Paris, 16 December 2013 – Hybrigenics (ALHYG), a bio-pharmaceutical company listed on the Alternext market of Euronext Paris, with a focus on research and development of new treatments against proliferative diseases, today announces the issuance by the Committee for Orphan Medicinal Products of the European Medicines Agency (EMA) of a positive opinion for the orphan designation of inecalcitol in chronic lymphocytic leukemia (CLL), during its meeting held on December 10-12, 2013. The complete EMA Public Summary of Opinion will be available early next year.
A Phase II clinical study is currently ongoing with oral inecalcitol in CLL patients not yet eligible for chemotherapy but at high risk of progression. “This positive opinion from EMA supports our clinical development strategy of inecalcitol as an orphan drug in chronic lymphocytic leukemia, an orphan disease with high unmet medical need. We look forward to receiving the full summary report,” said Jean-François Dufour-Lamartinie, Hybrigenics’ Head of Clinical R&D.
About Chronic Lymphocytic Leukemia (CLL)
CLL is the most frequent form of leukemia (cancerous proliferative disease of circulating blood cells) and accounts for about 35% of all leukemic patients. Annual estimates of newly diagnosed CLL cases amount to close to 15,000 in the United States (American Leukemia Lymphoma Society, Facts 2012), 14,000 in Europe and 130,000 world-wide (Globocan 2008). CLL is designated as an orphan disease in the United States, Europe and Japan.
People with CLL produce too many lymphocytes (mononuclear white blood cells) of one single abnormal “family” (monoclonal) which are not fully developed (immature). Over time, these circulating CLL cells (monoclonal immature lymphocytes) in excess build up in the lymphatic system and cause large, swollen lymph nodes. They may also fill the bone marrow, reducing the number of normal white cells, red cells and platelets that can be made, thereby lowering their blood counts. There is no definitive cure for CLL.
Hybrigenics (www.hybrigenics.com) is a bio-pharmaceutical company listed (ALHYG) on the Alternext market of Euronext Paris, focusing its internal R&D programs on innovative targets and therapies for the treatment of proliferative cancerous or non-cancerous diseases.
Hybrigenics’ current development program is based on inecalcitol, a vitamin D receptor agonist active by oral administration. Oral inecalcitol has shown excellent tolerance and strong presumption of efficacy for the first-line treatment of metastastic castrate-resistant prostate cancer in combination with Taxotere®, which is the current gold-standard chemotherapeutic treatment for this indication. Oral inecalcitol is currently being tested in chronic lymphocytic leukemia patients.
Hybrigenics has a research collaboration with Servier on deubiquitinating enzymes and their inhibitors in oncology, neurology, psychiatry, rheumatology, ophthalmology, diabetes and cardiovascular diseases. Hybrigenics continues to build on its pioneer research position in the field of ubiquitin-specific proteases by exploring their role in other areas of particular relevance, such as inflammation and virology.
Hybrigenics Services (www.hybrigenics-services.com), a fully-owned subsidiary, is the market leader in Yeast Two-Hybrid (Y2H) and related services to identify, validate and inhibit protein interactions for researchers in all areas of life sciences, using its ISO 9001-certified high-throughput Y2H screening platform, its sophisticated bioinformatics tools and extensive database, along with its chemical library and chemical screening platform. Hybrigenics also provides state-of-the-art genomic services specialized in DNA chips, DNA or RNA target enrichment and next generation sequencing.
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