Advanced Life Sciences Announces ALS-357 Granted FDA Orphan Drug Designation for Metastati...( Phase I/II Clinical Studie...),Health

Phase I/II Clinical Studies Set To Begin By Early 2008

WOODRIDGE, Ill., Aug. 28 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS) today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to its oncology product, ALS-357, for the topical treatment of metastatic melanoma. Melanoma is estimated to be the sixth most common cancer among new cases of cancer in the United States and accounts for about 4% of all skin cancers but causes about 79% of skin cancer deaths.

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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. ALS-357 has shown promise in both in vitro and in vivo preclinical studies. Rapid tumor regression has been shown in a mouse model and no observable toxicity was seen even at high doses. ALS-357 operates by inducing apoptosis, or programmed cell death, in the tumor cells.

Michael T. Flavin, Ph.D., chief executive officer of Advanced Life Sciences, commented on the notice of designation saying that "We are pleased with the orphan drug designation for ALS-357 as a topical treatment for metastatic melanoma. With a unique mechanism of action and a favorable preclinical safety profile, we believe ALS-357 can become an important oncology treatment in the future. 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. The Or
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