Antisense Pharma unveils its corporate strategy for 2013 - Seite 2

With this intent, Antisense Pharma is currently under way to launch a clinical Phase II study to evaluate systemic, intravenous trabedersen treatment in patients suffering from malignant melanoma, pancreatic cancer and other tumors by the second half of 2013. This clinical trial will be conducted in two stages. The first stage has a dose-confirmatory component and will further define the pharmacodynamic (PD) activity of trabedersen in terms of TGF-ß2 target down-regulation as a primary PD parameter and immunomodulation in the selected patient populations. Upon successful completion of the first stage, the second stage of the study is set to demonstrate a survival benefit over standard chemotherapy for one or two key tumor indications in a larger patient population.

Dr. Philippe Calais, Chief Executive Officer of Antisense Pharma commented: "Our revised trabedersen clinical program takes into consideration all learnings from the G005 and P001 studies. We move forward with the systemic intravenous administration of trabedersen in a well-tailored, two stage clinical development program aiming at further optimizing our chances of success in the regulatory path leading to approval and market. This creative development approach minimizes the risk and costs usually associated with larger, less tailored programs. Indeed trabedersen holds a strong value for the company, as it is supported by orphan drug designation for several indications in the US and Europe as well as a fully validated manufacturing process. In parallel, we are also exploring partnership opportunities to further accelerate trabedersen's development path."

Progress of 'Next Generation' TGF-ß oligonucleotide program and expansion of the scientific advisory board (SAB)

Since its foundation in 1998 Antisense Pharma has accumulated a vast amount of expertise and intellectual property by focusing its research and development efforts on the TGF-ß pathway and on oligonucleotides in high-medical-need diseases in oncology. This expertise is unique in the world.

The company recently merged its indication-focused advisory boards into a single corporate SAB comprised of 11 established academics, researchers and clinicians who are worldwide leaders in fields of TFG-ß, oncology, and oligonucleotides.

Upon strategic considerations from the company's senior management team supported by recommendations from the SAB, Antisense Pharma started a 'Next Generation' TGF-ß inhibitor oligonucleotide program that provides the company with a portfolio of additional assets, comprised of compounds specifically designed to down regulate the TGF-ß pathway by targeting different TGF-ß isoforms or combinations thereof, for the treatment of high unmet medical need cancer indications. These potent compounds have meanwhile shown highly impressive anti-TGF-ß activity in initial preclinical evaluations.