- Tyme Technologies Inc TYME announced a breast cancer trial with Georgetown University named OASIS. Enrollment is expected to start in Q3 of 2021.
- The investigator-initiated prospective open-label Phase 2 trial will evaluate the efficacy and safety of SM-88 for metastatic hormone receptor-positive, human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer after treatment with a CDK4/6 inhibitor.
- This trial is a two-stage trial, initially enrolling 30 patients, expanding up to 50 patients without standard background therapies. The primary endpoint is tumor response.
- As a result of the strategic review, Tyme has also decided to halt the TYME-88-Panc (Part 2) clinical trial evaluating SM-88 as third-line therapy in pancreatic cancer.
- Precision Promise, the Pancreatic Cancer Network-sponsored trial evaluating SM-88 as a second-line therapy, will continue, the company said.
- The company also beefed up its management by appointing Jan M. Van Tornout as the acting chief medical officer and Frank Porfido as the CFO.
- As of the fourth quarter ended March 31, the company had approximately $107.5 million in cash and cash equivalents.
- TYME currently anticipates that its quarterly cash burn rate will range from $6.0 to $8.0 million per quarter during the fiscal year 2022.
- Price Action: TYME shares are up 5.03% at $1.67 during the premarket session on the last check Friday.
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