Hypothesis: Oral administration of the oxalate metabolizing enzyme Oxazyme (OC4) will degrade food-borne oxalate and hence prevent its absorption from the gastrointestinal tract. In addition, by reducing oxalate concentrations in the gastrointestinal fluid, oxalate secretion from blood to the intestinal tract may be increased. Both effects would decrease blood levels of oxalate, and hence oxalate excretion in the urine.

开始日期2010-05-01

申办/合作机构

Mayo Clinic

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100 项与 Recombinant oxalate degrading enzyme(OxThera AB) 相关的临床结果

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100 项与 Recombinant oxalate degrading enzyme(OxThera AB) 相关的转化医学

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100 项与 Recombinant oxalate degrading enzyme(OxThera AB) 相关的专利（医药）

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项与 Recombinant oxalate degrading enzyme(OxThera AB) 相关的文献（医药）

2013-03-01·Journal of Endourology3区 · 医学

Second Place: The Effects of Oxazyme on Oxalate Degradation: Results and Implications ofIn VitroExperiments

3区 · 医学

Article

作者: Holmes, Ross P. ; Knight, John ; Mufarrij, Patrick W. ; Assimos, Dean G. ; Lange, Jessica N.

Abstract Background and Purpose: Urinary oxalate excretion influences the development of calcium oxalate kidney stones. Urinary oxalate is derived from dietary sources and endogenous synthesis. Oxalate decarboxylase metabolizes oxalate and, if consumed, could theoretically accomplish this in the gastrointestinal tract. This study aimed to determine whether a commercially produced form of oxalate decarboxylase (Oxazyme(®)) could degrade oxalate in simulated gastric and intestinal environments.MATERIALS AND METHODSOne buffer (pH 3.6) simulated the gastric environment, while another (pH 6.5), approximated the proximal intestine. Potassium oxalate (soluble form of oxalate) and whole and homogenized spinach (a high oxalate containing food) were incubated in the different buffered solutions, with or without Oxazyme. Oxalate content, after incubation, was measured using established ion chromatographic techniques.RESULTSOxazyme resulted in complete degradation of oxalate derived from potassium oxalate in the intestinal buffer; meanwhile, oxalate derived from potassium oxalate in the gastric buffer was profoundly digested by Oxazyme. Adding Oxazyme also substantially reduced the oxalate content of both whole and homogenized spinach preparations, in either buffer.CONCLUSIONSThese in vitro findings demonstrate that Oxazyme can metabolize oxalate in both simulated gastric and small intestinal environments.

2010-01-01·International Journal of Toxicology4区 · 医学

14-Day Repeat-Dose Oral Toxicity Evaluation of Oxazyme in Rats and Dogs

4区 · 医学

Article

作者: Li, Qing-Shan ; Dean, Robin R. ; Sidhu, Harmeet ; Ghoddusi, Majid ; Poage, Duane W. ; Cowley, Aaron B. ; Meschter, Carol L.

Oxazyme (OC4) is an orally administered formulation that has as an active component a recombinant mutant form of Bacillus subtilis oxalate decarboxylase (OxDC) enzyme C383S, designed to degrade dietary oxalate in the stomach. Fourteen-day repeat-dose studies were conducted in rats and dogs to evaluate toxicity and determine a no observed adverse effect level (NOAEL). Animals were administered OC4 by oral gavage twice daily for 14 consecutive days. Reversibility, progression, and delayed appearance of any observed changes were evaluated in a subset of animals that underwent a recovery of 7 days following 14 days of control or test-article. There were no test-article-related adverse effects or deaths in either species. Results indicate that the NOAEL under the conditions used in the studies was 720.8 mg/kg/d in rats and 187.2 mg/kg/d in dogs, the high dose tested in each species.

100 项与 Recombinant oxalate degrading enzyme(OxThera AB) 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
高草酸尿症	临床2期	-	OxThera AB	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01127087 (CTgov)	临床1/2期	高草酸尿症	22	Oxazyme (RYGB CaOx Stone Formers)	願淵獵遞鏇範壓選膚鬱(壓艱顧壓窪鏇遞廠鹹範) = 壓鏇顧繭齋艱齋鏇願鬱鹹衊積齋築簾鬱齋廠簾 (積夢願獵窪鬱憲鑰選簾, 觸餘構鬱築築憲窪網夢 ~ 蓋範糧築糧簾鹽鬱願構) 更多	-	2012-12-24
				Oxazyme (Idiopathic Hyperoxaluria CaOx Stone Formers)	願淵獵遞鏇範壓選膚鬱(壓艱顧壓窪鏇遞廠鹹範) = 獵繭顧夢夢積壓網齋膚鹹衊積齋築簾鬱齋廠簾 (積夢願獵窪鬱憲鑰選簾, 衊憲蓋鬱鏇積衊繭鑰範 ~ 廠蓋艱壓壓築選壓壓淵) 更多