LineaRx Platform Used in Phase II trial in
recurrent prostate cancer demonstrates the number of circulating
tumor cells correlates more directly with disease status
LineaRx, Inc., the majority-owned subsidiary of
Applied DNA Sciences, Inc. (NASDAQ: APDN) focused on
next-generation biotherapeutics, announced today that its invasive
Circulating Tumor Cells (iCTCs) platform demonstrated superior
correlation over Prostate Specific Antigen (PSA) in an ongoing
Phase II trial in recurrent prostate cancer. Most notably, the
concentration of rare iCTCs identified per milliliter of whole
blood correlated more directly with disease status than did the
levels of PSA. These iCTCs were captured and identified utilizing
LineaRx’s technology platform recently acquired from Vitatex
Inc.
LineaRx’s collaborator Tyme Technologies, Inc. (NASDAQ: TYME),
reported yesterday results of this recently completed Phase II
trial using SM-88 to treat recurrent prostate cancer at the
Congress of the European Society of Medical Oncology (ESMO), one of
the preeminent meetings for highlighting new cancer therapies and
diagnostics. The study updated the safety and antitumor effects of
SM-88 in men with non-castrate non-metastatic prostate cancer.
Antitumor effects were assessed by post-therapy changes in PSA and
the number of iCTCs. Results showed that patients treated with this
oral non-hormonal therapy maintained metastases-free survival
without testosterone deprivation or typical hormonal therapy side
effects.
Dr. Wen-Tien Chen, Principal Investigator of CTC Programs at
LineaRx stated: “This use of iCTC quantification for providing
earlier and more accurate identification of prostate cancer shows
the importance of running trials using the iCTC functional capture
and identification system from LineaRx. Published studies have
shown that the concentration of iCTCs in blood correlates with
disease status across other hard tumors, including metastatic
sarcoma, pancreatic, ovarian, breast, lung and colorectal cancers.
We believe our proprietary platform can help diagnose these
difficult cancers earlier and with superior predictive
capability.”
The current reported SM-88 Phase II study examines iCTCs in
prostate cancer for what we believe is the first time in a clinical
trial. While PSA has historically been the recognized biomarker for
prostate cancer, many studies over the last 20 years have shown it
is an inadequate biomarker, since it may become elevated in
patients with no apparent disease, or less serious pathology than
cancer. Intensive efforts have been directed towards alternative
prostate cancer biomarkers, particularly those that can predict
disease aggressiveness and help to drive better treatment
decisions. However, biomarker research has centered on disease
diagnostics, rather than prognosis and prediction, which could work
toward disease prevention—an important focus moving forward.
The authors concluded: "Reductions in iCTC number may be a more
informative indicator of benefit than changes in PSA.” Dr. Chen
added, “New prostate cancer biomarkers should be targeted to
addressing unmet clinical needs in prostate cancer management,
including indicators for disease with low PSA values (<10ng/mL),
prognostic markers to distinguish indolent from aggressive disease,
and biomarkers for metastatic cancer.”
LineaRx’s iCTC technology is unique in that it isolates iCTCs on
a functional basis (the invasion of a model tissue for the
extracellular matrix, or the tissue between cells in an organ) and
allows the cells to be cultured for deeper genomic analysis. iCTCs
are a model for metastasis, since the tumor cells have left the
primary tumor and entered the circulation. The LineaRx platform may
serve as a standalone device or as a front-end to increase the
sensitivity of approved diagnostics.
”iCTCs have the potential for metastasis, and may be very useful
in the diagnosis of cancer, even before tumors may be imaged,” said
Dr. James Hayward, CEO of LineaRx. “The present study is exciting
because we believe it shows that iCTCs may be used to accurately
follow therapy success in this very prevalent cancer while also
providing new tools for cell and gene therapy design and
production.”
About Tyme Technologies, Inc
Tyme Technologies, Inc., is an emerging biotechnology company
developing cancer therapeutics that are intended to be broadly
effective across tumor types and have low toxicity profiles. Unlike
targeted therapies that attempt to regulate specific mutations
within cancer, Tyme Technologies, Inc.’s therapeutic approach is
designed to take advantage of a cancer cell’s innate metabolic
weaknesses to compromise its defenses, leading to cell death
through oxidative stress and exposure to the body’s natural immune
system. For more information, visit www.tymeinc.com. Follow Tyme
Technologies, Inc. on social media: @tyme_Inc, LinkedIn, Instagram,
Facebook and YouTube.
About LineaRx
LineaRx seeks to commercialize the biotherapeutic value of
Applied DNA’s deep expertise and experience in the design,
manufacture and chemical modification of DNA by large scale
polymerase chain reaction (“PCR”). Linear DNA is a form of DNA
distinct from the circular form of DNA most commonly produced in
plasmids and grown in bacteria. Plasmids are extrachromosomal DNA
found in bacteria and are associated with the genes for antibiotic
resistance which are often exchanged between bacteria and
consequentially, are seen by many to embody a serious threat to
global health. In addition, many nucleic acid-based therapies also
rely on viral vectors for efficient transfection and expression of
plasmid DNA. These viral vectors carry additional nontrivial risks
and are extremely time consuming and expensive to manufacture. Go
to www.adnas.com for more information on LineaRx and to learn more
about how Applied DNA makes life real and safe. LineaRx is a
majority-owned Applied DNA Sciences, Inc. (Nasdaq: APDN)
company.
About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable
supply chain security, anti-counterfeiting and anti-theft
technology, product genotyping and pre-clinical nucleic acid-based
therapeutic drug candidates.
Applied DNA makes life real and safe by providing innovative,
molecular-based technology solutions and services that can help
protect products, brands, entire supply chains, and intellectual
property of companies, governments and consumers from theft,
counterfeiting, fraud and diversion.
Visit adnas.com for more information. Follow us on Twitter and
LinkedIn. Join our mailing list.
Common stock listed on NASDAQ under the symbol APDN, and
warrants are listed under the symbol APDNW.
Forward-Looking Statements
The statements made by Applied DNA in this press release may be
“forward-looking” in nature within the meaning of the Private
Securities Litigation Act of 1995. Forward-looking statements
describe Applied DNA’s future plans, projections, strategies and
expectations, and are based on assumptions and involve a number of
risks and uncertainties, many of which are beyond the control of
Applied DNA. Actual results could differ materially from those
projected due to the risk that the acquisition will not be
successfully integrated with LineaRx or that the potential benefits
of the acquisition will not be realized, the Company’s history of
net losses, limited financial resources, limited market acceptance
, the uncertainties inherent in research and development, future
clinical data and analysis, including whether any of Applied DNA’s
product candidates will advance further in the preclinical research
or clinical trial process, including receiving clearance from the
U.S. Food and Drug Administration or equivalent foreign regulatory
agencies to conduct clinical trials and whether and when, if at
all, they will receive final approval from the U.S. FDA or
equivalent foreign regulatory agencies, uncertainties relating to
its ability to maintain its NASDAQ listing in light of delisting
notices received and various other factors detailed from time to
time in Applied DNA’s SEC reports and filings, including our Annual
Report on Form 10-K filed on December 18, 2018, as amended, and our
subsequent quarterly reports on Form 10-Q filed on February 7,
2019,May 9, 2019 and August 13, 2019, and other reports we file
with the SEC, which are available at www.sec.gov. Applied DNA
undertakes no obligation to update publicly any forward-looking
statements to reflect new information, events or circumstances
after the date hereof to reflect the occurrence of unanticipated
events, unless otherwise required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20191001005369/en/
investor contact: Sanjay M. Hurry, LHA Investor Relations,
212-838-3777, shurry@lhai.com Program contact: Brian
Viscount, 631-240-8877, brian.viscount@adnas.com web:
www.adnas.com, www.linearxdna.com twitter: @APDN, @LineaRxDNA
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