Genomic Vision is a publicly-traded company on the Euronext regulated market in Paris
GENOMIC VISION: POSITIVE RESULTS OF THE CLINICAL STUDY EXPL-HPV-002 IN CERVICAL CANCER DETECTION
• Primary endpoint was met, showing the correlation between the integration of high-risk HPV into the genome detected by molecular combing and the severity of the cervical lesions in patient with an indication of colposcopy.
• Genomic Vision is now ready to select the right partner for registration and commercialization of an HPV integration test.
• This new test based on GV proprietary technology should change the paradigm of cervical cancer early diagnostic helping the clinicians to mitigate risk of developing the disease.
Bagneux (France), October 29, 2018 – 7.45 am (CET)– Genomic Vision (FR0011799907 – GV), a company specializing in the development of diagnostic tests for the early detection of cancers and hereditary diseases, and applications for life sciences research,announces today positive results of the study EXPL-HPV-002 in cervical cancer conducted in Czech Republic.
Initiated in June 2016, the clinical study enrolled 688 patients aged between 25 to 65 years in 2 main centers: Center for Ambulatory Gynaecology and Primary Care (Dr. Vladimír Dvořák, principal investigator) and the University Hospital Center of Brno (Prof. Pavel Ventruba). Among them 410 HPV HR (High risk) patients were included in the study. Primary endpoint consisted in assessing integration of HPV virus into the genome as a potential biomarker for cervical lesions.
The final results show that the median value of HR-HPV virus integration in high grade patients is 3 times higher than in patient with no lesion.
These study results reinforce interim data disclosed in October 2017 showing that the integration of 14 HR-HPV strains detected using the molecular combing technology was an indicator of the severity of precancerous cervical lesions.
Dr Vladimír Dvořák, Medical head of the Center for Ambulatory Gynaecology and Primary Care of Brno and principal investigator of the EXPL-HPV-002 Study declared: “Cervical cancer is one of the most frequent cancer in women with 570,000 new cases per year. These results clearly show the interest of the combing test in the decision-making process along with the follow-up of HR-HPV patients. It could definitely be a breakthrough in the management of high-risk patient care. I am now personally thrilled by pursuing the longitudinal part of the study to demonstrate the prognostic value of the Genomic Vision’s test. If first interim results expected by the end of 2019 are positive, it would demonstrate the relevance of virus integration measurement in cervical cancer occurrence.”
Aaron Bensimon, Cofounder and Chairman of the executive board of Genomic Vision, concluded: “Meeting the primary endpoint in this large clinical study is a great achievement for Genomic Vision. It clearly opens us the door to HPV integration diagnostic and cervical cancer early diagnostic test. We will be very proud if we could contribute in the reduction of the 275,000 yearly death caused by this disease. In parallel of pursuing the follow-up of patients in the EXPL study (longitudinal study) we are also going to open discussions with partners willing to license the test. We strongly believe that these results will trigger strategic partnerships on the HPV integration test in the short-mid-term.”
Complete results of the study will be presented at the conference Eurogin 2018 in Lisbon on December 2, 2018.
THE ABOUT GENOMIC VISION
GENOMIC VISION is a company specialized in the development of diagnostic solutions for the early detection of cancers and serious genetic diseases and tools for life sciences research. Through the DNA Molecular Combing, a strong proprietary technology allowing to identify genetic abnormalities, GENOMIC VISION stimulates the R&D productivity of the pharmaceutical companies, the leaders of the diagnostic industry and the research labs.
The Company develops a robust portfolio of diagnostic tests (breast, ovarian and colorectal cancers, myopathies) and analysis tools (DNA replication, biomarkers discovery, gene editing quality control). Based near Paris, in Bagneux, the Company has approximately 50 employees. GENOMIC VISION is a public listed company listed in compartment C of Euronext’s regulated market in Paris (Euronext: GV – ISIN: FR0011799907). For further information, please visit: www.genomicvision.com
Co-fondateur et Président du Directoire
Tél. : +33 1 49 08 07 50
Tel. : +33 1 42 68 29 70
Investor Relations & Strategic Communications
Tel. : +33 1 44 71 94 94
FORWARD LOOKING STATEMENT
This press release contains implicitly or explicitly certain forward-looking statements concerning Genomic Vision and its business.
Such forward-looking statements are based on assumptions that Genomic Vision considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the “Risk Factors” section in its Document de Reference filed with the French Autorité des Marchés Financiers (AMF) on March 28, 2017, under number R.17-009, available on the web site of Genomic Vision (www.genomicvision.com) and to the development of economic conditions, financial markets and the markets in which Genomic Vision operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Genomic Vision or not currently considered material by Genomic Vision. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Genomic Vision to be materially different from such forward-looking statements.
This press release and the information contained herein do not constitute and should not be construed as an offer or an invitation to sell or subscribe, or the solicitation of any order or invitation to purchase or subscribe for Genomic Vision shares in any country. The distribution of this press release in certain countries may be a breach of applicable laws. The persons in possession of this press release must inquire about any local restrictions and comply with these restrictions.