Digna Biotech and CIMA Receive EUR 1.3 Million Funding for Acute Intermittent Porphyria Gene Therapy as Part of an EU FP7 Grant for Clinical Development of Orphan Drugs

February 3, 2011

MADRID, February 3, 2011 /PRNewswire/ — 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.

Further information can be found at http://www.cima.es and

SOURCE Digna Biotech

Source: newswire

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