SAN FRANCISCO, Nov. 12, 2011 (GLOBE NEWSWIRE) -- ACT Biotech, Inc., a clinical stage biopharmaceutical company focused on the development of highly targeted, oral therapeutics for the treatment of cancer, announced that results from a Phase 2 gastric cancer trial of telatinib on biomarker response will be presented at the AACR-NCI-EORTC International Conference in San Francisco. The results demonstrate that patients who were treated with a combination regimen of telatinib, a potent and selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR), capecitabine and cisplatin and who responded with a large decrease of a specific angiogenesis biomarker - the soluble form of VEGFR2 (sVEGFR2) - were found to have a lower risk of disease progression and death compared to patients with smaller decreases.
In an analysis of serum sVEGFR2 levels taken from 28 patients who participated in the Phase 2 clinical study of telatinib (TEL0805 Phase 2 Gastric Cancer Trial First Line Treatment, an Open-label Phase 2 Multi-Center Study), researchers found that both Overall Survival (OS) and Progression-free Survival (PFS) were significantly longer for patients with a greater than 33 percent decrease in sVEGFR2 levels following telatinib treatment. For these patients with a greater decrease in sVEGFR2, PFS increased to 11.6 months as compared to 4.7 months for those patients with a smaller decrease in the biomarker levels. Similarly, OS was 7.6 months for patients with a smaller decrease in sVEGFR2 levels, and has not yet been reached for patients with larger decreases. Follow-up with surviving patients with larger decreases in serum levels ranges from nine to 14 months.
"The importance of angiogenesis in metastatic disease and poor outcome in stomach cancer is well documented. However, to date, a biomarker that correlates with anti-angiogenic treatment outcome has not been identified," said Lori A. Kunkel, M.D., chief medical officer for ACT Biotech and lead author of the study. "In our study, we saw a marked decrease in sVEGFR2 in response to telatinib treatment and hence, sVEGFR2 may be a quantitative biomarker that will allow us to identify patients that achieve the best response to telatinib. We intend to integrate this biomarker in upcoming trials of telatinib."
"The correlation between telatinib biomarker activity and patient benefit is yet another indicator of the significant potential of telatinib to improve patient outcome in stomach and other angiogenic-driven cancers," stated Ali Fattaey, Ph.D., president and chief scientific officer of ACT Biotech. "We look forward to working with the FDA to bring this distinctly selective, potent and safe drug to patients as soon as possible."
About Telatinib
Telatinib, a new chemical entity, is a distinctly selective and potent, oral antiangiogenic drug. Its unique mechanism of action specifically inhibits cell surface receptors critical for tumor blood vessel formation: vascular endothelial growth factor receptor (VEGFR) and platelet derived growth factor receptor (PDGFR), both of which are involved in angiogenesis, the process of new blood vessel formation needed for tumor growth. Telatinib, because of its highly selective nature, interferes with angiogenesis without disruption of off-target pathways, thereby distinguishing it from other oral anti-angiogenic tyrosine kinase inhibitors. The selectivity and safety profile likely account for cancer patients' ability to tolerate treatment with telatinib in combination with chemotherapy for long periods of time without an apparent increase in toxicity of the chemotherapy. Telatinib was granted orphan drug status for stomach cancer in 2010.
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 drugs to deliver high performance therapies to cancer patients. ACT's lead product candidate is telatinib, which has shown robust anti-tumor activity with an excellent safety profile in a Phase 2 clinical trial in stomach cancer. Telatinib has also shown encouraging anti-tumor activity as a single agent in colorectal, kidney, stomach and liver cancers. In addition to telatinib, the company's product pipeline includes ACTB1003, a potent pan-inhibitor of the FGF receptor and RSK family of kinases that is entering Phase 1 clinical testing in multiple cancer indications. 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.
Poster Presentation at AACR-NCI-EORTC
Session ID: Poster Session A
Session Title: Angiogenesis and Antiangiogenesis Agents 1
Session Date and Time: Sunday Nov 13, 2011 12:30 PM - 2:30 PM
Location: West Hall, Level One, Moscone Center West
Permanent Abstract Number: A6
Association of clinical outcomes and the change in circulating soluble VEGF receptor 2 (VEGFR2) levels in advanced gastric cancer patients treated with telatinib (Tel), capcitabine (X), and cisplatin.
LA Kunkel, A Fattaey, S Cruikshank, J Baker and JA Ajani