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| |  Preliminary CholestaGel Data Results Confirm Previous Findings WALTHAM, Mass., Jan. 22, 1997 -- A preliminary analysis by GelTex Pharmaceuticals, Inc. (Nasdaq: GELX) of data from two Phase II clinical studies of CholestaGel(R) non-absorbed cholesterol reducer was announced today. Among the key findings of the studies were comparable cholesterol lowering activity between once daily and split dosing, and better toleration than had been observed in a previous Phase II study reported last year. The CholestaGel material used in these two studies, manufactured by an improved process, did not affect the cholesterol lowering activity of the product. This new material did produce an increase in shelf-life and a lower cost of goods. The newly reported studies were designed to evaluate dose response and dose frequency. The first, comparing once daily dosing against split dosing in 120 patients, produced clear evidence that once daily dosing is at least as effective as split dosing. In the second, 147-patient, multi-center dose ranging study, the preliminary results demonstrated comparable efficacy, on a milligram/deciliter basis, with a Phase II study completed in March 1996. CholestaGel was well tolerated in both of the newly reported studies, with a lack of gastrointestinal side effects such as constipation, which are significant problems with existing bile acid sequestrants. The Company also announced that it has developed a 650 mg tablet formulation of CholestaGel which will be used in subsequent clinical studies of the drug, replacing the 400 mg capsule used in the studies conducted to date. The 650 mg formulation is designed to allow a reduction in the number of tablets needed to achieve the desired reduction in cholesterol levels. "The potential of CholestaGel as an important therapeutic product with significant patient benefits was supported by the results of these two trials," commented Mark Skaletsky, President and CEO of GelTex. "We believe that a reduction in the number of pills required, combined with once daily dosing, will offer maximum flexibility to the target population. "The next step in our development program will be to conduct another Phase II study with what we believe is the optimum treatment -- the 650 mg tablet formulation administered in a once a day regimen -- in order to advance into pivotal Phase III trials," Mr. Skaletsky added. GelTex is also conducting Phase III clinical trials with RenaGel(R) phosphate binder for the control of elevated phosphorus levels in chronic kidney failure patients. Preliminary data from these trials announced on January 8, 1997, indicated that RenaGel significantly decreased serum phosphorus without increasing serum calcium. Additionally, the Company is conducting research to develop non-absorbed, polymer-based pharmaceuticals for the treatment of certain infections of the intestinal tract. GelTex Pharmaceuticals, Inc. is developing polymer-based pharmaceuticals that selectively bind and eliminate target substances from the intestinal tract. The Company's products under development are orally delivered in a convenient capsule form, are not absorbed into the bloodstream, and are eliminated from the body through normal digestive processes. GelTex's advanced polymer technology is applicable to a broad number of diseases and conditions treatable through the intestinal tract. This press release may contain forward-looking statements based on current management expectations. There are certain key factors that could cause future results to differ from those anticipated by management. Such factors include, but are not limited to, technical risks associated with the development of new products, the continued progress of clinical trials of the Company's products, the Company's ability to continue to establish collaborative agreements with third parties, the continued availability of raw material for the Company's products, the competitive environment of the biotechnology and pharmaceutical industries, and general economic conditions.
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