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Advanced Life Sciences Announces ALS-357 Granted FDA Orphan Drug Designation for Metastatic Melanoma

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.


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 Orphan Drug Designation underscores the need for improved therapies to treat metastatic melanoma and represents an important milestone for our oncology program."

Dr. Flavin added "While our focus as a company is on moving our lead product, cethromycin, toward FDA approval and into the market, we have taken steps to advance our pipeline to the next level. The ALS-357 program opens up a new opportunity for Advanced Life Sciences."

About FDA Orphan Drug Designation

The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. Orphan Drug Designation may be obtained by requesting that FDA grant such designation for a particular drug for a particular disease or condition that affects fewer than 200,000 Americans. This designation provides Advanced Life Sciences with financial and regulatory benefits, such as eligibility for a seven-year period of orphan drug exclusivity upon approval for ALS-357, potential tax credits for research, potential grant funding for research and development, assistance with clinical trial protocol review, and excepts Advanced Life Sciences from paying the application user fee for a marketing application for ALS-357 for metastatic melanoma.

About Metastatic Melanoma

The American Cancer Society estimates that there are approximately 55,000 new cases of melanoma diagnosed annually in the United States and an estimated 8,000 deaths occur annually as a result of melanoma. Melanoma occurs in melanocytes, a type of cell in the skin that produces the pigment that gives skin its natural color. Melanoma occurs when melanocytes become malignant, which can occur on any skin surface. When melanocytes spread to form a new tumor, it is called a secondary, or metastatic tumor. In such cases, the cancer cells in the new tumor are still melanoma cells, and the disease is called metastatic melanoma rather than liver, lung, or brain cancer. Metastatic melanoma remains resistant to most of the currently available forms of 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 the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and inflammation. Visit us on the web at

Forward-Looking Statements

Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Except for historical information, the statements made in this press release are forward- looking statements about Advanced Life Sciences Holdings, Inc., including statements regarding the clinical trials and regulatory pathway of ALS-357. Forward-looking statements represent our management's judgment regarding future events and are accurate at the time they are made. The Company does not undertake any obligations to update any forward-looking statements whether as a result of new information, future events or otherwise. Our actual results could differ materially from those discussed herein due to several factors including the success and timing of our clinical trials and our ability to obtain and maintain regulatory approval and labeling of our product candidates; our plans to develop and commercialize our product candidates; the loss of key scientific or management personnel; the size and growth of potential markets for our product candidates and our ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of our estimates regarding expenses, capital requirements, and our ability to access capital through partnerships, stock offerings and future revenues; our ability to obtain and maintain intellectual property protection for our product candidates; the successful development of our sales and marketing capabilities; the success of competing drugs that become available; and the performance of third party collaborators and manufacturers. These and additional risks and uncertainties are detailed in the Company's filings with the Securities and Exchange Commission.

SOURCE Advanced Life Sciences Holdings, Inc.
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