Key evaluation to inform the US Food and Drug Administration regulatory submission
Prominent urology trials consortium The CUSP Group LLC to oversee study of the MiStat？ technology
Initial pilot investigation will be followed by larger pivotal study
New prostate cancer screening technology targeting global commercialisation in 2015
SYDNEY, September 18, 2014 /PRNewswire/ — Australian biomarker discovery company Minomic International Ltd will today launch an important US trial of its MiStat™ prostate cancer screening test, planning to achieve US Food and Drug Administration (FDA) regulatory approval upon completion.
Minomic’s proprietary MiStat™ technology is a screening assay capable of identifying the presence of a proprietary biomarker known as the MIL-38 antigen. This biomarker is present on the surface of prostate cancer cells.
Researchers at 11 leading urology centres in the United States will collect specimens from 300 male patients over age 50, in a non-randomised pilot study designed to further verify the accuracy and reliability of the existing MiStat™ ELISA in differentiating normal, benign and malignant prostate cancer samples.
This study will also evaluate the MiStat™ ELISA in comparison to the PSA test, evaluating MiStat’s ability to differentiate benign from malignant pathologic findings.
Dr Neal Shore MD FACS, Medical Director, CPI, Carolina Urologic Research Centre, is the study’s Principal Investigator and has conducted more than 200 clinical trials. Dr Shore has numerous peer-reviewed publications on prostate cancer biomarkers.
Information from this trial will inform a larger pivotal study examining 1200 patients. This second trial is anticipated to initiate in early 2015 and will comprise subjects from large urology practices throughout the United States.
A pre-submission meeting request to the FDA will be submitted following completion of the 300 patient trial; Minomic plans for the MiStat™ ELISA to be commercially available in 2015.
Minomic Chief Executive Officer, Dr Brad Walsh, foresees that the data from this pilot trial will further position Minomic toward completing its pivotal trial and the eventual commercial availability of the MiStat™ technology.
“We are ensuring a comprehensive data set in order to provide both regulatory authorities as well as potential licensing partners with all of the information required for efficacy evaluation of the MiStat™ technology,” said Dr Walsh.
“We would expect data from this US pilot study to further validate the extremely positive evidence we have collected to date, which suggests our technology is almost twice as specific as the PSA screening technology.”
Minomic International Ltd is an Australian privately owned biomarker discovery company specialising in in-vitro-diagnostics (IVD), diagnostic imaging and therapeutics for prostate cancer. Minomic has developed the in vitro diagnostic test called MiStat™ for the early detection of prostate cancer. The key reagents, including the MIL-38 antibody and antigen and related applications are protected by international patents.
Following a successful proof-of-concept clinical study on 125 Australian patients demonstrating good sensitivity and specificity for discriminating prostate cancer patients from those with benign prostatic hyperplasia or no disease the test has now commenced a multi-centre clinical validation.
Minomic is interested in partnerships or collaborations with larger pharmaceutical/diagnostic global partner able to produce, register and distribute the MiStat™ ELISA test and collaborate through clinical validation, registration and commercialization of future diagnostic imaging and therapeutic applications of the MIL-38 antibody for prostate cancer.
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