Origent Data Sciences and Cytokinetics Advance Collaboration Intended to Validate Predictive Analytics Model in ALS
23 March 2017 - 10:30PM
Origent Data Sciences, Inc. (Origent) and Cytokinetics, Inc.
(Nasdaq:CYTK) today announced the advancement of their research
collaboration to prospectively validate Origent’s computer model to
predict the course of ALS (amyotrophic lateral sclerosis) disease
progression using data from VITALITY-ALS, Cytokinetics’ ongoing
Phase 3 clinical trial of tirasemtiv. Funded by a grant from The
ALS Association to Origent, this joint research program is designed
to enable the first prospective validation of the predictive model
in a clinical trial. Previously, the Origent models predicting both
function and survival of ALS patients have been validated using the
placebo arms of retrospective clinical trial datasets.
Because ALS disease progression is heterogeneous
among patients, predicting an individual patient’s course is
difficult. This heterogeneity creates challenges for the design and
conduct of clinical trials as inclusion of patients who progress at
variable and unpredictable rates requires larger, longer and more
expensive trials in order to observe a potential treatment effect
of a therapeutic intervention. Origent’s statistical models are
designed to identify the patients whose symptoms are likely to
progress quickly or slowly, potentially providing a methodology to
address the complexity created by disease heterogeneity. Results
from the first part of the research collaboration were presented at
the 27th International Symposium on ALS/MND and showed that the
Gradient Boosting Machine (GBM) algorithm was the optimal model to
predict slow vital capacity (SVC) at times subsequent to baseline
and that forced vital capacity (FVC) records could be used to
predict SVC scores of ALS patients using this machine learning
technique.
“Following the successful completion of the
retrospective validation of our predictive models using baseline
characteristics data from BENEFIT-ALS, the Phase 2 b trial of
tirasemtiv, we look forward to taking this research collaboration
to the next level and thank Cytokinetics for providing us access to
the first real-time dataset for the prospective analysis of
patients with ALS, ” said Dave Ennist, Chief Science Officer,
Origent Data Sciences.
“The predictive power of the Origent computer
model is encouraging, particularly the ability to predict slow
vital capacity subsequent to baseline, as demonstrated in the first
phase of the research,” said Jinsy Andrews, M.D., Director of
Neuromuscular Clinical Trials at Columbia University and Medical
Monitor for VITALITY-ALS. “We are pleased to continue this
groundbreaking collaboration which we hope may pave the way towards
increased efficiencies in the conduct of clinical trials in
patients with ALS.”
About the Research
Collaboration
Origent will seek to prospectively validate
existing predictive models (including the ALSFRS-R, respiratory,
gross, fine, and bulbar sub-scores, SVC and survival models) using
baseline characteristics data from VITALITY-ALS, the ongoing Phase
3 clinical trial to assess the effects of tirasemtiv versus placebo
on SVC and other measures of skeletal muscle strength in patients
with ALS. Tirasemtiv is a fast skeletal troponin activator (FSTA)
being developed by Cytokinetics for the potential treatment of
patients with ALS. Using existing models in Origent's library,
predictions will be made for each patient using only screening and
baseline information from the placebo arm of the trial. Screening
and baseline data of placebo patients will be provided following
database lock and predictions will be made in the absence of access
to the subsequent outcomes of the patients from the placebo arm of
VITALITY-ALS. After the predictions are complete, clinical outcomes
data from patients in the placebo arm of VITALITY-ALS will be made
accessible to Origent for comparing actual placebo outcomes data to
the previously escrowed predictions.
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 patient 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 troponin activator (FSTA). Tirasemtiv is the
subject of VITALITY-ALS, an international Phase 3 clinical trial in
patients with 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. Cytokinetics is preparing for the
potential commercialization of tirasemtiv in North America and
Europe and has granted an option to Astellas for development and
commercialization in other countries. Cytokinetics is collaborating
with Astellas to develop CK-2127107, a next-generation fast
skeletal muscle activator. CK-2127107 is the subject of two ongoing
Phase 2 clinical trials enrolling patients with spinal muscular
atrophy and chronic obstructive pulmonary disease. Cytokinetics is
collaborating with Amgen Inc. to develop omecamtiv mecarbil, a
novel cardiac muscle activator. Omecamtiv mecarbil is the
subject of GALACTIC-HF, an international Phase 3 clinical trial in
patients with heart failure. Amgen holds an exclusive worldwide
license to develop and commercialize omecamtiv mecarbil with a
sublicense held by Servier for commercialization in Europe and
certain other countries. Astellas holds an exclusive worldwide
license to develop and commercialize CK-2127107. Licenses held by
Amgen and Astellas are subject to Cytokinetics' specified
co-development and co-commercialization 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
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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.
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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
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