- 40 percent of evaluable patients achieved survival of more than 12 months, 30 percent achieved a complete or partial tumor response
- All patients improved or maintained quality of life measures and pain scores
SAN FRANCISCO, Jan. 19, 2018 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (Nasdaq:TYME), a clinical-stage biotechnology company developing cancer therapeutics, today announced efficacy and safety data for SM-88 in patients with advanced metastatic or recurrent pancreatic cancer. The data were presented today in a poster presentation at the 2018 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco, Calif.
“We are encouraged by the early efficacy signals demonstrated by SM-88 without report of drug-related serious adverse events in pancreatic cancer, a devastating disease that lacks safe and effective treatment options,” said Giuseppe Del Priore, M.D., Chief Medical Officer of Tyme. “We look forward to exploring SM-88 in a larger prospective Phase II trial this year in pancreatic cancer patients who have failed prior therapy.”
Data from 10 pancreatic cancer patients treated with SM-88 in Tyme’s First Human Study or compassionate use program were evaluated for overall survival, overall response rate, progression-free survival, Eastern Cooperative Oncology Group (ECOG) performance status and pain scores.
Many evaluable patients demonstrated prolonged survival with 40 percent (4/10) surviving more than 12 months, and 30 percent (3/10) achieving a complete or partial response. All subjects (10/10) reduced or maintained pain scores during their first cycle of SM-88 therapy, in addition to gaining or maintaining weight. Eighty percent (8/10) of patients showed improvement in ECOG performance status during the first treatment cycle, with 30 percent (3/10) demonstrating an improvement of greater than one point during this six week period. All patients improved or maintained European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire subject-reported health and quality of life outcomes after initiating SM-88 therapy.
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 demonstrated 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). A Phase II clinical trial in pancreatic cancer is planned to initiate in 2018.
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. Tyme’s lead clinical program, SM-88, is a first-in-class combination therapy in Phase II development for prostate cancer. The Company is preparing to initiate an additional Phase II clinical trial in pancreatic cancer in 2018.
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 as “anticipates,” “believes,” “designed,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “would” and similar expressions intended to identify forward-looking statements. 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, 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 analysis, final results of additional clinical trials, or both, may be different from the preliminary data analysis and may not support further clinical development; 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 and Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission on November 3, 2017 (available at www.sec.gov). The data set forth in these updated analyses 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.
Chief Scientific Affairs Officer