HUTCHINSON, Kan. – Hutchinson based Genzada Pharmaceuticals announced today the official opening of a Phase 1B clinical trial for the oral therapeutic GZ17-6.02 (6.02) in combination with capecitabine in patients with metastatic breast cancer. The first site to open is Texas Oncology in Dallas, Texas, and will be headed by leading breast cancer expert Dr. Joyce O’Shaughnessy.
“This is a significant and exciting achievement for our company,” Chief Operating Officer Cameron West, MD 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.”
Dr. Joe Bailes, Genzada Chief Medical Officer, is optimistic about the study. “This is an important milestone for Genzada Pharmaceuticals and we are excited to partner with Dr. O’Shaughnessy and Texas Oncology to work toward bringing about additional treatment options for patients with advanced or metastatic hormone positive breast cancer,” Dr. Bailes said.
Genzada worked closely with TD2, a contract research organization, to optimize clinical trial design, project and data management, and other operational aspects of the study.
“We are thrilled to support the Phase 1B of 6.02 and delighted by the opportunity to partner with Genzada to develop their novel medicines,” Dr. Stephen Gately, President and CEO of TD2 said. “The team took a collaborative approach to designing the trial while leveraging TD2’s extensive experience in metastatic breast cancer to help guide the clinical strategy to focus on patients most likely to get clinical benefit.”
The 6.02 investigational agent 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 infections and cancer.
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