ACT Biotech reports positive interim data from Telatinib Phase 2 trial for advanced gastric cancer

ACT Biotech, IncOct 11 2010

ACT Biotech Inc., a privately held biotechnology company based in San Francisco, California, today announced positive interim data from a Phase 2 trial of the Company's lead oral kinase inhibitor, Telatinib, for the first-line treatment of patients with advanced gastric cancer. This proof-of-concept, multi-center, open label trial was designed to test the efficacy and safety of full-dose Telatinib, administered continuously, as a first-line treatment in combination with a standard regimen of capecitabine and cisplatin in US and European patients. Based on promising preliminary findings in April, 2010, the original planned enrollment of thirty-five patients was expanded to the current forty-eight. Interim findings indicate that the treatment:

“The overall response rate of 66% is roughly twice that which we have seen in prior clinical trials utilizing doublet chemotherapy. Telatinib has the potential to change the standard of care in this cancer indication.”

• Achieved a high overall response rate of 66% in thirty-two evaluable patients;
• Resulted in rapid and durable objective tumor response;
• Demonstrated evidence of mechanism-based anti-angiogenic activity; and
• Was well-tolerated and revealed no new or unexpected toxicities.

Follow up for progression free and overall survival is ongoing. The most common toxicities observed were mild and moderate fatigue/asthenia or gastrointestinal events. Severe hypertension, hand-foot-syndrome and neutropenia were all observed in less than 10% of patients. These data were presented on Saturday, October, 9, at the 35^th Congress of ESMO, the European Society of Medical Oncology (http://www.esmo.org/events/milan-2010-congress.html).

Based on these results the Company is preparing for a Phase 3 pivotal trial of Telatinib for the first-line treatment of advanced gastric cancer patients. As announced in June 2010, Telatinib has received orphan drug designation for gastric cancer from the US Food and Drug Administration (FDA).

"We are thrilled with the performance of Telatinib in this difficult-to-treat population of patients," said Prof. Josep Tabernero of the Vall d'Hebron University Hospital in Barcelona, Spain, a clinical investigator in the study. "The overall response rate of 66% is roughly twice that which we have seen in prior clinical trials utilizing doublet chemotherapy. Telatinib has the potential to change the standard of care in this cancer indication."

Added Wolf D. Busse, Chief Executive Officer and President of ACT Biotech, "These data support the initiation of registration trials in advanced gastric cancer, keeping Telatinib on track to file for marketing approval in both Europe and the United States by 2014."