Optimized LiPlaCis® allows for easier storage and transportation

Hoersholm, Denmark February 21st 2017 – Oncology Venture Sweden AB (OV:ST) announces that a new version of LiPlaCis can be stored at 2-8°C. This product has successfully been manufactured and has passed all quality checks. The original version of LiPlaCis is stored at-80°C and as not all sites have -80°C freezers it is a huge advantage that the product now can be stored and transported at refrigerator temperature.LiPlaCis® is an ongoing, multicenter Phase 2 study in metastatic Breast Cancer expected to be finalized in Q3 2017.

“As part of the development strategy for bringing LiPlaCis to market, Oncology Venture has manufactured an easier to store and easier to transport version of LiPlaCis,” Said Peter Buhl Jensen, Adjunct professor, MD, PhD and CEO of Oncology Venture. “For a period both versions will be used in Denmark. I believe that the new 2-8°C version of LiPlaCis will make it easier for sites to store. Potentially more sites will now be able to participate in the studies,” Peter Buhl Jensen further commented. 

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 in November 2016 and has demonstrated promising activity in patients already in the dose escalation part. LiPlaCis™ is administered intravenously in 3 week 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. Response (confirmed PR = Partial Response) has been published for the first DRP-screened patient with a hard to treat metastatic Breast Cancer.

LiPlaCis has received status as a phase 2 study by the Danish authorities and i.e. 3 out of 4 in total Danish centers are now active in recruiting 12-15 metastatic Breast Cancer patients screened and expected to be highly likely responders to LiPlaCis. We expect to finalize the study in Q3 2017.

LiPlaCis® has been registered together with its DRP™ companion diagnostic for an EU-marking. Next step in the regulatory strategy is building a data package for a ‘Pre-Submission meeting’ with the FDA. This is done in collaboration with US-experts.

Oncology Venture entered a collaboration agreement with Cadila Pharmaceuticals LTD xx. Cadila invest in kind in research and development activities of 310 cancer patients and DRP screening of more than 1400 patients. Cadila will perform four (4) Phase 2 trials in Prostate, Head & Neck, Skin and Esophageal cancers and a pivotal randomized clinical Phase 3 trial in metastatic Breast Cancer.

Together with our CRO Smerud LiPlaCis obtained a EUROSTARS grant (EU grant) in December 2016 supporting the development of LiPlaCis with a total value of 18 mSEK.

About the Drug Response Predictor - DRP™ screening tool

Oncology Venture uses the Medical Prognosis Institute (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.

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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 February 21ST, 2017.

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.

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 an oral phase 2 Tyrosine Kinase inhibitor.