2008-05-08
Interim Report - January to March 2008
Affibody Holding AB (publ) (“Affibody” or “the Company”), a Swedish biotech company focused
on molecular imaging and targeted cancer treatments, today issued its Interim Report covering the
First Quarter 2008.
Financial Highlights
Key Corporate Highlights
- Affibody is continuing to make good progress with its lead second-generation product ABY-025, a HER2-binding molecular imaging agent. This product, which is being developed for the diagnosis of breast cancer, is currently being prepared for a Phase I clinical study in Germany and the Company plans to file a clinical trial application (CTA) with the German authorities during the 2nd Quarter of 2008
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The protocol for the Phase I study with ABY-025 has been finalized and signed by the sponsor. The study will be carried out in two centers in Germany with Professor Mallmann (Cologne) acting as the Principal Investigator
- Affibody has finalized the formulation for the GMP for this first clinical study, as part of the work to support its CTA application. It has also completed toxicology studies showing no adverse effects at doses many times more than the highest with ABY-025 intended clinical dose.
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The Company has also continued to progress the development of its other pipeline products and technologies. These include Affibody’s albumin-binding domain (ABD) technology which could be of great value for improving the therapeutic properties of the broad range of biotherapeutics being developed by other pharmaceutical and biotechnology companies.
Erik Walldén, Affibody’s CEO, said: “Affibody has continued the work needed to start the clinical development of our lead cancer imaging product ABY-025. This product, which is for the improved diagnosis of an aggressive form of breast cancer, is expected to start patient recruitment into an initial Phase I study in 3rd Quarter 2008. Our ABD delivery technology is being progressed rapidly and is attracting interest from a growing number of companies in the biotherapeutics field. As we move through 2008, I expect to see Affibody deliver further important milestones towards our goal of bringing our unique molecular imaging and targeted therapeutic products to market for the benefit of cancer patients around the world.”