US-based biotech firm Senesco Technologies has completed patient enrolment in its ongoing Phase Ib/IIa clinical trial of SNS01-T to treat patients with relapsed or refractory multiple myeloma, plasma cell leukemia or B cell lymphoma.
A first-in-class modulator of eukaryotic translation initiation factor 5A (eIF5A), SNS01-T is a new approach to cancer therapy that is designed to trigger apoptosis in B-cell cancers.
The safety portion of the open-label, multiple-dose, dose-escalation trial has established a maximum tolerated dose following the reporting of a second dose limiting toxicity (DLT) in the fourth and highest dosing group, which included a total of eight patients.
Grade 4 infusion reaction was the first DLT observed in a patient who had not received the designated premedications, while the second DLT, an uncomplicated Grade 4 neutropenia, occurred after eight doses in a lymphoma patient.
Recruitment in the trial will be stopped with the completion of the high dose group.
The company said that all patients currently enrolled may continue treatment at the recommended group three dose level of 0.2mg/kg and will be monitored through completion of their trial treatment.
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The company intends to submit the clinical, pharmacokinetic and pharmacodynamic data from the Phase Ib/II trial at an upcoming meeting.
Senesco chief executive officer Ronald Martell said: "The eIF5A gene, with its ability to regulate programmed cell death and cell survival, is a promising target with broad potential application in multiple disease areas.
"The primary goal of this study was to assess safety and tolerability of our lead eIF5a product candidate, SNS01-T, at various dose levels.
"Having now reached a maximum tolerated dose, we will look to the final study results to inform our future development."
The Phase Ib/II trial sponsored by Senesco has enrolled patients at Mayo Clinic in Rochester, the University of Arkansas for Medical Sciences, the Mary Babb Randolph Cancer Center, the John Theurer Cancer Center at Hackensack University Medical Center, the Seattle Cancer Care Alliance in the US, and the Pretoria East Hospital and the Groote Schuur Hospital in South Africa.
Image: Micrograph of a plasmacytoma, the histologic correlate of plasma cell myeloma. Photo: courtesy of Nephron.