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.

Start Date01 May 2010

Sponsor / Collaborator

Mayo Clinic

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100 Clinical Results associated with Recombinant oxalate degrading enzyme(OxThera AB)

100 Translational Medicine associated with Recombinant oxalate degrading enzyme(OxThera AB)

100 Patents (Medical) associated with Recombinant oxalate degrading enzyme(OxThera AB)

Literatures (Medical) associated with Recombinant oxalate degrading enzyme(OxThera AB)

01 Mar 2013·Journal of EndourologyQ3 · MEDICINE

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

Q3 · MEDICINE

Article

Author: 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.

01 Jan 2010·International Journal of ToxicologyQ4 · MEDICINE

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

Q4 · MEDICINE

Article

Author: 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 Deals associated with Recombinant oxalate degrading enzyme(OxThera AB)

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Indication	Highest Phase	Country/Location	Organization	Date
Hyperoxaluria	Phase 2	United States	OxThera AB	01 May 2010

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01127087 (CTgov)	Phase 1/2	Hyperoxaluria	22	Oxazyme (RYGB CaOx Stone Formers)	jsgujyupya(rfzrwwuegx) = xcyxbejuqe xnmgzxwhxz (chqkilbtey, uhiyiztvvm - mpbxqngfsy) View more	-	24 Dec 2012
				Oxazyme (Idiopathic Hyperoxaluria CaOx Stone Formers)	jsgujyupya(rfzrwwuegx) = fhexjcawng xnmgzxwhxz (chqkilbtey, xbwfnupbis - tyayqalres) View more

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