Healthcare Industry News: sinusitis
News Release - August 10, 2006
Advancis Pharmaceutical Announces Positive Results for Amoxicillin PULSYS Phase III TrialAll Trial Endpoints Achieved; Amoxicillin PULSYS Demonstrated Bacterial Eradication of 85 Percent
GERMANTOWN, Md., Aug. 10 (HSMN NewsFeed) -- 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.
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.
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.
Source: Advancis Pharmaceutical
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