By Bill Poovey GSA Business

A Greenville biomedical researcher who has worked for years developing a radiation- and chemotherapy-free cancer treatment has opened a clinic in the Cayman Islands.

Thomas Wagner, Ph.D., said the offshore location is the best available option while the Food and Drug Administration decides if his treatment regimen will be approved for use in the United States.

Wagner said the clinic, which is more than 1,000 miles away from Greenville, is open because his immunotherapy treatment is a lifesaver and can benefit patients now. He said the FDA’s responses to his series of clinical trials have been encouraging but he predicts a final decision is still years away.

Stephen King, a spokesman for the FDA’s center for drug evaluation and research, said in an email that the FDA is “unable to discuss any drug applications that may or may not be pending before the Food and Drug Administration or regarding clinical trials.”

Wagner’s treatment at the clinic, Perseus PCI — or Personalized Cancer Immunotherapeutics — involves injecting patients with a vaccine made from their own tumor cells. He said the cells are injected just under the skin like other vaccines.

“Every human being is different and every cancer is different,” Wagner said. “If we take every molecule that is in a patient’s tumor and use that complete molecular profile to activate their immune system, that is the best you can get.”

He said “cancer starts in all of us about 10 times a day” and is naturally treated by some bodily process. Wagner said drugs interfere with that natural treatment, while his method enhances it.

Regulatory approval

Dr. Robert M. Sade, director of the Institute of Human Values in Health Care and professor of surgery at the Medical University of South Carolina, said “there are ethics questions involved.” Those questions, he said, should be directed as much to the FDA as to any medical company taking the medical care offshore.

“The FDA has produced a system that retards the introduction of effective new treatments,” Sade said. “It takes a billion dollars and 10 years to put a new product on the market because of the demands of the FDA for multiple studies, for all kinds of information that I believe is largely unnecessary.”

He said physicians who are involved in providing such offshore medical treatments are “ethically bound not to use treatments that have no basis in science. There are people who take treatments offshore because they are quacks.”

Sade said “if there is scientific evidence the treatment is effective but still hasn’t been approved by the FDA, it would not be unethical to take it offshore.”

Wagner is a pioneer in cell-based therapies. In the early 1980s he co-founded Diagnostic Hybrids, which makes and markets cellular and molecular diagnostic kits used for respiratory and other diseases. He is a founder of the Ohio Edison Biotechnology Institute and formerly directed the Greenville Health System’s Oncology Research Institute and Clemson University’s Biomedical Institute. He currently is a director of the Orbis Health Solutions medical research firm in Greenville, a funding partner of Perseus.

Wagner, 70, said his father and a brother both died of cancer.

“I spent my life around cancer patients,” he said.

Dr. Sam Smith, who worked with GHS cancer patients when Wagner was a researcher there, said Wagner developed a method that caused a “good immunological response to the cancer cells.”

Smith said having to open a clinic in the Caymans “smells of turkey feathers but I don’t know what alternative he has.”

Smith said “immunotherapy of cancer is significantly effective in a lot of people and it’s worth pursuing.”

Riley Polk, COO for the group who announced the Perseus clinic opening in March, said in an interview in Greenville that while there are numerous other immunotherapy treatment options, Wagner’s work has been “15 years ahead of everybody else.”

Other immunology cancer treatments use vaccines that are not made exclusively from the patient’s own tumor cells, he said.

“Nobody’s is as personalized as this,” Polk said.

He said the clinic has started scheduling treatments for patients, including some from the Greenville area.

Polk said he and other Perseus investors also have had relatives or close friends afflicted with cancer. He said they believe Wagner’s treatment method should be available to patients now, as an alternative to sickening chemotherapy and radiation and other immunotherapy treatments that do not only use a patient’s own cells.

Wagner, who has served as a scientific adviser to the World Health Organization, to Congress and to the Reagan administration, describes the comparable side effects of his treatment as a “better quality of life.”

“It is my belief that the future of medicine will not involve small molecules put in pills or injected into a patient,” he said.

Going offshore

Wagner said he and his supporters “thought long and hard” about how to best make the treatment an option for patients now. They decided on the Cayman Islands clinic.

Kate Crosby, a spokeswoman for the S.C. Medical Association, said in an email that the association supports the FDA but has no position on “processes/services in other countries” as it is up to them to protect their citizens.

“It’s not a question of escaping the United States or anything like that,” Wagner said. “(The Cayman Islands) have their own laws. Their Health Practice Commission is like the FDA. They decided this is something that should be offered to any cancer patient with a solid tumor at any stage. The health practices are very regulated. We have a facility there that meets and exceeds all FDA standards.”

Wagner predicted that results from treating patients at the clinic will further show that his immunotherapy method should be allowed in the U.S. Wagner said his clinical trials have involved about 44 patients who had stage 4 tumors.

Wagner said there are companies offering cancer and cosmetic treatments and some have five or six different locations globally while going through FDA trials.

“There is snake oil all over the place,” he said.

High costs

Insurance doesn’t cover treatment at the Perseus clinic or the out-of-country travel costs that combined range from $40,000 to $100,000. Wagner said that is half the cost of some other cancer treatments but his method doesn’t use drugs and isn’t embraced by a powerful force: pharmaceutical companies. Wagner said his nonpharmaceutical method “doesn’t fit most business models” and is at odds with a corporate mindset that steers the course of cancer treatment financially.

Another clinic investor, Perseus President Buddy Long of Austin, Texas, said his parents both suffered battles with cancer. Long said he was introduced to Wagner as a potential investor in 2012 and said he left wanting to be professionally involved. He said the clinic represents an investment of about $2.5 million.

Long, a former president and co-founder of the Level One firm in Greer, said he was further attracted to invest by the status of treatment today for the 13 million people who will be diagnosed this year in the U.S. with solid malignant tumors “who are suffering through cancer protocols.” Long said he believes in Wagner’s treatment and the clinic is “right now the quickest way to get it.”

“My mom and dad would be alive right now,” he said.

Long said it is “completely in the jurisdiction of anyone going through medical treatment to evaluate in a credible way” which treatment is most safe and effective.

Dr. Sook Yin, who earned her medical degree and specialty certifications in Great Britain, is the clinic’s treating physician for patient care plans. Each patient plan is being coordinated by a team of U.S-based and licensed doctors also licensed to practice in the Cayman Islands, according to a Perseus statement.

Survivor

Among stage 4 cancer patients who underwent Wagner’s treatment in early trials, Mary Carol Abercrombie of Greenville is the longest surviving at 11 years. Abercrombie in a video on the Perseus website says she had a mole on her calf and after her doctor and a dermatologist told her they didn’t believe it was anything serious, the dermatologist discovered it was malignant. Abercrombie said it was melanoma. She underwent treatment with Interferon and the cancer spread. When she was diagnosed at stage 4, her oncologist told her she had three to five months to live. He then told her about Wagner and she underwent his treatment in a clinical trial in Greenville.

“Eleven years later I’m still here,” she said. “I’m not supposed to be here.”

Wagner said eligibility for clinical trials is limited to “people who have failed everything else. If they die from this they are going to die anyway.” He said 14% of the patients who have participated in his treatments are still alive.

His goal: “How do we do it so we can scale it and make it cost efficient so people can get it?’’

PHOTOS:

Perseus co-founder Thomas Wagner, right, and Dr. Sook Yin, middle, the treating physician at the Cayman Islands clinic, consult with company President Buddy Long. (Photo/Provided)

Thomas Wagner, creator of Perseus PC

Greenville researcher Thomas Wagner has opened a cancer treatment clinic in the Cayman Islands. The treatment, which is not approved for use in the U.S., involves injecting patients with a vaccine made from their own tumor cells. (Photos/Provided)

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