QualityStocks News - European Medicines Agency Awards Arno Therapeutics AR-42 Orphan Drug Designation

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Orphan drug designation in the EU is a significant step toward clinical development for treatment of rare genetic disorder

QualityStocks would like to highlight Arno Therapeutics, a publicly traded 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.

In the company’s news yesterday,

Arno Therapeutics announced that its investigational compound AR-42 has been granted orphan-drug designation by the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products 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.

The EMA grants orphan-drug designation for medicines designed to treat life-threatening or debilitating conditions affecting no more than five in 10,000 people, and allows the developer to obtain inspection-fee reductions, protocol assistance, a centralized application procedure, and 10 years of marketing exclusivity when/if the drug is approved.

“The EMA’s orphan-drug designation represents another important step in our development program for AR-42 that will help us pursue its clinical development for the treatment in this rare and debilitating disease,” Glenn Mattes, president and CEO of Arno stated in the press release.

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.

The U.S. FDA has also awarded EMA, AR-42 orphan drug designation for the treatment of meningioma and schwannoma of the central nervous system, and is currently reviewing the candidate for U.S. orphan-drug designation for the treatment of neurofibromatosis type 2-associated central nervous system tumors.

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Forward-Looking Statement:

This release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. Risks and uncertainties applicable to the company and its business could cause the company's actual results to differ materially from those indicated in any forward-looking statements.

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