Origent Data Sciences and Cytokinetics Announce Research Collaboration on Predictive Analytics Model in ALS
March 31 2016 - 7:30AM
Origent Data Sciences, Inc. (Origent) and Cytokinetics, Inc.
(Nasdaq:CYTK) today announced a research collaboration to refine
and prospectively validate an Origent computer model to predict the
course of ALS disease progression leveraging data from
Cytokinetics’ clinical trials of tirasemtiv. Funded by Origent’s
receipt of a grant from The ALS Association, this joint research
program will enable the first prospective validation of the
predictive model in a clinical trial setting. Previously, the
Origent models predicting both function and survival of ALS
patients have been validated using internal and retrospective
external datasets.
ALS disease progression is extremely
heterogeneous among patients. While the average life
expectancy of a patient living with ALS is 3-5 years after
diagnosis, many patients survive only a few months, while still
others live with the disease for decades. This heterogeneity of
progression creates significant challenges for clinical trial
design and conduct, as patients who progress at highly variable
rates may confound traditional statistical analyses, and require
larger, longer and more expensive trials. Origent’s statistical
models are designed to identify the patients whose symptoms are
likely to progress quickly or slowly, thereby reducing the
statistical complexities created by this disease heterogeneity.
“We are extremely grateful to The ALS
Association for this generous grant and to Cytokinetics for the
opportunity to access their robust clinical trial data,” said Dave
Ennist, Chief Science Officer, Origent Data Sciences. “If
validated, the models we have developed will be submitted to the
FDA and may enable more nimble, cost-effective execution of ALS
clinical trials, resulting in a potentially quicker path to new
medicines.”
“This unique collaboration between Origent Data
Sciences, Cytokinetics and The ALS Association reflects another
step in our collective efforts to accelerate the clinical trial
process and make new medicines available to people with ALS in
desperate need of new therapeutic options,” said Jinsy Andrews,
M.D., Cytokinetics’ Senior Director Clinical Research and
Development and Head of Neuromuscular Therapeutics. “We are
pleased to join with Origent to potentially validate their
predictive model using datasets from BENEFIT-ALS and VITALITY-ALS
which we hope may then facilitate the use of this novel technology
to positively impact the design and conduct of future ALS clinical
trials.”
“We are extremely excited to see this collaboration get
underway,” said ALS Association Chief Scientist Lucie Bruijn,
Ph.D., M.B.A. “This tool has the potential to accelerate clinical
trials for ALS and the Cytokinetics’ Phase 3 trial provides an
excellent opportunity to validate the disease progression
algorithm.”
About the Research
Partnership
Origent will first seek to confirm the
retrospective external validation of the existing predictive models
(including the ALSFRS-R, respiratory, gross, fine, and bulbar
sub-scores, slow vital capacity (SVC) and survival models) using
baseline characteristics data from BENEFIT-ALS, the completed Phase
2b trial of tirasemtiv, Cytokinetics’ fast skeletal muscle
activator which is being developed for the potential treatment of
ALS. If these retrospective validations are confirmed, Origent
plans to prospectively validate the models with the data provided
by Cytokinetics following the completion of VITALITY-ALS, an
ongoing Phase 3 clinical trial designed to assess the effects of
tirasemtiv versus placebo on SVC and other measures of skeletal
muscle strength in patients with ALS.
About Origent Data Sciences
Origent Data Sciences, Inc. is a spinoff of
Sentrana, Inc., a pioneer in the field of Precision Sales and
Marketing and winner of the DREAM Phil Bowen ALS Prediction
Prize4Life Challenge. Since 2004, Sentrana has been a market
leader in operationalizing new applications using predictive
technologies. Similarly, Origent has become the market leader in
patient-level predictive modeling for neurological conditions
including ALS, and has developed many new applications to manage
and reduce drug development risks through better foresight.
Rather than considering a similar historic C to act “the same”
as a current patient, Origent treats and models each individual
patient separately, predicting their behavior individually.
By modeling patient-level dynamics rather than the characteristics
of a population, Origent’s tools uncover a deep level of insight
that allows biostatisticians and researchers to gain clearer
understanding and greater knowledge from their data. For
additional information about Origent, visit
www.origent.com.About Cytokinetics
Cytokinetics is a late-stage
biopharmaceutical company focused on discovering, developing and
commercializing first-in-class muscle activators as potential
treatments for debilitating diseases in which muscle performance is
compromised and/or declining. As a leader in muscle biology and the
mechanics of muscle performance, the company is developing small
molecule drug candidates specifically engineered to increase muscle
function and contractility. Cytokinetics’ lead drug candidate
is tirasemtiv, a fast skeletal muscle activator, for the
potential treatment of ALS. Tirasemtiv has been granted orphan
drug designation and fast track status by the U.S. Food and
Drug Administration and orphan medicinal product designation
by the European Medicines Agency for the potential treatment
of ALS. Cytokinetics retains the right to develop and
commercialize tirasemtiv. Cytokinetics is collaborating
with Amgen Inc. to develop omecamtiv mecarbil, a
novel cardiac muscle activator, for the potential treatment of
heart failure. Cytokinetics is collaborating
with Astellas Pharma Inc. to develop CK-2127107, a fast
skeletal muscle activator, for the potential treatment of spinal
muscular atrophy. Amgen holds an exclusive license
worldwide to develop and commercialize omecamtiv
mecarbil and Astellas holds an exclusive license worldwide to
develop and commercialize CK-2127107. Both licenses are subject to
Cytokinetics’ specified development and commercialization
participation rights. For additional information
about Cytokinetics, visit www.cytokinetics.com.
Cytokinetics Forward-Looking
Statements
This press release contains forward-looking
statements for purposes of the Private Securities Litigation Reform
Act of 1995 (the “Act”). Cytokinetics disclaims any intent or
obligation to update these forward-looking statements, and claims
the protection of the Act’s Safe Harbor for forward-looking
statements. Examples of such statements include, but are not
limited to, statements relating to Cytokinetics’ and its partners’
research and development activities, including Cytokinetics’ and
Origent’s predictive analytics research and the ability to validate
Origent’s predictive technology; the initiation, conduct, design,
enrollment, progress, continuation, completion and results of
clinical trials; the significance and utility of preclinical study
and clinical trial results, the expected availability of clinical
trial results, planned interactions with regulatory authorities and
the outcomes of such interactions; and the significance and utility
of Origent’s predictive modeling. Such statements are based on
management's current expectations, but actual results may differ
materially due to various risks and uncertainties, including, but
not limited to the U.S. Food and Drug Administration (FDA) or
foreign regulatory agencies may not accept the utility of
predictive modeling, including its utility in clinical trial
design; the FDA or foreign regulatory agencies may delay or limit
Cytokinetics' or its partners' ability to conduct clinical trials;
and Cytokinetics may incur unanticipated research and development
and other costs or be unable to obtain additional financing
necessary to conduct development of its products. For further
information regarding these and other risks related to
Cytokinetics' business, investors should consult Cytokinetics'
filings with the Securities and Exchange Commission.
Forward-looking statements are not guarantees of future
performance, and Cytokinetics' actual results of operations,
financial condition and liquidity, and the development of the
industry in which it operates, may differ materially from the
forward-looking statements contained in this press release. Any
forward-looking statements that Cytokinetics makes in this press
release speak only as of the date of this press release.
Cytokinetics assumes no obligation to update its forward-looking
statements whether as a result of new information, future events or
otherwise, after the date of this press release.
Contact:
Cytokinetics
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(650) 624-3060
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Apr 2023 to Apr 2024