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Tuesday, 19 September 2017

MPI - LiPlaCis Phase 2 Recruitment Ongoing in DRP Screened Breast Cancer Patients: Relevant Clinical Benefits in 3 out of 5 Treated Patients

Medical Prognosis Institute    

Published: 12:45 CEST 19-09-2017 /GlobeNewswire /Source: Medical Prognosis Institute / : MPI /ISIN: DK0060732477

MPI - LiPlaCis Phase 2 Recruitment Ongoing in DRP Screened Breast Cancer Patients: Relevant Clinical Benefits in 3 out of 5 Treated Patients

Hoersholm, Denmark, September 19, 2017 - Medical Prognosis Institute A/S ("MPI") today announced early data from Oncology Ventures (a spinout from MPI) ongoing LiPlaCis® Phase 1/2 study show response and clinical benefits in hard to treat patients with metastatic Breast Cancer. Patients have been included in the trial based on a positive LiPlaCis® Drug Response Predictor (DRP) analysis of each individual patients' tumor biopsy.

A total of 12-15 patients are to enter the Phase 2 part of the study, which as previously announced is expected to be achieved during this September. So far, a total of eight patients have been included in the phase 2 part, and as of now five of these have received LiPlaCis® treatment during a time period sufficient to evaluate efficacy - please see below!

Full clinical information will be published once mature data is available.

 

Early data from five evaluable included metastatic Breast Cancer patients predicted to be likely responders to LiPlaCis® shows:

  • One patient has a confirmed Partial Remission (PR, i.e. >30% reduction of her tumor) of 32 weeks.

In addition to surgery and adjuvant treatment, the patient has received five prior medical treatments for her disease, with the best response being Stable Disease (i.e. no change in overall measurement of the tumor burden) The patient is suffering from a hard to treat tumor.

  • Another patient has Stable Disease for >24 weeks. When SD > 24 weeks, patients are accounted for as responders. The patient is still receiving LiPlaCis® treatment. Prior to the LiPlaCis® treatment, the patient has received seven medical treatments of her disease, with the best response being Stable Disease (i.e. no change in the overall measurement of the tumor burden) Consequently, this is also a patient with a hard to treat tumor. Alongside a durable Stable Disease, this patient has clinical benefit of LiPlaCis® as metastases to the lung have resulted in production of fluid in the lungs (pleural effusion) which the patient needed to have removed.

This is normally a repetitive procedure but since the LiPlaCis® treatment started, no thoracentesis has been needed. In addition, the patient has resumed a part-time work.

  • A third patient, currently with Stable Disease for 17 weeks, has metastases in the liver. At the time of inclusion in the study, her liver function values were severely elevated as a consequence of her cancer disease. This patient belongs to a fragile and hard to treat group of mBC patients. During treatment with LiPlaCis®, the liver enzyme values have all been normalized, demonstrating a clinical response.
  • One patient has a short Stable Disease (SD), and one patient had Progressive Disease (PD). It may be of interest that both these patients have previously received 12 prior treatments, including carboplatin - a cisplatin-like product - and may be resistant to treatment with LiPlaCis®.
  • Five patients are currently receiving treatment in the study (are ongoing), whereof three have not yet been in the study for a sufficient time period to evaluate efficacy of LiPlaCis.

 

Furthermore, data show that LiPlaCis® is well tolerated with mainly mild and only few moderate side effects (five grade 3 and no grade 4).

 

"I'm excited about these early clinical results of LiPlaCis in hard to treat metastatic breast cancer and look forward to finalizing the study", said MD, PhD Erik Hugger, Senior Consultant and Investigator at Vejle Hospital.

"I'm excited about these promising early results of the Phase 2 part of the LiPlaCis® study, where patients are screened using the Drug Response Predictor -DRP- as high likely responders before entering the trial", says Peter Buhl Jensen, MD, PhD and CEO of MPI. "Several of the metastatic Breast Cancer patients are considered hard to treat, with seven to twelve lines of treatment before receiving LiPlaCis. We are dedicated to deliver DRP's for the development of new effective treatment options. My expectations are high for the DRP technology, as I believe it will bring new hope and better treatments for cancer patients. For LiPlaCis the goal is to obtain more than 10% response rate", comments Peter Buhl.

 

LiPlaCis® Phase 2 for metastatic Breast Cancer (mBC)

LiPlaCis® is an intelligent targeted liposomal formulation of cisplatin. LiPlaCis has finalized the dose escalation part of the trial, and has demonstrated promising activity in patients already in the dose escalation part.

The drug is administered intravenously in three (3) week cycles on day 1 and day 8. Upon the investigator's judgement, the patient may continue treatment for more than three (3) cycles when benefitting from it. LiPlaCis® has shown activity in Skin Cancer, Esophageal Cancer, Head and Neck Cancer, and Breast Cancer. Response (confirmed PR = Partial Response) has been published for the first DRP-screened patient with a hard to treat metastatic Breast Cancer.

The drug has received status as a phase 2 study by the Danish authorities and three out of four planned Danish Medical Centers are now active in recruiting 12-15 metastatic Breast Cancer patients who are screened and expected to be highly likely responders to LiPlaCis®. The Phase 2 study in metastatic Breast Cancer expect to finalize its recruitment during Q3 2017.

LiPlaCis® has been registered together with its DRP(TM) companion diagnostic for EU marking.

Next step in the regulatory strategy is building a data package for a Pre-Submission meeting with the FDA.

This will be done in collaboration with US experts.

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.

About Oncology Venture

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.

 

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 19, 2017.

 

Certified Advisor: Sedermera Fondkommission, Norra Vallgatan 64, 211 22, Malmö, Sweden



MPI - LiPlaCis Phase 2 Ongoing in DRP Screened Breast Cancer



This announcement is distributed by Nasdaq Corporate Solutions (One Liberty Plaza, 165 Broadway, New York, NY 10006. Tel: +1 212 401 8700. www.nasdaqomx.com) on behalf of NASDAQ OMX Corporate Solutions clients. Source: Medical Prognosis Institute, Venlighedsvej 1., Hørsholm 2970, Denmark
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