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TechnoPhage receives FDA clearance to begin human clinical trials of an innovative biological therapeutic

 

TECHNOPHAGE, a biotechnology company headquartered in Lisbon, Portugal, announced today that the company has received authorization from U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for TP-102, a bacteriophage cocktail for the treatment of infected chronic ulcers, namely diabetic foot infections.

This clearance will enable TechnoPhage to initiate trials in humans, confirming safety and efficacy of these therapeutics which has already been assessed in laboratory environment. At the moment, no current topical therapy is available specifically targeted at chronic diabetic foot infections. Therefore, TechnoPhage will address an unmet medical need with great impact on the wellbeing of these patients.

Bacteriophage-based products have been developed over the last eight years through a joint collaboration between TechnoPhage and the Portuguese Pharma company Tecnifar. The strong commitment of both companies has allowed this important achievement which is, at the national level, unique in the biotechnology sector.

"The approval of this IND by the FDA, for the initiation of clinical trials of our product TP-102, is a significant milestone for TechnoPhage which aims at becoming an important player in the biotech sector at the global level. This achievement is the result of a fruitful partnership between TechnoPhage and Tecnifar, a Portuguese Pharma company that demonstrated, from an early stage, strong engagement with bacterophage-related projects. This has been decisive for the success obtained thus far", stated Miguel Garcia, the company’s CEO.

 

About TechnoPhage

TechnoPhage (www.technophage.pt) is a biotechnology company focused on the R&D of new molecules in several therapeutic areas. The company’s laboratories are located in Lisbon, Portugal, in the facilities of the Instituto de Medicina Molecular, with whom TechnoPhage has a scientific collaboration protocol.

The company’s strategy is based on the use of its several technology platforms, in order to identify new molecules with potential for different therapeutic areas. After being identified, the molecules proceed to the development stage. At this moment, the company is conducting 11 programs within its pipeline of new therapeutic molecules, one of them being already in the last phases of preclinical tests, for the rheumatoid arthritis indication.

In May 2014 TechnoPhage signed two important collaboration agreements for the development of new therapeutics with the University of Macau and the Shanghai Institute of Materia Medica.

 

For further information please contact:
Mariana Pereira | Phone: +351 931647928 | email: mpereira@technophage.pt

 

(TechnoPhage, 24 July 2014)