Genzada Pharmaceuticals Announces FDA Clearance of IND Application and Launch of Phase I Human Clinical Trial for Middle Eastern-Derived Advanced Cancer Drug
Sterling, Kan. (November 16, 2018) Genzada Pharmaceuticals USA Inc., a subsidiary of Ionics Life Sciences Limited (Genzada), announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for a Phase 1 human clinical trial of the company’s flagship molecule GZ17-6.02 (6.02) for patients with advanced solid organ tumors or lymphoma.
“We are excited to bring 6.02 to the oncology community and we look forward to demonstrating its safety and efficacy as we move through the clinical trials process,” said Cameron E. West, MD, FAAD, chief operating officer of Genzada. “Based on numerous preclinical studies, we believe this therapeutic will be very well-tolerated and will achieve meaningful outcomes for cancer patients.”
6.02 has shown preclinical success in several therapeutic contexts, notably for pancreatic cancer and head and neck squamous cell carcinoma.
“It is great news that the IND clearance has been granted for 6.02,” said Daniel D. Von Hoff, MD, chief development officer at TD2 and adviser to Genzada. TD2 supported the research sponsor with its regulatory submissions, including the completion and filing of the drug’s IND application. The clinical research organization (CRO) will continue to manage the clinical trial for 6.02. “I know how hard the team has worked to get to this milestone for this very interesting combination with a unique mechanism of action.”
Functionally, the 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. 6.02 can inhibit several super-enhancer targets based on the cancer of origin.
GZ17-6.02 is derived in part from Arum palaestinum (black calla lily), a native plant found in several regions of the Middle East. Similar to the vinca alkaloids and taxanes, 6.02 is now a fully synthesized therapeutic, originally derived from naturally occurring compounds.
Enrollment of the first patient for the 6.02 trial will take place through the HonorHealth Research Institute, and will be announced in the coming months as the study initiates.
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 an area of 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, 3,700 affiliated physicians and 3,100 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.
Genzada Pharmaceuticals USA Inc. HonorHealth Media Relations
Jason West, 620-204-7150 Marketing Department
Translational Drug Development (TD2)
Amanda Rider, 972-770-5083
Genzada Pharmaceuticals is excited to announce that two research partners will deliver poster presentations at the American Association of Cancer Researchers meeting in Philadelphia, PA in October. This is particularly exciting due to the nature of the research conducted. Cameron West, MD, Genzada’s Chief Operating Officer, described their findings. “Our research partners at the University of Kansas Cancer Center and at Translational Genomics have independently corroborated each other’s findings regarding how one of our therapeutic candidates helps to treat pancreatic cancer. The research suggests that GZ 6.02 modulates superenhancer activity, essentially altering the activity of the molecular switch involved in cancer development.” West continues, “we are extremely proud of the work Drs. Han (TGen) and Dhar (KUCC) have done and are excited about the significance of this research, especially as we near first in human clinical trials. This mechanism of action has been relatively unexplored putting Genzada at the frontier of cancer research.”
Genzada Pharmaceuticals is excited to announce a grant to glioblastoma drug discovery group at Duke University, directed by Dr. Madan Kwatra. The research will involve multiple studies spanning two years and is the result of a grant, titled “Evaluation of novel anti-cancer agents, either alone or in combination, for activity against glioblastoma subtypes: a personalized medicine approach.”
Genzada is an oncology-focused drug development firm with an emphasis on finding effective, plant-derived treatments for different types of cancer. Cameron West, M.D., Chief Operating Officer, affirmed Genzada’s mission. “Glioblastoma Multiforme is a very aggressive malignancy of the brain with few effective treatments. Genzada is committed to finding an effective treatment for this condition and will not stop until an effective treatment for GBM is found. We are excited to begin this phase of research with Dr. Kwatra and Duke University.”
On November 15th, 2016 the Genzada Team made their way to Denver, Colorado for the American Association of Pharmaceutical Scientists’ Annual Meeting and Exposition. There, the team attended the Expo, meeting with various vendors, and other industry professionals, networking and viewing new advances in the field. Learning about new products and services allows us to work more efficiently towards our goal of improving the health of people around the world!