* 100% of patients classified with Severidia® in the "good outcome" subgroup
were alive after 2,500 days
* Improved p value (p < 10(-5))
Nancy, France, November 25, 2014 - Genclis, a molecular diagnostic company in
the fields of allergy and cancer, today presents additional clinical data for
its molecular diagnostic test Severidia® in non-metastatic triple-negative
breast cancer patients in the context of the 4(th) Munich Biomarker Conference,
to be held in Munich, Germany, on November 25 and 26, 2014.
In October 2014, Genclis presented the first clinical data for Severidia® at the
Personalized Diagnostics Today session of the American Association for Clinical
Chemistry (« AACC ») conference. These data were based on a robust retrospective
study conducted on a sample of 52 patients from 10 different clinical centers
and for which a genomic sequencing was performed through NGS technology. Twenty
patients were used in a training set and 32 patients, with a similar profile,
were used in blind replication. Data showed that Genclis' proprietary algorithms
were able to predict individual patient cancer severity with greater than 90 %
accuracy: i.e. 100% of patients classified in the "good outcome" subgroup (2/3
of patients in the replication set) were alive after 2,500 days.
Data presented in Munich include 15 additional TNBC patients and as well as a
longer duration of the clinical observation (+ 9 month) for the first 32
patients in the initial replication set. The 15 additional patients came from
the same NCI biobank, had same inclusion criteria and had DNA and RNA sequencing
under the same protocol.
In the larger population of 47 patients, the probability of survival after
2,500 days for patients classified with a good outcome was unchanged, at 100%,
and the p value of the statistical observation improved by a log (p < 10(-4) vs.
p < 10(-5)).
Dr. Bernard Bihain, CSO and Chairman of the Board of Genclis said: "These
additional clinical data confirm the robustness of the test as a diagnostic tool
for severity of triple-negative breast cancer". He added: "They warrant a rapid
development of Severidia®. We are currently starting additional studies to
confirm the clinical utility of the biomarker".
Stéphane Boissel, CEO of Genclis, said: "In 2015, we should obtain additional
data that would give Severidia® a level of evidence compatible with expectations
in terms of both registration and reimbursement of the test". He added: "In
parallel, we will be conducting clinical validation studies in other indications
so as to validate the cross-functional feature of this disruptive, proprietary
approach in the growing field of cancer prognostic biomarker".
The AACC poster is available on the Company's website (www.genclis.com).
The presentation made in 4(th) Munich Biomarker Conference will be posted on the
Company's website from November 27, 2014.
About triple-negative breast cancer ("TNBC"):
Breast cancer has a global incidence of 1.677.000 new cases per year, including
794.000 new cases in developed countries (source: Globocan), of which 233.000
new cases in the USA and 367.000 new cases in the European Union. Breast cancer
is qualified as "triple-negative" when estrogen, progesterone and HER2/Neu, the
3 main targets of modern breast cancer therapeutic agents, are not overexpressed
in these cells.
This type of cancer account for 15 to 25% of all breast cancers (source:
Medscape), or between 120.000 and 200.000 new cases per year in developed
countries. It is considered as the most deadly breast cancer form, with more
than 25% of deaths within 5 years of diagnostic. Chemotherapy is used in around
50% of TNBC cancer cases. TNBC tumors respond to chemotherapy. However, they are
genetically unstable and thus resistance to chemotherapy treatment are developed
in the first five years after chemotherapy. It is known that around 2/3 of TNBC
are non-severe TNBC. However, without any proper tool to segment patients based
on the severity of their cancer, most patients undergo chemotherapy.
It is commonly known that costs of care for TNBC are 80% above average breast
cancer costs.
About Severidia®:
Severidia® is the first diagnostic product from the pioneering work on DNA/RNA
transcription infidelity by Genclis. This work was patented (granted in the USA
and Europe) and published (in PNAS) in 2007. Whereas DNA/RNA transcription is
almost a match in normal cells, it has been shown to be divergent in cancer
cells. And Genclis has demonstrated that the level of divergence correlates with
clinical outcome of cancer patients.
By measuring precisely the divergence between DNA and RNA (the RNA/DNA
Divergence Rate, or "RDD Rate"), Severidia® could assess the risk of cancer
relapse at a robustness level unseen in solid tumors as it does not prejudge of
genes involved in the disease (a poorly documented information in solid tumors)
but instead measures a biological phenomenon universally found in any given
cancer.
This is why Genclis believes it could make of Severidia® a scientific and
technological gold standard of cancer prognostic biomarkers as the only test
capable of classifying the "hard-to-classify" cancers.
About Genclis:
Genclis is a molecular diagnostic company in the fields of allergy and cancer.
Started in 2004, the Company initiated the commercialization of its allergy
molecular diagnostic tests in 2014.
In the field of cancer diagnostic, Genclis based its development on the concept
of DNA/RNA divergences due to transcription infidelity, an original, proprietary
disruptive science. This science has already led to encouraging results in the
severity prognostic of triple negative breast cancer ("TNBC"), a severe form of
breast cancer. Genclis intends to rapidly impose its solution, Severidia©, as a
standard for oncologists to offer their patients alternative treatment and
monitoring options.
Based in Nancy and Paris, Genclis had 40 employees as of October 1, 2014. Please
visit: www.genclis.com.
Contacts:
Stéphane Boissel, CEO: +33.6.74.78.09.25 - sboissel@genclis.com
Bernard Bihain, Chairman and CSO: +33.6.33.02.90.88 - bbihain@genclis.com
ATCG Press : Judith Aziza, +33.6.70.07.77.51 - presse@atcg-partners.com
PR Genclis result:
http://hugin.info/164309/R/1873825/660019.pdf
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Source: Genclis SAS via GlobeNewswire
[HUG#1873825]
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