Hoersholm; March 4 2016 – Medical Prognosis Institute A/S (MPI) and Oncology Venture announced today that data from phase 1 dose-escalating PoC study to evaluate the safety and tolerability of LiPlaCis in patients with advanced refractory tumors will be presented at the AACR (American Association for Cancer Research) Annual Meeting April 16th – 20th 2016 in New Orleans. It is expected to be attended by more than 19500 professionals, scientists, doctors, patients, and students from all over the world.
“I look very much forward to have these data from the pharmacodynamic part of the Phase 1 study presented and discussed. The study compares the level of LiPlaCis delivered in the tumor to than in normal tissue. The LiPlaCis targeted therapy is expected to be more efficient than the conventional cisplatin treatment. In the following extension phase of the study high likelihood responding patients will be selected by the use of MPI’s DRP(TM),” Said Adjunct professor Peter Buhl Jensen, M.D., CEO of Medical Prognosis Institute.
The Phase 1 study to evaluate the safety and tolerability of LiPlaCis in patients with advanced tumours is running at a Phase 1 Unit at a University Hospital in Copenhagen and has included 18 patients in the dose escalation part of a phase 1 study in solid tumors. The LiPlaCis program is now on the verge of moving into the extension phase 2 designed trial (part of the phase 1 application where patients with a specific disease – here metastatic breast cancer – are included to investigate early Proof of Concept – i.e. effect of the drug. LiPlaCis(TM) is administered intravenously in cycles weekly on day 1, day 8 Upon the investigator’s judgement the patient may continue treatment for more than 3 cycles when benefiting from the study drug.
Session Title: Phase I Clinical Trials 2
Session Date and Time: Wednesday Apr 20, 2016 8:00 AM – 12:00 PM
Session Location: Convention Center, Halls G-J, Poster Section 13
Poster Board Number: 15
Permanent Abstract Number: CT154
Cisplatin is one of the most widely used drugs in the treatment of cancer due to its documented efficacy in a number of tumour types. Cisplatin is used in the treatment of large indications as lung cancer EU+US approx. 480,000 new cases annually), head and neck cancer (500,000 cases annually worldwide) bladder cancer (EU+US approx. 170,000 annually) and ovarian cancer (EU+US approx. 71,000 annually). The lipid formulation from LiPlasome is the answer to a well-established need for improving cisplatin therapy and improving the formulation of the drug, so that a more selective up-take of cisplatin administered takes place at the tumour sites. LiPlasome Pharma ApS has identified and incorporated a mechanism into their liposomes – called LiPlasomes – designed to trigger the release of an encapsulated drug specifically in the tumour tissue. An enzyme especially present on tumors called secretory phospholipase A2 (sPLA2), is utilised to break down the LiPlaCis once it has accumulated in the cancer tissue. The lipid composition of the LiPlasomes is tailored to be specifically sensitive to degradation by the sPLA2 enzyme and thereby for release of the encapsulated drug. The technology behind LiPlaCis(TM) was originally developed by scientists from Danish Technical University -DTU.
About MPI’s multiple biomarker called Drug Response Predictor – DRP(TM)
MPI’s lead product, the DRP(TM) diagnostic platform, is a tool to develop tumor-derived gene signatures that may predict which cancer patients are highly likely responders to a given anticancer product. The DRP(TM) has been tested in 37 trials, where 29 trials showed that drug-specific DRP(TM) Biomarkers could predict which patients had a positive effect of the treatment. The DRP(TM) platform has also 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 anticancer drug. Further to and in addition to this, individual patients’ gene patterns can be analyzed as part of a screening procedure for a clinical trial to ensure inclusion of those patients who have a high likelihood of response to the drug. This DRP(TM) method builds on the comparison of 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 messenger RNA 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 anticancer drugs in the US.
Medical Prognosis Institute advances personalized medicine by partnering with cancer drug developers to apply its DRP(TM) diagnostic platform to streamline and de-risk clinical trials and drug development via biomarker optimization, patient stratification, and development of companion diagnostics.
For further information, please contact
CEO, Peter Buhl Jensen, Adjunct Professor, MD, Ph.d.
e-mail: [email protected]
Phone: +45 21 60 89 22
Certified Advisor: Carsten Yde Hemme, PricewaterhouseCoopers, Strandvejen 44, 2900 Hellerup, Denmark