Advancis Pharmaceutical Announces Positive Results for Amoxicillin PULSYS Phase III Trial
10 Agosto 2006 - 12:25PM
PR Newswire (US)
All Trial Endpoints Achieved; Amoxicillin PULSYS Demonstrated
Bacterial Eradication of 85 Percent GERMANTOWN, Md., Aug. 10
/PRNewswire-FirstCall/ -- Advancis Pharmaceutical Corporation
(NASDAQ:AVNC), a pharmaceutical company focused on developing and
commercializing novel anti-infective products, today announced that
its Amoxicillin PULSYS Phase III clinical trial for the treatment
of adults and adolescents with pharyngitis/tonsillitis due to Group
A streptococcal infections (commonly referred to as strep throat)
achieved its desired microbiological and clinical endpoints.
Positive trial results were achieved with a once-daily 775
milligram dose of Amoxicillin PULSYS for 10 days. The most commonly
prescribed treatment for the management of Group A streptococcal
pharyngitis is 500 milligrams of amoxicillin dosed three-times
daily for a period of 10 days. Amoxicillin is currently not
approved for once-daily dosing to treat pharyngitis. "The positive
outcome of this trial provides proof-of-concept that PULSYS
antibiotic dosing is effective in eradicating streptococcal
bacteria in humans," stated Edward Rudnic, president and CEO of
Advancis. "If approved for marketing, we believe our once-daily
version of amoxicillin would represent a major advance in the most
widely used antibiotic in the U.S. and would be the first and only
once-daily amoxicillin therapy approved for marketing in the United
States." The trial compared Advancis' Amoxicillin PULSYS 775
milligram tablet dosed once-daily for 10 days to 250 milligrams of
penicillin VK dosed four times daily for 10 days in adults and
adolescents. According to top-line trial data received earlier
today, Amoxicillin PULSYS demonstrated statistical non- inferiority
to the comparator therapy in the trial's primary endpoints --
bacterial eradication at the post-therapy "test-of-cure" visit for
patients who fully complied with the trial protocol, as well as in
a larger patient population. Amoxicillin PULSYS also demonstrated
non-inferiority in the trial's secondary endpoints, including
clinical cure at the test-of-cure visit and bacterial eradication
at the late post-therapy visit. "The study results show that
once-daily PULSYS release dosing can effectively eradicate bacteria
in the pharynx while significantly reducing the total daily dose of
antibiotic. This approach could have far reaching implications for
the future treatment of infectious disease," noted George Drusano,
M.D., co-director, Ordway Research Institute and member of the
Advancis Scientific Advisory Board. Clinical Trial Results Summary
Advancis' trial enrolled 620 adult and adolescent patients in a
double- blind, double-dummy, randomized, parallel-group, 50-center
non-inferiority Phase III trial that began on November 9, 2005. The
Company compared its Amoxicillin PULSYS tablet for the treatment of
pharyngitis/tonsillitis due to S. pyogenes (Group A streptococcus)
delivered in a once-daily, 775 milligram tablet for a period of 10
days to 250 milligrams of penicillin dosed four times daily, for a
total of one gram per day, for 10 days. The primary endpoints for
the study were bacteriological eradication at the test-of-cure
visit following antibiotic therapy, as measured by throat cultures
both before and after treatment, for both the eligible
"per-protocol" patient population and the modified
"intent-to-treat" patient population. Per-protocol patients were
fully compliant with all required elements of the clinical study;
modified intent-to-treat patients received at least one dose of
study medication, had a positive culture for S. pyogenes at the
first office visit, and had clinical safety data available
following therapy. The trial was designed to demonstrate
statistical non-inferiority of Amoxicillin PULSYS therapy versus
the penicillin comparator therapy in each of the patient
populations. Bacteriological eradication at the post-therapy
test-of-cure visit in the per-protocol population was 85.0 percent
(198/233) of patients with Amoxicillin PULSYS and 83.4 percent
(191/229) with penicillin. These results demonstrate statistical
non-inferiority (95 percent confidence interval of -5.1, 8.2).
Bacteriological eradication at the post-therapy test-of-cure visit
in the modified intent-to-treat population was 82.4 percent
(211/256) of patients with Amoxicillin PULSYS and 78.4 percent
(207/264) with penicillin. These results demonstrate statistical
non-inferiority (95 percent confidence interval of -2.8, 10.8).
Secondary endpoints included non-inferiority of clinical cure rates
at the test-of-cure visit and bacterial eradication rates at the
late post-therapy visit, and the incidence of any adverse events
during the treatment period. Secondary endpoints in the trial were
consistent with the primary endpoints, with Amoxicillin PULSYS
therapy demonstrating statistical non-inferiority to the comparator
therapy in all categories. Advancis expects to receive full results
and safety data from the Phase III trial by the end of September.
Advancis also anticipates presenting results of the primary and
secondary endpoint analysis of the trial at upcoming scientific and
medical meetings and publishing detailed data in peer review
journals over the coming months. "With limited oral antibiotic
research underway in ambulatory patients, this advance is truly an
innovative step forward," said Stan L. Block, M.D., professor of
clinical pediatrics at the Universities of Louisville and Kentucky
Medical Schools and an investigator in the Amoxicillin PULSYS
study. "The outcomes were achieved through a single daily dose
administration, a significant factor with the potential to
positively impact patient compliance. The trial results hold
promise for pulsatile antibiotic dosing to provide an effective
first-line therapy to treat outpatient streptococcal infection and
prevent its complications." Based on its prior meetings with the
U.S. Food and Drug Administration (FDA), Advancis believes the
positive Amoxicillin PULSYS Phase III trial, along with existing
academic literature data and analysis from the Company's prior
Amoxicillin PULSYS Phase I and Phase III studies, provide the
necessary clinical data required to support a New Drug Application
(NDA) filing for product approval. Advancis will continue its work
already begun to complete a NDA for a once-daily adult amoxicillin
PULSYS product and plans on filing the NDA with the FDA in late
2006 or very early in 2007. Amoxicillin PULSYS Overview Advancis'
Amoxicillin PULSYS is a once-a-day pulsatile-release formulation of
amoxicillin for oral administration. Amoxicillin PULSYS is intended
to provide a lower treatment dose, once-daily alternative to
current approved penicillin and amoxicillin regimens for the
treatment of adults and adolescents with tonsillitis and/or
pharyngitis. Amoxicillin is indicated for a broad range of
infections, and is commonly prescribed as a first-line therapy for
common infections such as otitis media (middle ear infection),
pharyngitis (sore throat), and sinusitis (sinus infection). Group A
streptococcus, the primary bacteria causing pharyngitis, have been
uniformly susceptible to amoxicillin and have not developed
resistance to the penicillins, despite the long-term use of
amoxicillin for pharyngitis. According to data from IMS Health, a
pharmaceutical research company, approximately one-quarter of
amoxicillin prescriptions are written for pharyngitis, strep
throat, and tonsillitis in adults and children. Approximately 59
million prescriptions for amoxicillin were written in 2005 with
total retail sales of more than $640 million. About Pharyngitis
Pharyngitis is a painful inflammation of the throat caused by a
variety of microorganisms, both viral and bacterial. About 15
million patients annually seek relief of sore throat symptoms in
the United States. The most common bacterial cause of acute
pharyngitis is Streptococcus pyogenes, or Group A streptococcus,
which is referred to as "strep throat." Symptoms of strep throat
include fever, painful swallowing, swelling of the throat, and
headache. Strep throat can lead to complications, such as rheumatic
fever, and should be treated with antibiotic therapy. CONFERENCE
CALL The Company has scheduled a conference call for today,
Thursday, August 10, 2006 at 4:15 PM ET. During the call, Dr.
Edward Rudnic, chairman, president and CEO, and Dr. Susan Clausen,
vice president, clinical research and regulatory affairs, will
discuss the trial results and other corporate activities. Investors
can call 1-800-813-8504 (domestic) and 1-706-643-7752
(international) prior to the 10:30 AM start time and ask for the
Advancis Pharmaceutical conference call hosted by Dr. Rudnic. A
replay of the call will be available on August 10, 2006 beginning
at 6:30 PM ET and will be accessible until Friday, August 18, 2006
at 5:00 PM ET. The replay call-in number is 1-800-642-1687 for
domestic callers and 1-706-645-9291 for international callers. The
access number is 4352003. The conference call will also be
broadcast simultaneously on the Company's website,
http://www.advancispharm.com/. Investors should click on the
Investor Relations tab and are advised to go to the website at
least 15 minutes early to register, download, and install any
necessary audio software. The call will also be archived on the
Advancis website. ABOUT ADVANCIS PHARMACEUTICAL: Advancis
Pharmaceutical Corporation (NASDAQ:AVNC) is a pharmaceutical
company focused on the development and commercialization of drug
products that fulfill substantial unmet medical needs in the
treatment of infectious disease. The Company is developing a
portfolio of anti-infective drugs based on its novel biological
finding that bacteria exposed to antibiotics in frontloaded
staccato bursts, or "pulses," are killed more efficiently and
effectively than those under standard treatment regimens. Based on
this finding, Advancis has developed a proprietary, once-a-day
pulsatile delivery technology called PULSYS(TM). By examining the
resistance patterns of bacteria and applying its delivery
technologies, Advancis has the potential to redefine infectious
disease therapy and significantly improve drug efficacy, shorten
length of therapy, and reduce drug resistance versus currently
available antibacterial products. For more on Advancis, please
visit http://www.advancispharm.com/. This announcement contains
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities and Exchange Act of 1934, as amended. These statements
are based on Advancis' current expectations and assumptions. These
statements are not guarantees of future performance and are subject
to a number of risks and uncertainties that would cause actual
results to differ materially from those anticipated. The words,
"believe," "expect," "intend," "anticipate," and variations of such
words, and similar expressions identify forward-looking statements,
but their absence does not mean that the statement is not forward-
looking. The actual results realized by Advancis could differ
materially from these forward-looking statements, depending in
particular upon the risks and uncertainties described in the
Company's filings with the Securities and Exchange Commission.
These include, without limitation, risks and uncertainties relating
to the Company's financial results and the ability of the Company
to (1) reach profitability, (2) prove that the preliminary findings
for its product candidates are valid, (3) receive required
regulatory approvals, (4) successfully conduct clinical trials in a
timely manner with favorable results, (5) establish its competitive
position for its products, (6) develop and commercialize products
that are superior to existing or newly developed competitor
products, (7) develop products without any defects, (8) have
sufficient capital resources to fund its operations, (9) protect
its intellectual property rights and patents, (10) implement its
sales and marketing strategy and reach its sales goals, (11)
successfully attract and retain collaborative partners and have its
partners fulfill their obligations, and (12) retain its senior
management and other personnel. Existing and prospective investors
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of today's date. Advancis
undertakes no obligation to update or revise the information in
this announcement, whether as a result of new information, future
events or circumstances or otherwise. DATASOURCE: Advancis
Pharmaceutical Corporation CONTACT: Bob Bannon, Sr. Director,
Investor Relations, of Advancis Pharmaceutical, +1-301-944-6710 Web
site: http://www.advancispharm.com/
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