Advanced Life Sciences (OTCBB:ADLS)
Intraday Stock Chart
Today : Tuesday 10 August 2010
Advanced Life Sciences Holdings, Inc. (OTC Bulletin
Board: ADLS), a biopharmaceutical company engaged in the discovery,
development and commercialization of novel drugs in the therapeutic
areas of infection, oncology and respiratory diseases, announced today
that it has reached agreement with the United States
Food and Drug Administration (FDA), under the Special Protocol
Assessment (SPA) process, on the design of its planned Phase 3 study of
its novel once-daily oral antibiotic Restanza™ to treat community
acquired bacterial pneumonia (CABP). The trial is the first
prospectively designed superiority study to be conducted in CABP.
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The double-blind pivotal superiority study will compare the efficacy
and safety of once-daily oral administration of 300 milligrams of
Restanza over seven days of treatment to azithromycin. The primary
efficacy endpoint will be the clinical cure rate in a
macrolide-resistant Streptococcus pneumoniae (MRSP) population. The
protocol also includes several unique features, such as the inclusion
of patient-reported outcome measures, which have the potential to
generate a more robust demonstration of effectiveness and establish
Restanza as a new standard of care in treating pneumonia.
With reported resistance rates as high as 40 percent to
standard-of-care macrolide antibiotics in the U.S., there is a pressing
medical need for new drugs to treat CABP. Based on the data Advanced
Life Sciences has accumulated in its extensive pre-clinical and clinical
program to date, coupled with a thorough review of published literature
on the clinical relevance of macrolide resistance, the company believes
that Restanza has the potential to show a superior efficacy advantage
in patients who are resistant to marketed macrolide drugs.
"We are pleased that the FDA has agreed to a SPA which provides a
clear pathway to approval for Restanza in the CABP indication, and which
is designed to meet the needs of the community, industry and
regulators," said Michael T. Flavin,
Ph.D. CEO of Advanced Life Sciences. "We believe that the
superiority-based SPA represents a precedent-setting clinical trial
design for oral antibiotics and will make a significant contribution to
the field of CABP and antimicrobial clinical trial design. Regulators,
industry and experts in the field have long recognized the need for
clinical design protocols that will help to bring innovative and
important antimicrobial therapies to the market. Advanced Life Sciences
welcomes the opportunity to demonstrate the broad efficacy of our unique
product candidate and to play a leadership role in advancing the science and clinical practice of treating pneumonia."
Continued Dr. Flavin: "Using clinical response in the MRSP population
as the primary endpoint provides the most scientifically meaningful
approach to demonstrate a clinical efficacy advantage against resistant
strains of Streptococcus pneumonia. Importantly, this approach will
provide Advanced Life Sciences a viable path to move Restanza towards
approval and commercialization."
About Special Protocol Assessments
An SPA is a written agreement between the FDA and a drug sponsor
concerning the clinical trial design, clinical endpoints and other
clinical trial issues that can be used to support regulatory approval of
a drug candidate. The process is intended to provide assurance that if
the agreed upon clinical trial protocols are followed, the clinical
trial endpoints are achieved and there is a favorable risk benefit profile, the data may serve as the primary basis of an efficacy claim in support of a New Drug Application.
About Community Acquired Bacterial Pneumonia (CABP)
CABP is the sixth most common cause of death in the United States.
CABP and other respiratory tract infections are caused by pathogens
such as Streptococcus pneumoniae and Haemophilus influenzae.
Approximately 5.6 million cases of CABP are diagnosed each year in the United States with 10 million physician visits, resulting in an estimated total annual expenditure of $2.0 billion
for prescribed antibiotics to treat CABP. CABP is potentially fatal if
not treated properly, and the bacteria that cause CABP are developing
resistance to current standard of care treatments.
Macrolides and penicillins are currently the front-line treatments
for respiratory tract infections such as CABP. As macrolide and
penicillin resistance grows and has the potential to cause more clinical
failures, there is a need for new antibiotics with unique mechanisms of
action that can overcome this emerging resistance.
About Restanza
Restanza is a novel oral once-a-day antibiotic that is in late stage
development for the treatment of CABP and biodefense pathogens. It has
shown higher in vitro potency and a broader range of activity than
macrolides against Gram-positive bacteria including CA-MRSA and
pathogens associated with respiratory tract infections and appears to be
effective against penicillin-,
macrolide- and fluoroquinolone-resistant bacteria. Restanza's
demonstrated potency and ability to overcome bacterial resistance may be
due to its mechanism of action resulting in specificity for its
bacterial target. In addition to its utility in CABP, Restanza is also
being investigated for the prophylactic treatment of inhalation anthrax
post-exposure and other high priority biodefense pathogens, including
plague and tularemia. The FDA has designated Restanza as an orphan drug
for the prophylactic treatment of inhalation anthrax post exposure, as
well as for use in treating plague and tularemia, but the drug is not
yet approved for these or any other indications.
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 respiratory diseases. The
Company's lead candidate, Restanza™, is a novel once-a-day oral
antibiotic in late-stage development for the treatment of respiratory
tract infections including community acquired bacterial pneumonia (CABP)
and biodefense pathogens including anthrax, plague and tularemia.
For more information, please visit us on the web at www.advancedlifesciences.com or follow us on twitter at http://twitter.com/advancedlifesci.