Antisense Pharma unveils its corporate strategy for 2013

Antisense Pharma GmbH / Antisense Pharma unveils its corporate strategy for 2013 . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.

• Trabedersen clinical development program update
• Advances in 'Next Generation' TGF-ß oligonucleotide program and expansion of scientific advisory board
• Organization streamlined and senior management strengthened
• Strong, continued support from investors

Regensburg, February 26, 2013. The biopharmaceutical company Antisense Pharma GmbH, today announced its revised corporate and development strategy, receiving full support from its main investors.

The updated corporate strategy focuses on streamlining the organization to meet its current business objectives and strengthen key senior management positions in light of the new direction for trabedersen's clinical development program and the advancement of Antisense Pharma's 'Next Generation' TGF-ß inhibitor oligonucleotide program.

Revised development path for Trabedersen

The data analysis of "SAPPHIRE" (G005), trabedersen's early terminated phase III study in glioma, is in progress. Due to a need for additional outcome data collection, final results are now expected within the third quarter of 2013.

However, preliminary safety data analyses revealed that the benefit/risk ratio might not be in favor of the trabedersen treatment arm due to serious adverse events (SAE) associated with the local mode of administration of the drug in this trial. The convention-enhanced delivery (CED) of trabedersen via intra-cranial infusion with surgical catheter placement seemed to result in a distinct, clinically relevant imbalance of SAEs observed. In light of this finding, the company decided that the risk to the patient outweighs the potential clinical benefits for this type of administration of the drug. As a consequence, the company will no longer pursue further development of the local administration of trabedersen in glioma.

Future clinical development of TGF-ß targeted drugs in glioma is still considered for the 'Next Generation' TGF-ß oligonucleotide development program based on the encouraging survival data for anaplastic astrocytoma from an earlier glioma trial with trabedersen (G004).[1]

From now onwards, trabedersen's development path will only focus on the systemic intravenous (IV) mode of administration.

This decision is further supported by the findings from the Phase I/II clinical study (P001) presented at ASCO in June 2012.[2] The data demonstrated that the systemic IV administration of trabedersen treatment is safe and well tolerated by patients. First clinical signs of efficacy were observed in this study with encouraging survival outcomes for patients suffering from pancreatic cancer or malignant melanoma when compared to historical controls.