SM-88 Report; #2 of 2 from Tyme

[mistersafety]

Hello again,

I've been following Tyme Technologies and their development of SM-88 for a while. Very interesting metabolic approach that is being tested on several kinds of cancers, notably prostate and pancreatic.

Best to all,

Mr Safety

Pasted below from: globenewswire.com/news-rele...

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

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 (tymeinc.com/data-publications).

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

Racemetyrosine:

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

[Shanti1]

Very interesting, thanks for posting.