NEW YORK, Jan. 06, 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, announced the appointment of Shabnam Stanicky as Clinical Operations Officer.
With over 16 years experience in clinical oncology research operations, Stanicky has extensive experience in the management, design, execution and evaluation of clinical trials for cancer therapies. She joins Tyme from Quintiles, where she has worked since 2008, most recently as Clinical Operations Manager, Oncology. Prior to that, Stanicky worked for seven years performing and managing clinical oncology research at Eli Lilly and Co. and two years at the John Wayne Cancer Institute in Santa Monica, California.
“Tyme is entering a transformational 2017 that we expect will significantly change the clinical and operational profile of the company,” said Steve Hoffman, Tyme’s Chief Executive Officer. “Within our clinical programs during 2017, we plan to announce initial SM-88 Phase II data from our ongoing prostate cancer trial and begin a separate Phase II trial in pancreatic cancer. Previously described results from our Phase I and expanded access initiatives demonstrate that SM-88 has shown complete and partial responses in not only prostate, pancreatic, lung and breast cancers, but also in nine additional cancer types. We believe we have the opportunity to selectively advance SM-88 research for one or more of these cancer types that are not currently in a clinical trial. Operationally, we expect to bolster our team in the clinical, regulatory and business areas, and the hiring of Shabnam Stanicky is an important first step in achieving our goals and advancing our clinical programs.”
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. To date, SM-88 has been used in over 84 patients, with reported data from clinical trials or expanded access programs, and has shown a clinical response in thirteen cancer types. In its initial Phase I trial for end-stage, metastatic cancer patients, SM-88 monotherapy resulted in a median overall survival of 26 months, with 32% of patients alive at the end of the three year evaluation period without a single drug-related serious adverse event. 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 6, 2017 and Tyme assumes no obligation to update forward-looking statements contained in this release as a result of future events or developments.