Tyme Technologies, Inc. and the Joseph Ahmed Foundation Announce Planned Trial for SM-88 in Ewing’s Sarcoma

• Recognized sarcoma thought leader, Dr. Sant P. Chawla, will conduct the investigator-initiated Phase II study
• The Joseph Ahmed Foundation (“JAF”) will provide funding and patient support for the study while Tyme will provide study drug and certain administrative services
• The study is expected to begin enrollment during the first quarter of 2019

NEW YORK, Sept. 27, 2018 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (NASDAQ:TYME) today announced that JAF will provide funding and patient support for an investigator-initiated Phase II trial of SM-88 in patients with previously treated metastatic Ewing’s sarcoma.  During our compassionate use program, two third-line refractory metastatic Ewing’s sarcoma patients were treated with SM-88 and, based on available data through February 2018, both achieved complete or partial RECIST responses with no drug-related serious adverse events.

The trial will be conducted by Dr. Sant Chawla, a world-recognized leader in the treatment and clinical study of sarcomas.   He has been an author for over 100 peer-reviewed publications and books as well as a frequent presenter at the American Society of Clinical Oncology.  Dr. Chawla founded The Sarcoma Oncology Research Center in Santa Monica and is on the clinical faculty of numerous cancer centers, including UCLA, USC, Stanford, the John Wayne Cancer Institute, and M.D. Anderson.  The Sarcoma Oncology Research Center is also currently participating in Tyme’s Phase II trial in metastatic pancreatic cancer.

“This is an important milestone for JAF, as one of our core goals is to help discover new treatments for patients with this terrible disease,” said Junny Ahmed, Co-Founder of JAF. “We are excited to be working with Dr. Chawla and Tyme to study SM-88 in Ewing’s Sarcoma and intend to continue expanding to additional childhood sarcomas in the future.”

“We have had the pleasure of meeting Dr. Chawla from his leading one of our earliest and most active sites in our ongoing pancreatic cancer trial,” stated Tyme’s Chief Medical Officer, Dr. Giuseppe Del Priore. “Dr. Chawla and JAF separately approached us about using SM-88 in sarcoma given our treatment experience in the compassionate use setting.  We are very excited they have worked together to establish this proof of concept trial in such an important disease setting.” 

Ewing’s sarcoma is a rare form of cancer that mainly affects children and young adults with less than 500 cases per year in the United States.  Patients often have poor prognosis once the disease has progressed to the metastatic stage, with most treatment options demonstrating limited efficacy and high toxicity.

For this investigator-initiated study:

• The Sarcoma Oncology Research Center will be the sole enrolling site and will lead clinical and regulatory operations
• JAF will provide funding to support the trial and utilize its nationwide sarcoma advocacy network to assist potential patients and their families
• Tyme will supply SM-88 at no cost as well as provide limited administrative support
• If proof-of-concept is demonstrated, initiating a multi-site confirmatory study will be evaluated.
• Additional detail on the study will be provided when enrollment is initiated

About The Joseph Ahmed Foundation: Our mission at the Joseph Ahmed Foundation is to promote the treatment and cure of Ewing’s Sarcoma as well as other childhood Sarcomas by: Funding research that may discover the root causes of pediatric cancer; Promoting the development of effective pediatric cancer treatments that will increase survival rates and ultimately provide a cure; Developing public awareness of pediatric cancer detection, prevention, and treatment; Providing support services and essential information to pediatric cancer patients, their families and loved ones.

For more information, visit .

About Tyme

Tyme Technologies, 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 .

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 and ongoing and planned clinical trials; and readers can identify forward-looking statements by sentences or passages involving the use of terms such “believes,” “expects,” “hopes,” “may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,” “would,” “continue,” “seeks,” or “anticipates,” and similar words (including their use in the negative) or by discussions of future matters such as the development and potential commercialization of our lead drug candidate and of other of new products, possible collaborations, the timing, scope and objectives of our planned clinical trials and other statements that are not historical. 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, that the information is of a preliminary nature and may be subject to change; uncertainties inherent in research and development, including the ability to complete clinical studies with current subject enrollment, 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 may differ from prior study data or preliminary Phase II data; final results of additional clinical trials that may be different from the preliminary data analysis and may not support further clinical development; that past reported data are not necessarily predictive of future subject or clinical data outcomes; 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 13, 2018, as well as subsequent reports we file from time to time with the U.S. Securities and Exchange Commission (available at ).

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.

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