-- SM-88 with MPS arm of Phase 2/3 platform
trial in metastatic pancreatic cancer discontinued for futility on
primary endpoint of overall survival –
TYME Technologies, Inc. (Nasdaq: TYME) (the Company or TYME), an
emerging biotechnology company developing cancer metabolism-based
therapies (CMBTs™), today announced the discontinuation of SM-88
with MPS in the Precision Promise trial in metastatic pancreatic
cancer (mPDAC) upon learning from the trial sponsor, Pancreatic
Cancer Action Network (PanCAN), that it terminated the arm due to
futility compared to the control of standard of care chemotherapy
in second-line mPDAC. Based on the information provided by PanCAN,
the overall survival for SM-88 with MPS in monotherapy was lower
compared to standard of care chemotherapies with either Gemcitabine
and Abraxane or modified FOLFIRINOX.
The Precision Promise trial is an adaptive randomized Phase 2/3
trial in mPDAC for patients treated in both first-line and
second-line therapies. SM-88 (racemetyrosine) with MPS (10 mg
methoxsalen, 50 mg phenytoin, and 0.5 mg sirolimus) was the first
therapy to join this trial and was being studied as a standalone
monotherapy in second-line patients versus control arms of standard
of care regimens of either Gemcitabine and Abraxane or modified
FOLFIRINOX.
“Given pancreatic cancer’s high mortality rate, we wanted to
make a difference in the lives of these patients. Our team
understood that many efforts before us have failed, but based on
SM-88's prior activity and safety profile, we were hopeful we could
provide an effective new option for those fighting against this
devastating disease,” said Richie Cunningham, Chief Executive
Officer of TYME. “I want to express my sincerest appreciation to
the patients, their loved ones, the researchers, and the principal
investigators involved in this trial, as well as thank PanCAN and
Precision Promise for their passionate dedication to exploring new
treatment options for pancreatic cancer patients.”
“Given our prior promising results with SM-88 plus MPS in a
subset of patients in second-line pancreatic cancer1, we are
disappointed that we couldn’t make an impact in this very difficult
to treat population. We will work with PanCAN and Precision Promise
leadership to further analyze the data with the SM-88 arm, as it
becomes available,” said Dr. Jan M. Van Tornout, MD, MSC, Acting
Chief Medical Officer of TYME.
TYME remains committed to advancing its current pipeline and the
continued research and development of SM-88.
About TYME Technologies, Inc.
TYME is an emerging biotechnology company developing cancer
metabolism-based therapies (CMBTs™) that are intended to be
effective across a broad range of solid tumors and hematologic
cancers, while also maintaining patients’ quality of life through
relatively 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 cause cancer cell death.
The Company is currently focused on developing its novel
compound, SM-88. The Company believes that early clinical results
demonstrated by SM-88 in multiple advanced cancers, including
prostate, sarcomas and breast, reinforce the potential of its
emerging CMBT™ pipeline.
For more information about the Company, visit www.tymeinc.com
and connect on Facebook, LinkedIn, and Twitter.
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 lung, breast, prostate and sarcoma cancers with
minimal serious grade 3 or higher adverse events. SM-88 is being
evaluated in a Phase II study evaluating SM-88 in breast cancer
(HR+/HER2-), as well as continuing enrollment of a Phase II study
in high-risk metastatic sarcomas. SM-88 is an investigational
therapy that is not approved for any indication in any disease.
Learn more.
Forward-Looking Statements
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 or clinical trials,
preliminary data results, and the therapeutic design and mechanisms
of our drug candidates. The words “believes,” “expects,” “hopes,”
“may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,”
“would,” “continue,” “seeks,” “anticipates,” and similar
expressions (including their use in the negative) are intended to
identify forward-looking statements. Forward-looking statements can
also be identified by discussions of future matters such as: the
effect of the COVID-19 pandemic and the associated impact on the
national and global economy as well as 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 product candidates;
expected releases of interim or final data from our clinical
trials; possible collaborations; the timing, scope, status,
objectives of our ongoing and planned trials; the success of
management transitions and strategic initiatives; and other
statements that are not historical. The forward-looking statements
contained in this press release are based on management’s current
expectations and projections which are subject to uncertainty,
risks and changes in circumstances that are difficult to predict
and many of which are outside of our 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, performance 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; our ability
to achieve the intended benefits of our strategic initiatives; that
certain 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 in the ability to achieve
adequate start and completion dates, as well as uncertainties in
clinical trial design and patient enrollment, dropout or
discontinuation rates; the possibility of unfavorable study
results, including unfavorable new clinical data, additional
analyses of existing data and results that may lead to a
discontinuation of trials; risks associated with early, initial
data, including the risk that the final data from any clinical
trials may differ from prior or preliminary study data or analyses
and may not support further clinical development; and 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 or other drug candidates 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 or other drug candidates; the
ability of TYME and its collaborators to develop and realize
collaborative synergies; competitive developments; the ability of
TYME to maintain compliance with Nasdaq listing standards; and the
factors described in the section captioned “Risk Factors” of TYME’s
Annual Report on Form 10-K for the fiscal year ended March 31, 2021
filed with the U.S. Securities and Exchange Commission on June 10,
2021 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.
1 Hoffman, S., et al. SM-88 therapy in patients with advanced or
metastatic pancreatic cancer. Journal of Clinical Oncology
36:4_supp, 457-457 (2018);
Noel, M., et al. Oral SM-88 plus MPS: An effective yet less
toxic treatment option in second-line advanced pancreatic cancer?
Final Phase II/III study results. DOI:
10.1200/JCO.2022.40.4_suppl.585 Journal of Clinical Oncology 40,
no. 4_suppl (February 01, 2022) 585-585.
Stega, J., et al. A first-in-human study of the novel
metabolism-based anti-cancer agent SM-88 in subjects with advanced
metastatic cancer. Invest New Drugs (2019).
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version on businesswire.com: https://www.businesswire.com/news/home/20220126005344/en/
Investor Relations: Lisa M. Wilson, In-Site
Communications, Inc. T: 212-452-2793 E: lwilson@insitecony.com
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