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Therapeutic combinations to treat red blood cell disorders

A technology for red blood cells and diseases, applied in the field of combined preparations

Active Publication Date: 2019-04-19
HARTIS PHARMA SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Managing patients with transfusion-dependent beta-thalassemia remains a challenge for clinicians, and despite effective transfusion regimens, transfusional hemosiderosis is the leading cause of death in these patients

Method used

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  • Therapeutic combinations to treat red blood cell disorders
  • Therapeutic combinations to treat red blood cell disorders
  • Therapeutic combinations to treat red blood cell disorders

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0096] Example 1: Administration of a combination of human recombinant LCAT and a lutein-zeaxanthin mixture

[0097] Combination of the present invention comprising human recombinant LCAT as agent for increasing HDL activity and combination of lutein-zeaxanthin for the treatment of SCD using a mouse SCD model (Fabry, 1993, Cell Mol Life Sci., 49: 28- 36).

[0098] Human Recombinant LCAT rhLCAT (ACP-501) (US 2014 / 0023631) during dose optimization phase (0.3, 3.0 and 9.0 mg / kg) intravenously 3 times over 1 hour, then 3.0 or 9.0 mg every 1 to 2 weeks during maintenance phase / kg for 7 months, daily oral administration of 5, 10, 20 mg lutein-zeaxanthin such as described in US 6,663,900 (Kemin industries, USA). Various parameters, such as increased plasma LCAT activity, HDL particle number, HDL cholesterol, ApoAl, plasma levels of fat-soluble antioxidants and reductions in markers of oxidative stress (eg MDA, lipid peroxides, conjugated dienes) are determined. Tissue and cellul...

Embodiment 2

[0099] Example 2: Administration of a combination of ApoA1 or an ApoA1 mimic and a lutein-zeaxanthin mixture

[0100] The present invention comprises at least one ApoA1 mimetic (including ApoA1-mimetic peptide), such as D-4F and / or full-length ApoA1, prepared as described in US 9,187,551 or US 8,436,152, as a combination of agents that increase HDL activity, and a corpus luteum Combination zeaxanthin for the treatment of SCD, Ryan et al., 1997, Science, 278, 5339, 873-876. Fully formulated ApoA1 mimetics and / or full-length ApoA1 (US 9,125,943, US 8,999,920, US 9,439,946, US 6,287,590, and US 9,187,551) are administered subcutaneously, intravenously or orally in therapeutically effective doses simultaneously with daily oral administration of 5 or 10 or 20mg lutein-zeaxanthin, eg (Commin Corporation, USA). Readouts were monitored as described in Example 1.

Embodiment 3

[0101] Example 3: Administration of apolipoprotein or its mimetic peptide in combination with a lutein-zeaxanthin mixture

[0102] The present invention comprises a combination of at least one apolipoprotein selected from ApoA1, ApoA2, ApoE, ApoC1, ApoC3, ApoL, ApoM, ApoJ, ApoAIV or at least one α-helical mimetic peptide thereof, such as US 9,125,943, US 8,999,920, US9, 439,946, prepared as described in US 6,287,590 or US 9,187,551, as an agent to increase HDL activity, and a combination of lutein-zeaxanthin for the treatment of SCD validated using the SCD mouse model, such as Ryan et al., 1997, Science, 278, 5339, 873-876. Suitably formulated ApoA1, ApoA2, ApoE, ApoC1, ApoC3, ApoL, ApoM, ApoJ, ApoAIV proteins or peptides are administered subcutaneously, intravenously or orally in therapeutically effective doses together with 5 or 10 or 20 mg of lutein-zeaxanthin orally daily qualitative example (Commin Corporation, USA). Readouts were monitored as described in Example 1. ...

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Abstract

The present invention is related to a combination useful in the prevention and / or treatment of red blood cell disorders, in particular, acute and chronic complications associated with red blood cell dysfunction, increased red blood cell cholesterol and decreased plasma levels of lipophilic antioxidant (sickle cell disease, thalassemia, diabetes). The invention in particular relates to pharmaceutical formulations, regimens, methods of treatment and uses thereof.

Description

field of invention [0001] The present invention relates to a combined preparation for the prevention and / or treatment of erythrocyte disorders, in particular acute and chronic complications associated with erythrocyte dysfunction, increased erythrocyte cholesterol and decreased plasma levels of lipophilic antioxidants (sickle cell disease, thalassemia, diabetes). Background of the invention [0002] Sickle cell anemia (SCA) is a common manifestation of sickle cell disease (SCD) and the most common hemoglobinopathy in the world, affecting more than 50 million people worldwide. SCA severely affects quality of life and shortens lifespan. Although hemolytic anemia and frequent vaso-occlusive crises are the most common complications in patients with SCA, these patients develop pulmonary hypertension, cerebrovascular disease leading to stroke, osteonecrosis, retinopathy, priapism, leg ulcers, acute The risk of chest syndrome and glomerulopathy is also very high (Kato et al., 200...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/00A61P7/06
CPCA61K45/06A61K31/045A61K31/07A61K31/122A61K31/216A61K31/421A61K31/4439A61K31/517A61K38/1709C12Y203/01043A61P3/06A61K31/167A61K31/355A61K31/455A61K31/724A61K38/45A61K2300/00A61K31/05A61K31/192A61K38/17
Inventor J·E·聂索尔R·班加西F·拉穆尔
Owner HARTIS PHARMA SA