Irofulven Phase 2 clinical study application approved by the Danish Medicines Agency and the Ethics Committee
Hoersholm, Denmark -- December 22th 2017 – Oncology Venture Sweden AB:s (OV:ST) (“Oncology Venture” or “OV”) has received approval for the application to run a phase 2 protocol of Irofulven for castration- and docetaxel resistant Prostate Cancer by the Danish Ethics Comitte and tha Danish Medicines Agency (DHMA).
The study will include 13-27 patients selected for Irofulven benefit from DRP screened Swedish and Danish patients. The study will be run at two Danish sites – Swedish patients will be refered for Irofulven treatment at the University Hospital in Copenhagen. Using genomic information from the individual cancer patient’s tumor, Oncology Ventures patented DRP® technology will identify patients most likely to benefit from Irofulven.
Irofulven will be the third active phase 2 study in Oncology Ventures pipeline accompanied by LiPlaCis for metastatic Breast cancer and APO010 for Multiple Myeloma.
About Prostate Cancer
Prostate Cancer is the second most common cancer among men worldwide, and the second leading cause of death from cancer in men. A majority of Prostate Cancers are adenocarcinomas, i.e. cancers that begin in cells producing and releasing mucus and other fluids. Progress is typically slow, and symptoms late. Prostate Cancer is most prevalent in older men, with a common age for diagnose around age 70. Treatment varies greatly, but in progressed Prostate Cancer usually comprises two or more of the alternatives surgery, radiation, chemotherapy and hormone treatment.
In progressed stages, the cancer eventually becomes resistant to hormone treatment (castration resistance) and chemotherapy (docetaxel resistance). It is among these patients that Irofulven will primarily be tested.
Irofulven is a unique product within the DNA damage repair field which also includes the successful PARP inhibitors. The development of the product was stopped when there was no routes to identify responding patiets eventhough it had clear benefit and worked in 10% of prostate cancer, 12% of ovarian cancer and also demonstrated good activity in certain patients with liver cancer. Irofulven (6-hydroxymethylacylfulvene) is a semi-synthetic derivative of illudin S, a natural toxin isolated from the Jack O’lantern mushroom (Omphalotus illudens). A pro-drug, Irofulven requires catalysis by prostaglandin reductase 1 to become active.
Created at the University of California, San Diego (UCSD), Irofulven was exclusively licensed to US biotech company MGI Pharma, which was acquired by Eisai in 2007. After being returned to UCSD in 2009, Lantern Pharma licensed Irofulven in 2015, and subsequently sub-licensed Irofulven to Oncology Venture.
Irofulven is more active in vitro against tumour cells of epithelial origin and is more resistant than other alkylating agents to deactivation by p53 loss and MDR1. Irofulven exhibits impressive anti-cancer results in xenograft models in vivo, shows synergy with topoisomerase I inhibitors, and has demonstrated activity against cell lines that are resistant to other therapies. Irofulven has significant scope for combination with other therapies, including standard chemotherapeutic regimes.
For further information, please contact:
Ulla Hald Buhl, COO and
Chief IR & Communications
Mobile: +45 2170 1049
Peter Buhl Jensen, CEO
Mobile: +45 21 60 89 22
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 December 22st, 2017
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 an exclusive license to use the Drug Response Predictor (DRP™) technology 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 with DRP™ 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 which will test and potentially develop the Novartis small molecule kinase inhibitor. Oncology Venture currently owns 92% of 2X Oncology Inc. and 40% of OV-SPV2 ApS.