Questions? +1 (202) 335-3939 Login
Trusted News Since 1995
A service for medical industry professionals · Saturday, January 18, 2020 · 507,534,702 Articles · 3+ Million Readers

TYME Presented Updated Data at ESMO 2019 from SM-88 Phase II Prostate Cancer Study Demonstrating Encouraging Clinical Benefit in Patients with Recurrent Prostate Cancer

  • Study results demonstrate that oral SM-88 may play a clinically meaningful role in postponing use of hormonal castration in prostate cancer patients with rising prostate-specific antigen (PSA):  More than 450,000 of these patient cases annually in the U.S. alone
  • SM-88 therapy did not exhibit typical side effects associated with hormonal castration from androgen-deprivation therapy (ADT)
  • At 6 months, 100% of patients (23/23) were free of metastatic progression (mPFS), and 87% of patients (20/23) remained free of radiographic progression (rPFS)
  • After 12 weeks, 78% of patients (18/23) demonstrated a median 65% decrease in median CTCs from baseline
  • 52% of patients (12/23) showed improvement in median PSA doubling time (DT)
  • No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months

/EIN News/ -- NEW YORK, Oct. 01, 2019 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism- based therapies (CMBTs™), announced encouraging results from its Phase II trial of oral SM-88 (racemetyrosine) in patients with non-metastatic, biochemical-recurrent prostate cancer. The study demonstrated that SM-88 had very encouraging efficacy and safety outcomes for prostate cancer patients where sparing testosterone is important. The study also showed that reduction of CTCs, an important prognostic indicator, may prove to be a better surrogate for patient outcomes than PSA, particularly for SM-88 and other non-hormonal agents. The updated data from the Phase II prostate study were presented at the European Society of Medical Oncology Congress (ESMO) being held on September 27- October 1, 2019 in Barcelona, Spain.

“Based on these clinical results, we are encouraged by the broad positive impact that our new approach with cancer metabolism-based therapies is having on biomarker recurrent prostate cancer patients,” said Giuseppe Del Priore, M.D., M.P.H., Chief Medical Officer at TYME. “Toxicities typically associated with ADT have not been seen with our lead CMBT candidate, SM-88, which suggests that ADT may be avoided or delayed in patients with non-metastatic prostate cancer. This new treatment approach may offer more than 450,000 prostate cancer patients in the U.S. alone another option to live longer with a higher quality of life.”

From September 2016 to April 2019, twenty-three evaluable patients with non-metastatic pancreatic cancer with rising prostate-specific antigen levels, detectable circulating tumor cells and no radiographically detectable metastases were assessed in a Phase II trial. All patients received 230 mgs twice per day of SM-88 orally. Patients also received oral doses of methoxsalen (10 mg), phenytoin (50 mg), and sirolimus (0.5 mg) once per day. Most patients had previously received ADT after radiation therapy or surgery, but ADT treatment was not permitted during the trial.

From the initial diagnoses of PSA rise, 100% of patients (23/23) remained free of metastatic progression (MFS) and 87% of patients (20/23) have maintained radiographic progression-free survival (rPFS) with a median duration of 6.5 months since starting SM-88 treatment. All patients who have maintained rPFS also exhibited meaningful reductions in circulating tumor cells (CTCs).

At baseline, the median PSA for patients with radiographic progression was 13.4 compared to 5.6 for patients with no radiographic progression (p=0.02). In evaluable patients, PSA declined in 4% of patients (1/23); PSA stabilized in 83% of patients (19/23) and PSA increased in 13% of patients (3/23). Importantly, 52% of patients (12/23) experienced an improvement in median PSA doubling time (DT), a positive prognostic indicator. In all patients who completed three cycles of therapy, the median DT improved nearly 34.4% from 6.1 to 8.2 months. After 12 weeks, or three cycles of therapy, 78.2% of patients (18/23) demonstrated a 65.3% decrease in median CTCs from baseline with all patients having CTC counts below baseline.

Patients without local progression (20/23) had slightly higher testosterone levels at baseline and throughout treatment on SM-88 as compared to those who experienced local radiographic progression (3/23). According to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, patients generally reported stable cognitive and sexual function domain measures, with no detectable worsening in any domain. Patient weight, EKG QTc, glucose and hematocrit and other measures, which are often side effects of ADT, did not appear affected while receiving SM-88.

The SM-88 therapy was well tolerated in all patients. There were no treatment-related serious adverse events. No adverse events resulted in dose delay, discontinuation, or reduction. The majority of Grade 1 AEs possibly or probably related to the SM-88 investigational therapy were gastrointestinal in nature.

The Phase II prostate cancer trial results are from an investigational study. SM-88 is not approved for the treatment of patients with any disease condition. 

Details of this study were presented at the European Society of Medical Oncology Congress in Barcelona, Spain on Monday, September 30, 2019, from 12:00 PM CET to 1:00 PM CET during the Poster Display Session 3 in Poster Hall 4. The poster is available on our website (

The SM-88 poster on prostate cancer presented at the ESMO Congress in Barcelona is as follows:  

Title: Phase II trial of SM 88 in Non-Metastatic Biochemical Recurrent Prostate Cancer

Authors:   Benjamin Adam Gartrell1, Mack Roach III2, Avi S. Retter3, Wen-Tien Chen4, Gerald H. Sokol5, Alexander G. Vandell6, Giuseppe Del Priore6, Howard Scher7

Institutions: (1)Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY; (2) University of California, San Francisco, San Francisco, CA, (3)Eastchester Cancer Care Center, Bronx, NY; (4)Vitatex Inc., Stonybrook, NY ; (5)Florida Cancer Institute, Hudson, FL; (6)Tyme Inc., New York, NY, (7)Memorial Sloan-Kettering Cancer Center, New York, NY.

Session Title: Poster Display Session 3
Session Date and Time: Monday, September 30, 2019 12:00 PM CET – 1:00 PM CET
Session Location: Poster Hall 4
Abstract Number: 3611

Poster Number: 873P

About Advanced Prostate Cancer
Prostate cancer is the most common malignancy in men, accounting for approximately 31,620 deaths in the United States in 2019.1 Approximately 15% of men with prostate cancer present with metastatic disease, and 20% to 30% of men with localized disease treated with definitive local therapy subsequently develop metastatic disease. While the vast majority of patients with metastatic disease demonstrate a transient response to androgen deprivation, eventually all patients develop hormone refractory prostate cancer (HRPC) and virtually all prostate cancer deaths are due to the development of metastatic HRPC.2 While chemotherapy regimens have shown a modest survival advantage in HRPC patients, median survival remains approximately 19 months,3,4 and not all patients are candidates for chemotherapy. Novel agents and new approaches such as oral cancer metabolic-based therapies are needed. 

About SM-88
SM-88 is an oral investigational modified proprietary tyrosine derivative that is hypothesized to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events.

About Tyme Technologies
Tyme Technologies, Inc., is an emerging 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  Follow us on social media: @tyme_Inc, LinkedIn, Instagram, Facebook and YouTube.

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 candidate SM-88 and its clinical potential and non-toxic safety profiles, our drug development plans and strategies, 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 cost of development and potential commercialization of our lead drug candidate and of other new products, expected releases of interim or final data from our clinical trials, possible collaborations, the timing, scope and objectives of our ongoing and 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 the cost and outcomes of 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, 2019, 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 its release date and TYME assumes no obligation to update forward-looking statements contained in this release as a result of future events or developments.

2Vogelzang N: One hundred thirteen men with prostate cancer died today. J Clin Oncol 14::1753,1996-1755
3Tannock IF, deWit R, Berry WR, et al: Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 351::1502,2004-1512
4Petrylak D, Tangen CM, Hussain MH, et al: Docetaxel and estramustine compared with mitoxantrone and prednisone in hormone refractory prostate cancer. N Engl J Med 351::1513,2004-1520,

For Investor Relations & Media Inquiries:

1-212- 461-2315 

Primary Logo

Powered by EIN News

EIN Presswire does not exercise editorial control over third-party content provided, uploaded, published, or distributed by users of EIN Presswire. We are a distributor, not a publisher, of 3rd party content. Such content may contain the views, opinions, statements, offers, and other material of the respective users, suppliers, participants, or authors.

Submit your press release