Advanced Life Sciences Announces Orphan Drug Designation for ALS-357

Advanced Life Sciences Holdings announced that the FDA has granted orphan drug status to ALS-357 for the topical treatment of metastatic melanoma.

ALS-357 is a novel drug entering Phase I/II clinical development that has demonstrated potent antitumor activity. The drug candidate has shown promise in both in vitro and in vivo preclinical studies, Advanced Life Sciences said.

The company added that tapid tumor regression has been shown in a mouse model and no observable toxicity was seen even at high doses.