�Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) proclaimed modifications to the clinical protocol for TIGER-2, the Company's on-going second Phase 3 test with denufosol tetrasodium for the treatment of cystic fibrosis (CF).
"The handiness of the extensive information set from the incontrovertible TIGER-1 trial provides an excellent opportunity to optimise the TIGER-2 trial design," stated Christy L. Shaffer, Ph.D., President and CEO of Inspire. "In interview with key experts, we determined that a yearner treatment geological period of 48 weeks is appropriate based on the progressive betterment from baseline in FEV1 observed in patients wHO received denufosol in both the 24-week, placebo-controlled period of TIGER-1, as well as the 24-week open-label safety extension. Importantly, based on further analysis of preliminary information available in July 2008 from patients who received denufosol for the full 48 weeks, the miserly change from baseline in FEV1 more than than twofold compared to the 24-week trial terminus.
"We ar working with the participating clinical trial sites and the CF Foundation to increase cognizance about TIGER-2 and recruit patients in order to complete the trial as quickly as possible. We will leave periodic updates on registration as the trial progresses," concluded Dr. Shaffer.
"The positive results of TIGER-1 have generated additional interest in denufosol in the CF medical community, which should facilitate enrollment in TIGER-2," stated Felix Ratjen, M.D., Ph.D., Professor of Pediatrics and Division Chief, Respiratory Medicine, University of Toronto, and lead principal investigator of TIGER-2. "The potential for denufosol to treat the underlying ion channel defect in CF, coupled with the efficacy and guard shown in TIGER-1, is an exciting step fore in the search for novel treatments for CF."
TIGER-2 is a double blind, placebo-controlled, randomized study comparison 60 mg of denufosol inhaled tierce times day-to-day to placebo. The cay changes to the protocol are:
� Increasing the length of the trial from 24 to 48 weeks, such that the chief efficacy termination will be change from baseline in FEV1 (Forced Expiratory Volume in One Second) (in liters) at the 48-week trial termination;
� Increasing the target registration from 350 patients to approximately 450 patients; and
� Modifying entrance criteria to add an upper demarcation to the lung function criteria (targeting patients with a baseline FEV1 ? 75% and ? 110% predicted normal).
In addition, although in that respect is no regulatory requirement to do so, Inspire plans to offer patients completing TIGER-2 an option to encounter denufosol through participation in a subsequent open-label trial.
Inspire has submitted a protocol amendment to the U.S. Food and Drug Administration (FDA) and has begun effectuation with clinical trial sites. Based on the changes in the protocol, the availability of TIGER-2 results will be dependent on the rate of enrollment in the trial, only will likely follow receipt of the final field report of the on-going two-year carcinogenicity study in rodents.
TIGER-2 Enrollment Status Currently, at that place are 62 patients enrolled at 25 of the approximately 90 participating clinical trial sites in the U.S. and Canada. Of the 65 sites that have non yet enrolled patients, or so 15 are currently quick to inscribe patients and it is expected that most of the unexpended 50 sites will be ready to enroll patients by the end of 2008. Inspire expects the majority of the patients currently enrolled to elect to enter in the 48-week trial.
TIGER-1 Open-Label Safety Extension Status Following the 24-week placebo-controlled period of TIGER-1, approximately 315 patients continued into the open-label refuge extension share of the trial and as of early July 2008, just about 245 of those patients had completed the good trial for a tally of 48 weeks. The safety extension is ongoing with the remaining patients.
About Denufosol Tetrasodium Denufosol is intentional to heighten the lung's innate mucosal hydration and mucociliary headroom mechanisms, which in CF patients ar impaired due to a genetic mar. By hydrating airways and stimulating mucociliary clearance through activation of the P2Y2 receptor, denufosol can potentially help hold back the lungs of CF patients unclutter of thickened mucus, subjugate infections and limit the damage that occurs as a event of the prolonged retention of thick and flashy infected secretions.
Denufosol is currently in Phase 3 testing for the intervention of CF. Positive top-line results from the first Phase 3 trial, TIGER-1, were announced in June 2008. Denufosol for the treatment of CF has been granted Fast Track designation and orphan drug status in the United States by the FDA and orphan drug identification in Europe by the European Medicines Agency (EMEA). Inspire holds world-wide rights for denufosol.
About Cystic Fibrosis Cystic fibrosis is a serious disease involving a genetical mutation that disrupts the cystic fibrosis transmembrane regulator (CFTR) protein, resulting in poorly hydrous, thickened mucose secretions in the lungs, as well as severely impaired mucociliary clearance. According to the U.S. Cystic Fibrosis Foundation (CFF), there are about 30,000 CF patients in the United States and the median life expectancy for patients is approximately 37 years (CFF Patient Registry Annual Data Report 2006).
About Inspire Inspire is a biopharmaceutical company dedicated to discovering, developing and commercializing prescription pharmaceutical products for ophthalmic and pneumonic diseases. Inspire is currently developing products for dry eye, cystic fibrosis and glaucoma. Inspire employs a U.S. gross revenue force for the promotion of AzaSite� (azithromycin ophthalmic solution) 1% for bacterial conjunctivitis, Elestat� (epinastine HCl ophthalmic solution) 0.05% for supersensitised conjunctivitis and Restasis� (cyclosporine ophthalmic emulsion) 0.05% for dry eye. Elestat and Restasis are registered trademarks owned by Allergan, Inc. AzaSite is a registered trademark owned by InSite Vision Incorporated.
http://www.inspirepharm.com
Forward-Looking Statements The forward-looking statements in this news sacking relating to management's expectations and beliefs are based on preliminary information and management assumptions. Specifically, no assurance can buoy be made with respect to the outcome of the TIGER-2 trial, including without limit the impingement, if any, of the changes in the protocol on the likelihood that the trial run will converge its primary or secondary endpoints, or otherwise be successful. No assurance can be made that the improvement from baseline in FEV1 discovered in those patients world Health Organization received denufosol and completed the 24-week, placebo-controlled period and the 24-week open-label safety prolongation, will be seen in those patients who received denufosol and who completed the 24-week, placebo-controlled flow, but have not yet completed the 24-week open-label safety extension. No assurance can be made with respect to the timing of the TIGER-2 trial, including without limitation the timing or ability of Inspire, the participating clinical trial sites or the CF Foundation to gain awareness nigh TIGER-2 and recruit patients in order to complete the trial as quickly as possible; the ability of the results of TIGER-1 to facilitate registration in TIGER-2; the likelihood that the results of TIGER-2 volition follow receipt of the final study report of the ongoing two-year carcinogenicity study in rodents; the likelihood that patients currently enrolled in TIGER-2 testament elect to participate in the 48-week trial; and the timing of the commencement of enrollment at any of the clinical trial sites. Furthermore, no assurance be made with respect to the planned open-label trial subsequent to TIGER-2, including the design, timing or results. Such innovative statements ar subject to a broad range of risks and uncertainties that could cause results to differ in material respects, including those relating to product development, revenue, expense and earnings expectations, intellectual property rights, adverse judicial proceeding developments, inauspicious developments in the U.S. Securities and Exchange Commission (SEC) probe, competitive products, results and timing of clinical trials, success of marketing efforts, the penury for extra research and testing, delays in manufacturing, funding, and the timing and content of decisions made by regulatory authorities, including the U.S. Food and Drug Administration. Further information regarding factors that could strike Inspire's results is included in Inspire's filings with the SEC. Inspire undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that english hawthorn be made to contemplate events or circumstances after the date hereof.
Inspire Pharmaceuticals, Inc.
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