Tyme Initiates Pivotal Stage Of Pancreatic Cancer Study

Tyme Technologies, Inc. (NASDAQ:TYME) ) announced that it has commenced the pivotal stage of the TYME-88-Panc study to evaluate the clinical benefits of its lead cancer metabolism-based therapies (CMBT) candidate, oral SM-88 (racemetyrosine), for third-line treatment of patients with metastatic pancreatic cancer. Enrollment is expected to begin in the fourth quarter of 2019 at leading pancreatic cancer research centers across the United States

SM-88 is a combination therapy that uses a proprietary dysfunctional tyrosine derivative to interrupt the metabolic processes of cancer cells, breaking down their defenses and making them vulnerable to oxidative stress and death.

Shares of the company have slumped 54.8% year to date against the industry’s growth of 5.2%.

TYME-88-Panc study is a multi-center, randomized (1:1), controlled pivotal study 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. The primary endpoint of the study will be overall survival (OS). Key secondary endpoints will be 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 phase II portion of the TYME-88-Panc study was presented at the European Society of Medical Oncology 21st World Congress on Gastrointestinal Cancer in Barcelona, Spain, in July 2019. The study demonstrated encouraging OS trends in patients with advanced pancreatic cancer.

Advanced pancreatic cancer is a difficult-to-treat cancer with the lowest survival rates among all cancer types. There are several companies developing treatments for this disease. In February, AstraZeneca plc (NYSE:AZN) and partner Merck’s (NYSE:MRK) PARP inhibitor, Lynparza, met the primary endpoint in a late-stage study evaluating it as the first-line maintenance treatment in germline BRCA-mutated metastatic pancreatic cancer.

Zacks Rank & Another Stock to Consider

Currently, Tyme is a Zacks Rank #1 (Strong Buy) stock.

Another top-ranked stock in the same space is FibroGen Inc. (NASDAQ:FGEN) , carrying a Zacks Rank #1. You can see the complete list of today’s Zacks #1 Rank stocks here.

FibroGen’s loss per share estimates have narrowed from $1.09 to 37 cents for 2019 and from 32 cents to 18 cents for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, the average beat being 346.59%.

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