SCOLR Reports Promising Results from Second CDT(R)-Raloxifene Trial.BELLEVUE, Wash. -- SCOLR Pharma, Inc. (AMEX AMEX See: American Stock Exchange : DDD DDD Direct Distance Dialing DDD Digital/Digital/Digital (audio CD format, recording/mixing/mastering) DDD Degenerative Disc Disease DDD Domain Driven Design DDD Data Display Debugger (GNU Project) ) announced today promising results from its recently completed CDT CDT abbr. Central Daylight Time CDT Central Daylight Time CDT n abbr (US) (= Central Daylight Time) → hora de verano del centro; (BRIT [R]-raloxifene bioavailability bioavailability /bio·avail·a·bil·i·ty/ (bi?o-ah-val?ah-bil´i-te) the degree to which a drug or other substance becomes available to the target tissue after administration. bi·o·a·vail·a·bil·i·ty n. testing in Canada. The objective of the testing was to assess and compare the pharmacokinetic parameters of raloxifene CDT tablets to the reference formulation of Evista[R] 60 milligram milligram /mil·li·gram/ (mg) (mil´i-gram) one thousandth (10-3) of a gram. mil·li·gram n. Abbr. mg A metric unit of mass equal to one thousandth (10-3) of a gram. (mg) tablets. The trial was a 36-subject (32 completed the study), single dose, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , four way cross-over, open label study. It was conducted in fasted, post-menopausal or surgically sterile healthy females. The CDT-raloxifene tablets were well tolerated. Stephen J. Turner, SCOLR's Chief Technical Officer, stated, "We are very pleased with the overall trial outcome and especially with the performance of one of our CDT-raloxifene tablet treatment groups. The best performing formulation utilized a combination of a CDT amino acid formulation with new technology designed to overcome the inherent bioavailability limitations of the drug. The relative bioavailability seen in this treatment group was approximately 20% higher than that obtained with the Evista[R] controls. As reported in a previous study, the CDT-raloxifene treatment groups also resulted in less variability than did the Evista controls." Dr. Reza Fassihi, a member of SCOLR's Board of Directors, a technical advisor to SCOLR, and the primary innovator of the CDT technology, commented, "I am very encouraged by the performance of SCOLR's CDT-based raloxifene in this recent study. It clearly demonstrates that SCOLR's oral drug delivery technology can improve the bioavailability and reduce the variability of this difficult to absorb and highly variable compound without the use of more complex solubilization techniques such as nano-particulate, micronization micronization a process for preparing medication in which the particle size is greatly reduced, thereby increasing absorption following oral administration. , or encapsulation." A summary of the study's results will be available for discussion at SCOLR's exhibit booth during the 20th Annual Meeting of the American Association of Pharmaceutical Scientists, October 30 - November 2, 2006 in San Antonio, Texas “San Antonio” redirects here. For other uses, see San Antonio (disambiguation). San Antonio is the second most populous city in Texas, the third most populous metropolitan area in Texas, and is the seventh most populous city in the United States. As of the 2006 U.S. . Raloxifene hydrochloride hydrochloride /hy·dro·chlo·ride/ (-klor´id) a salt of hydrochloric acid. hy·dro·chlo·ride n. A compound resulting from the reaction of hydrochloric acid with an organic base. is the active ingredient in Evista[R], Eli Lilly's immediate release tablets for osteoporosis. Evista uses a different solubilization technology. In 2004, Eli Lilly (NYSE NYSE See: New York Stock Exchange :LLY - News) reported over $1 billion in global Evista sales. Commercially available Evista 60 mg. immediate release tablets served as controls in this study. Relative bioavailability referenced in this press release is a comparison of the amount of measurable raloxifene found in the trial subjects' plasma for a milligram of raloxifene administered in the CDT tablets versus a milligram of raloxifene administered in the Evista[R] control tablets. Based in Bellevue, Washington, SCOLR Pharma, Inc. is a specialty pharmaceutical company leveraging formulation expertise and its patented CDT platform to introduce distinctive and novel OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). products, prescription drugs and dietary supplements. SCOLR Pharma's CDT drug delivery platform provides distinctive products with tangible benefits for the consumer and competitive commercial advantages for licensees. For more information on SCOLR Pharma, please call (425) 373-0171 or visit www.scolr.com. This press release contains forward-looking statements (statements which are not historical facts) within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These forward-looking statements involve risks and uncertainties, including activities, events or developments that we expect, believe or anticipate will or may occur in the future. A number of factors could cause actual results to differ from those indicated in the forward-looking statements, including our ability to successfully develop new formulations and complete research and development, including pre-clinical and clinical studies, our ability to raise additional funds, the continuation of arrangements with our product development partners and customers, competition, government regulation and approvals, and general economic conditions. For example, if our clinical trials are not successful or take longer to complete than we expect, we may not be able to develop and commercialize our products. And we may not obtain regulatory approval for our products, which would materially impair our ability to generate revenue. Additional assumptions, risks and uncertainties are described in detail in our registration statements, reports and other filings with the Securities and Exchange Commission. Such filings are available on our website or at www.sec.gov. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances. |
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