OV – Oncology Venture requests meeting with FDA to discuss pathway for LiPlaCis and DRP approval in the US



Investor News

Hørsholm, Denmark and Cambridge, MA, US, October 19, 2018 – Oncology Venture A/S today announced that the Company has submitted a meeting request to the US Food and Drug Administration, FDA, to discuss the concept of LiPlaCis® and its companion diagnostic DRP® -Drug Response Predictor.

Provided a successful outcome of the meeting, Oncology Venture plans to submit an IND/IDE application to the FDA to start a phase 2 trial of LiPlaCis® and its companion diagnostic Drug Response Predictor (DRP®) in breast cancer patients in the US. 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. The meeting with the FDA is supposed to be held in late November or early December 2018.

For further information, please contact:

For investor inquiries
Ulla Hald Buhl, IR & Communication
E-mail: uhb@oncologyventure.com
Telephone +45 21 70 10 49

 
     For media inquiries
     Thomas Pedersen, Frontpage PR & Communications
     E-mail: thomas.pedersen@frontpage.dk
     Telephone +45 60 62 93 90

About Oncology Venture A/S
Oncology Venture A/S is engaged in the research and development of anti-cancer drugs via its wholly-owned subsidiary, Oncology Venture Product Development ApS. Oncology Venture uses Drug Response Prediction – DRP® -to significantly increase the probability of success in clinical trials. DRP® has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in 29 out of 37 clinical studies that were examined and is currently demonstrating promising results in an ongoing phase 2 study prospectively using LiPlaCis and its DRP® to track, match and treat patients with metastatic breast cancer. The DRP® alters the odds in comparison with traditional pharmaceutical development. Instead of treating all patients with a particular type of cancer, patients’ tumors genes are first screened, and only the patients most likely to respond to the treatment will be treated. Via a more well-defined patient group, risks and costs are reduced while the development process becomes more efficient. 

The current OV product portfolio includes: LiPlaCis®, a liposomal formulation of cisplatin in an ongoing Phase 2 trial for breast and prostate cancer; 2X-121 a PARP inhibitor in an ongoing Phase 2 for breast cancer; dovitinib a post phase 3 product, which will enter Phase 2 trials for indications dependent on further Dovitinib-DRP analysis of studies completed by Novartis. 2X-111, a liposomal formulation of doxorubicin under manufacturing for Phase 2 in breast cancer; irofulven is in Phase 2 in prostate cancer; and APO010, an immuno-oncology product in Phase 1/2 for multiple myeloma. 

Oncology Venture has spun out two companies as Special Purpose Vehicles: Oncology Venture U.S. Inc. (previously 2X Oncology Inc.), a US-based precision medicine company focusing on developing 2X-121 and 2X-111, and OV-SPV 2, a Danish company that will test and develop dovitinib. Oncology Venture A/S has an ownership of 92% in Oncology Venture US and 55% of dovitinib with an opportunity to acquire further 30%. 

Learn more at oncologyventure.com

Follow us on social media:

Facebook: https://www.facebook.com/oncologyventure/
LinkedIn: https://www.linkedin.com/company/oncology-venture/
Twitter: https://twitter.com/OncologyVenture

Forward-looking statements 
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of OV’s control and which could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning OV’s plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. OV undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

Press Contact

For any inquiries, please contact:

Ulla Hald Buhl
E-mail: Email Us
Tel. +45 21 70 10 49