Safety Data Committee approves recommended dose for LiPlaCis in Breast Cancer – recruitment satisfactory
Hoersholm, Denmark November 21st 2017 – Oncology Venture Sweden AB (OV:ST) announces today that the dose of 75mg + 75mg per patient on days 1 and 8 in a three weeks schedule was found safe and was approved by the data safety committee as the Recommended Dose (RD) for future treatments with LiPlaCis®.
Furthermore, recruitment rate for the ongoing phase 2 part of the study of metastatic breast cancer patients in treatment with LiPlaCis has accelerated during the last couple of months and is satisfactory.
Oncology Venture expects as previously announced to report on the progress of the study every quarter next time in January 2018. Last patient included is expected to be in Q1 2018 and data from the full study is expected to be communicated in Q2-Q3 2018 depending on how long the patients will continue in the study.
About 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 followed up by publication of clinical relevant benefit in three out of five treated patients in the ongoing study (please see press release of September 19, 2017). 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.
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.
About the Drug Response Predictor – DRP® Companion Diagnostic
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 patient’s 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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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.
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