SCOTTSDALE, Ariz. – Jan. 29, 2008 – TGen Clinical Research Services (TCRS) at Scottsdale Healthcare and Mayo Clinic are testing a new drug that may offer broad potential to treat solid tumors.
Clinical trials of the drug TH-302 are being conducted at TGen Clinical Research Services at Scottsdale Healthcare, a partnership of the Phoenix-based Translational Genomics Research Institute (TGen) and Scottsdale-based Scottsdale Healthcare Corp., and at Mayo Clinic in Arizona.
Dr. Glen Weiss, Director of Thoracic Oncology at TCRS at Scottsdale Healthcare, said the new drug appears promising and may be more effective and less toxic to healthy tissues than conventional drugs.
"TH-302 is a new, novel, small molecule that is activated under a metabolic condition characteristic of cancer cells — hypoxia (lack of oxygen). The drug candidate may provide an opportunity to treat slowly dividing tumor cells within hypoxic regions that generally evade traditional chemotherapeutic agents and ultimately contribute to relapse," Dr. Weiss said.
Phase 1 and Phase 1/2 trials are underway to investigate the safety and activity of TH-302 in patients with advanced solid tumors. After evidence of tumor activity was observed in the Phase 1 trial in patients with advanced melanoma – both non-small cell lung cancer and small cell lung cancer – the study was expanded to further investigate TH-302 anti-tumor activity in these tumors. Both Phase 1 and 1/2 trials continue to enroll patients with other solid tumors. If successful, Phase 2 and 3 clinical trials will confirm the drug's effectiveness on solid tumors.
In cancer, as a tumor grows, it rapidly outgrows its blood supply, leaving portions of the tumor with regions where the oxygen concentration is significantly lower than in healthy tissues. This condition is called tumor hypoxia. Several studies have shown that higher levels of tumor hypoxia correlate with poor treatment outcomes for a variety of solid tumors. It is believed that hypoxia may severely limit the curability of tumors.
TH-302 is converted selectively in the presence of hypoxia to the drug's active form, bromo-isophosphoramide mustard, a potent DNA alkylator. TH-302 targets levels of hypoxia that are common in tumors but are rare in normal tissues – this is how selective targeting of the tumor occurs. After conversion to the active form of the drug, the more resistant hypoxic cells are exposed to high concentrations of released cytotoxic agent, which can also diffuse into the oxygenated regions of a tumor cell.
The Phase 1/2 trials are investigating the safety and activity of TH-302 in combination with a number of conventional chemotherapies that are believed to be effective in the non-hypoxic regions of solid tumors.
The clinical trial at TCRS at Scottsdale Healthcare will investigate the safety and pharmacology of multiple doses of TH-302 in patients with late-stage cancer. For more information about this clinical trial, please call Joyce Ingold, R.N., research patient care coordinator for Scottsdale Healthcare, at 480-323-1339. At Mayor Clinic, clinical trial coordinator Dianna Boughter can be reached at 480-301-9875.
About TGen
The Translational Genomics Research Institute (TGen) is a non-profit organization dedicated to conducting groundbreaking research with life changing results. Research at TGen is focused on helping patients with diseases such as cancer, neurological disorders and diabetes. TGen is on the cutting edge of translational research where investigators are able to unravel the genetic components of common and complex diseases. Working with collaborators in the scientific and medical communities, TGen believes it can make a substantial contribution to the efficiency and effectiveness of the translational process. For more information, visit: www.tgen.org.
About Scottsdale Healthcare
Scottsdale Healthcare is a primary clinical research site for TGen. TGen Clinical Research Services (TCRS) at Scottsdale Healthcare is housed in the Virginia G. Piper Cancer Center at Scottsdale Healthcare, located on the Scottsdale Healthcare Shea medical campus. Scottsdale Healthcare is the not-for-profit parent organization of the Scottsdale Healthcare Shea, Scottsdale Healthcare Osborn and Scottsdale Healthcare Thompson Peak hospitals, Virginia G. Piper Cancer Center, Scottsdale Clinical Research Institute, TGen Clinical Research Services at Scottsdale Healthcare, Scottsdale Healthcare Home Health Services, Scottsdale Healthcare Community Health Services, and Scottsdale Healthcare Foundation. For additional information, visit www.shc.org.
Contact:
Alice Sluga
Public Relations Coordinator
Scottsdale Healthcare
480-882-4915
asluga@shc.org
About Mayo Clinic
Mayo Clinic Cancer Center is one of only 39 U.S. medical centers that have been named as a National Cancer Institute (NCI) Comprehensive Cancer Center. To receive this designation, an institution must meet rigorous standards demonstrating scientific excellence and the ability to integrate diverse research approaches to address the problem of cancer. Mayo Clinic Cancer Center is the only national, multi-site center with the NCI's Comprehensive Cancer Center designation. In Arizona, Mayo's clinical and research experts work together to address the complex needs of cancer patients, with a dedication to understanding the biology of cancer; discovering new ways to predict, prevent, diagnose and treat cancer; and transforming the quality of life for cancer patients today and in the future.
About Threshold Pharmaceuticals
Threshold is a biotechnology company focused on the discovery and development of drugs targeting Tumor Hypoxia, the low oxygen condition found in microenvironments of most solid tumors. This approach offers broad potential to treat most solid tumors. By selectively targeting tumor cells, we are building a pipeline of drugs that hold promise to be more effective and less toxic to healthy tissues than conventional anticancer drugs. For additional information, please visit our website (www.thresholdpharm.com).