Precision Biopsy Expands the Clinical Trial of Its ClariCore™ Biopsy System in Prostate Cancer Patients
September 12 2016 - 2:00AM
Business Wire
- Precision Biopsy will enroll
patients for the Transrectal Ultrasound (TRUS) and MR/Fusion arms
of the Cohort A at U.S. clinical trial sites.
- Precision Biopsy has enrolled 33
patients in a Retropubic Radical Prostatectomy (RRP) study at Johns
Hopkins Hospital, Memorial Sloan Kettering Cancer Center, and the
University of Colorado.
- The company is adding three
additional sites, including Carolina Urologic Research Center in
Myrtle Beach, South Carolina; Associated Medical Professionals in
Syracuse, New York; and The Urology Center of Colorado
in Denver.
Precision Biopsy announced that its application for an
Investigational Device Exemption (IDE) was approved by the U.S.
Food and Drug Administration (FDA), allowing the company to expand
its clinical trial for the ClariCore™ Biopsy System by enrolling
prostate cancer patients in the Transrectal Ultrasound (TRUS) and
MR/Fusion arms of its study. ClariCore is designed to provide
accurate, real-time classification of prostate tissue during biopsy
procedures.
Precision Biopsy’s Cohort A clinical trial aims to collect
prostate tissue and associated optical signatures to help develop
the ClariCore System’s real-time tissue classification algorithm.
About 200 patients will be included in the three arms of the trial,
which is taking place across the U.S. at sites including the
University of Colorado, Johns Hopkins Hospital in Baltimore and
Memorial Sloan Kettering Cancer Center in New York. Additional
patients for the Cohort A are expected to be enrolled at three new
sites, including Carolina Urologic Research Center in Myrtle Beach,
South Carolina; Associated Medical Professionals in Syracuse, New
York; and The Urology Center of Colorado in Denver.
Precision Biopsy has already enrolled 33 patients in its
Retropubic Radical Prostatectomy (RRP) study at Johns Hopkins
Hospital, Memorial Sloan Kettering Cancer Center and the University
of Colorado, more than half the number of patients required to
complete this arm of the trial.
“The approval from the FDA marks an important step forward in
our efforts to finalize development of the ClariCore Optical Biopsy
System and help to improve the biopsy process for patients being
evaluated and monitored for prostate cancer, the second-most deadly
cancer in men,” said Amir Tehrani, Chief Executive Officer of
Precision Biopsy.
“We are looking forward to enrolling prostate biopsy patients in
the Cohort A clinical trial using the ClariCore Optical Biopsy
system. ClariCore is a breakthrough technology that should both
benefit patient outcomes and also reduce healthcare costs,” said
Dr. Neal D. Shore, Director of Carolina Urologic Research
Center.
Equipped with an optical fiber and companion console, Precision
Biopsy’s ClariCore system performs spectral analysis of prostate
tissue during a prostate biopsy, providing in-vivo tissue
classification that seeks to minimize the number of normal core
samples taken by up to 90 percent, while offering actionable
diagnostic information at the time of the biopsy.
“The ability to expand the trial is an important milestone in
the development of the ClariCore system and we are excited by the
progress achieved by the Precision Biopsy team,” said Omar Amirana,
MD, Precision Biopsy Board member and Senior Vice President at its
parent company, Boston-based Allied Minds.
More than 2 million men worldwide undergo TRUS-guided prostate
biopsies each year due to risk factors that include elevated PSA
levels, physical exam abnormalities and family history. Of the 12
million biopsy core samples that are analyzed, less than 10 percent
are shown to be positive for cancer — at a cost of nearly $1
billion dollars in the U.S. alone.
These TRUS-guided prostate biopsies also miss as much as 30
percent of cancers that require therapy. Reducing that error rate
could have measurable impact: In the U.S., about 28,000 men die
each year from prostate cancer, according to the American
Cancer Society.
More information about Precision Biopsy can be found at
www.precisionbiopsy.com. The company is a subsidiary of
Boston-based Allied Minds (LSE: ALM).
About Precision
BiopsyPrecision Biopsy, Inc., a subsidiary of Allied
Minds (LSE: ALM), aims to develop and commercialize a novel
technology for the accurate real-time classification of tissue
initially focused on prostate biopsies — a procedure that is
performed in an estimated 1.75 million patients each year in the
U.S. and Europe. It is also developing a Focal Therapy system,
which incorporates the ClariCore technology. The company’s
diagnostic technology, licensed from the University of Colorado,
uses advanced spectroscopy imaging techniques in combination with
tissue biopsy. After developing a first-generation system in 2011,
Precision Biopsy evaluated human subjects in 2012. The success of
that first human study led Precision Biopsy to focus on developing
its next-generation product, the ClariCore Optical Biopsy System™,
as it prepares for global commercialization. More information about
Precision Biopsy can be found at: www.precisionbiopsy.com.
About Allied MindsAllied Minds is a diversified holding
company focused on venture creation within the life science and
technology sectors. With unparalleled access to hundreds of
university and federal labs across the U.S., Allied Minds forms,
funds, and operates a portfolio of companies to generate long-term
value for its investors and stakeholders. Based in Boston, with
nationwide presence in Los Angeles and New York, Allied Minds
supports its businesses with capital, central management, and
shared services. For more information, please
visit www.alliedminds.com.
Allied Minds Forward-Looking StatementThis press release
contains statements that are or may be forward-looking statements,
including statements that relate to the company’s future prospects,
developments and strategies. The forward-looking statements are
based on current expectations and are subject to known and unknown
risks and uncertainties that could cause actual results,
performance and achievements to differ materially from current
expectations, including, but not limited to, those risks and
uncertainties described in the risk factors included in the
company’s regulatory filings. These forward-looking statements are
based on assumptions regarding the present and future business
strategies of the company and the environment in which it will
operate in the future. Each forward-looking statement speaks only
as at the date of this press release. Except as required by law,
regulatory requirement, the Listing Rules and the Disclosure and
Transparency Rules, neither the company nor any other party intends
to update or revise these forward-looking statements, whether as a
result of new information, future events or otherwise.
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ArcPoint Strategic CommunicationsChristine Dunn, 617-484-1660
x101cdunn@arcpointstrategy.com
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