Tyme Technologies has opened the first site for its Phase II clinical trial examining SM-88 therapy for treating metastatic pancreatic cancer.
The company expects to open more than 35 sites across North America over the next few weeks, thereby exceeding its original number of target sites.
The trial will be conducted in collaboration with IQVIA unit Novella Clinical. It will enrol around 100 patients with metastatic pancreatic cancer who have failed at least one prior line of therapy.
In the first phase of the study, around 30 patients will be randomised 1:1 to receive a dose of either 460mg or 920mg of Tyme’s proprietary tyrosine derivative per day.
The other SM-88 dose components will remain unchanged in this phase.
Following a review of the safety, efficacy and pharmacokinetics of patients enrolled in the first phase, Tyme will continue providing the selected tyrosine derivative dose into the trial’s second phase for the remaining 70 patients.
Tyme Technologies CEO Steve Hoffman said: “We have been very pleased with the high level of excitement for this trial from the clinical community, including many well known academic centres and oncology networks.
“We believe this demonstrates both the unmet need in pancreatic cancer and highlights the potential important role for SM-88 as a treatment.
“We remain on track to announce initial results from the first stage of the trial around year-end 2018.”
The company is currently conducting a Phase II clinical trial of SM-88 for the treatment of prostate cancer, with additional data from the trial expected to be available by the end of the year.
