- Currently enrolling at multiple sites for Phase II participation, including investigators affiliated with Mount Sinai Beth Israel, AECOM, NYU School of Medicine, and Winthrop-University Hospital
- Circulating tumor cells at non-detectable or declining levels in first evaluable research subjects
- Positive preliminary pharmacokinetic and safety analysis
- No serious adverse events related to SM-88 administration in any clinical trial testing to date
NEW YORK, Jan. 05, 2017 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (OTCQB:TYMI), a clinical-stage biotechnology company developing cancer therapeutics that are designed to be effective across multiple tumor types, today announced that it has begun enrolling research subjects in the second stage of its Phase Ib/II open-label trial using monotherapy SM-88 treatment for progressive prostate cancer. This follows encouraging preliminary data from the first stage of this trial in safety and circulating tumor cells (CTCs) at both dosage levels.
Three subjects in the trial have been enrolled for a sufficient period for evaluable data and have shown consistent preliminary data trends. CTCs in the first subject dropped below detectable levels and have remained undetectable for the subsequent two monthly cycles. CTCs for the next two subjects fell by the start of the second and third cycles, respectively. In all three subjects, no drug-related Grade 2 or higher toxicities were observed and subjects self-reported some improvement in quality-of-life measurements. A fourth subject is also enrolled, but not for sufficient time to have evaluable data. As there were no observed differences in safety or tolerability between the lower-dose version of SM-88, given to the first subject, and the higher dose version, given to the other subjects, the higher-dose version will be used for the second stage of the trial.
“Although these are early data, they demonstrate an encouraging safety profile and biomarker trends that are aligned with our expectations for SM-88's anti-cancer activity,” said Dr. Giuseppe Del Priore, Tyme’s Chief Medical Officer. “We have completed the preliminary pharmacokinetic and safety analysis associated with the first stage of the trial and are now moving into the second stage. All sites for the second stage are running and several started screening potential patients in December.”
During the second stage, the company expects to enroll an additional thirty subjects for up to six months. In addition to safety and tolerability, the Phase Ib/II study is designed to further evaluate SM-88’s previously reported anti-tumor activity in prostate cancer, determined by improving PSA levels and radiographic-determined tumor response. The trial also includes secondary endpoints evaluating correlative measures and biomarker indicators, including circulating tumor cells, testosterone levels, and quality-of-life.
About Tyme
Tyme Technologies is developing a novel first-in-class therapy, SM-88, that is designed to use cancer’s unusual metabolism to selectively break down the cellular defenses of tumors, leading to tumor cell death. Through clinical trials and expanded access programs, SM-88 has been used in over 84 individuals and shown a clinical response in thirteen cancer types. In its initial Phase I trial for end-stage, metastatic cancer patients, SM-88 treatment resulted in a median overall survival of 26 months, with 32% of patients alive at the end of the three year evaluation period without any drug-related serious adverse events. The Company is currently conducting a Phase Ib/II trial in prostate cancer in addition to ongoing collaborations with the Mayo Clinic, Mount Sinai, the Albert Einstein College of Medicine and other institutions. For more information, visit our website: www.tymeinc.com.
Forward-Looking Statements/Disclosure Notice
In addition to historical information, this press release contains forward-looking statements 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), our drug development plans and strategies, our completed and planned clinical trials 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 1b 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 March 30, 2016 (available at www.sec.gov).
The information contained in this press release is as of January 5, 2017 and Tyme assumes no obligation to update forward-looking statements contained in this release as a result of future events or developments.