NEW YORK, June 13, 2016 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (OTCQB:TYMI) (“Tyme”), a clinical-stage pharmaceutical company focused on discovering and developing highly targeted cancer therapeutics for a broad range of oncology indications, announced that it has begun recruiting for a Phase 1b/2 clinical trial, using its proprietary compound, SM-88, to treat prostate cancer. Unlike traditional chemotherapy, SM-88 is designed to target only active cancer cells.
The trial is designed to confirm SM-88’s earlier reported activity in reducing the Prostate-Specific Antigen (PSA) without causing the castration-like effects often experienced with the current standard of care.
“We are excited that this trial is underway,” said Steve Hoffman, Chief Executive Officer, “and are confident that under the guidance of our Chief Medical Officer, Dr. Giuseppe Del Priore, this trial will contribute to the body of knowledge surrounding cancer treatments. We look forward to reporting the future results of this study and the potential for a new cancer treatment option, if approved.”
Study Design
The trial will be a single-arm, open label trial and up to five clinical sites will be involved. The study will enroll 30 subjects as specified on ClinicalTrials.gov. Prospective enrollees will have prostate cancer, rising PSA levels, without metastatic disease, and have failed ADT.
Recruitment for the study is currently underway. The trial is expected to last seven to 18 months. Tyme will report results on PSA levels and novel biomarker components, as well as progression free survival data at the conclusion of the study, or earlier, if appropriate milestones are met.
Tyme has received Institutional Review Board (IRB) approval and has met U.S. Food and Drug Administration (FDA) regulatory requirements for new drug development.
For more information, visit: www.tymetechnologiesinc.com.
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 abilities 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 multiple mechanisms including 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.
Forward-Looking Statements
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).