Enrollment Begins in FORESEE Clinical Trial Using Biocept’s CNSide™ to Evaluate Patients with Leptomeningeal Metastases
24 Marzo 2023 - 6:00AM
Business Wire
Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular
diagnostic assays, products and services, announces enrollment of
the first patient in the FORESEE clinical trial with the Company’s
proprietary cerebrospinal fluid assay CNSide (NCT05414123). This
first patient was seen at the UT Southwestern Medical Center, one
of the largest and most respected hospitals in the nation.
The FORESEE trial is a multicenter, prospective clinical trial
expected to enroll 40 patients with breast or non-small cell lung
cancer (NSCLC) who have suspicious or confirmed leptomeningeal
metastases (LM). The goal of the FORESEE trial is to evaluate the
performance of CNSide in monitoring the LM's response to treatment
and to assess the impact of CNSide on treatment decisions made by
physicians.
Standard-of-care methods to diagnose or assess the treatment
response of LM (i.e., clinical evaluation, MRI and cytology) have
limited sensitivity and specificity. This creates challenges for
physicians to manage LM or determine the best course of treatment.
CNSide is a Laboratory Developed Test (LDT) that is used
commercially at the physician's discretion, with samples processed
in Biocept's CLIA-certified, CAP-accredited laboratory.
“The enrollment of the first patient in the FORESEE clinical
study is a major milestone for the management of patients with
leptomeningeal disease,” said Michael Youssef, MD, Assistant
Professor in the Department of Neurology and the Department of
Hematology and Oncology at UT Southwestern Medical Center. “We are
excited to be at the forefront of this innovation, which will
greatly benefit patients.”
Priya Kumthekar, MD, Associate Professor of Neurology and
Medicine (hematology and oncology) at the Feinberg School of
Medicine at Northwestern University and Principal Investigator of
the FORESEE trial, said, “I am impressed by the ease of use and the
versatility of the CNSide technology, and how it can facilitate
disease diagnosis and management for our leptomeningeal patients
who are truly in need of improved diagnostics and
therapeutics.”
“The FORESEE trial evaluates the medical and clinical utility,
when compared to standard of care, of the CNSide laboratory test, a
revolutionary technology designed to detect cells in the cerebral
spinal fluid of central nervous system brain metastasis patients,”
said Sam Riccitelli, Chairman and interim President and CEO of
Biocept. “The test can be used to detect the presence of tumor, as
well as guide and monitor therapy, an area of critical need for
these terminally ill patients.”
Dr. Kumthekar is a consultant to Biocept and Dr. Youssef has no
financial interest in Biocept.
About CNSide
Using our proprietary CNSide™ assay to analyze and interrogate
CSF-TCs and cfDNA for certain biomarkers, physicians can be better
informed about the actionable molecular information associated with
a patient’s metastatic cancer and develop a personalized cancer
treatment plan. Through CNSide™, Biocept’s test menu focuses on
cancer biomarkers that are clinically actionable based on clinical
treatment guidelines listed by the National Comprehensive Cancer
Network® (NCCN®). For more information, please visit
https://biocept.com/technology/.
About Biocept
Biocept is a molecular diagnostics company with commercialized
assays for patients with carcinomas or melanomas. Our experts have
spent years working to change the way physicians look at
cerebrospinal fluid (CSF) in cancer patients. Biocept has developed
a unique, patented methodology to isolate cancer material that is
shed from the primary tumor, such as CSF tumor cells (CSF-TCs) and
cell-free DNA (cfDNA). As such, Biocept is a leading commercial
provider of testing services designed to enable clinicians to
rapidly detect and monitor cancer biomarkers from a cerebrospinal
fluid sample. For more information visit
https://www.biocept.com.
Forward-Looking Statements Disclaimer
This press release contains forward-looking statements that are
based upon current expectations or beliefs, as well as a number of
assumptions about future events. Although we believe that the
expectations reflected in the forward-looking statements and the
assumptions upon which they are based are reasonable, we can give
no assurance that such expectations and assumptions will prove to
be correct. Forward-looking statements are generally identifiable
by the use of words like "may," "will," "should," "could,"
"expect," "anticipate," "estimate," "believe," "intend," “goal,” or
"project," or the negative of these words or other variations on
these words or comparable terminology. To the extent that
statements in this press release are not strictly historical,
including, without limitation, statements regarding the potential
strategic alternatives the company is exploring and any potential
enhancement of shareholder value or other benefit to the company’s
shareholders; the company’s projected year-end cash position; the
potential preservation or extension of the company’s cash runway;
the potential of CNSide; opportunities for CNSide; and other
statements that are not historical fact, such statements are
forward-looking, and are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
The reader is cautioned not to put undue reliance on these
forward-looking statements, as these statements are subject to
numerous risks and uncertainties, including risks related to
preliminary financial results as described above, risks related to
the company’s business, market risks, our need for additional
capital, and the risk that our products and services may not
perform as expected. These and other factors are described in
greater detail under the "Risk Factors" heading of Biocept’s
Quarterly Report on Form 10-Q for the quarter ended September 30,
2022, filed with the Securities and Exchange Commission (SEC) on
November 21, 2022. The effects of such risks and uncertainties
could cause actual results to differ materially from the
forward-looking statements contained in this press release. We do
not plan to update any such forward-looking statements and
expressly disclaim any duty to update the information contained in
this press release except as required by law. Readers are advised
to review our filings with the SEC at http://www.sec.gov/.
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