Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage
pharmaceutical company developing innovative, targeted
radiotherapeutics for rare and difficult-to-treat cancers, and
Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular
diagnostic assays, products and services, announce a multi-year
agreement to employ Biocept’s cerebrospinal fluid (CSF) assay
CNSide1 in Plus Therapeutics’ ReSPECT-LM Phase 1/2a dose-escalation
clinical trial of Rhenium-186 NanoLiposome (186RNL) for the
treatment of patients with leptomeningeal metastases (LM), which is
cancer in the membranes that surround the brain and spinal cord.
CNSide is an assay based on Biocept’s
proprietary quantitative tumor cell capture method paired with
advanced digital imaging and molecular markers used to detect,
characterize and quantify tumor cells in CSF of patients with a
variety of solid organ carcinomas and suspected LM, particularly
breast and lung cancer which are leading causes of LM. CNSide
provides a robust quantitative method to evaluate tumor status and
response to treatment compared to conventional CSF cytology or
radiologic monitoring.
“LM and the therapeutic response to 186RNL can
theoretically be assessed through periodic sampling of tumor cells
in the CSF,” said Norman LaFrance, M.D., Chief Medical Officer and
SVP of Plus Therapeutics. “Every LM patient in the ReSPECT-LM trial
will have permanent access to the CSF via an intraventricular
catheter placed in the cerebral ventricles before treatment,
permitting medical staff to draw CSF as easily as blood. The CNSide
technology is the most sophisticated and powerful technology
available for monitoring tumor status and therapeutic response and
can be seamlessly implemented into the ReSPECT-LM trial for the
potential benefit of patients with LM.”
“We see a significant opportunity for Plus
Therapeutics to use our CNSide assay to monitor tumor burden in the
CSF and response to treatment, and to profile specific cellular
biomarkers which may inform their cancer radiotherapeutic drug
development activities,” said Michael Dugan, M.D., Biocept’s Chief
Medical Officer and Medical Director. “CNSide has the potential to
improve our understanding of therapy response in patients with LM
treated with novel therapeutic approaches. This represents an area
of very high unmet need in the care of cancer patients with certain
forms of brain metastasis that are life-threatening.”
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage
pharmaceutical company focused on the development, manufacture, and
commercialization of complex and innovative treatments for patients
battling cancer and other life-threatening diseases. Our
proprietary nanotechnology platform is currently centered around
the enhanced delivery of a variety of drugs using novel liposomal
encapsulation technology. Liposomal encapsulation has been
extensively explored and undergone significant technical and
commercial advances since it was first developed. Our platform
is designed to facilitate new delivery approaches and/or
formulations of safe and effective, injectable drugs, potentially
enhancing the safety, efficacy and convenience for patients and
healthcare providers. More information may be found
at PlusTherapeutics.com and ReSPECT-Trials.com.
About Biocept, Inc.
Biocept, Inc. develops and commercializes
molecular diagnostic assays that provide physicians with clinically
actionable information for treating and monitoring patients
diagnosed with a variety of cancers. Biocept has developed and is
commercializing the CNSide™ cerebrospinal fluid assay that detects
cancer cells that have metastasized to the central nervous system.
Biocept’s patented Target Selector™ technology captures and
quantitatively analyzes CSF tumor cells for tumor-associated
molecular markers, using technology first developed for use in
blood. Biocept also is leveraging its molecular diagnostic
capabilities to offer nationwide COVID-19 RT-PCR testing to support
public health efforts. For more information, visit
www.biocept.com.
1The CNSide assay is not an FDA cleared or
approved assay. It is a Biocept lab developed test and its
performance characteristics were determined in Biocept’s
CLIA-certified, CAP-accredited laboratory.
Plus Therapeutics Cautionary Statement
Regarding Forward-Looking Statements
This press release contains statements that may
be deemed “forward-looking statements” within the meaning of U.S.
securities laws. All statements in this press release other than
statements of historical fact are forward-looking statements. These
forward-looking statements may be identified by future verbs, as
well as terms such as “designed to,” “will,” “can,” “potential,”
“focus,” “preparing,” “next steps,” “possibly,” and similar
expressions or the negatives thereof. Such statements are based
upon certain assumptions and assessments made by management in
light of their experience and their perception of historical
trends, current conditions, expected future developments and other
factors they believe to be appropriate. These statements include,
without limitation, statements regarding the following: the
potential promise of 186RNL including the ability of 186RNL to
safely and effectively deliver radiation directly to the tumor at
high doses; expectations as to the Company’s future performance
including the next steps in developing the Company’s current
assets; the Company’s clinical trials including statements
regarding the timing and characteristics of the ReSPECT-LM trial;
possible negative effects of 186RNL; the continued evaluation of
186RNL including through evaluations via a seventh patient cohort;
and the intended functions of the Company’s platform and expected
benefits from such functions.
The forward-looking statements included in this
press release are subject to a number of risks and uncertainties
that may cause actual results to differ materially from those
discussed in such forward-looking statements. These risks and
uncertainties include, but are not limited to: the Company’s actual
results may differ, including materially, from those anticipated in
these forward-looking statements as a result of various factors,
including, but not limited to, the following: the early stage of
the Company’s product candidates and therapies, the results of the
Company’s research and development activities, including
uncertainties relating to the clinical trials of its product
candidates and therapies; the Company’s liquidity and capital
resources and its ability to raise additional cash, the outcome of
the Company’s partnering/licensing efforts, risks associated with
laws or regulatory requirements applicable to it, market
conditions, product performance, litigation or potential
litigation, and competition within the cancer diagnostics and
therapeutics field, among others; and additional risks described
under the heading “Risk Factors” in the Company’s Securities and
Exchange Commission filings, including in the Company’s annual and
quarterly reports. There may be events in the future that the
Company is unable to predict, or over which it has no control, and
its business, financial condition, results of operations and
prospects may change in the future. The Company assumes no
responsibility to update or revise any forward-looking statements
to reflect events, trends or circumstances after the date they are
made unless the Company has an obligation under U.S. federal
securities laws to do so.
Biocept Cautionary Statement Regarding
Forward-Looking Statements
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
Biocept believes that the expectations reflected in the
forward-looking statements and the assumptions upon which they are
based are reasonable, Biocept 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 "will," "expect," “opportunity,” “objective,” "believe"
or "intend" 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
capabilities, performance, and potential benefits of Biocept’s
CNSide assay, 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 and uncertainties associated with the continually
evolving COVID-19 pandemic; we may be unable to compete
successfully with our competitors; we may be unable to identify
additional collaborators willing to work with us to conduct
clinical utility studies, or the results of those or currently
planned studies may not demonstrate that an assay provides
clinically meaningful information and value or have the other
benefits that we expect; Medicare and private payors may not
provide coverage and reimbursement or may breach, rescind or modify
their contracts or reimbursement policies or delay payments; 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 March 31, 2022, filed with the SEC
on May 23, 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. Biocept does not plan
to update any such forward-looking statements and expressly
disclaims any duty to update the information contained in this
press release except as required by law. Readers are advised to
review Biocept’s filings with the SEC at http://www.sec.gov/.
Plus Therapeutics Contacts
Investors:Peter VozzoICR Westwicke(443)
377-4767Peter.Vozzo@westwicke.com
Media:Terri ClevengerICR Westwicke(203)
856-4326Terri.Clevenger@westwicke.com
Biocept Investors & Media
ContactLHA Investor RelationsJody Cain(310)
691-7100Jcain@lhai.com
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