NEW YORK – Greenwich LifeSciences said on Thursday that Baylor College of Medicine will serve as the lead site for a Phase III study evaluating its investigational immunotherapy, called GP2, for the prevention of breast cancer recurrence.
The Stafford, Texas-based drug developer is still working out the protocol of the study, in which researchers hope to explore the ability of GP2 to prevent recurrence in HER2-postive breast cancer patients who have undergone surgery.
Mothaffar Rimawi, executive medical director and co-leader of the breast cancer program at Baylor's Duncan Comprehensive Cancer Center, will serve as the global principal investigator of the study. Rimawi and Kent Osborne, founding director of Baylor's cancer center, will both be on Greenwich's clinical advisory board for the development of GP2 "across all indications and HER2-expressing cancers," the company said in a statement.
In a prospective, randomized, placebo-controlled, Phase IIb trial completed two years ago, HER2-positive breast cancer patients who were fully immunized with GP2 in the adjuvant setting and followed for a median of five years did not experience recurrence. To date, 138 patients have received GP2 within four trials, in which the drug was well tolerated and didn't cause serious adverse events, according to the company.
"We believe that our patients will seek to participate in the upcoming [Phase III] trial as the GP2 Phase IIb clinical trial data suggests that GP2 could be both safe and effective and could be easily administered during standard-of-care follow-up visits," Rimawi said in a statement. "Our patients are seeking safe preventative treatments that allow them to transition away from the trauma of surgery, trastuzumab-based therapies, other HER2 targeted therapies, chemotherapy, and radiation as they seek to return to normal and healthy lives."
Greenwich is currently gathering input from leading clinicians on the design of the Phase III study and is exploring working with breast cancer cooperative groups in the US and Europe.