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.
About Arno TherapeuticsArno Therapeutics is a clinical-stage biopharmaceutical company developing innovative products for the treatment of cancer. Arno has exclusive worldwide rights to develop and market three innovative clinical-stage anti-cancer product candidates with unique mechanisms of action. These compounds are in clinical testing as potential best- or first-in-class products to treat hematologic malignancies and solid tumors. For more information about the company, please visit www.arnothera.com. Forward-Looking Statements: This press release contains forward-looking statements that involve substantial risks and uncertainties. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include, without limitation, statements regarding the potential for AR-42 to treat meningioma, schwannoma and other diseases, the timing, progress and anticipated results of the clinical development of AR-42, Arno’s ability to fund the development of AR-42 to completion, as well as Arno’s strategy, future operations, outlook, milestones, future financial position, future financial results, plans and objectives. We may not actually achieve these plans, intentions or expectations and Arno cautions investors not to place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Various important factors could cause actual results or events to differ materially from the forward-looking statements that we make. Such factors include, among others, risks that the results of clinical trials will not support our claims or beliefs concerning the effectiveness of AR-42 or any of our other product candidates, our ability to finance the development of our product candidates, regulatory risks, and our reliance on third party researchers and other collaborators. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2010. Arno is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.