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Orphan drug designation in the EU is a significant step toward clinical development for treatment of rare genetic disorder
Scottsdale, AZ (PRWEB) May 13, 2012
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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