Hoersholm, Denmark, January 31, 2018 - Medical Prognosis Institute A/S (MPI.ST) spinout Oncology Venture AB (OV:ST) today announces the second interim report from the Phase 2 part of an ongoing LiPlaCis® Phase 1/2 study in hard to treat metastatic breast cancer patients. The selection of patients for the Phase 1/2 study is aided by the MPI developed DRP® companion diagnostic tool, allowing inclusion of those patients most likely to respond to treatment. Clinical response to LiPlaCis - a targeted liposomal formulation of cisplatin - is shown in 7 out of 10 evaluable patients, whereas conventional cisplatin treatment of metastatic breast cancer has reported a response rate of only 10 percent in previously conducted trials. In the third of patients identified by DRP® to be most susceptible to treatment, 5 out of 5 experienced clinical benefit. Further, 3 out of 5 heavily pretreated patients had a better response than with all prior medical therapies.
When looking at the top third of the patients most likely to respond to LiPlaCis® treatment based on the DRP® analysis, five out of five experienced clinical benefit from study treatment. Further to this, three out of five of these heavily pretreated patients had a better or longer response than with previous medical treatments for advanced disease, including combination- and hormone therapies.
The Phase 2 part of the study is set up to recruit a total of 20 evaluable patients with high likelihood of response (a DRP® cutoff of two third, i.e. the two thirds of a patient population most likely to respond). The study is progressing according to plan, and the last patient is expected to be included before end of Q1 2018.
"It is very encouraging that in this prospective study the DRP with statistical significance can identify responding and non-responding patients", said Steen Knudsen, CSO and founder of MPI.
"To choose the right anticancer treatment and to opt out a treatment that will not benefit the patient is what all Oncologists want to offer patients. Therefore there is a huge need for a technology like Oncology Ventures DRP which looks promising in identifying the right patient for the right anticancer drug," Said DMSc, PhD Bent Ejlertsen, Copenhagen University Hospital, Rigshospitalet and Chairman of Scientific Committee for Medical Therapy at the Danish Breast Cancer Cooperative Group "I look forward to the final data and to participate in the subsequent randomized trial", Dr Ejlertsen further commented.
Detailed enrolment status
To date, a total of 17 patients have been included in the Phase 2 part of the study. Ten of these have been followed sufficiently long for evaluation of efficacy. In total, seven patients have experienced clinical benefit, whereof two had a Partial Remission (PR) and five had Stable Disease (SD). Three had Progressive Disease (PD) and three patients are not evaluable for response (two due to early death - by the Data Committee not deemed to be related to the study drug - and one due to inclusion failure).
Data from Top third DRP® level and excluding patients previously treated with platin drugs
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Medical Prognosis Institute 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 1,400 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. MPI has ownership of Oncology Venture (Publ) a spinout with three anti-cancer drugs in pipeline entered and of the privately hold Special Purpose Vehicles, 2X Oncology Inc. and OV-SPV2 Aps with four products in pipeline.
About the Drug Response Predictor (DRP®) Companion Diagnostic
Oncology Venture uses the Medical Prognosis Institute (MPI) multi gene DRP® technology to select those patients that, by the genetic signature in their cancer, is found to have a high likelihood of response to a given drug. The goal is to develop the drug for the right patients by screening patients before treatment, whereby the response rate can be significantly increased. The DRP® 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. The DRP® is based on messenger RNA from the patients' biopsies. The DRP® platform (i.e. the DRP® and the PRP(TM) biomarkers) can be used in all cancer types, and is patented for more than 70 anti-cancer drugs in the US. The PRP(TM) is commercialized by MPI for Personalized Medicine. The DRP® is commercialized by Oncology Venture for drug development.
About Oncology Venture Sweden AB
Oncology Venture Sweden AB is engaged in the research and development of anti-cancer drugs via its wholly owned Danish subsidiary Oncology Venture ApS. Oncology Venture has an exclusive license to use the Drug Response Predictor (DRP®) technology in order to significantly increase the probability of success in clinical trials. DRP® 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 with DRP® 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 two companies in Special Purpose Vehicles: 2X Oncology Inc. a US based company focusing on Precision medicine for women's cancers with a pipeline of three promising phase 2 product candidates and Danish OV-SPV 2 will test and potentially develop the Novartis small molecule kinase inhibitor.
LiPlaCis® Phase 2 study in 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. Recommended dose per patient is 75 mg on day 1 and 75mg on day 8. 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 two DRP-screened patient with a hard to treat metastatic Breast Cancer.
The drug candidate has received clearance for phase 2 studies by the Danish authorities and three out of four planned Danish Medical Centers are now active in recruiting up to 20 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 Q1 2018.
LiPlaCis® has been registered together with its DRP® 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.
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 January 31, 2018.
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