TYME Announces First Patient Dosed in Metastatic Pancreatic Cancer Treatment Trial

Tyme Technologies announced the first pancreatic cancer patient has been dosed in Part 2 of the TYME-88-Panc pivotal trial designed to support approval of SM-88 (racemetyrosine) for the third-line treatment of patients with metastatic pancreatic cancer. CMBTs are proprietary investigational compounds that are believed to disrupt cancer cells’ protein synthesis, leading to a breakdown of the cancer’s key defenses and cell death. In clinical trials, SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, prostate, sarcoma, breast, lung, and lymphoma cancers with minimal serious grade 3 or higher adverse events.

"Patients with metastatic pancreatic cancer have a very poor prognosis. For those 10,000 patients actively seeking third-line treatment, there are currently no FDA-approved therapies and no oncology guideline recommendations for active therapy. We are passionate about advancing new treatment options for these patients," said Giuseppe Del Priore, M.D., Chief Medical Officer at TYME. "In clinical trials, SM-88 has demonstrated clinical responses across 15 different tumor types in clinical trials involving approximately 180 patients. We are excited about the potential of SM-88 as a first-in-class cancer metabolism-based therapy and are looking forward to evaluating this promising new approach in our pivotal study."

Based on encouraging results demonstrated in Part 1 of the TYME-88-Panc study of SM-88, TYME has launched Part 2 of TYME-88-Panc study designed as a multi-center randomized (1:1), controlled pivotal trial that will evaluate the efficacy and safety of SM-88 used with MPS (methoxsalen, phenytoin, sirolimus) in patients with metastatic adenocarcinoma of the pancreas whose disease has progressed or recurred and have received two lines of prior systemic therapy. Approximately 250 patients will be randomized to receive 920 mg of SM-88 with MPS (Arm A n=125) or one of three pre-defined single agent therapies (Arm B n=125). Patients will be treated until there is unacceptable toxicity or disease progression or if any treatment discontinuation criteria are met. The primary endpoint is overall survival (OS). Key exploratory endpoints include progression free survival (PFS), clinical benefit response rate (CBR), defined as patients achieving stable disease or better, circulating tumor cells (CTCs) and quality of life (QOL). The study will include leading pancreatic cancer research sites across the United States.

The study demonstrated a median overall survival in evaluable patients (38 of 49) of 6.4 months. These survival results compare very favorably to the analysis of 19 prospective pancreatic cancer trials where the median reported survival after progressing on second-line therapy was 2.0 – 2.5 months based on reported historical trials. In Part 1 of the TYME-88-Panc study, a RECIST CBR of stable disease or better was achieved by 44% of patients (11 of 25) with available imaging. Patients achieving stable disease or better demonstrated a statistically significant (p=0.02) improvement in survival with a 92% reduction in risk of death (hazard ratio=0.08). The CBR was durable with majority of patients remaining in stable disease or better for more than 7 months after receiving treatment with SM-88. The study showed a median reduction of 63% in CTC burden in evaluable patients. Of the 24 patients with available results, those reaching an 80% reduction or greater in CTCs (10 of 24) demonstrated a 60% decrease in risk of death (hazard ratio=0.40).

The Phase II portion of the TYME-88 Panc study reported that SM-88 was well tolerated with only 4.0% of patients (2 of 49) experiencing serious adverse events (SAEs) deemed at least possibly related to SM-88 (abdominal pain, arthralgia, and hypotension). One patient with reported SAEs continued on treatment.

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