Advanced Life
Sciences Holdings, Inc. (Nasdaq: ADLS) 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 advancedlifesciences
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.
Advanced Life Sciences Holdings, Inc.
advancedlifesciences