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Arno Therapeutics, Inc. (OTCBB: ARNI) announced today that its investigational compound known as AR-42 has been granted orphan-drug designation by the European Medicines Agency (EMA) for the treatment of meningioma and schwannoma. Meningiomas are benign tumors that can present in different locations within the brain and the spinal cord and may cause substantial morbidity for those affected individuals. Schwannomas are benign tumors that can present in different locations within the brain, spinal cord and peripheral nerves, which may cause substantial morbidity for those affected individuals. In May, 2012 the EMA designated AR-42 an orphan drug for the treatment of neurofibromatosis type 2 (NF2), a rare genetic disorder characterized by the growth of noncancerous tumors in the brain and spinal cord, juvenile cataracts and neurofibromas of the skin.
Orphan-drug designation is granted in the European Union for medicines to treat life-threatening or debilitating conditions affecting no more than 5 in 10,000 people. It qualifies the developer for inspection-fee reductions, protocol assistance, a centralized application procedure and 10 years of marketing exclusivity upon the drug's approval.
Glenn Mattes, president and chief executive officer of Arno, stated: “These orphan-drug designations will facilitate the development of AR-42 which has shown promising activity in preclinical studies as a potential treatment for a variety of tumor types. We look forward to advancing its clinical development in multiple indications.”
AR-42 is a novel, orally available, broad-spectrum deacetylation inhibitor of both histone and non-histone proteins which has demonstrated greater potency and activity in solid tumors and hematological malignancies when compared in preclinical studies to vorinostat (also known as "SAHA" or Zolinza®), the first of two marketed compounds in this class. AR-42 is currently being studied in a Phase I/IIa clinical trial in adult patients with relapsed or refractory hematologic malignancies and solid tumors. It been designated an orphan drug by the U.S. Food and Drug Administration for the treatment of meningioma and schwannoma of the central nervous system.