NanoSmart Pharmaceuticals has received Orphan Drug designation from the Food and Drug Administration (FDA) for a second drug product that uses its nanoparticle drug delivery system.

The drug product is a formulation of dactinomycin for the treatment of Ewing’s sarcoma, a rare type of childhood bone cancer. The FDA granted NanoSmart’s Orphan Drug Designation on the basis of a plausible hypothesis that the novel formulation may be clinically superior to the original drug.

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Dactinomycin, an antineoplastic antibiotic, is incorporated into a proprietary ANA-conjugated nanoemulsion. Cytotoxic agents like dactinomycin are known to be effective for Ewing’s sarcoma and other cancers, but are limited by toxicity and often cause life-long complications. NanoSmart’s formulation is expected to localize drug delivery to the tumor site, thereby increasing effectiveness at the tumor while simultaneously improving safety by reducing collateral damage to healthy tissues.

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