NEW YORK, March 27, 2018 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (NASDAQ:TYME) ("Tyme" or the "Company") announced today that the first site for the Phase II clinical trial evaluating SM-88 therapy for metastatic pancreatic cancer is open and additional clinical sites are scheduled to open within the coming weeks. Tyme has more than 35 sites currently in the process of opening across North America, exceeding its original number of target sites.
"We have been very pleased with the high level of excitement for this trial from the clinical community, including many well known academic centers 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," said Tyme's CEO, Steve Hoffman. "We remain on track to announce initial results from the first stage of the trial around year-end 2018."
This Phase II trial is designed as an open-label, multi-center study of SM-88 in approximately 100 patients with metastatic pancreatic cancer who have failed at least one prior line of therapy. In Stage 1, approximately 30 patients will be randomized 1:1 to receive a dose of either 460mg or 920mg per day of Tyme's proprietary tyrosine derivative, while the doses of the other components of SM-88 will remain unchanged. After a planned analysis of the safety, efficacy and pharmacokinetics of patients from the patients in Stage 1, it is intended that the selected tyrosine derivative dose will be continued into Stage 2 of the trial for the remaining approximately 70 patients.
Tyme is conducting the Phase II trial with Novella Clinical, a division of IQVIA™ (formerly "Quintiles"). Novella is a specialty contract research organization focused on the unique needs of oncology, medical device and dermatology sponsors, with extensive experience working with mid-stage biotechnology companies on similar stage trials.
Tyme is also evaluating SM-88 in an ongoing Phase II clinical trial for the treatment of prostate cancer, with additional data from that trial also expected around year-end 2018.
About Tyme Technologies
Tyme Technologies, Inc. is a clinical-stage biotechnology company developing cancer therapeutics that are intended to be broadly effective across tumor types, while having a low toxicity profile. Unlike targeted therapies that attempt to regulate specific mutations within cancer, the Company's therapeutic approach is designed to take advantage of a cancer cell's innate metabolic weaknesses to compromise its defenses, leading to cell death through oxidative stress and exposure to the body's natural immune system. The Company's lead clinical program, SM-88, is a novel combination therapy currently in Phase II development for prostate cancer, and the Company is preparing to initiate an additional Phase II clinical trial in pancreatic cancer.
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