Tiziana Life Sciences Announces Data Demonstrating StemPrintER’s Superiority Compared to Oncotype DX in Providing Prognosti...
14 May 2020 - 4:00PM
Tiziana Life Sciences plc (Nasdaq: TLSA) (“Tiziana” or the
“Company”), a biotechnology company focused on innovative
therapeutics for oncology, inflammation and infectious diseases,
announces today that a new study will be presented by scientists
from the European Institute of Oncology in Milan in collaboration
with the Royal Marsden Hospital and Queen Mary University in London
on the Company’s stem cell biology-based genomic tool, StemPrintER,
for the prediction of disease recurrence in breast cancer patients
during a poster discussion session at the American Society of
Clinical Oncology (ASCO) Virtual Conference. The study demonstrates
greater refinement and superiority of StemPrintER over current
market leader Oncotype DX in delivering prognostic information as
part of the therapeutic decision-making process in ER+/HER2- breast
cancer patients. An additional abstract from the scientists at the
European Institute of Oncology will be presented in a separate
poster session, which details a further refined risk model, the
SPARE model, based on the combination of StemPrintER with clinical
parameters for distant metastasis prediction. Both abstracts,
became available May 13, 2020, while the posters and discussion
session will be held during The American Society of Clinical
Oncology (ASCO) Virtual Conference May 29-31, 2020.
Each of these studies independently provides
significant additional information on the value of StemPrintER --
and its derivative SPARE (detailed below) -- as clinical tools to
aid personalized therapeutic decision-making in women with
ER+/HER2- breast cancer. Of particular note is the comparative
precision of StemPrintER over Oncotype DX in predicting the
potential recurrence of certain types of breast cancer following
treatment. The two studies highlight the importance of the stem
cell approach to develop a potentially powerful prognostic tool to
predict breast cancer prognosis.
Abstract #1020, “Comparison of StemPrintER, a
novel biology-based genomic predictor of distant recurrence in
breast cancer, with Oncotype DX in the TransATAC cohort,” is an
independent validation of the prognostic value of StemPrintER in a
cohort of more than 800 luminal ER+/HER2- postmenopausal breast
cancer patients from the international TransATAC study and a
head-to-head comparison of the prognostic power of StemPrintER with
Oncotype DX. Results provide independent validation of StemPrintER
as a potentially powerful prognostic tool to stratify patients for
the risk of early or late recurrence independently of other
clinicopathological parameters. Importantly, the study also shows
that StemPrintER is superior to Oncotype DX in the prediction of
10-year recurrence risk in all patients, as well as in N0 and N1-3
patients. The study further demonstrates that StemPrintER is
capable of outperforming Oncotype DX in providing additional
prognostic information to the standard clinicopathological
parameters.
Abstract #1057, “Integration of the stem cell
biology-based genomic tool, StemPrintER, with clinicopathological
parameters for the prediction of distant recurrence in ER+/HER2-
breast cancer (BC) patients,” develops a more refined risk model
for distant metastasis prediction, which combines StemPrintER with
tumor size (pT) and nodal status (pN). The new model is termed
SPARE (StemPrintER for Personalized Adjuvant Therapy in Endocrine
Receptor-Expressing Patients) and, in the analysis of a
consecutive-retrospective cohort of more than 1,800 ER+/HER2-
breast cancer patients with 15-year complete follow-up from the
European Institute of Oncology (IEO) in Milan, revealed to be an
even more powerful tool, compared to the original StemPrintER for
predicting early and late distant metastasis risk independently of
standard clinical parameters.
“These data sets demonstrate that StemPrintER
has the potential to become an essential prognostic tool that will
help clinicians to tailor more or less aggressive therapy based on
a more accurate risk assessment of disease recurrence compared to
what we have seen to date,” added Dr. Kunwar Shailubhai, CEO &
CSO of Tiziana Life Sciences. “This product also represents an
important addition to our existing therapeutic pipeline as it opens
Tiziana into the area of precision medicine, creating an entirely
new business line beyond our current patented technology in
offering new delivery mechanisms for monoclonal antibodies.”
About StemPrintERStemPrintER is
a multi-gene prognostic assay intended for the prediction of the
risk of recurrence in luminal, estrogen receptor-positive
HER2-negative breast cancer patients, based on the detection of 20
cancer stem cell markers. The assay has been evaluated in an
initial retrospective validation study using a consecutive cohort
of approximately 2,400 patients with breast cancer.
The person who arranged for the release of this
information is Dr Kunwar Shailubhai, the Company's Chief Executive
Officer and Chief Scientific Officer.
About Tiziana Life
SciencesTiziana Life Sciences plc is a dual listed
(NASDAQ: TLSA & UK AIMS: TILS) biotechnology company that
focuses on the discovery and development of novel molecules to
treat human diseases in oncology, inflammation and infectious
diseases. In addition to milciclib, the Company will be shortly
initiating phase 2 studies with orally administered foralumab for
Crohn’s Disease and nasally administered foralumab for progressive
multiple sclerosis. Foralumab is the only fully human anti-CD3
monoclonal antibody (mAb) in clinical development in the world.
This phase II compound has potential application in a wide range of
autoimmune and inflammatory diseases, such as Crohn’s Disease,
multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel
disease (IBD), psoriasis and rheumatoid arthritis, where modulation
of a T-cell response is desirable. The company is accelerating
development of anti-Interleukin 6 receptor (IL6R) mAb, a fully
human monoclonal antibody for treatment of IL6-induced
inflammation, especially for treatment of COVID-19 patients.
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at https://ir.tizianalifesciences.com.
Forward-Looking
StatementsCertain statements made in this announcement are
forward-looking statements. These forward-looking statements are
not historical facts but rather are based on the Company’s current
expectations, estimates, and projections about its industry; its
beliefs; and assumptions. Words such as ‘anticipates,’ ‘expects,’
‘intends,’ ‘plans,’ ‘believes,’ ’seeks,’ ‘estimates,’ and similar
expressions are intended to identify forward-looking statements.
These statements are not guarantees of future performance and are
subject to known and unknown risks, uncertainties, and other
factors, some of which are beyond the Company’s control, are
difficult to predict, and could cause actual results to differ
materially from those expressed or forecasted in the
forward-looking statements. The Company cautions security holders
and prospective security holders not to place undue reliance on
these forward-looking statements, which reflect the view of the
Company only as of the date of this announcement. The
forward-looking statements made in this announcement relate only to
events as of the date on which the statements are made. The Company
will not undertake any obligation to release publicly any revisions
or updates to these forward-looking statements to reflect events,
circumstances, or unanticipated events occurring after the date of
this announcement except as required by law or by any appropriate
regulatory authority.
Contacts:
Tiziana Life
Sciences plc |
|
United Kingdom: |
|
Gabriele Cerrone, Chairman and founder |
+44 (0)20
7495 2379 |
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Cairn Financial Advisers LLP (Nominated adviser) |
|
Liam Murray / Jo Turner |
+ 44
(0)20 7213 0883 |
|
|
Shore Capital (Broker) |
|
Antonio Bossi / Fiona Conroy |
+44 (0)20
7601 6125 |
|
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United States: |
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Investors |
|
CORE IR |
|
ir@coreir.com |
|
|
|
Media |
|
Jules
Abraham |
|
CORE
IR |
|
(917)
885-7378 |
|
julesa@coreir.com |
|
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