Introduction

The present invention concerns the modalities of intranasal administration of Nerve Growth Factor (NGF) through a MAD (Mucosal Atomizer Device) for the treatment of hypoxic-ischemic and traumatic brain lesions of neonatal and pediatric age. This method allows delivery of NGF to cerebral parenchyma in a non-invasive way and without any side effects.

Technical features

The Nerve Growth Factor (NGF) is a neurotrophin which encourages neurogenesis, neuronal growth, and differentiation and survival of neurons. NGF can be useful in counteracting damages caused by traumatic and/or hypoxic-ischemic brain lesions by promoting the growth of new nerve cells in brain tissue and the revascularization of ischemic areas.

The MAD is applicable as a syringe: the drug in the liquid state, while passing through its nozzle, is atomized into particles of 30 μm in diameter, which allows absorption in the nasal cavity.Therefore, MAD represents a simple and non-invasive device, capable of conveying drugs to the level of the Central Nervous System (CNS) through the nose-to-brain pathway in a very short time and without any side effects.

Possible Applications

• Treatment of neurobehavioural and neurosensory deficits in subjects with hypoxic-ischemic and traumatic brain lesions;
• Possible use in the treatment of other CNS neurodegenerative disorders such as Parkinson’s Disease and Alzheimer‘s Disease.

Advantages

• First pharmacological therapy for the treatment of neurological outcomes secondary to hypoxic-ischemic and traumatic brain lesions (see PET images enclosed herewith);
• Excellent bioavailability of the drug;
• Fast and safe route of administration;
• Minimal invasiveness;
• Excellent security profile.