STERLING, Kan.--(BUSINESS WIRE)--Genzada Pharmaceuticals USA Inc. (Genzada), a subsidiary of Ionics Life Sciences Limited, announced today that the first patient enrolled in its Phase 1 clinical trial for the oral therapeutic GZ17-6.02 received the first dose this week at HonorHealth Research Institute in Scottsdale, Ariz. 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.
“We’re excited to have reached the clinical stage of development of GZ17-6.02. Through the rigorous preclinical developmental path, we have discovered a unique mechanism of action via super-enhancer inhibition. We’re confident that this agent will be both safe and effective in cancer patients and are thrilled to bring this into the clinic,” said Genzada Chief Operating Officer Cameron West, MD. “Additionally, as GZ17-6.02 is composed of three active pharmaceutical ingredients—originally derived from medicinal plants—we’re hopeful that 6.02 will tackle various malignancies on multiple fronts.”
Genzada chose TD2, a contract research organization (CRO), to manage the operational aspects of the trial, including trial design, project management, data management, monitoring, clinical site management, safety and statistics.
“Reaching the clinical stage is a huge milestone for the companies we work with, as it takes a lot of hard work and preparation to get to this point,” said Stephen Gately, president and CEO of TD2. “This particular drug is quite interesting in its composition, and we’re honored to be part of this trial that could potentially improve the lives of cancer patients.”
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 (6.02), an investigational compound, at HonorHealth Research Institute in Scottsdale. In the future, additional trial sites may be included as the study progresses.
“GZ17-6.02 is truly a novel therapy with the potential to transform cancer care. With the support of Genzada and TD2, we are pleased to make this treatment available at HonorHealth Research Institute,” said Frank Tsai, MD, medical oncologist, principal investigator at HonorHealth Research Institute.
In November 2018, the project’s Investigational New Drug (IND) application received clearance from the U.S. Food and Drug Administration (FDA) 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.
About Genzada Pharmaceuticals USA Inc.
Genzada is a drug discovery and development company focused on generating clinically useful molecules for today’s most challenging diseases, with an initial focus on pancreatic adenocarcinoma, head and neck squamous cell carcinoma, and glioblastoma multiforme. Genzada 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. For more information, visit www.genzada.com.
About Translational Drug Development (TD2)
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 customize clinical trial design and execution. TD2’s suite 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. For more information, visit www.TD2inc.com.
About HonorHealth Research Institute
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 1.6 million 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. HonorHealth's mission is to improve the health and well-being of those we serve. Learn more at www.HonorHealth.com.