A Sterling company received approval today from the Food and Drug Administration to conduct human clinical trials for its new cancer treatment.
Trials could begin early next year for Genzada Pharmaceuticals' cancer-fighting agent made from a lily that grows in Palestine.
Genzada, which plans to move its headquarters to Hutchinson, received word Friday that the FDA approved its Investigational New Drug application.
The proposed cancer drug centers around a molecule called GZ17-6.02. Genzada owners Gene Zaid and his son Jason West say it can help patients with advanced solid organ tumors or lymphoma. Preclinical testing, the company said, has shown effectiveness in battling pancreatic cancer and squamous cell carcinoma -- cancers of the mouth, nose and throat.
"Based on numerous preclinical studies, we believe this therapeutic will be very well-tolerated and will achieve meaningful outcomes for cancer patients," Dr. Cameron E. West, chief operating officer of Genzada, said in a statement released Friday morning.
The company, which recently bought the former Dillons store building at the corner of 30th and Plum in Hutchinson, said the compound blocks super-enhancers -- clusters of genes that cause cancer cells to grow and spread.
The Dillons building will house Genzada's headquarters, an eventual molecule development lab and office spaces for lease to other businesses.
"We're grateful to be part of a community that supports us," Zaid said, "and we're looking forward to expanding our operations and improving life in Hutch and the entire country.
GZ17-6.02 is derived from the black calla lily, a native plant found in the Middle East, including Zaid's native Palestine.
Other cancer-fighting drugs also started as plant materials, including chemotherapy drugs vinca alkaloids, derived from the periwinkle plant in Madagascar.
Zaid, however, said he expects Genzada's treatments to have fewer side effects.
"This is a normal process in cancer drug development," West said. "You get inspiration from mother nature and take it from there. There's a now host of drugs that came from natural products."
Zaid came to Kansas as a chemist in the oil and gas industry and founded JACAM Chemicals in Sterling in 1982. He said he began developing what would become 6.02 as an extract from the lily made into a tea and developed in a lab Zaid built in the basement of a church.
People with cancer who drank the tea around the Sterling and Great Bend area claimed it put them in remission.
Word spread about the tea and Zaid began Genzada in 2010 to further develop the treatment.
By 2016, Zaid and Thomas Burgoyne, a chemist and researcher who had worked at the University of Oklahoma and Indiana University, had acquired more than a dozen patents for therapeutic agents for treating cancer.
That same year, Genzada opened a new headquarters in Sterling, also on the site of a former grocery store.
The company now grows the black calla lily, which resembles a Peace Lily but with a dark purple, almost black flower, in two 5,000-square-foot greenhouses in Sterling.
Genzada has been working with Transitional Drug Development, a firm located on the Mayo Clinic campus in Scottsdale, Arizona, that works to bring oncology drugs to market.
TD2 supported the research sponsor with its regulatory submissions, including the completion and filing of the FDA application.
"I know how hard the team has worked to get to this milestone for this very interesting combination with a unique mechanism of action," Dr. Daniel D. Von Hoff, chief development officer at TD2 and adviser to Genzada, said in a news release.
The clinical research organization will continue to manage the clinical trial for 6.02, along with the HonorHealth Research Institute, also in Scottsdale.