NEW YORK, Dec. 12, 2016 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (“Tyme” or “the Company”) (OTCQB:TYMI), a clinical-stage pharmaceutical company focused on developing highly targeted cancer therapeutics for a broad range of oncology indications, today announced that it had completed enrollment of the Phase Ib portion of its open-label Phase Ib/II trial of SM-88 in patients with prostate cancer with rising Prostate-Specific Antigen (PSA) non-metastatic disease. The trial is designed to confirm SM-88’s earlier reported activity in reducing PSA.
On June 13, 2016, Tyme announced that the Company had started recruiting for this clinical trial. The purpose of the Phase Ib was to establish the recommended dose of the treatment for further study in the Phase II dose expansion portion of the study. In the Phase II, the dose selected for evaluation will be administered in up to 30 patients for up to six cycles. Efficacy of SM-88 will be measured by PSA level, circulating tumor cells, and other outcomes according to the Prostate Cancer Working Group 3 (PCWG3) guidelines.
SM-88 is Tyme‘s lead development program and is designed to synergistically target the unique metabolic features of cancer cells and selectively alter the susceptibility of cancer cells to oxidative stress.
Tyme will report results on PSA levels and novel biomarker components, as well as progression free survival data at the conclusion of the prostate study, or earlier, if appropriate milestones are met.
“We are pleased with how quickly this study has moved forward," said Dr. Giuseppe Del Priore, Tyme’s Chief Medical Officer. "We hope that our metabolic approach that targets only active cancer cells will have fewer and less severe side effects than current standards of care and will improve outcomes."
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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