On June 3, 2019 Oncology Venture A/S ("OV" or "the Company") reported that the FDA has given its initial response to the Company’s IND application and proposed pivotal Phase 3 study of LiPlaCis in the US (Press release, Oncology Venture, JUN 3, 2019, View Source [SID1234536822]). The FDA has requested some additional testing of the LiPlaCis related to the product characterization. Oncology Venture expects to have these additional tests completed in good time before initiation of the study. Oncology Venture will in parallel modify the study design to accommodate FDA’s recommendation for the pivotal study. The earlier communicated timeline for the development of the LiPlaCis is unchanged.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The LiPlaCis pivotal Phase 3 study in the US will, in similarity to the ongoing Danish Phase 2 trial evaluate LiPlaCis and its companion diagnostic LiPlaCis-DRP for the treatment of metastatic breast cancer. The protocol will be upgraded from a single arm study to a randomized study and the number of patients is expected to be around 200 as previously communicated. The new design is also expected to comply with the requirements that the European Medicines Agency, EMA, has on registrational studies.

LiPlaCis is an intelligent, target controlled liposome formulation of one of the world’s most widely used chemotherapies, cisplatin. The specific LiPlaCis formulation allows delivery of LiPlaCis directly at tumor site. Oncology Ventures drug specific diagnostic tool DRP selects the patients whom are expected to benefit from the treatment. LiPlaCis is showing promising results in an ongoing Phase 2 study in patients with metastatic breast cancer.

"As expected, there will always be questions to a registrational study. Upon the useful feedback from the FDA we will design a randomized study, and we are confident that we can deliver the requested product characterization information allowing us to keep the timelines. The ongoing Phase 2 study in Denmark is showing strong results. The OV team has taken advantage of the DRP technology as a differentiating factor and moved this project forward from a phase 1 study to a registrational study in only two years," says Peter Buhl Jensen, M.D., CEO of Oncology Venture.

For further information, please contact:

For investor inquiries
Ulla Hald Buhl, IR & Communications
E-mail: [email protected]
Telephone +45 21 70 10 49 For media inquiries
Thomas Pedersen, Carrotize PR & Communications
E-mail: [email protected]
Telephone +45 60 62 93 90