Tyme Initiates Dosing In Pivotal Pancreatic Cancer Study

Tyme Technologies, Inc. (NASDAQ:TYME) announced that it has dosed the first patient in part 2 of the pivotal study — TYME-88-Panc — evaluating lead cancer metabolism-based therapies ("CMBT") candidate, oral SM-88 (racemetyrosine), for third-line treatment of patients with metastatic pancreatic cancer. Data from this study will support regulatory submissions seeking approval for SM-88 in this indication.

Part 2 of TYME-88-Panc study will evaluate SM-88 in combination with three other drugs — methoxsalen, phenytoin and 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 is improvement in overall survival and secondary endpoints include progression free survival, clinical benefit response rate and quality of life.

Shares of the company have slumped 43.2% in the past year against the industry’s growth of 0.2%.

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. The candidate demonstrated encouraging tumor responses across 15 different oncology indications including pancreatic, prostate, sarcoma, breast, lung and lymphoma cancers in clinical studies.

Part 2 of the pivotal study was initiated based on encouraging results observed in part 1 of the study. Data from part 1 study showed that treatment with SM-88 in similar patient population achieved a median overall survival (“OS”) of 6.4 months. The company believes that the observed OS is better compared to OS of 2–2.5 months observed in patients with disease progression on second-line therapy in historical studies.

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.

Earlier this month, Tyme announced a collaboration with Eagle Pharmaceuticals (NASDAQ:EGRX) to co-promote SM-88 in the United States. Tyme is eligible to receive $20 million in upfront payment along with additional $20 million in milestone payment if primary endpoints in the above pivotal study are met or if SM-88 is approved for a cancer indication in the United States. However, there is no FDA approved therapy for treating pancreatic cancer in third-line setting. This may prove advantageous for SM-88, following successful development and commercialization.

Zacks Rank & Stocks to Consider

Tyme currently carries a Zacks Rank #3 (Hold).

A couple of better-ranked stocks in the medical drugs sector are Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) and Corcept Therapeutics Inc. (NASDAQ:CORT) . While Rigel sports a Zacks Rank #1 (Strong Buy), Corcept carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Rigel’s loss per share estimates have narrowed from 20 cents to 14 cents for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with the average positive surprise being 8.18%.

Corcept’s earnings per share estimates have increased from 96 cents to 98 cents for 2020 in the past 60 days. The company delivered a positive earnings surprise in each of the trailing four quarters with the average being 20.02%.

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