Policy & Regulation
First Cancer Patient Receives Dose of Super-Enhancer Inhibitor GZ17-6.02, an Advanced Cancer Drug from Genzada Pharmaceuticals, at HonorHealth Research Institute
21 March 2019 - - US-based drug discovery and development company Genzada Pharmaceuticals USA Inc, a subsidiary of Ionics Life Sciences Ltd., has enrolled the first patient in its Phase 1 clinical trial for the oral therapeutic GZ17-6.02 and administered the first dose this week at HonorHealth Research Institute in Scottsdale, Arizona, the company said.

Genzada's GZ17-6.02 will be administered to patients with advanced solid cancers and lymphoma.

The drug is derived in part from the black calla lily (arum palaestinum), a native plant found in several regions of the Middle East. Traditional Middle Eastern medicine has used the lily for more than 1,000 years as an herbal remedy for multiple maladies, including inflammation, viral infection and cancer.

Genzada chose TD2, a contract research organization, to manage the operational aspects of the trial, including trial design, project management, data management, monitoring, clinical site management, safety and statistics.

With enrollment for the study projected to reach 30-40 patients nationally, Genzada expects continued treatments among trial patients throughout the remainder of 2019.

Currently, patients enrolled in this clinical trial will receive the GZ17-6.02, an investigational compound, at HonorHealth Research Institute in Scottsdale. In the future, additional trial sites may be included as the study progresses.

In November 2018, the project's Investigational New Drug application received clearance from the US Food and Drug Administration to proceed with the Phase 1 human trial of 6.02 in patients with advanced solid cancers and lymphoma.

The 6.02 compound acts as an inhibitor to super-enhancers, the areas of the genome bound by transcription factors that are uniquely susceptible to repair signal disruption. It previously showed success in many therapeutic settings, including patients with pancreatic cancer and those with head and neck squamous cell carcinoma.

Genzada is a drug discovery and development company focused on generating clinically useful molecules for the most challenging diseases, with an initial focus on pancreatic adenocarcinoma, head and neck squamous cell carcinoma, and glioblastoma multiforme.

The company also has a robust pipeline of compounds in various stages of development which have shown promise in a host of unmet areas of cancer research. As newcomers in the field of pharmaceutical research, we are eager to demonstrate our capabilities on behalf of the physicians and patients we aim to serve.

TD2 is an oncology development organization that provides innovative services for oncology-focused companies. 

Using a dedicated team of professionals with broad experience and understanding in drug development, TD2 is uniquely positioned to support improved and accelerated development of medicines for life-threatening oncology diseases. 

TD2 applies rigorous and high-throughput translational preclinical development, combined with regulatory affairs expertise, to customise clinical trial design and execution. 

Itssuite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, and the rapid identification of clinically significant endpoints. 

TD2 is committed to reducing the risks and uncertainty inherent in the drug development process and to the acceleration of patient access to promising treatments. 

HonorHealth Research Institute in Scottsdale, Ariz., offers comprehensive cancer care and research through clinical trials, diagnosis, treatment, prevention and support services in collaboration with leading scientific researchers and community oncologists.

HonorHealth is a nonprofit health system serving 1.6m people in the greater Phoenix area.

The network encompasses five acute care hospitals, an extensive medical group, outpatient surgery centers, a cancer care network, clinical research, medical education, a foundation and community services with approximately 11,500 employees, 3,400 affiliated physicians and 3,000 volunteers.

HonorHealth was formed by a merger between Scottsdale Healthcare and John C. Lincoln Health Network.