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Grupo de investigación clínica francés ofrece un tratamiento temprano de la epilepsia en recién nacidos

Resumen

Tipo:
Oferta Tecnológica
Referencia:
TOFR20181025003
Publicado:
09/11/2018
Caducidad:
10/11/2019
Resumen:
Un laboratorio francés de investigación clínica ha desarrollado una nueva forma galénica para un fármaco de la epilepsia sensible a vitaminas apto para recién nacidos. Esta formulación galénica específica permite la administración temprana de P5P en recién nacidos que no responden al fenobarbital. Se trata de una solución efervescente que permite la solubilización completa de P5P. Su aspecto incoloro y la posibilidad de incorporar cualquier sabor permiten su uso en pediatría. El grupo de investigación busca compañías farmacéuticas con el fin de establecer acuerdos de cooperación técnica o licencia.

Details

Tittle:
Early treatment of epilepsy in newborn offered by a French clinical research team
Summary:
An innovative newborn-suitable galenic form has been set up for a vitamin-sensitive epilepsy drug. It has been designed and proved to be efficient by a French clinical research lab.
The Technology Transfer Office (TTO) acting on behalf the clinical research team, is looking for pharmaceutical companies interested by a technical cooperation agreement or a licensing agreement.
Description:
A French clinical research team has developed an innovative treatment for paediatric epileptic seizures coming from a vitamin-sensitive effect. This research team is represented by a Technology Transfer Office (TTO) which is responsible for protecting and leveraging the intellectual property. It aims to create the best conditions to bring to market innovative products and services directly from hospital care and clinical research.

Market challenges :
The highest epilepsy prevalence has been shown to occur during the neonatal period. About 1 per cent of live births have concerns with the incidence of epilepsies. Recovery ratio is limited under 50% using current treatment. This represents about 3 to 4 thousands of newborns per year.
There is a need for another treatment leading to better results. In addition, it should be suitable for newborn and children.

State of the art :
The current treatment for paediatric epilepsies is phenobarbital administration. Unfortunately, the response of such a treatment is only about 50%. Focusing on non-responding clinical cases, it has been shown that it should be explained by a vitamin-sensitive epilepsy. On one hand, pyridoxine-dependent epilepsy comes from a lack of B6 vitamin. Another vitamin-dependent disease is the deficit in pyridoxamin 5-phosphate oxidase. This deficit comes from a lack of pyridoxal 5 phosphate (P5P), which is the active form of B6 vitamin.
Unfortunately, there is no suitable galenic formulation which allows to administrate P5P in newborns. Moreover, diagnosis of vitamin-sensitive epilepsy can only be performed 2 weeks to 1 month after stating that phenobarbital is not relevant.

Proposed technology :
In order to optimize the treatment of both above-mentioned vitamin-sensitive epilepsies, a specific galenic formulation has been developed which allows the early administration of P5P in newborns who don´t respond to phenobarbital drug.
The developed formulation is an effervescent solution which allows a complete solubilization of P5P. Moreover, the resulting colourless aspect of the solution and the possibility of any aroma addition allows its use in paediatrics.

The TTO acting on behalf the clinical research team, is looking after companies operating in pharmaceutics for paediatrics. Expected outcomes are either a technical cooperation agreement or a licensing agreement for futher clinical development.

Keywords : pediatrics, neurology, reformulation, neonatal epilepsy, galenic.
Advantages and Innovations:
A new galenic formulation of Pyridoxal 5 Phosphate (P5P) has been set up by a French clinical research team. The formulation is an alternative treatment of epilepsy in newborns not-responding to phenobarbital, before and after confirmation of vitamin-dependent diagnosis.

The advantages of this innovative formulation are :

- fast and complete solubilization of P5P: about 4 times faster than with the current formulation with bicarbonate,

- easy, newborn and child-suitable drug and dosage form, which ensures oral absorption of the right dose and its reproducibility,

- gain in the nursing time : about 2 min are saved before each oral administration as compared to the current formulation.
Stage of Development:
Under development/lab tested
IPs:
Patent(s) applied for but not yet granted
CommeR Statunts Regarding IPR Status:
In addition to the French patent application, a PCT extension has been processed.

Partner sought

Type and Role of Partner Sought:
Requested partners are companies operating in pharmaceutics or drug forms, that may be interested in :

- a licencing agreement as the Technology Transfer Office (TTO) is ready to negotiate directly the patents rights so the partner can drive further clinical development of this new galenic solution for epilepsies in paediatrics,

- a technical cooperation agreement based on the innovative galenic solution, in order to target other usecases or medical indications.

Client

Type and Size of Client:
Industry SME 11-49
Already Engaged in Trans-National Cooperation:
Si
Languages Spoken:
English
French

Keywords

Technology Keywords:
06002007 Ensayos in vitro, experimentos
06001014 Neurología, investigación cerebral
06001015 Productos farmacéuticos / medicamentos