Data from the ongoing Phase II LiPlaCis study in patients with metastatic breast cancer shows 50% response rate. Oncology Venture intends to file on phase II information.

Data from the ongoing Phase II study for LiPlaCis in patients with metastatic breast cancer shows: 50% response rate (five out of ten patients) in the upper one third of DRP selected patients. 24% response rate (6 out of 25 patients) in the upper two thirds of DRP selected patients. These data should be compared with response rates to the established cancer drugs in metastatic breast cancer: 10-12% of eribulin, vinorelbine and gemcitabine and 10% of conventional cisplatin .

Oncology Venture has applied for a meeting with the FDA to discuss the filing of an IDE and IND application (the DRP technology to track and match and the protocol for the LiPlaCis treatment, respectively) with the intention to conduct LiPlaCis breast cancer clinical trials also in the US. The aim is a first approval of LiPlaCis by a single arm pivotal study.

On the basis of current good data OV's advisors and statisticians expect that a study in 100-200 patients will be sufficient for a marketing approval of LiPlaCis as a new treatment of breast cancer. The ongoing phase II study of LiPlaCis may continue and bridge into such a pivotal trial. Recruitment timelines will be updated later, following feed-back from the FDA.

Oncology Venture's regulatory strategy is firstly to obtain approval in the US, as the DRP technology facilitates conduction of focused studies in a small number of patients to determine the efficacy of LiPlaCis . The aim is then to run randomized pivotal studies in Europe and Greater China, provided necessary clearances from relevant regulatory bodies.