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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

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.

“This demonstrates both the unmet need in pancreatic cancer and highlights the potential important role for SM-88 as a treatment.”

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.