HUTCHINSON – Hutchinson-based Genzada Pharmaceuticals announced this week that a cancer-fighting drug it has been developing for several years has entered a new phase of clinical trials.
The oral therapeutic, identified as GZ17-6.02, is derived in part from the black calla lily (Arum palaestinum), a native plant found in several regions of the Middle East, which the company grows by the thousands in greenhouses in Sterling.
Genzada, a subsidiary of Ionics Pharmaceuticals of Ireland, reported the official opening of a phase 1B clinical trial, with its first site at Dallas-based Texas Oncology.
The pill from Genzada will be administered in combination with another oral chemotherapy drug, capecitabine, to patients with metastatic breast cancer.
Capecitabine is prescribed for a lot of different cancers, said Dr. Cameron West, chief operating officer with Genzada, including as a topical cream, for pre-cancerous spots on the skin, or as an injection.
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“It’s the standard of care given (breast cancer) patients as a third line of chemotherapy” when the first and second line of drugs are not working or are counter-indicated.
“This is a significant and exciting achievement for our company,” West said. “Our phase 1 study demonstrated that 6.02 has a favorable safety profile and provided clinical benefit to patients. Based on this data, in addition to the robust preclinical data, we are optimistic that 6.02 in combination with capecitabine in patients with metastatic breast cancer may provide increased benefit over single-agent capecitabine.”
Genzada’s formulation has been in phase 1 clinical trials since March 2019. The purpose of a phase 1 trial is to determine if drugs are safe and at what levels people tolerate them, West said.
The phase 1B trials expand on that, now looking at whether the combination of drugs is safe and effective, using a larger number of patients.
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The company anticipates this phase will take 12 to 18 months, West said, depending on how quickly they can get patients enrolled.
Texas Oncology has hundreds of clinics nationwide, and the study will be under the direction of leading breast cancer expert Dr. Joyce O’Shaughnessy.
“It’s a good place to be able to study our drug with capecitabine,” West said. “Dr. O’Shaughnessy is very familiar with it and is definitely a national and international expert.”
“I am delighted to be participating in the trial of G217-6.02, as I’m very excited to be able to offer metastatic breast cancer patients a highly novel super-enhancer inhibitor therapy that holds great promise in the studies conducted to date,” Dr. O’Shaughnessy stated in a news release.
Super-enhancer inhibitors are a fairly new concept, West said. In oversimplified terms, they work at the cellular level to interrupt cancer cell growth and reprogram cell development.
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Genzada worked closely with Translational Drug Development (TD2), a contract research organization focused on oncology development, to design the clinical trial, for project and data management and other operational aspects of the study.
After phase 1 trials, the company will submit its application and analysis to the Food and Drug Administration to move into phase 2.
“They make decisions regarding extra steps we need to do; if there are things they want to see explored or any safety concerns that need more understanding,” West said. “If not, we’re allowed to move into phase 2.”
Phase 2 looks at how the drug works in specific diseases indicated or determines the cancers it might best treat. That phase still involves a relatively small number of people, West said.
“If that goes well, then we move into phase 3, which is a much bigger study,” he said, and then the drug can go to the market.
“Sometimes there is a phase 4, which is a post-market study and involves tens of thousands of patients,” West said.
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6.02 has demonstrated preclinical activity in multiple tumor types, including breast cancer, colorectal cancer, pancreatic cancer and head and neck squamous cell carcinoma (cancers of the mouth, nose, and throat), according to the company news release.
GZ17-6.02 is the only drug the company has in clinical trials. Although Hyatt Life, like Genzada, is a Sterling-based company also founded by Gene Zaid and managed by the West family. Hyatt Life has developed a half-dozen dietary supplements using elements of the same lily and markets their products to treat things such as prostate health in men, respiratory health for COVID patients and cancer and joint health in dogs.
“This is a huge milestone for our company, to be moving things forward,” West said. “It’s exciting because to do a 1B we had to show that, in terms of cancer, it’s relatively safe and of potential benefit to patients.”