ACT Biotech releases telatinib Phase 2 trial data for metastatic stomach cancer

ACT Biotech, Inc., a biopharmaceutical company focused on the development of highly targeted, oral therapeutics for the treatment of cancer, today released data on additional analysis of the Phase 2 clinical trial of telatinib in patients with metastatic stomach cancer that further supports the highly-potent nature of the antiangiogenic agent. These data were presented at the eighth annual ASCO 2011 Gastrointestinal Cancer Symposium that is taking place on January 20-22, 2011, in San Francisco, CA.

The results presented at ASCO GI summarized the ongoing analysis of pharmacokinetic and pharmacodynamic data, focusing on the ability to continuously dose telatinib in patients with stomach cancer combined with full-dose, standard-of-care chemotherapy. In addition, morphological data from radiographic scans of tumor response demonstrated a unique and characteristic feature of potent antiangiogenic activity from treatment with telatinib, verifying the on-target effect of the drug. Positive interim results of the Phase 2 trial of telatinib with combination chemotherapy for first-line treatment of metastatic stomach cancer patients, a very difficult to treat population, were reported in October 2010 and demonstrated rapid onset of objective tumor responses in two-thirds of the treated patients.

"We are very pleased that this further analysis of the telatinib Phase 2 data confirms the potent mechanism-based activity of telatinib. The results showed that telatinib achieved not only a rapid and sustained reduction in VEGFR2 levels, but achieved levels that exceed less-targeted therapies and appeared to correlate with robust anti-tumor activity," said Ali Fattaey, Ph.D., chief operating and scientific officer, ACT Biotech.

"The combination of telatinib with two commonly-used chemotherapy drugs in patients with advanced stomach cancer has demonstrated a remarkable rate and level of tumor shrinkage along with good tolerance of this therapy by patients," said Jaffer Ajani, M.D., professor of medicine at the University of Texas M.D. Anderson Cancer Center in Houston and one of the leading telatinib investigators.  "In addition, the length of survival of patients in this trial is encouraging enough that further development of telatinib in stomach cancer should become a high priority."

"Stomach cancer is a very deadly disease and the second leading cause of cancer death in the world. Less than 30 percent of stomach cancer patients respond to standard chemotherapy treatments making it a high unmet medical need," said Lori Kunkel, M.D., chief medical officer, ACT Biotech. "We are hopeful that telatinib may offer these patients an effective treatment that can be safely combined with chemotherapy without adding toxicity. We are on track to initiate Phase 3 clinical testing of telatinib for frontline treatment of stomach cancer patients this year. Because of telatinib's unique ability to effectively combine with multiple chemotherapy regimens at full, continuous dosing, we are encouraged to develop telatinib in other solid tumor indications, including colorectal, breast, and kidney cancers."


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