CHICAGO, Aug. 10 /PRNewswire-FirstCall/ -- 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.
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. Forward-looking statements represent our
management's judgment regarding future events. 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, future revenues and capital requirements; our
ability to obtain financing on terms acceptable to us; 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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