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Evergreen Hematology & Oncology, of Spokane, says it has joined in a Phase 1 clinical trial of a potential new drug for patients who have advanced, incurable cancerous tumors.
The study is mainly for patients with breast or prostate cancer, but might include others, says Dr. Stephen Anthony, an oncologist and hematologist who owns Evergreen.
Anthony says Evergreen is testing Berkeley, Calif.-based drug developer Plexxikon Inc.'s cancer drug PLX3397. The Spokane medical practice is one of a small number of providers selected to join in the Phase 1 trial, he says.
The oral drug targets host cells to prevent or slow the spread of cancer, Anthony says. The clinical study is targeted at cancer patients who are not responding to standard therapy and have no other treatment options available.
He says providers will enroll about 18 to 30 patients for the trial initially. The trial should last about a year and a half, he says. The first patient received a dose of the drug in October.
A Phase 1 clinical trial is the first study of a drug conducted on human subjects and is used to evaluate the safety of the drug, how well patients tolerate it, and other pharmaceutical properties of the drug.
"Drugs such as PLX3397, if successful, would allow us to bridge patients to another treatment while maintaining their quality of life, and might allow patients to find a more successful, if not curable, treatment," Anthony says.
A second phase study targets the drug to treat a specific cancer, and a third phase places a drug in a head-to-head study with the current top drug used to treat an illness to see which works better, he says.
Anthony opened Evergreen in September 2008. The practice works with patients who have cancer or blood disorders. It currently has about 1,000 patients, he says.
Evergreen employs 22 people, including Anthony, another doctor, and a nurse practitioner. Anthony says he expects to have three doctors on staff by June.
In addition to Anthony, the practice includes Dr. Howard Stang, a medical oncologist and hematologist who joined Evergreen's staff in late 2008. Stang has been practicing in Spokane since 1983.
Anthony leases about 9,000 square feet of floor space in the Wandermere Professional Building, at 309 E. Farwell Road, in the Wandermere commercial district.
The practice is equipped with a PET-CT scanner, which is used to conduct positron emission tomography, or PET, scans to locate the metabolic signal of actively growing cancer cells in the body. Computerized tomography, or CT, scans provide detailed pictures of a patient's internal anatomy, showing the location, size, and shape of cancerous growths. Anthony says Evergreen is one of 16 facilities in the state to have its PET services accredited by the American College of Radiology, headquartered in Reston, Va.
From 1998 to 2006, Anthony worked at Cancer Care Northwest, of Spokane. From 2006 to 2008, Anthony was with the Translational Genomics Research Institute, a nonprofit biomedical research institute in Phoenix, where he was senior investigator and chief medical officer for drug development services.
He says Evergreen is participating in other drug trials, including some for breast, colon, lung, and pancreatic cancer, as well as for lymphoma, a cancer of part of the immune system called the lymphatic system. One type of lymphoma is called Hodgkin's disease.
Anthony says that by participating in the drug trials, Evergreen becomes experienced with more drug treatments, and the trials enable the medical practice to offer more drugs to patients.
In July, the research of Anthony and 21 other doctors who co-authored a pilot study was presented at the annual meeting of the American Association for Cancer Research, in Denver. The study demonstrated that "molecular profiling" of tumors could provide cancer patients with a longer progression-free survival than prior treatment regimens. Progression-free survival means the cancer still exists, but the disease isn't progressing.
Anthony says molecular profiling is reserved for patients with tumors that have not responded to conventional therapies.
"Often, this is a patient who has been treated with two lines of standard chemotherapy," he says.
Anthony says that by targeting specific mutations within tumors, molecular profiling enables doctors to select and personalize treatment, giving therapies a better chance of working. He also says it improves patients' quality of life by keeping patients from being exposed to drugs that have a limited chance of success.
He says most patients with what's called metastatic cancer, which is the spreading of the disease in the body, eventually run out of options.
"It's what's called 'refractory cancer," he says. "It simply doesn't respond to treatment."
The molecular profiling study that Anthony helped author, conducted at nine sites across the U.S., was designed to determine not only whether potential target mutations could be identified, but if molecular profiling at a particular stage of the disease would provide any clinical benefit.
Shrinkage of tumors was shown to occur in 47 percent of the profiled patients, and 27 percent showed improvement in progression-free survival compared with the previous therapy. Improved overall survival in patients also was suggested, he says.