The year 2009 was quite turbulent for gene therapy companies, with lay-offs, bankruptcies and general financial crisis. Earlier 2008 FDA refused US based Introgen’s Biologics License application (1) and during 2009 now bankrupt Introgen sold it’s GMP facilities and other remaining assets to Vivante GMP Solutions, ceasing to exist as gene therapy company. Similarly other gene therapy companies have had difficulties on getting their products to the market, especially with the economic crisis hindering their financing. After facing extensive difficulties, the path often leads to turning into a CMO, field with heavy competition.

There are still some promising signs of new interest rising towards gene and cell therapy. Big Pharma seems to be more active to open discussions with innovative new gene therapy companies and progress to the marketing approval-stage by several companies has convinced the investors that soon the first product should be on the markets also in the Western World.

First Gene Therapy eCTD

Diamond BioPharm Limited, announce a cutting edge first. As well as the submission of a Marketing Application for a Gene Therapy Product in December 2009 - on behalf of Amsterdam Molecular Therapeutics, a leading company in the development of gene-based therapies - the dossier is also in eCTD format. Maureen Graham, founder of Diamond BioPharm Limited said that it was a major achievement for both companies and is both proud and honoured that Diamond BioPharm Limited has had an opportunity to be part of this innovative project.

Oxford, UK – 1 June 2009: Oxford BioMedica (LSE: OXB), a leading gene therapy company, today announces updated results from open-label Phase I/II and II trials of TroVax in metastatic colorectal cancer and metastatic renal cancer. TroVax is Oxford BioMedica’s therapeutic cancer vaccine that targets the 5T4 tumour antigen. Two cross-trial analyses were presented at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida. In all trials, TroVax was well tolerated with no serious adverse events attributed to vaccination. The most frequent TroVax-related side effect was low-grade transient irritation at the injection site.