Advanced Life Sciences Files Investigational
New Drug Application for Anti-Inflammatory Agent
Woodridge, Ill, June 27, 2002 - Advanced Life Sciences announced
today that it has filed an Investigational New Drug (IND) application
with the Food and Drug Administration for the compound ALS-886.
In preclinical testing, ALS-886 demonstrated a reduction in lung
vascular tissue damage often associated with Acute Respiratory
Distress Syndrome (ARDS) and revealed no safety issues at the
doses tested. ARDS can be a lethal complication of auto-destructive
inflammation caused by sepsis, severe pneumonia, trauma and drug
overdose and has a mortality rate in excess of 50%. Licensed from
Baxter International, ALS-886 possesses unique characteristics
which make it an excellent candidate to develop for the treatment
of ARDS.
"ARDS is a syndrome of inflammation and increased pulmonary
vascular permeability that results in severe lung damage. Oxidants
released from cells during inflammation have been implicated in
the cause of lung tissue damage associated with ARDS. Despite
significant progress that has been made in recent years in the
understanding of ARDS pathogenesis, and even with advances in
technology, the mortality rate remains high," said Dr. Michael
T. Flavin, CEO of Advanced Life Sciences.
The Company will evaluate the safety and tolerability of ALS-886
when administered to healthy volunteers and characterize the pharmacokinetic
profile of ALS-886 when administered intravenously at each dose
level.
"We are very excited about achieving this latest milestone
in our drug development program," added Dr. Flavin. "We
look forward to commencing human clinical trials on ALS-886."
Advanced Life Sciences (www.advancedlifesciences.com), based in
Woodridge, Illinois, is a privately held drug development company
that discovers and develops therapeutic compounds to fight infection,
inflammation and cancer. The Company facilitates drug development
between drug discovery and pharmaceutical commercialization, and
focuses on diseases that have significant unmet medical needs
in important markets.
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