CHICAGO, June 05, 2017 (GLOBE NEWSWIRE) — Tyme Technologies, Inc. (OTCQB:TYMI) today presents positive interim data from an ongoing Phase Ib/II clinical trial (NCT02796898) evaluating the safety, pharmacokinetics, and efficacy of its investigational therapy candidate TYME-88 in the treatment of recurrent, non-metastatic prostate cancer at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
The ongoing six-month, open label, multi-center study is enrolling subjects with prostate-specific antigen (PSA) biomarker recurrent prostate cancer, prior to radiographically detectable lesions. Results in eight (8) prostate cancer subjects evaluable to date show improvement in the study’s primary endpoints:
- Prevention of radiographically detectable lesions (100 percent),
- Reduction in circulating tumor cells (87.5 percent),
- Stabilization or improvement in PSA doubling time (87.5 percent),
- Delay of subsequent toxic therapy, including ADT or chemotherapy (100 percent), and
- Avoidance of worsening patient reported outcomes (all subjects).
No drug-related serious adverse events and few grade one or two adverse events have been identified in the study subjects to date. Additional results of this trial are also being released elsewhere in conjunction with the meeting (Del Priore et al. ASCO 2017 e16540; Del Priore et al. ASCO 2017 e16567).
“Although these are preliminary results in a small sample size, the consistency of response across subjects and outcomes, suggest that TYME-88 may be a viable alternative for maintenance therapy in recurrent, non-metastatic prostate cancer,” said Dr. Giuseppe Del Priore, Chief Medical Officer at Tyme. “Given the important quality of life issues that patients with prostate cancer face, it is our hope that TYME-88 will become a relatively non-toxic treatment option for patients and medical professionals looking to delay or avoid more toxic treatments.”
Results from a Phase I clinical trial in 11 subjects with refractory pancreatic cancer were also released elsewhere at the meeting (Hoffman et al. J Clin Oncol 35, 2017 (suppl; abstr e14060)). In this trial, a reduction in tumor size was seen in 27.3 percent (3/11) of subjects, including one complete response by RECIST 1.1 criteria with progression-free survival (PFS) of at least six months duration, and two partial responses with one known PFS of 15 weeks. Further, 72.7 percent (8/11) had stable disease for six to 61 weeks. One subject with stable disease had an overall survival of 23.3 months with no further treatment, and one other stable disease subject had an overall survival of 43.2 months. The Company is preparing to begin a Phase II study in refractory pancreatic cancer by the first quarter of 2018.
About Tyme
Tyme Technologies is a clinical-stage biopharmaceutical company focused on development and commercialization of highly targeted cancer therapeutics with a broad range of oncology indications. Its lead investigational candidate, TYME-88, is a novel first-in-class therapy 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, TYME-88 has been used in over 84 individuals and shown a clinical response in thirteen cancer types. In its first-in-human trial for end-stage, metastatic cancer subjects, TYME-88 treatment resulted in a median overall survival of 26 months, with 32 percent of subjects alive at the end of the three-year evaluation period without any drug-related serious adverse events. The Company is currently conducting a Phase II trial in prostate cancer in addition to ongoing collaborations with the Mayo Clinic, Mount Sinai 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 TYME-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 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 TYME-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 TYME-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 June 5, 2017 and Tyme assumes no obligation to update forward-looking statements contained in this release as a result of future events or developments.
CONTACT: Contacts: ICR Healthcare Media / Investors James Heins / Stephanie Carrington T: 203.682.8251 / 646.277.1282 E: james.heins@icrinc.com / stephanie.carrington@icrinc.com
