TORONTO, Feb. 20, 2018 (GLOBE
NEWSWIRE) -- 3D Signatures Inc. (TSX-V:DXD) (OTCQB:TDSGF)
(FSE:3D0) (the "Company" or
"3DS") is pleased to announce that a
preliminary third-party analysis of the trial data for
Telo-HLTM, 3DS' test
in development for Hodgkin's lymphoma (HL), shows that the
Company's TeloViewTM platform is
able to distinguish, with a high degree of statistical
significance, multiple differences between a patient group that
responds to standard ABVD chemotherapy, and a group that relapses
or is refractory to treatment within the first 12 months.
Telo-HLTM is intended
to provide clinicians with the first biomarker to identify the 15%
- 20% of new HL patients who will likely fail standard
chemotherapy, and who should immediately be considered for more
advanced treatment or inclusion into clinical trials to access
emerging treatments such as immunotherapies.
3DS has established a
clinically-compliant methodology for application of its
TeloViewTM process to
diagnostic Hodgkin lymphoma biopsy samples, employing more
sensitive imaging technology than its previous HL trials. Specimens
from over 400 HL patients (who were subsequently treated with ABVD)
were processed for this trial, from four contributing hospital
sites across Canada and Europe. The 3DS three-step process was
applied, comprising a wet lab co-immuno-telomeres FISH assay,
3-dimensional imaging (with identification of 30 Hodgkin and 30
Reed-Sternberg cells), followed by TeloView(TM) software
analysis.
The multi-parametric telomeric
analysis with TeloViewTM was
performed by 3DS (blinded to patient status), and the results were
then shared with statistical partner BioStat Solutions Inc.
("BSSI"), who compared the TeloViewTM data with
the corresponding clinical outcomes for patients, and identified
highly significant group differences across multiple
TeloViewTM
parameters.
"BSSI is excited to be
collaborating with 3DS, helping them ensure the quality of the data
being used is to the highest standards, and that they are poised to
deliver the best possible analysis of this predictive technology
for HL treatment," said Ronald L. Bromley, CEO of BioStat
Solutions, Inc.
"We believe that these results
from the application of our TeloViewTM platform to
Hodgkin's lymphoma are so strong, the Company will now even more
confidently proceed with developing the final scoring model for its
Telo-HLTM test to
predict response at the individual patient level," said Jason
Flowerday, CEO of 3D Signatures. "This is great news for the
Telo-HLTM program, and
we remain on track to complete all phases of the test development
and analytical validation by April 2018."
The Company intends to submit the
completed test development and validation work to a highly
reputable clinical journal for publication in the latter half of
2018.
"This trial builds on the
foundational work done in Dr. Sabine Mai's academic laboratory to
establish 3D telomere profiling as a novel biomarker platform. We
see this as a new genomic stability testing paradigm applicable
broadly across clinical trial research and laboratory medicine",
says Dr. Kevin Little, CSO of 3D Signatures.
About
Telo-HL(TM)
Powered by 3DS' proprietary
TeloView(TM) software platform, Telo-HL(TM) is intended to provide
clinicians with the first set of biomarkers that will distinguish
between patients that will respond to standard ABVD chemotherapy,
and the 15% - 20% of patients who will fail standard chemotherapy
and be refractory or relapse within the first year. The Company
expects Telo-HL(TM) to benefit patients seeking personalized
treatment and to provide significant cost savings to payors and
insurers that are currently burdened with expensive treatments and
procedures that may not be necessary if patients could be
considered for more targeted and effective therapies at the outset
of treatment.
About
BSSI
BioStat Solutions, Inc. (BSSI) is
a privately held professional service corporation providing
statistical and bioinformatics expertise to pharmaceutical and
biotech companies as well as to the government and its contractors.
BSSI's diverse team of statisticians, bioinformaticists,
epidemiologists and geneticists provides answers to complex and
challenging analytical questions. Whether the client is facing big
data or machine learning problems, or is looking for new biomarker
or diagnostic device strategies, BSSI provides solid results
towards effective decision-making. For more information, visit
BSSI's website at: http://www.biostatsolutions.com.
About
3DS
3DS (TSX-V:DXD; OTCQB:TDSGF;
FSE:3D0) is a personalized medicine company with a proprietary
software platform, TeloViewTM, that is
designed to predict the course of certain diseases and to tailor
treatment options for the individual patient. The technology is
based on the three-dimensional analysis of telomeres, the
protective caps at the ends of chromosomes. 3DS'
TeloViewTM software
platform measures the organization of the genome and its
correspondence to; the stage of a given disease, the rate of
progression of the disease, how different diseases will respond to
various therapies, and a drug's efficacy and toxicity. 3DS'
proprietary imaging software is designed to go beyond identifying
whether a patient suffers from a specific disease or condition.
Instead, the TeloViewTM platform is
designed to inform clinicians and patients with respect to how to
personalize treatment and best manage an individual's disease based
on their unique TeloView ScoreTM. As
healthcare moves increasingly toward better informed,
patient-centric approaches, the Company intends for the
TeloViewTM platform to
deliver personalized medicine that allows for better treatments,
leading to better outcomes.
The TeloViewTM
platform is supported by 25 clinical studies involving more than
3,000 patients and 20 different cancers, plus Alzheimer's disease.
3DS benefits from twenty years of research, $25M of non-dilutive
investment into its platform and more than 130 supporting
publications, and holds a portfolio of patents related to
three-dimensional telomere analysis for proliferative diseases,
including (but not limited to) hematological disorders such as
Hodgkin's lymphoma, multiple myeloma, and chronic myeloid leukemia.
3DS' intellectual property portfolio also covers prostate cancer,
breast cancer, lung cancer, melanoma, colorectal cancer, and
Alzheimer disease.
For more information, visit the
Company's website at: http://www.3dsignatures.com.
For further
information, please contact:
Jason Flowerday
CEO & Director
416-673-8487
investors@3dsignatures.com
Cautionary
Note Regarding Forward-Looking Statements
This news release contains forward
looking statements which constitute "forward looking information"
within the meaning of applicable Canadian securities legislation
("Forward-Looking
Statements"). All statements included herein, other
than statements of historical fact, are Forward Looking Statements
and are subject to a variety of known and unknown risks and
uncertainties which could cause actual events or results to differ
materially from those reflected in the Forward Looking Statements.
Often, but not always, these Forward-Looking Statements can be
identified by the use of words such as "estimates", "potential",
"open", "future", "assumes", "projects", "anticipates", "believes",
"may", "continues", "expects", "plans", "will", "to be", or
statements that events "could" or "should" occur or be achieved,
and similar expressions, including negative variations.
Such Forward Looking Statements
reflect the Company's current views with respect to future events,
are subject to risks and uncertainties and are necessarily based
upon a number of estimates and assumptions that, while considered
reasonable by 3DS as of the date of such statements, are inherently
subject to significant medical, scientific, business, economic,
competitive, political and social uncertainties and contingencies.
Many risk factors could cause the Company's actual results,
performance, achievements, prospects or opportunities to be
materially different from any future results, performance or
achievements that may be expressed or implied by such Forward
Looking Statements, including risks related to 3DS' management's
discretion over the actual application of the net proceeds and
ability to allocate proceeds differently from what is described
herein; the risk that the Telo-HLTM test may not
be commercially launched as an LDT by the first quarter of 2018, or
at all; uncertainties related to 3DS' clinical trials and test
development; risks related to the volatility of the price of 3DS'
common shares; risks related to the possibility that 3DS'
shareholders may experience dilution; risks related to 3DS'
requirements for additional financing and future access to capital,
including the risk that the proceeds raised under the Private
Placement may be insufficient to finance 3DS' business objectives;
the risk that a positive return on an investment in 3DS' common
shares is not guaranteed; risks related to 3DS' intention to retain
earnings and not pay cash dividends on its common shares in the
foreseeable future; risks related to 3DS' early stage of
development; the risk that 3DS' tests will not be successfully
deployed; risks related to 3DS' dependence on third parties,
including collaborative partners, licensors and others; risks
related to 3DS' clinical trial recruitment; that there is currently
no market for 3DS' products and that such market may be slow to
develop if at all; risks related to 3DS' reliance on key personnel;
risks related to the competitive nature of the biotechnology
industry; risks related to 3DS' limited operating history, lack of
revenue, history of losses and inability to assure that it will
earn profits in the future or that profitability will be sustained;
risks related to government regulation; risks related to rapid
technological change; risks related to the fact that 3DS' software
may now or in the future contain undetected errors, bugs or
vulnerabilities; the risk that 3DS or its directors and officers
may be subject to a variety of civil or other legal proceedings,
with or without merit, including product liability claims; risks
related to the protection of 3DS' intellectual property rights;
risks related to 3DS' limited sales, marketing and distribution
experience; risks related to the possibility that 3DS' directors
and officers may be placed in a conflict of interest as a result of
their employment or affiliation with third parties, risks related
to 3DS' use and storage of personal information and compliance with
applicable privacy laws, as well as those risks discussed under the
heading "Risk Factors" in the Company's management's discussion and
analysis dated November 29, 2017 and filed on SEDAR. Although the
Company has attempted to identify important factors that could
cause actual actions, events or results to differ materially from
those described in the Forward-Looking Statements, there may be
other factors that cause actions, events or results to differ from
those anticipated, estimated or intended.
In making the Forward-Looking
Statements, the Company has made various material assumptions
including, but not limited to, obtaining positive results from 3DS'
current and planned clinical trials and research and development
initiatives; that the Telo-HLTM test will be
commercially launched as an LDT by the first quarter of 2018;
obtaining regulatory approvals with respect to 3DS' clinical trials
which are now ongoing or may in the future be commenced; 3DS'
ability to successfully develop its tests; assumptions regarding
general business and economic conditions; that 3DS' current
positive relationship with third parties will be maintained; the
availability of future financing on reasonable terms; 3DS' ability
to attract and retain skilled staff; assumptions regarding market
competition and the products and technology offered by 3DS'
competitors; and 3DS' ability to protect patents and proprietary
rights.
3DS believes that the assumptions
and expectations reflected in the Forward-Looking Statements in
this press release are reasonable, but no assurance can be given
that these expectations will prove to be correct. Forward Looking
Statements should not be unduly relied upon. This information
speaks only as of the date of this press release, and 3DS will not
necessarily update this information, unless required to do so by
securities laws.
Neither the TSX
Venture Exchange nor its Regulation Service Provider (as that term
is defined in the policies of the TSX Venture Exchange) accepts
responsibility for the adequacy or accuracy of this
release.