NEW YORK, Jan. 30, 2018 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (NASDAQ:TYME), a clinical-stage biotechnology company developing cancer therapeutics, today announced that Mack Roach III, M.D., FASTRO, FACR, Professor of Radiation Oncology, Medical Oncology and Urology at the University of California, San Francisco (UCSF), will lead one or more investigator-initiated trials to evaluate SM-88 therapy in prostate cancer.
As part of the collaboration, Tyme will provide support to Dr. Roach to conduct a randomized, investigator-sponsored trial comparing active surveillance (AS) to SM-88 maintenance therapy in patients prior to definitive therapy. In addition, the collaboration will evaluate trials in select patient populations after relapsing from definitive therapy. These trials will be conducted at UCSF and potentially expand to other academic sites.
“A spectrum of patients including those suitable for Active Surveillance (AS) to those with high-risk and relapsing prostate cancer face a number of difficult choices concerning their disease. In some, it is whether to delay treatment and be followed with AS, waiting for symptomatic progression, or be aggressive by initiating potentially toxic treatment as soon as possible,” said Dr. Roach. “Based on the early results showing improved biomarkers in early stage patients and RECIST responses in late stage patients, while a very manageable safety profile to date, SM-88 could have a potential role throughout the wide spectrum of this disease. I believe this could become an important alternative for the large number of treatment-naïve patients.”
“We were very excited to have a leader in the field like Dr. Roach approach us with the idea for these trials,” said Dr. Giuseppe Del Priore, Tyme’s Chief Medical Officer. “Moving to the treatment naïve setting is the logical extension of our current Phase II trial in biomarker-recurrent prostate cancer. By partnering with UCSF, we hope to demonstrate proof-of-concept for SM-88 in this important treatment category without diverting core resources from our critical work in metastatic cancers.”
About Mack Roach III, M.D., FASTRO, FACR
Mack Roach III, M.D., is a Professor of Radiation Oncology, Medical Oncology and Urology at the University of California, San Francisco. Dr. Roach chaired one of the most important large prospective randomized trials comparing different strategies for locally advanced prostate cancer. He has gained international recognition as an authority on treatment planning for prostate cancer and served as senior author for the guidelines for treatment planning recently published by the American College of Radiology. Dr. Roach earned his M.D. from Stanford University School of Medicine.
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 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.
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 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 release date and Tyme assumes no obligation to update forward-looking statements contained in this release as a result of future events or developments.
Contacts :
Tyme:
Jonathan Eckard
Chief Scientific Affairs Officer
Investors:
ICR
Stephanie Carrington
Tel: +1 646 277 1282
Email: stephanie.carrington@icrinc.com
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Sarah Hall
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