Method to increase the growth velocity of human infants
A technology of growth rate and infant formula, which is applied in the field of improving the growth rate of human infants, and can solve problems such as unpublished curative effect results
Inactive Publication Date: 2013-07-10
SWEDISH ORPHAN BIOVITRUM AB
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Problems solved by technology
Recently, it was announced that a further phase II trial had been completed using an oral suspension of rhBSSL (described therein as "Bucetase alpha alpha") at a dose of 170 mg 3 times a day 5-6 days to assess the effect on fat absorption in adult patients with CF and PI, however no efficacy results have been published thus far (Clinical Trial. Government Identification Number NCT00743483)
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[0173] The following examples, including experiments performed and results performed, also illustrate various present specific embodiments of the invention, and are provided for illustrative purposes only and are not to be construed as limiting the invention.
[0174] Section 1: Drug Substances, Their Characterization, and Preparation of Investigational Drug Products
[0175] According to the standard procedure, the predicted amino acid with SEQ ID. Sequence of API (human bile salt-stimulated lipase). Briefly, the 2.3 Kb cDNA sequence encoding the full-length hBSSL including the leader sequence (described by Nilsson et al., 1990; Eur J Biochem, 192:543-550) was obtained from pS146 (Hansson et al., 1993; : 26692-26698) and cloned into the expression vector pAD-CMV1 (Boehringer Ingelheim) - a pBR-based plasmid containing the CMV promoter / SV40 polyA signal (for gene expression) and the dhfr gene (for selection / amplification) - to form pAD-CMV-BSSL. Afterwards, pAD-CMV-BSSL w...
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Abstract
The present invention relates to a method to increase the growth velocity of a human infant, said method comprising the enteral administration to said infant of recombinant human bile-salt- stimulated lipase (rhBSSL). Such method has particular utility for underweight or preterm human infants, particular those in medical need of increasing their growth velocity. In other aspects, the invention relates to compositions, including infant feeds, kits, packaged-pharmaceutical-products and pharmaceutical compositions, and also to methods to prepare infant feeds, in each case useful for increasing the growth velocity of a human infant. In another aspect, the present invention relates to methods to: (X) protect the small bowel mucosa of a human infant from damage; to (Y) protect an immature intestinal epithelium of a human infant from the deleterious effects of incompletely digested and / or excess fat and / or lipid; and / or to (Z) limit accumulation of incompletely digested and / or excess fat and / or lipid in the ileum of a human infant; said methods in each case comprising the step of enteral administration of recombinant human bile salt stimulated lipase to said infant. The present invention also relates compositions, including infant feeds, kits, packaged-pharmaceutical-products and pharmaceutical compositions, and also to methods to prepare infant feeds, in each case useful for these protective or accumulation-limiting methods.
Description
technical field [0001] The present invention relates to a method for increasing the growth rate of a human infant, the method comprising administering recombinant human bile-salt-stimulated lipase (rhBSSL) to the intestine of the infant. Such methods are particularly useful in underweight or premature human infants, especially those in medical need to increase their growth rate. In yet other aspects, the present invention relates to compositions, including baby food, kits, packaged pharmaceutical products and pharmaceutical compositions, and also to methods for preparing baby food, which in each case are useful for improving human The baby's growth rate. In another aspect, the invention relates to a method for: (X) protecting the small intestinal mucosa of a human infant from damage; (Y) protecting the immature intestinal epithelium of a human infant from incompletely digested and / or excess fat and / or the detrimental effects of lipids; and / or (Z) limiting the accumulation of...
Claims
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IPC IPC(8): A61K38/43A61P1/00A23L33/00
CPCC12Y301/01013A23L5/00A23L33/40A23L33/17C12Y301/01003A61K38/465A61P1/00A61P43/00A23V2002/00
Inventor 奥勒·赫内尔帕特里克·施特龙贝格伦纳特·斯文松克里斯蒂娜·蒂姆达尔马尔滕·沃格勒马里亚·厄曼比吉塔·奥尔森
Owner SWEDISH ORPHAN BIOVITRUM AB