Tyme Announces Positive Efficacy Data for SM-88 in Pancreatic Cancer at 2018 ASCO Gastrointestinal Cancers Symposium
January 19 2018 - 11:46AM
Tyme Technologies, Inc. (Nasdaq:TYME), a clinical-stage
biotechnology company developing cancer therapeutics, today
announced efficacy and safety data for SM-88 in patients with
advanced metastatic or recurrent pancreatic cancer. The data were
presented today in a poster presentation at the 2018 American
Society of Clinical Oncology (ASCO) Gastrointestinal Cancers
Symposium in San Francisco, Calif.
“We are encouraged by the early efficacy signals
demonstrated by SM-88 without report of drug-related serious
adverse events in pancreatic cancer, a devastating disease that
lacks safe and effective treatment options,” said Giuseppe Del
Priore, M.D., Chief Medical Officer of Tyme. “We look forward to
exploring SM-88 in a larger prospective Phase II trial this year in
pancreatic cancer patients who have failed prior
therapy.”
Data from 10 pancreatic cancer patients treated
with SM-88 in Tyme’s First Human Study or compassionate use program
were evaluated for overall survival, overall response rate,
progression-free survival, Eastern Cooperative Oncology Group
(ECOG) performance status and pain scores.
Many evaluable patients demonstrated prolonged
survival with 40 percent (4/10) surviving more than 12 months, and
30 percent (3/10) achieving a complete or partial response. All
subjects (10/10) reduced or maintained pain scores during their
first cycle of SM-88 therapy, in addition to gaining or maintaining
weight. Eighty percent (8/10) of patients showed improvement in
ECOG performance status during the first treatment cycle, with 30
percent (3/10) demonstrating an improvement of greater than one
point during this six week period. All patients improved or
maintained European Organisation for Research and Treatment of
Cancer (EORTC) Quality of Life Questionnaire subject-reported
health and quality of life outcomes after initiating SM-88
therapy.
About SM-88
SM-88 is a novel combination therapy that
utilizes a proprietary dysfunctional tyrosine derivative to
interrupt the metabolic processes of cancer cells, breaking down
the cells’ key defenses and making them vulnerable to oxidative
stress and death. SM-88 has demonstrated efficacy in the treatment
of multiple oncology indications, including breast and prostate
cancer, without reports of significant toxicity or serious adverse
events.
SM-88 is being evaluated in a Phase II clinical
trial for prostate cancer (NCT02796898). A Phase II clinical trial
in pancreatic cancer is planned to initiate in 2018.
About Tyme
Tyme 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. Tyme’s lead clinical program, SM-88, is a
first-in-class combination therapy in Phase II development for
prostate cancer. The Company is preparing to initiate an additional
Phase II clinical trial in pancreatic cancer in 2018.
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 as “anticipates,” “believes,” “designed,”
“could,” “estimates,” “expects,” “intends,” “may,” “plans,”
“potential,” “predicts,” “projects,” “should,” “would” and similar
expressions intended to identify forward-looking statements. 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, 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 analysis, final results of additional clinical trials, or
both, may be different from the preliminary data analysis and may
not support further clinical development; 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 and Quarterly Report on Form
10-Q filed with the U.S. Securities and Exchange Commission on
November 3, 2017 (available at www.sec.gov). The data set
forth in these updated analyses are not necessarily predictive of
future patient or clinical data outcomes.
The information contained in this press release
is as of the 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
Tyme Inc.Jonathan EckardChief Scientific Affairs
Officerjon.eckard@tymeinc.com
ICR HealthcareInvestorsStephanie
CarringtonStephanie.Carrington@icrinc.com646-277-1282
6 DegreesMediaSarah Hallshall@6degreespr.com 215-313-5638
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