January 06, 2020
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FDA grants orphan drug designation to HSB-1216 for small cell lung cancer

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The FDA granted orphan drug designation to HSB-1216 for the treatment of small cell lung cancer, according to the agent’s manufacturer.

The agency based the designation on nonclinical pharmacology data.

HSB-1216 (Hillstream BioPharma) is a novel formulation of salinomycin — a potent cancer stem cell inhibitor — encapsulated within the company’s Quatramer delivery technology. The encapsulation may increase patients’ ability to tolerate salinomycin.

“We are very excited and pleased that HSB-1216 received orphan designation from the FDA,” Randy Milby, Hillstream’s CEO, said in a company-issued press release. “Now is an exciting time for the development of medicines for small cell lung cancer. We believe treatment with HSB-1216 may represent a complementary approach to other potential therapies by inhibiting cancer stem cells.”

The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.