Tyme Releases Detailed Data and Analyses with SM-88 From the First Human Study and Compassionate Use Programs

NEW YORK, June 12, 2018 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. TYME, a clinical-stage biotechnology company developing cancer therapeutics, today release detailed patient data and analyses from both the First Human Study (FHS) and Compassionate Use Program of SM-88 in metastatic cancer patients following the completion of review of all available data by blinded radiologists. 

The First Human Study was conducted in 2012, and enrolled thirty (30) metastatic cancer patients who had failed or refused all approved/available therapies.  The compassionate use program enrolled a total of 77 metastatic cancer patients who failed or refused all approved/available treatments between late 2011 into 2017.  Of the total of 107 patients, 83 were deemed "evaluable" because they received at least 6 weeks (one cycle) of SM-88 treatment and had data available that could be evaluated to measure for relevant disease response criteria such as RECIST 1.1 (Response Evaluation Criteria In Solid Tumors version 1.1).

The analyses focused on tumor response rates (RECIST 1.1 in solid tumors) and overall survival (OS) in several important subgroups.  Some of the key findings from these analyses were:

• There were confirmed tumor responses (partial (PR) or complete responses (CR)) observed in 15 different cancer types across the two programs
  
  
• The objective response rate (ORR;  CR+PR) in the FHS and Compassionate use program were 33% and 45%, respectively
  
  
• A majority of PRs and CRs occurred in patients receiving monotherapy SM-88
  
  
• The ORR in all breast cancer patients (n=25) was 44%, and appeared consistent across patients with different hormonal status, including triple-negative breast cancer (TNBC) where two of five patients (40%) experienced a response 
  
  
• Patients with stable disease (33 of 83, 40%) had a median OS of 43 months, suggesting to us that RECIST 1.1 may not be the only predictor of clinical benefit with SM-88

Presentation materials detailing this historical patient data and analyses have been provided by the company in a current report on Form 8-K and can be found in the "Investors" section of the company's website. 

"We are highly encouraged by the data with SM-88 from these studies in terms of the apparent safety and efficacy shown by the drug, as well as the breadth of cancer indications for which responses were observed," stated Tyme CEO Steve Hoffman. "We remain focused on completing our current trials, and will look to expand SM-88 development into additional cancer settings in the future."

About Tyme Technologies

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 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 "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 of new products, technology enhancements, possible collaborations, the timing, scope and objectives of our planned clinical trials, funding plans and planned uses of proceeds, 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 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 patient 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 12, 2017, as well as subsequent reports we file from time to time with the U.S. Securities and Exchange Commission (available at www.sec.gov). The data analyses discussed above 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

LifeSci Advisors
Ashley Robinson
arr@lifesciadvisors.com
617-535-7742