Tiziana Life Sci PLC - Further re: ASCO Conference - StemPrintER
("Tiziana" or the "Company")
· StemPrintER Outperforms Oncotype DX in analysis with 800+ samples from ER+/HER2- postmenopausal breast cancer patients
· SPARE Model is up to 40-50% more accurate than standard clinical markers in analysis with 1800+ samples for prediction of distant metastasis
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
1. 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)
2. 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.
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.
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
About ER+/Her2- breast cancer
Endocrine 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.
StemPrintER, 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.
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Certain 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.
Antonio Bossi / Fiona Conroy +44 (0)20 7601 6125
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