premiere international forum for the presentation of scientific research and state-of-the-art education in clinical oncology. The five-day event attracts 30,000 attendees from around the world. Clinical trial results and updates presented at ASCO's Annual Meeting represent the significant progress made each year in the fight against cancer. For further information on Oncology Venture please contact This information is that Oncology Venture Sweden AB 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 May 17th 2017. About the DRP(TM) Companion Diagnostic Developed by and in-licensed from Medical Prognosis Institute, the DRP(TM) screening platform utilizes messenger RNA (mRNA) gene expression signatures from patient biopsies to identify patients with a high likelihood of responding to specific cancer-fighting therapies. This DRP(TM) method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines, combined with clinical tumor biology and clinical correlates in a systems biology network. Specific DRP(TM)'s are developed for each pipeline product, which will enable us to identify and predict which patients are most likely to respond and thereby benefit from a given pipeline product.  This would enable likely responders to receive appropriate treatment while expediting the decision path for predicted non-responders, saving them critical time and money in their cancer fight. About Oncology Venture Sweden AB (OV) OV is engaged in the research and development of anti-cancer drugs via its wholly owned Danish subsidiary Oncology Venture ApS. Oncology Venture has a license to use Drug Response Prediction - DRP(TM) - in order to significantly increase the probability of success in clinical trials. DRP(TM) has proven its ability to provide a statistically significant prediction of clinical outcomes from drug treatment in cancer patients in 29 of the 37 clinical studies that were examined. The Company uses a model that alters the odds in comparison with traditional pharmaceutical development. Instead of treating all patients with a particular type of cancer, patients' tumors genes are screened first and only those who are most likely to respond to the treatment will be treated. Via a more well-defined patient group, the risk and costs are reduced while the development process becomes more efficient. The current product portfolio: LiPlaCis for Breast Cancer in collaboration with Cadila Pharmaceuticals, Irofulven developed from a fungus for prostate cancer and APO010 - an immuno-oncology product for Multiple Myeloma. Oncology Venture has spun out 2X Oncology Inc. a company focused on developing precision medicine for women's cancer with three anticancer products in pipeline and OV-SPV2 which will test and potentially develop an oral Tyrosine Kinase inhibitor from a Big Pharma the treatment of cancers. 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. 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 May 17th 2017.


Jorgensen J.T.,Dx Rx Institute | Moller S.,Danish Breast Cancer Cooperative Group | Rasmussen B.B.,Herlev Hospital | Winther H.,Dako Denmark | And 2 more authors.
American Journal of Clinical Pathology | Year: 2011

The present study was done to investigate the concordance between the HER2 status measured by immunohistochemical analysis (HercepTest, DAKO, Carpinteria, CA) and fluorescence in situ hybridization (FISH; HER2 FISH pharmDx, DAKO) in a large study cohort (n = 681) of patients with high-risk breast cancer. A high agreement between immunohistochemical and FISH results was demonstrated. For the whole study population, the agreement between the 2 assays was 93.1% with a corresponding κ coefficient of 0.85. When the equivocal immunohistochemical 2+ cases were excluded from the analysis (n = 79), the agreement increased to 95.0% with a κ coefficient of 0.90. When the cutoff value for amplified/nonamplified cases in the HER2 FISH assay was increased from 2.0 to 2.2 as recommended in the American Society of Clinical Oncology/College of American Pathologists guidelines, the concordance between the 2 assays was 94.3% with a κ coefficient of 0.87 in the whole study population. When the equivocal immunohistochemical 2+ cases were excluded from this analysis, the concordance is similar (95.7% with a κ coefficient of 0.91). © American Society for Clinical Pathology.


Tvedskov T.F.,Copenhagen University | Jensen M.-B.,Danish Breast Cancer Cooperative Group | Balslev E.,Herlev Hospital | Ejlertsen B.,Copenhagen University | Kroman N.,Copenhagen University
European Journal of Cancer | Year: 2011

Purpose: To estimate the size and therapeutic consequences of stage migration after introduction of sentinel lymph node dissection (SLND) in breast cancer treatment in Denmark. Patients and methods: We compared the distribution of lymph node metastases in breast cancer patients operated in 1993-1996 and 2005-2008; before and after introducing SLND. The study was based on data from the national Danish Breast Cancer Cooperative Group (DBCG) database. Results: We included 24,051 patients in the study; 10,231 patients from the first period and 13,820 from the second period. The proportion of patients having macrometastases was not significantly different in the two periods, whereas the proportion of patients with micrometastases increased from 5.1% to 9.0% (P < 0.0001). However, this only resulted in an estimated change, from 7.8% to 8.8%, in the proportion of patients offered adjuvant systemic treatment due to positive nodal status as the only high-risk criterion, when using today's criteria for risk-allocation. In addition, we found that negative hormone receptor status was associated to negative nodal status when adjusted for confounders (odds ratios (OR) 0.83, P < 0.0001). Conclusion: Introduction of SLND in breast cancer treatment in Denmark has resulted in a stage migration on 4% due to identification of more micrometastases. However, this stage migration has only minor impact on patients offered adjuvant systemic treatment because nodal status today is less important in risk-allocation. © 2010 Elsevier Ltd. All rights reserved.


Jorgensen C.L.T.,Herlev University Hospital | Jorgensen C.L.T.,Danish Breast Cancer Cooperative Group | Nielsen T.O.,Vancouver Coastal Health Research Institute | Bjerre K.D.,Danish Breast Cancer Cooperative Group | And 5 more authors.
Acta Oncologica | Year: 2014

Background. In vitro studies suggest basal breast cancers are more sensitive to gemcitabine relative to other intrinsic subtypes. The main objective of this study was to use specimens from a randomized clinical trial to evaluate whether the basal-like subtype identifies patients with advanced breast cancer who benefit from gemcitabine plus docetaxel (GD) compared to single agent docetaxel (D). Material and methods. From patients randomly assigned to GD or D, RNA was isolated from archival formalin-fixed, paraffin-embedded primary breast tumor tissue and used for PAM50 intrinsic subtyping by NanoString nCounter. Statistical analyses were prespecified as a formal prospective-retrospective clinical trial correlative study. Using time to progression (TTP) as primary endpoint, overall survival (OS) and response rate as secondary endpoints, relationships between subtypes and outcome after chemotherapy were analyzed by the Kaplan-Meier method, and Cox proportional hazards regression models. Data analysis was performed independently by the Danish Breast Cancer Cooperative Group (DBCG) statistical core and all statistical tests were two-sided. Results. RNA from 270 patients was evaluable; 84 patients (31%) were classified as luminal A, 97 (36%) luminal B, 43 (16%) basal-like, and 46 (17%) as HER2-enriched. PAM50 intrinsic subtype was a significant independent prognostic factor for both TTP (p = 0.014) and OS (p = 0.0003). Response rate was not different by subtype, and PAM50 was not a predictor of TTP by treatment arm. PAM50 was however a highly significant predictor of OS following GD compared to D (pinteraction = 0.0016). Patients with a basal-like subtype had a significant reduction in OS events [hazard ratio (HR) = 0.29, 95% confidence interval (CI) = 0.15-0.57; pinteraction = 0.0006]. Conclusion. A significantly improved and clinically important prolongation of survival was seen from the addition of gemcitabine to docetaxel in advanced basal-like breast cancer patients. © 2014 Informa Healthcare.


Tvedskov T.F.,Copenhagen University | Jensen M.-B.,Danish Breast Cancer Cooperative Group | Balslev E.,Herlev Hospital | Kroman N.,Copenhagen University
Acta Oncologica | Year: 2014

Background. Benefit from axillary lymph node dissection in sentinel node positive breast cancer patients is under debate. Based on data from 1820 Danish breast cancer patients operated in 2002-2008, we have developed two models to predict high risk of non-sentinel node metastases when micrometastases or isolated tumor cells are found in sentinel node. The aim of this study was to validate these models in an independent Danish dataset. Material and methods. We included 720 breast cancer patients with micrometastases and 180 with isolated tumor cells in sentinel node operated in 2009-2010 from the Danish Breast Cancer Cooperative Group database. Accuracy of the models was tested in this cohort by calculating area under the receiver operating characteristic curve (AUC) as well as sensitivity and specificity. Results. AUC for the model for patients with micrometastases was comparable to AUC in the original cohort: 0.63 and 0.64, respectively. The sensitivity and specificity for predicting risk of non-sentinel node metastases over 30% was 0.36 and 0.81, respectively, in the validation cohort. AUC for the model for patients with isolated tumor cells decreased from 0.73 in the original cohort to 0.60 in the validation cohort. When dividing patients with isolated tumor cells into high and low risk of non-sentinel node metastases according to number of risk factors present, 37% in the high-risk group had non-sentinel node metastases. Specificity and sensitivity was 0.48 and 0.88, respectively, in the validation cohort when using this cut-point. Conclusion. In this independent dataset, the model for patients with micrometastases was robust with accuracy similar to the original cohort, while the model for patients with isolated tumor cells was less accurate. The models may be used to identify patients where axillary lymph node dissection should still be considered. © 2014 Informa Healthcare.


Ahern T.P.,Harvard University | Pedersen L.,Aarhus University Hospital | Tarp M.,Aarhus University Hospital | Cronin-Fenton D.P.,Aarhus University Hospital | And 6 more authors.
Journal of the National Cancer Institute | Year: 2011

Background Accumulating evidence suggests that statins affect diseases other than cardiovascular disease, including cancer, and that these effects may depend on the lipid solubility of specific statins. Though many studies have reported an association between statin use and breast cancer incidence, the relationship between statin use and breast cancer recurrence has not been well studied. Methods We conducted a nationwide, population-based prospective cohort study of all female residents in Denmark diagnosed with stage I-III invasive breast carcinoma who were reported to the Danish Breast Cancer Cooperative Group registry between 1996 and 2003 (n = 18769). Women were followed for a median of 6.8 years after diagnosis. Prescriptions for lipophilic and hydrophilic statins were ascertained from the national electronic pharmacy database. Associations between statin prescriptions and breast cancer recurrence were estimated with generalized linear models and Cox proportional hazards regression with adjustment for age and menopausal status at diagnosis; histological grade; estrogen receptor status; receipt of adjuvant therapy; type of primary surgery received; pre-diagnosis hormone replacement therapy; and co-prescriptions of aspirin, angiotensin-converting enzyme inhibitors, nonsteroidal anti-inflammatory drugs, or anticoagulants. All statistical tests were two-sided.ResultsMost prescriptions for lipophilic statins in the study population were for simvastatin. Exclusive simvastatin users experienced approximately 10 fewer breast cancer recurrences per 100 women after 10 years of follow-up (adjusted 10-year risk difference =-0.10, 95% confidence interval =-0.11 to-0.08), compared with women who were not prescribed a statin. Exclusive hydrophilic statin users had approximately the same risk of breast cancer recurrence as women not prescribed a statin over follow-up (adjusted 10-year risk difference = 0.05, 95% confidence interval =-0.01 to 0.11). ConclusionsSimvastatin, a highly lipophilic statin, was associated with a reduced risk of breast cancer recurrence among Danish women diagnosed with stage I-III breast carcinoma, whereas no association between hydrophilic statin use and breast cancer recurrence was observed. © 2011 The Author.


Njor S.H.,Copenhagen University | Olsen A.H.,University of Tromsø | Blichert-Toft M.,Danish Breast Cancer Cooperative Group | Schwartz W.,University of Southern Denmark | And 2 more authors.
BMJ (Online) | Year: 2013

Objective To use data from two longstanding, population based screening programmes to study overdiagnosis in screening mammography. Design Population based cohort study. Setting Copenhagen municipality (from 1991) and Funen County (from 1993), Denmark. Participants 57 763 women targeted by organised screening, aged 56-69 when the screening programmes started, and followed up to 2009. Main outcome measures Overdiagnosis of breast cancer in women targeted by screening, assessed by relative risks compared with historical control groups from screening regions, national control groups from non-screening regions, and historical national control groups. Results In total, 3279 invasive breast carcinomas and ductal carcinomas in situ occurred. The start of screening led to prevalence peaks in breast cancer incidence: relative risk 2.06 (95% confidence interval 1.64 to 2.59) for Copenhagen and 1.84 (1.46 to 2.32) for Funen. During subsequent screening rounds, relative risks were slightly above unity: 1.04 (0.85 to 1.27) for Copenhagen and 1.14 (0.98 to 1.32) for Funen. A compensatory dip was seen after the end of invitation to screening: relative risk 0.80 (0.65 to 0.98) for Copenhagen and 0.67 (0.55 to 0.81) for Funen during the first four years. The relative risk of breast cancer accumulated over the entire follow-up period was 1.06 (0.90 to 1.25) for Copenhagen and 1.01 (0.93 to 1.10) for Funen. Relative risks for participants corrected for selection bias were estimated to be 1.08 for Copenhagen and 1.02 for Funen; for participants followed for at least eight years after the end of screening, they were 1.05 and 1.01. A pooled estimate gave 1.040 (0.99 to 1.09) for all targeted women and 1.023 (0.97 to 1.08) for targeted women followed for at least eight years after the end of screening. Conclusions On the basis of combined data from the two screening programmes, this study indicated that overdiagnosis most likely amounted to 2.3% (95% confidence interval -3% to 8%) in targeted women. Among participants, it was most likely 1-5%. At least eight years after the end of screening were needed to compensate for the excess incidence during screening.

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