WOODRIDGE, Ill., Aug. 28 Advanced Life SciencesHoldings, Inc. (Nasdaq: ADLS) today announced that the United States Food andDrug Administration (FDA) has granted Orphan Drug Designation to its oncologyproduct, ALS-357, for the topical treatment of metastatic melanoma. Melanomais estimated to be the sixth most common cancer among new cases of cancer inthe United States and accounts for about 4% of all skin cancers but causesabout 79% of skin cancer deaths.
ALS-357 is a novel drug entering phase I/II clinical development that hasdemonstrated potent anti-tumor activity against malignant melanoma. ALS-357has shown promise in both in vitro and in vivo preclinical studies. Rapidtumor regression has been shown in a mouse model and no observable toxicitywas seen even at high doses. ALS-357 operates by inducing apoptosis, orprogrammed cell death, in the tumor cells.
Michael T. Flavin, Ph.D., chief executive officer of Advanced LifeSciences, commented on the notice of designation saying that "We are pleasedwith the orphan drug designation for ALS-357 as a topical treatment formetastatic melanoma. With a unique mechanism of action and a favorablepreclinical safety profile, we believe ALS-357 can become an importantoncology treatment in the future. Our Phase I/II study, which is currentlyslated to commence in early 2008, will help determine whether the promisingresults we observed in preclinical studies can be translated into the humanpopulation. The Orphan Drug Designation underscores the need for improvedtherapies to treat metastatic melanoma and represents an important milestonefor our oncology program."
Dr. Flavin added "While our focus as a company is on moving our leadproduct, cethromycin, toward FDA approval and into the market, we have takensteps to advance our pipeline to the next level. The ALS-357 program opens upa new opportunity for Advanced Life Sciences."
About FDA Orphan Drug Designation
The U.S. Orphan Drug Act is intended to assist and encourage companies todevelop safe and effective therapies for the treatment of rare diseases anddisorders. Orphan Drug Designation may be obtained by requesting that FDAgrant such designation for a particular drug for a particular disease orcondition that affects fewer than 200,000 Americans. This designation providesAdvanced Life Sciences with financial and regulatory benefits, such aseligibility for a seven-year period of orphan drug exclusivity upon approvalfor ALS-357, potential tax credits for research, potential grant funding forresearch and development, assistance with clinical trial protocol review, andexcepts Advanced Life Sciences from paying the application user fee for amarketing application for ALS-357 for metastatic melanoma.
About Metastatic Melanoma
The American Cancer Society estimates that there are approximately 55,000new cases of melanoma diagnosed annually in the United States and an estimated8,000 deaths occur annually as a result of melanoma. Melanoma occurs inmelanocytes, a type of cell in the skin that produces the pigment that givesskin its natural color. Melanoma occurs when melanocytes become malignant,which can occur on any skin surface. When melanocytes spread to form a newtumor, it is called a secondary, or metastatic tumor. In such cases, thecancer cells in the new tumor are still melanoma cells, and the disease iscalled metastatic melanoma rather than liver, lung, or brain cancer.Metastatic melanoma remains resistant to most of the currently available formsof therapy and in most instances results in the death of the patient.
About Advanced Life Sciences
Advanced Life Sciences is a biopharmaceutical company engaged in thediscovery, development and commercialization of novel drugs in the therapeuticareas of infection, cancer and inflammati