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Anti-TGF-Beta Antisense AP 12009 Shows Very Good Safety and Tolerability in Systemic Treatment of Pancreatic Carcinoma, Malignant Melanoma and Colorectal Carcinoma
Date:6/2/2008

ave been treated with the second schedule, confirming the excellent safety profile of the drug. The dose escalation is still ongoing.

"Our recent data suggest, that intravenous infusion of AP 12009 is safe in patients suffering from malignant tumors, such as pancreatic carcinoma or melanoma. The survival data, observed in this Phase I/II study are very good, given the poor prognosis associated with these diseases," said Dr. Hubert Heinrichs, Chief Medical Officer of Antisense Pharma.

To further study the potential of the antisense treatment in pancreatic carcinoma, a Phase II study on AP 12009 in combination with the standard of care is scheduled to start in 2009. A Phase II study in malignant melanoma in combination with the current standard of treatment is currently being planned.

"The results of the Phase I/II study underscore again the high efficacy of AP 12009, which we have seen in high-grade glioma patients in the active-controlled Phase IIb study AP12009-G004. This study showed a strong survival benefit in patients treated with AP 12009 compared to standard chemotherapy treatment," commented Dr. Karl-Hermann Schlingensiepen, CEO of Antisense Pharma. "We have made huge progress in bringing the drug AP 12009 to patients with highly malignant tumors, who are in need of better therapies that prolong survival benefited by high quality of life."

Literature

(1) Hilbig, A. et al. "Systemic i.v. Administration of AP 12009: Preliminary Results of a Phase I/II Study in Pancreatic Carcinoma, Malignant Melanoma, or Colorectal Carcinoma", ASCO Annual Meeting, 2008, Abstract ID 4621

The Phase I/II study AP 12009-P001

In the open-label, multicenter, dose-escalation Phase I/II study, patients with either pancreatic carcinoma (stage IVA/IVB), metastatic melanoma (stage III/IV), or advanced colorectal carcinoma (stage III/IV) repeatedly receive intravenous infusions of AP 12009. Primary study objective is to determine the maximu
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SOURCE Antisense Pharma GmbH
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