- The Phase II Prostate Cancer
study demonstrated that oral SM-88 (racemetyrosine) was associated
with disease control while maintaining QOL; More than 450,000 of
these patient cases annually in U.S. alone
- Based on study results, SM-88
may have a clinically meaningful role in postponing medical
castration in prostate cancer patients with rising
prostate-specific antigen (PSA)
- At 6 months, 100% of patients
(23/23) were free of metastatic progression (MFS), and 87% of
patients (20/23) remained free of any radiographic progression
(rPFS)
- After 12 weeks, 78% of
patients (18/23) demonstrated a 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
- TYME is evaluating regulatory
strategies in the interest of advancing SM-88 for patients with
non-metastatic recurrent prostate cancer
Tyme Technologies, Inc. (NASDAQ: TYME), an emerging
biotechnology company developing cancer metabolism-based therapies
(CMBTsTM), announced that the final results of its SM-88 Phase II
Prostate Cancer study designed to evaluate the safety, tolerability
and efficacy of SM-88 in patients with non-metastatic biochemical
recurrent prostate cancer, was published on September 13th, 2020 in
the peer-reviewed journal Investigational New Drugs. The article,
titled “Phase II Trial of SM-88, a Cancer Metabolism Based Therapy,
in Non-Metastatic Biochemical Recurrent Prostate Cancer,” is
available online at https://doi.org/10.1007/s10637-020-00993-4.
The study demonstrated that SM-88 had promising efficacy and
safety outcomes for prostate cancer patients while sparing
testosterone. The study also demonstrated a reduction of CTCs, an
important prognostic indicator, that may prove to be a better
surrogate for patient outcomes than PSA, particularly for
SM-88.
“Oral SM-88 has demonstrated potential efficacy and a
well-tolerated safety profile that may represent a new treatment
option for more than 450,000 prostate cancer patients in the U.S.
alone seeking a non-cytotoxic, non-hormonal therapy,” said Giuseppe
Del Priore, M.D., M.P.H., Chief Medical Officer at TYME. “We are
encouraged by the clinical results of our unique proprietary
approach using cancer metabolism-based therapies that we believe
attack the cancer cells from within, interrupting the cancer
metabolic processes.”
From September 2016 to April 2019, twenty-three evaluable
patients with non-metastatic pancreatic cancer with rising PSA
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 androgen-deprivation therapy (ADT) after radiation therapy
or surgery, but ADT treatment changes were 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 therapy of 6.5 months since
starting SM-88 treatment. All patients who have maintained
meaningful reductions in circulating tumor cells (CTCs) on SM-88
were 100% free of any radiographic progression.
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). Among evaluable patients, PSA
stabilized in 83% of patients (19/23). Importantly, 52% of
evaluable 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 (n=20). After 12
weeks, or three cycles of therapy, 78.2% of patients (18/23)
demonstrated a decrease in CTC from baseline, with a median
decrease of 65.3%.
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.
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 believed 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.
SM-88 is an investigational therapy that is not approved for any
indication in any disease. Learn more.
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 cancer metabolism-based 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. 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
candidates, including SM-88 and TYME-18, and their clinical
potential and non-toxic safety profiles, our drug development plans
and strategies, ongoing and planned preclinical and clinical
trials, including the proposed TYME-19 proof-of-concept study,
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
as “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 effect of
the novel coronavirus (COVID-19) pandemic and the associated
economic downturn and impacts on the Company's ongoing clinical
trials and ability to analyze data from those trials, 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, the severity,
duration, and economic impact of the COVID-19 pandemic; 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 cost and availability of
acceptable-quality clinical supply and the ability to achieve
adequate clinical study design and 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 data from any clinical trial may differ from prior or
preliminary study 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; the ability of TYME and its collaborators to develop and
realize collaborative synergies; 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 May 22, 2020, 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 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.
1https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html
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
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