DRP(TM) enables Irofulven clinical trial in prostate cancer

2015-11-08

Hoersholm, Denmark; November 8th, 2015 - Medical Prognosis Institute A/S (MPI.CO) has in collaboration with Oncology Venture AB, Denmark; Lanthern Pharma Inc., USA;  and Faculty of Health and Medical Sciences, University of Copenhagen, Denmark, have published a poster under the title: "A two stage prospective clinical trial with irofulven treatment targeting a selected subgroup of castration- and docetaxel resistant prostate cancer patients., at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics announcing in Boston  announcing the use of the DRP(TM) technology for a  planned prospective trial with Irofulven treatment targeting a selected subgroup of castration and docetaxel resistant prostate cancer patients.

An Irofulven DRP(TM), a gene expression data based Irofulven responsive predictor has been developed. A total of 205 mRNAs were selected for the final response profile which can be converted to a single score of prediction.
Irofulven has been studied in 38 clinical trials (19 published) between 1995 and 2007, for which it has demonstrated promising single agent activity in a range of indications, including HRPC, ovarian, liver and pancreatic cancer, and clinical activity in combination treatments targeting HRPC, colorectal and tyroid cancers. For example, Irofulven demonstrated a 10% response rate in prostate cancer patients pre-treated with docetaxel.
A prospective clinical trial including a screening process is now to be initiated in selected patients with castration - and docetaxel resistant prostate cancer by using the Irofulven DRP(TM). 600 patients are expected to be screened to find the 10% patients with the highest likelihood of benefit from Irofulven treatment. The aim is to improve the Response Rate to a clinical relevant and approvable level. The primary endpoints are objective response rate and changes in serum PSA.

"I look forward to initiate this prospective clinical trial where our DRP® technology will be able to demonstrate its strength and ability to bring effective cancer treatments to the cancer patients." Said Adjunct professor Peter Buhl Jensen, M.D., CEO of MPI.  

Link to abstract

About MPI
Medical Prognosis Institute advances personalized medicine by partnering with cancer drug developers to apply its DRP(TM) diagnostic platform to streamline and de-risk clinical trials and drug development via biomarker optimization, patient stratification, and development of companion diagnostics.

About MPI's multiple biomarker called Drug Response Predictor - DRP(TM)
MPI's lead product, the DRP(TM) diagnostic platform, is a tool to develop tumor-derived gene signatures that may predict which cancer patients are highly likely responders to a given anticancer product. The DRP(TM) has been tested in 32 trials, where 26 trials showed that drug-specific DRP(TM) Biomarkers could predict which patients had a positive effect of the treatment. The DRP(TM) platform has also been externally validated and published in collaboration with leading statisticians at the MD Anderson Cancer Center. The DRP(TM) method can be used to design the Clinical Development Plan, i.e. to select which indications are relevant for a given anticancer drug.  Further to and in addition to this, individual patients' gene patterns can be analyzed as part of a screening procedure for a clinical trial to ensure inclusion of those patients who have a high likelihood of response to the drug. The DRP(TM) platform can be used in all cancer types and has been patented for more than 60 anticancer drugs in the US.

For further information, please contact
Peter Buhl Jensen, CEO
e-mail: pbj@medical-prognosis.com
Cell Phone: +45 21 60 89 22

Certified Advisor: Carsten Yde Hemme, PricewaterhouseCoopers, Strandvejen 44, 2900 Hellerup, Denmark