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Private Australian biotechnology company Minomic International Ltd will launch two overseas trials of its MiStat™ prostate cancer screening test, following an agreement with the prestigious CUSP Group, LLC a Uro-Oncology Trials Management Organisation in the United States.
An initial pilot study to be launched in April will examine 300 patient samples and is designed to verify the accuracy and reliability of the existing MiStat™ test in differentiating normal, benign and malignant prostate cancer samples.
Preliminary data from this trial will be available by August and will inform a larger pivotal study examining 1200 patient samples. This second trial is expected to begin in September and will source subjects from 12 large urology practices across the United States. Data from this trial will be available by early 2015.
Both trials will provide critical, late stage evaluation of Minomic’s proprietary MiStat™ technology, which is capable of identifying the presence of a proprietary biomarker. This biomarker is present on the surface of prostate cancer cells. All data to date suggests the MiStat™ test is almost twice as specific as the Prostate Specific Antigen (PSA) test that is currently the standard test for prostate cancer screening globally. It has been controversial, largely due to the high number of false positive results it generates. Current PSA tests have 40% specificity; MiStat™ has a demonstrated specificity of 73%.
The CUSP Group, LLC is headquartered in Fairfax, Virginia and is comprised of 20 large integrated tertiary community urology group practices. It is regarded as a peak organisation in conducting uro-oncology research with each practice comprising at least 12 urologists. The organisation conducts centralised, multicentre, prostate and bladder cancer biomarker clinical validation studies under strict compliance with Food and Drug Administration (FDA) Guidelines and recommended clinical validation practices.
Principal Investigator for both studies will be Dr. Neal Shore, MD, FACS, who is Medical Director of the Carolina Urologic Research Centre. He has conducted more than 200 clinical trials, focusing mainly on prostate and bladder cancer and has numerous publications in peer-reviewed journals. He has lectured extensively on the treatment of prostate cancer.
Data from both CUSP studies will underpin a detailed regulatory submission to the FDA, as well as a commercial data pack for offering to potential partners/licensees.
Minomic Chief Executive Officer Dr. Brad Walsh said the CUSP Group was globally regarded in the urology arena for conducting high-quality clinical trials and delivering positive outcomes.
He commented: “We look forward to further validating this important technology in these clinical trials and are confident of replicating the extremely positive data recorded in Australia. The CUSP organisation is a peak authority globally on prostate cancer and we are confident their expertise under Dr Shore’s guidance will assist our continued development and global commercialisation of this important technology.”
Source: PR Newswire