Tiziana Life Sciences announces presentation of StemPrintER, a superior prognostic test as compared to Oncotype DX to predict...
May 29 2020 - 2:00AM
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 results, from a poster selected for discussion
session at the American Society of Clinical Oncology (ASCO) Virtual
Conference, demonstrating the superiority of StemPrintER stem cell
based genomic prognostic tool versus the market leader, Oncotype
DX, in predicting recurrence in ER+/HER2- postmenopausal breast
cancer patients. A second poster describing results on prediction
of distant recurrence using a next generation StemPrintER model,
named SPARE, presented in a separate ASCO session, showed even more
refined accuracy than standard clinicopathological markers in
predicting risk of distant recurrence. Both posters were authored
by a team of scientists from the European Institute of Oncology in
Milan, and the head-to-head comparison of StemPrintER with Oncotype
DX was conducted in collaboration with the Royal Marsden Hospital
and Queen Mary University in London.
As announced previously, the Company intends to
demerge its StemPrintER and SPARE (together "StemPrintER")
genomics-based personalized medicine businesses into a separate
company and effect a capital reduction to facilitate the spin-out
and listing of StemPrintER as an independent entity.
Major Highlights of Results
- The first poster, which was also part of a discussion session,
“Comparison of StemPrintER, a Novel Biology-based Genomic Predictor
of Distant Recurrence in Breast Cancer, with Oncotype DX in the
TransATAC cohort,” shows that StemPrintER
- Outperforms Oncotype DX in 10-year risk prediction in more than
800 ER+/HER2- postmenopausal breast cancer patients in the
analysis, including in lymph node-negative (N0) and 1 to 3 lymph
node-positive (N1-3) patients1.
- Significantly (p<0.0001) stratifies high vs. low risk groups
when adjusted for clinical parameters as expressed by clinical
treatment scores (CTS).
- The second poster, “Integration of the stem cell biology-based
genomic tool, StemPrintER, with clinicopathological parameters for
the prediction of distant recurrence in ER+/HER2- breast cancer
patients,” demonstrates that the next-generation StemPrintER Risk
Score (SPARE) model
- Shows approximately 20% superiority to the traditional
clinicopathological parameters, as expressed by the CTS, in
providing prognostic information for the more than 1,800 patients
analyzed and in certain populations was demonstrated to be up to
40-50% more accurate.
- Investigators found that SPARE added substantial prognostic
information to CTS, but the inverse was not proven to be the
case.
This announcement contains inside information
for the purposes of Article 7 of EU Regulation 596/2014. 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 ER+/Her2- breast
cancerEndocrine receptor-positive (ER+) breast cancers
constitute the majority of breast cancer cases (~75-80%) and
display remarkable variability in clinical behaviour. This
heterogeneity makes prognosis and therapy response often
challenging to predict using the standard clinicopathological
features of the tumor. Although the overall prognosis for this
group of patients is good, a significant proportion (>20%) of
these women will experience distant recurrence in the first 10
years post-surgery. For ER+ patients who also have a negative HER2
status (HER2-), the standard of care is endocrine therapy with the
addition of adjuvant chemotherapy in those patients considered to
be at risk of recurrence according to clinicopathological
parameters. However, it has become apparent that these parameters
are often insufficient to predict risk of recurrence in ER+/HER2-
BC patients, and, as a consequence, a significant proportion of
these patients are either over- or under-treated. Multigene
prognostic tests can assist decision making on treatments,
differentiating low risk patients who could be safely SPARE
chemotherapy from higher risk patients who might benefit from
chemotherapy.
About
StemPrintER/SPAREStemPrintER, and its next generation
derivative SPARE that combines StemPrintER with two clinical
markers, namely lymph nodal status and tumor size, in a more
refined risk model, is a multi-gene prognostic assay intended for
the prediction of the risk of recurrence in luminal, ER+/HER2-
breast cancer patients, based on the detection of 20 cancer stem
cell markers normalized to 4 housekeeping genes. The assay has been
evaluated in an initial retrospective validation study using a
consecutive cohort of approximately 2,400 patients with breast
cancer.
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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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
plcUnited Kingdom:Gabriele Cerrone, Chairman and
founder+44 (0)20 7495 2379
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
United States:InvestorsCORE
IRir@coreir.com
MediaJules AbrahamCORE IR(917)
885-7378julesa@coreir.com
1 N0 means nearby lymph nodes do not
contain cancer. Numbers after the N (such as
N1, N2, and N3) might describe the size, location, and/or the
number of nearby lymph nodes affected
by cancer. The higher the N number, the
greater the cancer spread to nearby
lymph nodes.
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