Hybrigenics Determines The Maximum Dosage Of Inecalcitol
5/19/2010 12:19:04 PM
Paris, May 19, 2010 – Hybrigenics (ALHYG), a bio-pharmaceutical company listed on Alternext (NYSE-Euronext) in Paris, with a focus on research and development of new cancer treatments and specialised in protein interactions, today announces that it has reached the maximal tolerated dose of inecalcitol at 4 mg in hormone-refractory prostate cancer patients. The clinical tolerance observed at high and frequent exposure to inecalcitol is excellent. This makes it possible to consider other potential therapeutic indications such as hormone-dependent prostate cancer and severe psoriasis.
All prostate cancer patients tested at 4 mg showed good tolerance to this dose of inecalcitol once a day, and some even twice a day, in addition to the standard Taxotere(R) chemotherapy every three weeks. At this dose, levels of inecalcitol circulating in the blood after oral administration reached concentrations that have been shown to exert anti-proliferative effects on cancer cells in in vitro culture, without inducing hypercalcemia. The excellent clinical tolerance of inecalcitol offers the opportunity to investigate its potential therapeutic benefit in the early hormone-dependent stage of prostate cancer, and also possibly in severe psoriasis.
Several vitamin D analogues are already successfully used for the treatment of mild to moderate psoriasis, but only by local applications because of their hypercalcemic activity by the oral route. However, patients suffering from severe psoriasis, characterized by a large proportion of body surface being affected by the disease, cannot be conveniently treated only with local treatments. At the moment, these patients receive injectable therapeutics targeting tumor necrosis factor alpha representing a USD 2.4 billion a year market. Inecalcitol might reach all lesions at the same time by systemic circulation after oral administration without the limitations of hypercalcemia, and exert the beneficial effects of vitamin D on all of them. This is the rationale behind the project to develop inecalcitol in severe psoriasis in addition to prostate cancer.
Inecalcitol is an orally active agonist targeting the vitamin D receptor. The therapeutic rationale behind its development is to add its cytostatic potential to the established efficacy of the reference treatments of the two stages of prostate cancer: anti-hormonals (LH-RH agonists and anti-androgens) for the hormone-dependent stage and Taxotere(R) - based chemotherapy for the hormone-refractory stage.
Hybrigenics (http://www.hybrigenics.com) is a bio-pharmaceutical company listed (ALHYG) on Alternext (NYSE-Euronext) in Paris, focusing its internal R&D programs on innovative targets and therapies for the treatment of cancer. Hybrigenics’ development program is based on inecalcitol, a vitamin D analogue, for the treatment of hormone-refractory prostate cancer in combination with Sanofi-Aventis' Taxotere(R), which is the current gold-standard chemotherapeutic treatment for this indication. Hybrigenics’ research program explores the role of enzymes known as ubiquitin-specific proteases (USP) in the degradation of onco-proteins, and the effectiveness of proprietary USP inhibitors in treating various types of cancer.
Hybrigenics is also 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.