– LineaRx Functional iCTC Capture Assay Will be
Used by TYME to Monitor iCTC Counts for Trial Participants –
Applied DNA Sciences, Inc. (NASDAQ: APDN; the “Company” or
“Applied DNA”) announced today that LineaRx, Inc., the Company’s
majority-owned subsidiary focused on next-generation
biotherapeutics and diagnostics, has signed a definitive agreement
with Tyme Technologies, Inc. to supply the Company’s Vita-AssayTM
invasive Circulating Tumor Cell (iCTC) capture assay and associated
services for use in the pivotal stage of the TYME-88-PANC clinical
trial for patients with third-line pancreatic cancer (the
“Agreement”).
Under the terms of the Agreement, TYME has the option to
purchase from the Company up to 3,000 Vita-Assay kits and
associated iCTC analytical and storage services over the course of
treatment of up to 250 patients. The potential value of the
Agreement is the largest contract to-date for LineaRx, and the
largest in the development history of the iCTC assay.
The Company and TYME have previously announced a study
demonstrating correlation between the number of iCTCs in a
patient’s blood and their disease status, as observed in TYME’s
SM-88 Phase II trial for recurrent prostate cancer. The study
demonstrated that SM-88 had very encouraging efficacy and safety
outcomes for prostate cancer patients where sparing testosterone
was important. The study also showed that reduction of CTCs, an
important prognostic indicator, may prove to be a better surrogate
for patient outcomes than PSA, particularly for SM-88 and other
non-hormonal agents.
“We continue to commercialize our Vita-Assay functional iCTC
capture assay and iCTC identification technologies, which we
recently acquired in August of this year,” said Dr. James Hayward,
President, Chairman and CEO of Applied DNA. “We are excited to work
with TYME to support their important pivotal stage trial for
pancreatic cancer and, together with TYME, to potentially compile
additional evidence of iCTC-count correlation with cancer disease
status and therapeutic efficacy.”
Dr. Giuseppe Del Priore, Chief Medical Officer of TYME, stated:
“We are impressed by the distinguishing character of the iCTC assay
developed by LineaRx; they have a functional assay which directly
mimics the behavior of metastatic cells in the body, by capturing
iCTCs after they invade a cellular adhesion matrix directly from
fresh blood. These live metastatic cells can be counted and
characterized by the unique biomarkers from LineaRx. iCTCs can be
cultured and analyzed by the latest genomic methods.”
Dr. Hayward concluded: “Our contract with TYME, and other recent
collaborations not yet announced, will, we believe, help advance
our understanding of the metastatic process and the underlying
genomic changes that accompany late-stage cancers. We believe that
an oral cancer treatment like SM-88 may be used as a monotherapy or
in combination therapy across multiple cancers and potentially
provide an opportunity to also intervene with genetic
immunotherapeutic approaches that may one day be delivered via
linear DNA.”
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.
Forward-Looking Statements
The statements made by Applied DNA in this presentation may be
“forward-looking” in nature within the meaning of Section 27A of
the Securities Act of 1933, Section 21E of the Securities Exchange
Act of 1934 and the Private Securities Litigation Reform 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 substantial
doubt relating to Applied DNA’s ability to continue as a going
concern, the possibility of failure to make timely payment on its
outstanding secured convertible notes and resulting enforcement by
noteholders of remedies on collateral which includes substantially
all of Applied DNA’s assets, its history of net losses, limited
financial resources, limited market acceptance, its ability to
penetrate key markets, the uncertainties inherent in research and
development, future clinical data and analysis, including whether
any of Applied DNA’s or its partners 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, 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, 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 or 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/20191126005689/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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