Successful inclusion in Phase 2 of LiPlaCis® for metastatic Breast cancer
Hoersholm, Denmark September 29th 2017 – Oncology Venture Sweden AB (OV:ST) announces that today 12 metastatic breast cancer patients have been successfully included in the phase 2 part of the LiPlaCis for metastatic breast cancer. As previously announced we expected to include 12-15 patients by Q3 2017. The initial good clinical results have led Oncology Venture to continue the trial and the company has been allowed to expand the number of patients to up to 20 patients. The company has increased the inclusion from the top 20% sensitive patients to include the top 2/3 of patients. This has been done in agreement with the oncologists as the company and the clinicians believe that the fraction of patients that could benefit from treatment with LiPlaCis could be greater than the top 20%.
As communicated in the press release of 19 September 2017 early data shows promising response in the ongoing study. Oncology Venture expects to report on the progress of the study every quarter next time in Q1 2018.
The multi gene DRP™ for LiPlaCis is developed to select those patients that by the genetic signature in their cancer is found to have a high likelihood of response to LiPlaCis. The goal is to develop LiPlaCis for the right patients and by pre-screening patients we avoid treating patients that are not likely to benefit LiPlaCis. Hereby the response rate and benefit rate can be significantly increased.
“I’m very happy that we have been able to include patients in the LiPlaCis study as promised and am thankful to the hospital sites as well as our CRO partner Smerud for the diligent effort to do so. I believe that the broadened inclusion rate of the DRP from 20% to 66% will give us important information about the relevant DRP cut of level. Oncology Ventures goal is to develop new effective personalized treatment options for cancer patients, guided by our Drug Response Predictor, DRP™,” comments CEO, MD Peter Buhl Jensen “My expectations are high for LiPlaCis and the DRP technology, as I believe the focused treatment will bring new hope and better treatments for cancer patients,” Buhl Jensen further comments.
Strong support of randomized Phase 2 in Breast Cancer
The above data supports the ongoing LiPlaCis development in collaboration with Cadila Pharmaceuticals LTD (“Cadila”) and Smerud Medical Research. Oncology Venture entered a collaboration agreement with Cadila. Cadila invest in kind i.e. 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.
A total of 18 million SEK has, as previously communicated, been granted to OV’s LiPlaCis project by Oncology Ventures partner Smerud Medical Research and the EUROSTARS program and Oncology Venture and Smerud now starts the preparation of a randomized Phase 2 in Breast Cancer which is expected to include other European countries.
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. 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.
For further information, please contact
|Ulla Hald Buhl, COO and
Chief IR & Communications
Mobile: +45 2170 1049
|Or||Peter Buhl Jensen, CEO
Mobile: +45 21 60 89 22
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 agency of the contact person set out above, on September 29th, 2017