NEW YORK, Sept. 20, 2016 (GLOBE NEWSWIRE) — Tyme Technologies, Inc. (“Tyme” or the “Company”) (OTCQB:TYMI), a research and development company focused on developing drug candidates for the treatment of cancer in humans and operating through its wholly-owned subsidiary Tyme Inc., today announced that William K. Oh, M.D., Chief of the Division of Hematology and Medical Oncology in the Department of Medicine at Mount Sinai Hospital, will serve as Special Advisor in the Company’s phase 2 clinical trial, using its proprietary compound, SM-88, to treat prostate cancer. Dr. Oh also serves as Associate Director at Mt Sinai’s Tisch Cancer Institute, Professor of Medicine and Urology and the Ezra M. Greenspan, MD Professor in Clinical Cancer Therapeutics at The Mount Sinai School of Medicine.
Dr. Oh is an internationally recognized expert in the management of genitourinary malignancies, including prostate, renal, bladder, and testicular cancers. He is regarded as a leading clinical trialist, known for his expertise in using biological data banks to advance the understanding of cancer and cancer treatment.
The phase 2 trial is designed to evaluate the effect of SM88 on prostate cancer progression as measured by the blood marker, PSA, in patients who have failed therapy with surgery or radiation. The prostate study will be conducted in the United States and expected to accrue over 12 months with reportable milestones within six months. At Mount Sinai, the study will evaluate recurrent prostate patients with rising PSAs, a population of men with few well-tolerated treatment options.
“We are pleased with the progress made during the quarter in advancing our compound, SM-88,” said Steve Hoffman, President and Chief Executive Officer of the Company. “Our phase 2 trial is expected to accrue over 12 months and we are optimistic that the results will contribute to the overall body of knowledge around the treatment of patients with recurrent forms of prostate cancer.”
“Our goal remains to provide oncologists with a novel treatment option that, unlike chemotherapy, targets only the active cancer cells themselves. We hope this metabolic approach will improve outcomes and have fewer and less severe side effects. Preliminary measures are trending in a way that makes us optimistic,” concluded Mr. Hoffman.
About Tyme Technologies
Our research and development efforts are based on a proprietary platform technology, for which we retain global IP and commercial rights. Our lead program is SM-88, a proprietary combination drug product. We believe SM-88 is a first-in-class oncology therapy that increases the power of the body’s innate defenses to utilize oxidative stress to kill cancer cells. SM-88 is designed to penetrate only living cancer cells without toxic effects and without involving healthy body tissue. We believe that SM-88’s therapeutic potential is based on its ability to increase the availability of free radicals and promote their entry into cancer cells by stripping the cancer cells of their normal barriers to these toxic electrons. SM-88 is a combination of a proprietary novel molecule with three currently-marketed drugs that are generally considered safe for their already approved indications, which are in areas other than cancer treatment.
In addition to historical information, this press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the U.S. Securities Act of 1933, and Section 21E of the U.S. Securities Exchange Act of 1934. Such forward-looking statements may include projections regarding Tyme’s future performance, 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. Forward-looking statements within this press release include, without limitation, statements regarding our drug development strategies, the therapeutic mechanisms of our drug candidates and our completed and planned clinical trials. 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, 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).
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