Oncology Ventures lead product LiPlaCis is now in phase 2

Hoersholm, Denmark, November 21th, 2016 – Oncology Venture Sweden AB (OV.ST) today announce that the Danish Health Authorities (DKMA) and the Ethics Committee have accepted that the ongoing dose escalation phase 1 + extension phase can continue as a phase 1/2 study. The study title is accordingly: ‘Phase 1/2 study to evaluate the safety and tolerability of LiPlaCis (Liposomal Cisplatin formulation) in patients with advanced or refractory tumours’. The study has until now been running on dedicated Phase 1 Units and can now move to ’normal’ oncology wards. Work is in progress to open 4 sites in Denmark to include the previously announced total of 12-15 high likelihood LiPlaCis responders among patients with metastatic breast cancer. More than 1100 patients have given consent to having their tumor DRP-screened by which patients’ individual biopsies are analyzed for sensitivity (effect) to LiPlaCis. At the same time the inclusion of patients in the LiPlaCis phase 2 trial will be increased to the top 20% of high likely responders as defined by the DRP™. Using a conservative cut-off of top 20% we demonstrate the ability of the DRP™ to select sensitive patients. Later, the cut off is expected to be less conservative, as the relevant patient population is expected to be at a cut off around 30-40%. Also as previously announced the extension phase i.e. now the phase 2 part of the trial will take approximately 12 months which is Q2 2017, with interim data expected during the period.

“The Danish Health Authority and Ethics Committee have agreed to classify the ongoing LiPlaCis study for metastatic Breast Cancer as a phase 1/2 study. We can now open sites on ‘normal’ oncology wards as we have passed the dose escalation part of the study and the recommended dose has been established. We look forward to open new sites and run the study on a total of 4-5 sites,” says Peter Buhl Jensen, M.D., CEO of Oncology Venture. “I’m very happy for the highly qualified collaboration we have had on LiPlaCis at special Phase 1 Units and look forward to including a total of 12-15 DRP-screened patients with metastatic breast cancer who we believe are high likely responders to our lead drug candidate LiPlaCis,” Buhl Jensen further comments.

About LiPlaCis

Cisplatin is one of the most widely used drugs in the treatment of cancer due to its documented efficacy in a number of tumor types. Cisplatin is used in the treatment of large indications as lung cancer Europe+US ≈ 673,000 new cases annually), head and neck cancer (500,000 cases annually worldwide) bladder cancer (EU+US ≈ 170,000 annually) and ovarian cancer (EU+US ≈ 71,000 annually). The lipid formulation from LiPlasome is an 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 tumor sites. The liposomes are designed to trigger the release of an encapsulated drug specifically in the tumor 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.

More about LiPlaCis™ and the clinical testing

The Phase 1 study to evaluate the safety and tolerability of LiPlaCis in patients with advanced tumors has been running at two University Hospitals in Copenhagen and have included 21 patients and its extension phase, now classified as a phase 2 part where patients with metastatic breast cancer screened for sensitivity to LiPlaCis by the DRP can now be included and treated at standard oncology wards. LiPlaCis has demonstrated promising signs of good activity in a small number of patients in the ongoing study. LiPlaCis™ is administered intravenously in 3 weeks cycles on day 1 and day 8. Upon the investigator’s judgement the patient may continue treatment for more than 3 cycles when benefitting from the study drug.  

About the Drug Response Predictor - DRP™ screening tool

Oncology Venture uses the MPI multi gene DRP™ to select those patients that by the genetic signature in their cancer is found to have a high likelihood of response to the drug. The goal is to develop the drug for the right patients and by screening patients before treatment the response rate can be significantly increased.

This 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™ tools can be used in all cancer types, and is patented for more than 70 anti-cancer drugs in the US. The PRP™ is used by MPI for Personalized Medicine. The DRP™ is used in Oncology Venture for drug development.

For further information, please contact

This information is information 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 November 21th 2016.

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 a license to use Drug Response Prediction – DRP™ – 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 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.