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Ruconest - Traumatic brain injury (TBI) US army

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[verwijderd] 5 december 2018 19:51

Efficacy of Recombinant Human C1INH in the Therapeutic Treatment of TBI

Traumatic brain injury (TBI) affects over 1.4 million Americans each year. In 2008, the most recent year that complete statistics are available, 27,507 US military service members sustained a "mild or greater" TBI. This level of brain injury can have significant chronic or long-term effects. Long-term effects of TBI include difficulties in concentration and memory, balance and vision changes, sleep disturbances, and an increase in seizures. Edema (swelling) and inflammation (a response of the immune system to injury) are significant contributors to the underlying damage. One component of inflammation is the humoral Complement response, where Complement refers to a cascade of specific inflammatory proteins. High Complement levels may be related to poor neurological or brain function after TBI injury in humans. Despite clinical and animal model evidence documenting a role for inflammation in TBI, only corticosteroids have undergone clinical trials in TBI, resulting in recent calls for the testing and pursuit of more anti-inflammatory agents for this type of injury. Accordingly, this grant proposal seeks to investigate the role of Complement in TBI, using a unique inhibitor of Complement protein C1 (C1INH), which regulates vascular permeability (how well components of the blood stream can enter the brain) and inflammation (what components of the immune system are activated or suppressed). C1INH inactivates a variety of Complement cascade proteins, as well a proteases of the coagulation, contact, and fibrinolytic systems. C1INH has been tested extensively in other animal models of disease and injury where inflammation plays a role with promising results. For the present studies, we propose to use a recombinant human Complement component 1 (C1) esterase inhibitor (rhC1INH), the recombinant analogue of human C1 esterase inhibitor (C1INH). rhC1INH has been developed as a treatment for hereditary angioedema (HAE), a life-threatening disease resulting from genetic deficiencies in endogenous C1INH. The efficacy and safety of rhC1INH in treating HAE has been evaluated in eight clinical studies, including two randomized double-blind, placebo-controlled clinical trials. We believe that the experiments proposed here, which use Complement-sufficient animal models of TBI and rhC1INH to block multiple routes of Complement pathway activation, may provide new insight into the inflammatory mechanisms of TBI, and data that could permit the development of anti-inflammatory therapeutic strategies for TBI. This proposal is particularly promising because if positive evidence for rhC1INH improving function in a model of TBI is found in these studies, the pathway to a clinical trial in human is shorter than for a compound that has not already been tested in humans.

.. For the present studies, we propose to use a recombinant human Complement component 1 (C1) esterase inhibitor (rhC1INH), the recombinant analogue of human C1 esterase inhibitor (C1INH). rhC1INH has been developed as a treatment for hereditary angioedema (HAE), a life-threatening disease resulting from genetic deficiencies in endogenous C1INH.

cdmrp.army.mil/search.aspx?LOG_NO=DM1...

[verwijderd] 5 december 2018 19:58

..if positive evidence for rhC1INH improving function in a model of TBI is found in these studies, the pathway to a clinical trial in human is shorter than for a compound that has not already been tested in humans.

kijk kijk korter clinical trials..

JHDE 5 december 2018 22:23

. Nevertheless, analysis of data from on demand trials showed that clinical efficacy of plasma and recombinant C1-INH was dependent on the initial dose and not influenced by the pharmacokinetic profile. Moreover, an ani- mal model of stroke, showed rhC1-INH to be superior to the pdC1- INH in protecting from extension of the ischemic brain injury [78]. Such a difference appeared to be explained by the stronger affinity of rhC1-INH for mannan binding lectin (MBL) and thus better inhibit the lectin pathway of complement: rhC1-INH binds MBL with a relatively high affinity (230nM), whereas pdC1-INH does not show any binding up to 40um [79]. ...

www.researchgate.net/publication/2686...

[verwijderd] 30 april 2020 00:53

Dear Dr. Fauci,
have you heard about the promising Pharming study 'encouraging test results ruconest against Covid-19' from the Netherland, the best country in Europe? This could well be a better next standard in the treatment of COVID19 patients!! Ruconest is normally prescribed for angio oedema to which COVID19 has many similarities:

www.iex.nl/Nieuws/ANP-210420-099/Phar...

Leiden (AFN) - Leiden biotechnologist Pharming reports encouraging results with his drug Ruidest against Covid-19, which is caused by the new coronavirus. Results from tests in five patients prompted a more extensive study into the effect of the drug against the lung virus.

Pharming initially developed Ruconest as a medicine against hereditary forms of angioedema, or acute swelling in the body. The drug was tested on five patients with Covid-19 in Basel, Switzerland, through a special research program. Four out of five patients mention the fever and were signs of inflammation. They healed quickly. A patient had to go to intensive care for extra ventilation.

Now a larger investigation follows into the effect of Ruconest against the consequences of the new coronavirus. It is being tested in 150 patients with Covid-19 under the supervision of researchers from the University Hospital of Basel.

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