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news.Merrimack Pharmaceuticals has included an additional arm, which combines MM-398 with 5-fluorouracil (5-FU) and leucovorin (folinic acid) (LV), in Phase 3 NAPOLI-1 late stage pancreatic cancer study.
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MM-398 is designed to optimise the delivery of irinotecan by extending the duration of circulation in the body and preferentially activating the drug within the tumour to achieve higher levels of the active drug, SN-38.
Merrimack vice president and MM-398 medical director Eliel Bayever said that expanding the trial will greatly enhance the design and long term ability to favourably impact patients with the terrible disease.
"Physicians have increasingly been utilizing combination treatments for patients with second line pancreatic cancer if they feel that the patient is well enough to tolerate more aggressive treatment," Bayever added.
The randomised, open label study is planned to begin enrolment on the amended protocol in July 2012.
According to the company, the protocol amendment enlarges the study population by 135 patients, calling for a total enrolment of 405 patients equally randomised across the three arms MM-398 as a monotherapy and MM-398 in combination with 5-FU/LV compared with the shared control arm of 5-FU/LV.