The FDA has granted orphan drug designation to Advanced Life Sciences for its metastatic melanoma treatment.
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ALS-357 is a novel drug entering Phase I/II clinical development that has demonstrated potent anti-tumor activity against malignant melanoma. Rapid tumor regression has been shown in a mouse model and no observable toxicity was seen even at high doses, according to the company. ALS-357 operates by inducing apoptosis, or programmed cell death, in the tumor cells.
“Our phase I/II study, which is currently slated to commence in early 2008, will help determine whether the promising results we observed in preclinical studies can be translated into the human population,” commented Michael Flavin, CEO of Advanced Life Sciences.
Melanoma is estimated to be the sixth most common cancer among new cases of cancer in the US, It accounts for about 4% of all skin cancers but causes about 79% of skin cancer deaths.
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