Tyme Announces Interim Phase II Safety and Efficacy Data for SM-88 in Prostate Cancer at 2018 ASCO Genitourinary Cancers Symposium

  • 92% of Patients Have Maintained Radiographic Progression-Free Survival at a Median of 12 Months Since Biochemical-Recurrence
  • All Patients Have Reported Stable Cognitive and Sexual Function on SM-88 Treatment
  • No Reported Drug-Related Serious Adverse Events on SM-88 Treatment to Date
  • Data will be Presented Today by Professor Mack Roach III, M.D., UCSF

SAN FRANCISCO, Feb. 08, 2018 (GLOBE NEWSWIRE) — Tyme Technologies, Inc. (NASDAQ:TYME), a clinical-stage biotechnology company developing cancer therapeutics, today announced efficacy and safety data from an ongoing Phase II trial of SM-88 in patients with non-metastatic, biochemical-recurrent prostate cancer (nmPC). Mack Roach III, M.D., FASTRO, FACR, University of California, San Francisco (UCSF), will present the data in a poster session today at the 2018 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in San Francisco, Calif.

“Prostate cancer patients have limited treatment options and are likely to receive ADT (androgen deprivation therapy), a hormone therapy that lacks sufficient evidence of efficacy in non-metastatic prostate cancer and may produce considerable toxicities and a reduction in quality of life,” said Dr. Roach, Professor of Radiation Oncology, and Urology at UCSF. “Toxicities typically associated with ADT have not been seen with SM-88, which suggest that ADT may be avoided or delayed without progression in patients with non-metastatic prostate cancer. I look forward to continuing to work with Tyme to explore the benefits of SM-88 as an alternative to hormone therapy in prostate cancer patients, particularly those pursuing active surveillance.”

Thirteen evaluable patients were assessed from an ongoing Phase II trial of SM-88 in nmPC with rising prostate-specific antigen levels, detectable circulating tumor cells and no radiographically detectable metastases. Most patients had previously received ADT after radiation therapy or surgery, but ADT treatment was not permitted during the trial.

Currently, 92 percent of patients (12/13) have maintained radiographic progression-free survival (rPFS) with a median of 12 months since documented biochemical recurrence, and 10 months since starting SM-88 treatment. All 12 patients who have maintained rPFS also exhibited meaningful reductions in circulating tumor cells (CTCs), while the one patient experiencing radiographic progression had a rise in CTCs.

“CTCs are emerging as an important biomarker in predicting outcomes in prostate and other cancers,” said Giuseppe Del Priore, M.D., Chief Medical Officer of Tyme. “We are encouraged by the broad impact SM-88 appears to have on CTCs and will continue to assess these effects in this and future trials of SM-88.”

Eighty-five percent (11/13) of patients demonstrated rising or stable testosterone levels, with no drug-related serious adverse events (grades 3 or 4) observed. According to the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire, all patients reported stable cognitive and sexual function domain measures, including 100 percent (13/13) reporting improved or stable “interest in sex,” 62 percent (8/13) reporting no or resolved hot flashes, and 54 percent (7/13) reporting to have “excellent” “overall health” and “quality of life.” Patient weight, EKG QTc, osteoporosis (measured by urine NTx), glucose and hematocrit did not appear affected while receiving SM-88.

“We are excited by the promising safety, tolerability and efficacy data seen in non-metastatic prostate cancer patients treated with SM-88 therapy,” said Dr. Del Priore. “We look forward to reporting full Phase II data in the second half of 2018 and advancing our prostate cancer collaboration with Dr. Roach in various settings of active surveillance.”

About SM-88

SM-88 is a novel combination therapy that utilizes a proprietary dysfunctional tyrosine derivative to interrupt the metabolic processes of cancer cells, breaking down the cells’ key defenses and making them vulnerable to oxidative stress and death. SM-88 has shown efficacy in the treatment of multiple oncology indications, including breast and prostate cancer, without reports of significant toxicity or serious adverse events.

SM-88 is being evaluated in a Phase II clinical trial for prostate cancer (NCT02796898) and Tyme is finalizing the preparations for the Phase II clinical trial in metastatic pancreatic cancer.

About Tyme

Tyme Inc., is a clinical-stage biotechnology company developing cancer therapeutics that are intended to be broadly effective across tumor types and have low toxicity profiles. Unlike targeted therapies that attempt to regulate specific mutations within cancer, the Company’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic weaknesses to compromise its defenses, leading to cell death through oxidative stress and exposure to the body’s natural immune system.

For more information, visit www.tymeinc.com.

Forward-Looking Statements/Disclosure Notice

In addition to historical information, this press release contains forward-looking statements under the Private Securities Litigation Reform Act that involve substantial risks and uncertainties. Such forward-looking statements within this press release include, without limitation, statements regarding our drug candidates (including SM-88), their clinical potential and non-toxic safety profiles, our drug development plans and strategies, our completed studies, ongoing and planned clinical trials, preliminary data results and the therapeutic design and mechanisms of our drug candidates; and readers can identify forward-looking statements by sentences or passages involving the use of terms such “believes,” “expects,” “hopes,” “may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,” “would,” “continue,” “seeks,” or “anticipates,” and similar words (including their use in the negative) or by discussions of future matters such as the development of new products, technology enhancements, possible collaborations, the timing, scope and objectives of our planned clinical trials, funding plans and planned uses of proceeds, and other statements that are not historical. The forward-looking statements contained in this press release are based on management’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of Tyme’s control. These statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from any historical results and future results, performances or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, that the information is of a preliminary nature and may be subject to change; uncertainties inherent in research and development, including the ability to achieve clinical study start and completion dates; the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing data; risks associated with early, initial data, including the risk that the final Phase II data may differ from prior study data or preliminary Phase II data; final results of additional clinical trials that may be different from the preliminary data analysis and may not support further clinical development; that past reported data are not necessarily predictive of future patient or clinical data outcomes; whether and when any applications or other submissions for SM-88 may be filed with regulatory authorities; whether and when regulatory authorities may approve any applications or submissions; decisions by regulatory authorities regarding labeling and other matters that could affect commercial availability of SM-88; competitive developments; and the factors described in the section captioned “Risk Factors” of Tyme’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on June 12, 2017, as well as subsequent reports we file from time to time with the U.S. Securities and Exchange Commission (available at www.sec.gov). The data analyses discussed above are not necessarily predictive of future patient or clinical data outcomes.

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


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