Bench to Bedside: Happy Trials
Phase 1 trial center allows U-M cancer discoveries to move forward
The concept
In labs across the U-M Medical School, cancer researchers are discovering potential treatments that show great promise in early studies. Health System officials have long seen the need for a place at U-M where these discoveries can move to a crucial next step: the first clinical trials in people, called Phase 1 trials.
Now the U-M Comprehensive Cancer Center has a place dedicated to conducting Phase 1 trials—the new Ravitz Foundation Phase 1/Translational Research Center, located on the second level of the Cancer Center.
The idea behind the center is to make it possible for researchers to take this first step in the FDA approval process right here at U-M. Phase 1 trials typically test the safety and effective doses of novel therapies in relatively small groups of people. U-M Phase 1 trials aim to learn a drug’s biological effects as they happen in the patient’s body.
Too often, a promising early discovery in the lab can have difficulty moving into Phase 1. With the new center, the hope is that valuable new drugs and other cancer therapies can reach patients sooner.
How the center works
The center offers translational research resources to Cancer Center faculty. It is also open to investigators at other academic institutions and pharmaceutical and biotechnology companies.
The trials typically seek about 30 to 50 participants. The center has six infusion stations. It is staffed with five nurses, a nursing director, a team of data managers and a regulatory specialist. David C. Smith, M.D., is clinical director of the new center as well as medical director of the Cancer Center Clinical Trials Office.
Three trials under way
There are currently three Phase 1 trials under way at the center. One is testing a new drug to treat patients with chronic myelogenous leukemia. Another tests a new targeted therapy that holds promise for all types of solid tumors. A third trial is testing a drug that targets a factor that contributes to hematological conditions.
One exciting trial soon to begin will test a drug developed by U-M pharmacologist Shaomeng Wang, Ph.D., co-director, molecular therapeutics program at the Cancer Center. The synthetic molecule, which allows critical cell growth regulator p53 to function, holds promise in treating many forms of cancer. It is being manufactured by Ascenta Therapeutics, Inc., a company Wang co-founded.
According to Moshe Talpaz, M.D., director of translational research, Cancer Center, and professor, Department of Internal Medicine, they expect to have 11 trials under way in the center in the next six to nine months. The ultimate goal is to launch 10 Phase 1 trials each year.
Next steps toward drug approvals
Phase 1 trials at the center can be expected to last up to two years. If a treatment proves promising, it can move on to Phase 2 and Phase 3 trials. The whole drug approval process typically can take eight to 10 years, but “hopefully less than that for cancer,” says Talpaz.
To find out more about the center, visit the Ravitz Foundation Phase 1/Translational Research Center Web site. To learn more about research proposals or enrolling subjects, contact Dr. Moshe Talpaz, 734-764-8195; or Dr. David C. Smith, 734-936-6884. |
