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.