TYME Reports Third Quarter Fiscal 2019 Financial and Operating Results

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NEW YORK, Feb. 11, 2019 (GLOBE NEWSWIRE) -- , an emerging biotechnology company developing metabolic-based cancer therapies, today reported its financial and operating results and provided a business update for the fiscal quarter ended December 31, 2018. Based on encouraging preliminary results from the TYME-88-Panc Phase II study, the Company’s lead pipeline candidate SM-88 is moving forward into pivotal trials for first- and second-line treatment of pancreatic cancer in partnership with PanCAN and its “Precision Promise” program. TYME is also in discussions with the FDA to pursue a pivotal path for SM-88 in third-line treatment of pancreatic cancer.

Mr. Steven Hoffman, Chairman and Chief Executive Officer of Tyme Technologies, Inc., stated, “Based on the broad support that we have received during the quarter from pancreatic physicians, patients, and patient advocacy groups, we are excited to advance SM-88 into the next stage of pivotal trials.” “Pancreatic Cancer is a devastating disease, predicted to be the second cause of cancer death by 2030,” said Martin E. Fernandez-Zapico, MD, a Professor of Medicine and Pharmacology at the Department of Oncology at the Mayo Clinic. “In advanced pancreatic cancers, there is an urgent need for new treatment options. SM-88 represents a new therapeutic approach aimed at disrupting the tumor metabolic program."TYME continues to focus on advancing SM-88 in pancreatic cancer research, while also planning for development into other indications where SM-88 has shown encouraging results and a well-tolerated safety profile in previous clinical testing. TYME highlights the following developments that took place during the quarter completed December 31, 2018 and through January 2019:TYME announced that its open-label Phase II clinical trial, TYME-88-Panc, evaluating SM-88 as an oral monotherapy in end-stage patients with advanced pancreatic cancer, demonstrated encouraging preliminary results and a well-tolerated safety profile.  The preliminary TYME-88-Panc Phase II results involved 38 heavily pretreated patients with radiographically progressive metastatic pancreatic cancer who had received a median of two prior systemic therapies and had significant disease related morbidity before receiving TYME’s investigational agent. TYME-88-Panc is a two-stage Phase II study intended to determine optimal dosing and assess if early clinical benefit supported further development of SM-88 in pancreatic cancer. This study is being performed under a TYME IND with input from the FDA prior to study initiation. As a Phase II, open-label study, the design involved comparison of two dose levels with an independent Data and Safety Monitoring Board determining continuation.

Preliminary results of the first stage of TYME-88-Panc, using information available as of January 6, 2019, demonstrated that 68% of evaluable patients (19 of 28) were alive at a median follow-up of 4.3+ months (with further survival data to be evaluated as the patients and study progress) and that patients also avoided significant grade 4/5 toxicities normally associated with standard of care treatments. Median survival had also not been reached on an intent-to-treat (ITT) basis, with 60% (23 of 38) of patients still alive.  In addition, to assess the natural history for survival, as a comparator, in these advanced cancer patients, TYME performed a review of published studies to determine expected patient outcomes in collaboration with PanCAN.

We believe that these outcomes justify further development of SM-88. The results compare favorably to the analysis of 19 prospective second-line+ pancreatic cancer trials where the mean and median reported survival after progressing on second-line therapy was 3 months based on reported historical trials.TYME-88-Panc also demonstrated monotherapy activity with SM-88 in some patients based on common measures of anti-tumor activity, including computed tomography (CT), positron emission tomography (PET), and reductions in biomarkers carcinoembryonic antigen (CEA), CA-19.9 and circulating tumor cell (CTC) burden.

As of January 6, 2019, the study reported that SM-88 was well tolerated with only 2 out of 31 (6.5%) serious adverse events deemed at least potentially-related to the study drug. These SAEs both occurred in one patient, who continued on the investigational SM-88 treatment. The 88-Panc research results are from an investigational study. SM-88 is not approved for the treatment of patients with advanced pancreatic cancer. 

“I am encouraged by the early signs of efficacy in this research involving this heavily pretreated population of advanced pancreatic cancer patients,” said Allyson Ocean, MD, a pancreatic cancer specialist at New York-Presbyterian Hospital/Weill Cornell Medical Center and Associate Professor of Medicine at the Weill Medical College of Cornell University. “It’s very hard to administer therapy in the 3rd-line and beyond setting, so these patients are in desperate need of effective therapies. Research results to date also indicate that SM-88 has a favorable toxicity profile so that’s extremely important.” 

At the ASCO GI Meeting in January, TYME presentations, which are available on our website (), included:

Phase II trial of SM-88 in Patients with Metastatic Pancreatic Cancer: Preliminary Results of the 1 Stage:

Designing Clinical Trials in Third-Line+ Pancreatic Cancer:

Feasibility of SM-88 in Pancreatic Cancer After Multiple Prior Lines & ECOG 2:       

Phase II Pharmacokinetics of Oral SM-88 in Heavily Pretreated Advanced Pancreatic Ductal Adenocarcinoma:

In 2019, PanCAN’s Precision Promise plans to launch its adaptive pivotal trials at 14 high-volume pancreatic cancer treatment centers in the United States, which represent some of the nation’s most prestigious medical institutions and oncologists in the field. Initiation of the first adaptive randomized pivotal trial evaluating SM-88 as second-line monotherapy in patients with pancreatic cancer is expected for the first half of 2019. SM-88 is expected to be evaluated in an adaptive pivotal trial as a first-line combination therapy with gemcitabine (Gemzar) and nab-paclitaxel (Abraxane) in patients with pancreatic cancer. The primary end point of these randomized trials is expected to be overall survival.

TYME is nearing enrollment completion of its multi-center, open label Phase II study of patients with biomarker-recurrent prostate cancer who have rising prostate specific antigen (PSA) levels and no radiographically detectable lesions. The Company will provide updated data from this trial at the 2019 ASCO Genitourinary Cancers Symposium, which will be held February 14-16, 2019.

This is a prospective open-label Phase II trial evaluating the efficacy and safety of SM-88 in two cohorts of patients. Up to 24 evaluable patients (12 per cohort) will be enrolled. The first cohort will evaluate oral SM-88 as maintenance monotherapy following standard primary or palliative treatments for Ewing's sarcoma patients with a high risk of relapse or disease progression. The second cohort will determine the clinical benefits of SM-88 as salvage monotherapy for patients with clinically advanced sarcomas. The Joseph Ahmed Foundation, a 501(c) not for profit organization is providing funding and patient support for this investigator-initiated Phase II (HopES) trial of SM-88 in patients with previously-treated metastatic sarcoma. The trial is expected to begin in the first quarter of 2019.TYME expanded its leadership team and research capabilities with the addition of:

Net Loss: Net loss was $8.0 million for the third quarter ended December 31, 2018, or a net loss per basic and diluted share of $0.08, as compared to a net loss of $5.6 million for the third quarter ended December 31, 2017 or a net loss per basic and diluted share of $ 0.06. The increase in losses were due to the expanded clinical activities, primarily the Company’s Phase II pancreatic and prostate clinical trials.TYME has reported its full financial results for the quarter ended December 31, 2018 in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission ("SEC"). TYME’s 10-Q is located on the Company’s website under recent SEC filings at ir.tymeinc.com  Advanced pancreatic cancer is a difficult-to-treat cancer with the lowest survival rates among all cancer types. Across all patients with pancreatic cancer, relative 5-year survival is 8% and is less than 3% for those with advanced disease. The median survival for patients in end-stage of the disease is approximately 3 months. There are two main types of pancreatic cancer - adenocarcinomas, which accounts for approximately 90% of all pancreatic cancer, and neuroendocrine tumors.  Pancreatic cancer is relatively uncommon with new cases accounting for only 2.1% of all newly diagnosed cancers. However, pancreatic cancer is the fourth most common cause of cancer death for men and women in the United States.  

The information contained in this press release is as of its release date and TYME assumes no obligation to update forward-looking statements contained in this release as a result of future events or developments.

IR & Media Contact:Ashley R. Robinson LifeSci Advisors, LLC 617-535-7742

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Globe Newswire: 12:30 GMT Monday 11th February 2019

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