Phase 2 Data in Stomach Cancer Show Telatinib's Potent Antiangiogenic Activity

Data Presented in Two Posters at ASCO GI Symposium

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| Source: ACT Biotech, Inc.

SAN FRANCISCO, Jan. 20, 2011 (GLOBE NEWSWIRE) -- 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."

ASCO GI posters:

Poster No. A84

Onset CT scan morphological changes in metastatic lesions and associated responses in gastric cancer patients treated with telatinib

Lead author: Priya R. Bhosale, M.D.: Department of Radiology, MD Anderson Cancer Center, Houston, TX

Presentation information: 11:15 am-2:00 pm and 5:30-6:30 pm PST, Moscone West Building, Level 1, West Hall

Poster No. A118

Pharmacokinetic and pharmacodynamic analysis of gastric cancer patients treated with telatinib

Lead author: Amy Burd, Ph.D., ACT Biotech, Inc.

Presentation information: 11:15 am-2:00 pm and 5:30-6:30 pm PST, The Moscone West Building, Level 1, West Hall

About stomach cancer

Stomach, or gastric, cancer is responsible for more than 865,000 deaths globally each year, making it the second leading cause of cancer death in the world. According to the NCI, in the U.S. alone, more than 21,000 people were diagnosed with stomach cancer and more than 10,500 died from the disease in 2010. Currently, more than 64,000 Americans are living with stomach cancer and studies have shown that the incidence of stomach cancer in younger patients is on the rise.

Stomach cancer is a very difficult cancer to treat since most cases are detected late (in the Americas and Europe), and once detected, the cancer has already spread and is usually fatal within a year. Most patients do not respond to standard chemotherapy treatment and 85-90 percent of stomach cancer patients have no targeted therapy options.

About ACT Biotech, Inc.

ACT Biotech is a biopharmaceutical company focused on the development and commercialization of highly targeted, oral cancer drugs. ACT's lead product candidate is telatinib, a highly selective, orally-available antiangiogenic therapeutic that targets the VEGFR and PDGFR receptor tyrosine kinases to inhibit the blood supply to tumors. Telatinib showed robust antitumor activity with a solid safety profile in a Phase 2 clinical trial in stomach cancer. These results have triggered ACT to move telatinib to Phase 3 development. Telatinib has also been studied in other solid tumors including colorectal and kidney cancers. In addition to telatinib, the company's product pipeline includes three other oncology candidates. ACT's pipeline products were originally discovered at Bayer Pharmaceuticals and were licensed by ACT Biotech in 2008 following Bayer's merger with Schering AG. ACT Biotech is headquartered in San Francisco, CA, and backed by NGN Capital. To learn more about ACT Biotech and the company's pipeline of innovative medicines, visit www.actbiotech.com.

Media contact:
Stephanie Ashe
Continuum Health Communications
650-245-0425