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The innovative molecule developed on the basis of the studies by Rita Levi Montalcini in ophthalmology

Italian research at the SOI Congress: focus on therapeutic prospects of NGF, the innovative molecule developed on the basis of the studies by Rita Levi Montalcini in ophthalmology

  • The aim of the symposium promoted by the Italian biopharmaceutical company Dompé at the 94th National Congress of the Italian Ophthalmological Society was to highlight the potential applications of this Nobel Prize-winning molecule.
  • Recombinant human Nerve Growth Factor, which was developed at Dompé’s biotech plant in L’Aquila, is currently being clinically tested in patients with eye diseases such as Neurotrophic Keratitis, Retinitis Pigmentosa and Dry Eye syndrome.
  • The innovative mechanism of action of this candidate drug may also make it a therapeutic solution for other severe eye diseases that can lead to blindness such as Glaucoma.

Milan, 22 November 2014. NGF, the Nerve Growth Factor discovered by Rita Levi Montalcini and her collaborator Stanley Cohen, now represents a promising potential treatment for various eye diseases. The important role of this protein, which is capable of regulating the growth, maintenance and survival of neurons, has been confirmed at today’s symposium entitled “From experimentation to clinical practice: therapeutic prospects for NGF in ophthalmology”, which was held as part of the 94th National Congress of the Italian Ophthalmological Society (SOI) taking place in Rome.

“Italy is an international point of reference for research in this field – explains Stefano Bonini, Director of the Ophthalmological Department at Campus Bio-Medico, Rome, and Principal Investigator of the REPARO trial. Some years ago, in collaboration with some Italian researchers including Alessandro Lambiase of La Sapienza University in Rome and Paolo Rama of San Raffaele Hospital in Milan, we started to formulate a hypothesis concerning the efficacy of the topical use of NGF in the treatment of Neurotrophic Keratitis, a rare degenerative eye disease affecting about one in 5,000 people throughout the world that is characterised by progressive corneal damage and can cause a gradual loss of vision.”.

The rationale underlying the studies is clear: the cornea is the most innervated organ in the human body, and maintains its integrity precisely because of its diffuse innervation, and so treating corneal disease with NGF could be the most functional solution for a complex problem.

“The key step in the research came from the studies of the Dompé Group, which had developed a specific process for the production of recombinant human NGF (rhNGF) at its biotech plant in L'Aquila – continues Bonini. This innovation led us to the first clinical testing of the molecule in ophthalmology: the international REPARO trial, which is currently ongoing in 39 centres in nine Europan countries, and involves patients with moderate-severe unilateral Neurotrphic Keratitis.”.

In addition to the REPARO trial, the therapeutic potential of rhNGF is currently being evaluated in other diseases of the anterior and posterior segments of the eye.

The first results of an exploratory phase II study that was started in March 2014 with the aim of evaluating its safety and efficacy in patients with Dry Eye syndrome are expected to be available during the course of next year. Furthermore, the American Food and Drug Administration (FDA) and the European Medicines Agency have recently designated rhNGF an orphan drug for the treatment of Retinitis Pigmentosa, a condition that is the subject of the phase Ib/II LUMOS study.

Identifying innovative therapeutic solutions for currently untreatable diseases and making them available to patients throughout the world is the fundamental objective of what we mean by research. This approach characterises the involvement of Dompé in its various of interest and underlies our efforts in the field of ophthalmology – explains Eugenio Aringhieri, CEO of the Dompé Group. Dompé chose biotechnologies as a means of promoting original and innovative research hypotheses, and has decided to count on the possibilities offered by studying rhNGF. These results were obtained in our laboratories, which today form part of a network of 44 research centres in the world. In the near future, our aim is to assess the potential of rhNGF in diseases such as glaucoma with the involvement of new international partners such as the United States”.