Georgia Cancer Specialists (GCS) — the largest private medical oncology/hematology practice in the Southeast — continues its dedication to advancing novel cancer treatments through clinical research. GCS became the first clinic worldwide to conduct a first-time-in-human Phase I clinical trial of the novel agent LY2510924. A young breast cancer patient became the first patient ever to receive the new treatment Tuesday, December 16, at the GCS Northside office.
LY2510924 is a small peptide molecule that binds to a specific target – the CXCR4 receptor – found on tumors’ cells. In doing so, the drug inhibits tumor cell motility, replication, invasion, and metastatic potential. It is envisioned that this novel drug would be an effective anti-tumor agent either by itself or in combination with chemotherapy.
“We are extremely excited about this first-time-in-human clinical trial and our ability to offer patients a novel option in their battle against cancer,” said Dr. Mansoor Saleh, GCS Director of Clinical Research.
The patient, identified only as J.I., had failed multiple prior conventional treatments for breast cancer and consented to participate in the LY2510924 clinical trial. She tolerated the treatment well and is currently receiving the study drug as a daily subcutaneous injection.
The protocol is open for patients with any type of cancer that has progressed following conventional treatment.
In order to qualify, patients have to meet specific protocol criteria, which have been mandated by the sponsor and the Food and Drug Administration (FDA).
GCS was the first in Georgia to offer Phase I clinical trials, and is one of only a few community-based oncology practices in the nation involved in novel Phase I first-time-in-human clinical trials. Phase I trials are not designed to show effectiveness; they are designed to study the toxicity profile and the maximum tolerated dose in human subjects. Little is known about the effectiveness of drugs in Phase I trials, because this is when they are usually tested in humans for the first time, or are evaluations of a new dosage or new mode of administration.
For more information, please contact James Gilmore, GCS EVP, Pharmacy, Research, and Imaging Services, at 770.496.9400.
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