Digna Biotech and the Centro de Investigacion Medica Aplicada (CIMA) de la Universidad de Navarra announced today that the European Union (EU) has finalized a EUR 3.3 million grant to AIPGENE consortium. Digna Biotech and CIMA will receive, as members of the consortium, EUR 0.5 and EUR 0.8 million respectively for the clinical development of a gene therapy product for Acute Intermittent Porphyria (AIP).

the AIPGENE consortium is led by CIMA (University of Navarra), and in addition to Digna Biotech includes Clinica Universidad de Navarra, Amsterdam Molecular Therapeutics (AMT), Stockholms Lans Landsting, Deutsches Krebsforschungszentrum and Servicio Madrileno de Salud.

As part of the AIPGENE grant, Digna Biotech and CIMA will complete a Phase I/II study in humans. with the support of all AIPGENE partners, Digna Biotech anticipates AIP patient enrolment in the trial in early 2012.

under a co-development agreement, Digna Biotech transferred to AMT global rights to develop and commercialize this adeno-associated based gene therapy vector for acute intermittent porphyria. AMT was granted Orphan Drug Designation for this vector.

about Acute Intermittent Porphyria

Acute intermittent porphyria is a rare genetic disease where mutations in the porphobilinogen deaminase (PBGD) gene results in insufficient activity of a protein necessary for heme synthesis that produce a wide variety of problems including acute and severe abdominal pain and psychiatric and neurological symptoms. there is currently no cure for this condition and the disease is typically progressive.

about CIMA

CIMA (University of Navarra) brings pure research closer to its clinical application, carrying out high-quality scientific work in the service of humankind, combating diseases that cause great suffering and for which no cure has yet been discovered.

about Digna Biotech and CIMA

Digna Biotech is a biotechnological company focused on the development products originated from CIMA. Currently, Digna’s portfolio includes 3 more products in clinical development: P144, a peptide inhibiting TGF-beta 1 that has completed Phase II in patients with scleroderma, Interferon alpha 5 for the treatment of hepatitis C infection in Phase I/II) and cardiotrophin for liver resection that will start Phase I in mid 2011.