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Thymosin alpha peptide for preventing, reducing the severity of, and treating infection

A Thymosin, Severity Technology, Applied in the Field of Infections

Inactive Publication Date: 2013-12-18
SCICLONE PHARMACEUTICAL INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is not possible or cost-effective to vaccinate individuals against all potential pathogens (especially those that can manifest as nosocomial infections such as pneumonia or septicemia), and especially in immunocompromised patients

Method used

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  • Thymosin alpha peptide for preventing, reducing the severity of, and treating infection
  • Thymosin alpha peptide for preventing, reducing the severity of, and treating infection
  • Thymosin alpha peptide for preventing, reducing the severity of, and treating infection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0078] Example 1: Enhancement of H1N1 Vaccination in Mice

[0079] summary

[0080] A study was conducted to determine the role of TA1 (thymalfasin) in seasonal influenza vaccines Potential to enhance anti-influenza antibody formation in CD-1 mice following different vaccination schedules in 2008-2009. Mice received control articles or vaccines on study days (SD) 1 and 10 or SD 8 and 17. Mice also received different doses of TA1 at different times relative to vaccine administration. Both the control article and the vaccine were administered via intramuscular injection to both the right and left hind limbs; TA1 was administered by the intraperitoneal route. All mice were given a fixed dose of control / vaccine regardless of body weight. Mice were observed twice daily for mortality, moribundity, general health, and signs of toxicity; body weights were recorded prior to dosing. Blood samples were collected at SD 20 or 27 (10 days after the final vaccine administration) and ...

Embodiment 2

[0107] Example 2: Enhancement of H1N1 Vaccination in Ferrets

[0108] Thymosin has been shown to exert immune regulation in several microbial and tumor settings through a variety of mechanisms, which include enhancing antibody responses. To control the current influenza pandemic caused by the novel A / H1N1 virus of porcine origin, mass active vaccination will be performed in most countries and vaccines with or without adjuvant will be used. At least some of these vaccines will require a booster dose 1 month later to induce detectable virus-neutralizing antibody production in most vaccinated individuals. Furthermore, the availability of these vaccines to the entire target population is doubtful. Therefore, it is important to assess whether an appropriate dose of thymosin administered separately but concurrently with influenza vaccine can boost the antibody response against the virus.

[0109] Experimental Study

[0110] Influenza-free ferrets are very responsive to influenz...

Embodiment 3

[0120] Example 3: Boosters of H1N1 Vaccination in Hemodialysis Patients

[0121] Investigating the effect of thymosin TA1 enhancement on the H1N1 influenza monovalent vaccine Focetria adjuvanted with MF59 TM ability of the immune response. Studies were conducted in hemodialysis patients. Patients with end-stage renal disease requiring hemodialysis or other conditions that compromise the immune system, as well as the elderly, often do not develop enough antibodies to fight off infectious diseases such as the H1N1 flu. Additionally, many patients who achieve protective titers are initially unable to maintain these for longer periods of time, making them susceptible to infection and requiring revaccination or booster injections.

[0122] A randomized three-arm study in approximately 120 patients with end-stage renal disease on long-term dialysis. One subgroup of patients received the H1N1 vaccine alone, while the other two groups received two lower doses of thymofasin (TA1) in...

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PUM

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Abstract

The present invention provides methods for preventing, treating, or reducing the severity of infection, including bacterial, viral, and fungal infections, and including infections of more complex etiology. The invention involves the administration of an alpha thymosin peptide regimen, so as to prime or enhance a patient's immune response for pathogen exposure. In certain embodiments, the alpha thymosin regimen is scheduled or timed with respect to potential or expected pathogen exposures. The regimen of alpha thymosin peptide as described herein provides the patient with a more robust immune response to pathogen exposure, including higher antibody titers and / or a more rapid antibody response. In certain embodiments, the patient is immunodeficient or immunecompromised, and / or the patient is hospitalized or scheduled for hospitalization, such that the regimen of alpha thymosin peptide helps to protect the patient from, or reduce the severity of, nosocomial infection or illness.

Description

[0001] priority [0002] This application claims priority and benefit to US Provisional Application No. 61 / 441,250, filed February 9, 2011, which is hereby incorporated by reference in its entirety. field of invention [0003] The present invention relates to the field of infections, including the prevention of infection, the reduction of the severity of infection, or the treatment of infection, including acute and hospital-acquired sexual infection. Background of the invention [0004] Hospital-acquired infections, such as pneumonia and sepsis, cause considerable patient mortality and morbidity and add significantly to the overall cost of health care [Michael Klompas, Prevention of ventilator-associated pneumonia , Expert Rev. Anti Infect. Ther.8(7):791-800(2010); Wheeler DS et al., Novel Pharmacologic Approaches to the Management of Sepsis: Targeting the Host Inflammatory Responses , Recent Pat. Inflamm. Allergy Drug Discov. 3(2):96-112 (2009)]. In fact, sepsis was...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A01N25/00
CPCA61K38/2292Y02A50/30A61K45/06
Inventor C.塔特希尔
Owner SCICLONE PHARMACEUTICAL INC
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