TGen's Clinical Research Service (TCRS), a strategic alliance with Scottsdale Healthcare (SHC), provides a direct clinical research site for TGen.

Dr. Daniel Von Hoff, TGen’s Physician-in-Chief, serves as TCRS Chief Scientific Officer.

TCRS clinicians focus on clinical trials with targeted agents and genomics-based individualized therapy. The TCRS, with an initial focus on cancer, allows the unique opportunity for TGen to transition its laboratory-based research to patient care centered on individualized therapy.

TCRS staff currently working on the Phase I clinical trials

TCRS includes the Genomics Medicine and Individual Therapy Center, the Pancreas Cancer Center, and a Pharmacodynamic and Pharmacokinetic Lab, each explained further below. Additional clinical research programs focused on other cancer types are planned.

TCRS will bring new clinical research into the community, to those patients who would otherwise have to travel someplace else for access to new therapies or prevention agents.

According to the National Institutes of Health, only 3% of adults with cancer are participating in clinical trials. A recent study shows that if given the opportunity and access to clinical trials, 63% of the population would participate, according to a survey by the Charlton Research Co.

The Genomic Medicine and Individualized Therapy Center
The Genomic Medicine and Individualized Therapy Center is based on the idea of individualized treatment, also known as personalized medicine. As technology continues to accelerate our ability to rapidly look at the large amount of genetic materials in tumors in combination with information from the database, new treatments that are less toxic and more effective will come forth.

The Genomic Medicine and Individualized Therapy Center (working under the guidance of TCRS) is focused on translating genomic discoveries into advances in human health. The center assimilates the most advanced medical and scientific technology into a streamlined process for gathering information about an individual patient. For example, TCRS is currently sponsoring a unique pilot study that puts cancer patients first in line to benefit from cutting-edge technologies that can analyze tumors and provide the patient with a viable therapeutic alternative. This will hopefully enhance their likelihood of having a clinical benefit. A recently launched molecular profiling study is focused on applying genomic technologies to assist physicians in determining the most effective treatment for their individual patients based on the molecular profile of the patient's tumor. Researchers anticipate that this will generate a meaningful database that can one day be used to develop a general treatment algorithm. This algorithm can be used in any office or hospital anywhere in the world, giving patients the opportunity to receive a more customized option of treatment.

Current initiatives include:

1. Multiple clinical trials underway to investigate new chemical agents for a variety of tumor types in different cancers.

2. Incorporation of modern tools to identify patients' genomic characteristics that could lead to a more targeted approach.

The Pancreas Cancer Center
The Pancreas Cancer Center provides research-driven patient care for patients with pancreas cancer. The center functions in collaboration with physicians in the community and conducts clinical trials for patients who are not helped by standard oncology treatments. For those patients where current therapies have failed in treating their tumors, we are able to administer specific agents that target molecules or pathways that are aberrant in pancreas cancer.

In 2005, TGen was awarded a five-year $15 million grant from the National Cancer Institute to lead a group of research centers in the discovery and development of new therapies for patients with pancreatic cancer. This federally funded multi-center program project grant is the first of its kind that focuses exclusively on pancreatic cancer. The grant funds three projects with the key theme of accelerating the delivery of new treatments for patients with pancreatic cancer, one new compound for each year of the grant. Dr. Von Hoff serves as the principal investigator for the study.

The Pharmacodynamic and Pharmacokinetic Lab
The Pharmacodynamic and Pharmacokinetic Lab is a key component of TCRS in analyzing new compounds and determining the fate of a drug’s absorption and distribution. The impact of the drug on the body can be measured with certain test that includes the spectrum of either biopsies, CT scans, CT perfusion scans, MRI scans, MRI perfusion scans and PET scans. The timing and coordination of these scans in combination with measuring the proposed effects of new drugs lies in the domain of the Pharmacodynamic and Pharmacokinetic Lab. The lab will be equipped with high-resolution equipment to detect drug in the serum and urine or other areas of the body. Once this data is obtained and organized, this information can then help more accurately pinpoint the dosage needed to attain the proposed effect in addition to the frequency of treatment. This new entity is scheduled to open in late 2007 and will include 1,500 feet of lab facilities.

TCRS works in collaboration with physicians in the local Arizona community and across the U.S. to provide options for the care of their patients. TCRS serves as an international referral center for patients from anywhere in the world. Every patient with a physician referral is welcome, provided they meet the requirements. In some cases, the patient may be evaluated through the new clinic, but receive treatment from their referring physician. We work flexibly to ensure the best and most complete care for patients.

Additionally, TCRS enthusiastically works in collaboration with other clinical trial sites throughout the U.S. who share our ideas and passion for getting this done quickly, including current collaborators (Mayo Clinic, U.S. Oncology, M.D. Anderson Cancer Center, the Arizona Cancer Center, and others) who wish to participate. TCRS will not establish exclusive relationships that preclude others from participating.