The Spanish Ministry of Education has approved a €9.6 million ($12.7 million) project coordinated by Progenika Biopharma to translate pharmacogenomics tools into clinical practice in Spain, Progenika said this week.
The four-year research program calls for 15 research centers across the country exploit genomic, proteomic, and metabolomic biomarkers to develop prognostic tools for and inflammatory disease, the company said.
Additionally, the project aims to develop a supporting bioinformatics platform as well as a new generation of technologies that can identify genes, proteins, and metabolites implicated in disease development and progression, Progenika said.
The announcement of the project signals that 2007 will be a busy year for Progenika. The company‘s flagship diagnostic chip for inflammatory bowel disease is currently undergoing validation in the European Union that is scheduled to end by the fourth quarter of ’07, and at the same time the firm has invested in building a 6,500-square-foot facility in Derio, Spain, also planned to open next year.
According to Progenika spokesperson Simon Santa Cruz, the Spanish PGx project will run through 2009 and is intended to “determine the benefits to patients of pharmacogenetic testing in terms of selection of optimal therapeutic and dosing regimes.”
Phase I of the project, which is currently underway, calls for 4,000 individuals to be genotyped using Progenika’s DRUGchip that tests for approximately 90 polymorphisms associated with drug metabolism including cytochrome P450 and NAT, according to Santa Cruz.
“The primary focus of the investigation is on inter-individual responses to treatments in the following therapeutic areas: oncology, psychiatric disease, psychotic illness as well as response to immunomodulatory drugs,” he wrote in an e-mail to BioArray News this week.
In phase II of the project, scheduled to take place in 2008-2009, the study will be expanded to evaluate a further 26,000 patient samples, Santa Cruz wrote. Additionally, of the company will evaluate the protein and metabolite markers. However, this phase will be managed by Progenika’s proteomics subsidiary Proteomika and OWL Genomics, a separate company also located in Spain’s biotech sector in the northeast of the country, he added.
The company’s DRUGchip is currently available for research use only.
IBDchip to Hit US in ’08
As Progenika moves ahead with the PGx project, it is also validating its IBDchip for inflammatory bowel disease. The chip, first launched in 2005, is an array-based test that screens for 80 or so SNPs related to IBD. The chip can either assess a patient's susceptibility to diseases such as Crohn's disease and ulcerative colitis, or help physicians diagnose the disease and monitor patients' response to treatment (see BAN 4/13/2005).
According to Santa Cruz, the IBDchip received a CE Marking earlier this year, but before marketing the test for routine clinical diagnostic and prognostic use, the company is performing a Europe-wide validation in an EU-funded, multi-center study.
“Progenika expects to have preliminary results by the end of 2007 with “the aim of marketing IBDchip in the US during 2008.”
“This research program, funded by the European Union, is already underway and the validation phase of the project is due to finish by the end of 2007,” Santa Cruz wrote. Centers testing the IBDchip include the Institut D'Investigacions Biomèdiques August Pi i Sunyer in Barcelona; the Katholieke Universiteit in Leuven, Belgium; and University Hospital of Schleswig-Holstein, Germany.
In addition, a multi-center validation study is starting in the US and Progenika expects to have preliminary results by the end of 2007 with “the aim of marketing IBDchip in the US during 2008,” Santa Cruz wrote. He added that in the US, Progenika is working with gastroenterologists from institutions that include the Cleveland Clinic Foundation, the University of Chicago, and the Medical College of Wisconsin.
As Progenika prepares to launch the IBDchip on two continents and gets involved in the Spanish PGx project, the company has also decided to invest in its own facility in Derio, on the outskirts of Bilbao. According to Santa Cruz, Progenika and its subsidiary Proteomika currently lease a 3,280-square-foot facility that houses R&D, production, and administrative functions in the Zamudio Technology Park in Derio.
The company has now invested €5.7 million ($7.6 million) to build a new facility that it believes will provide its entire needed laboratory and office space. It is expected to open towards the end of 2007.
“Due to ongoing and projected growth in company personnel, together with the need for increased production capacity due to the launch of new arrays, the companies are investing in a purpose-built facility in order to anticipate future needs,” Santa Cruz wrote.
Progenika, founded in 2002, as well as Proteomika, and OWL Genomics, are all the result of a Spanish-funded program called BioBask 2010 that seeks to create a new biosciences "pole" in northern Spain’s Basque country (see BAN 4/13/2005).