Origent Data Sciences and Cytokinetics Present Analyses Demonstrating Baseline Data Predict Measures of Vital Capacity in Pat...
December 07 2016 - 7:30AM
Origent Data Sciences, Inc. (Origent) and Cytokinetics, Inc.
(Nasdaq:CYTK) today announced results from the first part of 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. The poster, presented by David L. Ennist, Ph.D., MBA,
Chief Science Officer, Origent Data Sciences and Jinsy A. Andrews,
M.D., Director of Neuromuscular Clinical Trials, Columbia
University, at the 27th International Symposium on ALS/MND in
Dublin, Ireland, 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 slow vital capacity
(SVC) scores of ALS patients using this machine learning technique.
“We are pleased to have completed this
first-ever step toward using machine learning models for
prospectively predicting ALS outcomes and disease progression in
late-phase human clinical trials and look forward to continuing
this important collaboration with Cytokinetics,” said Dave Ennist,
Chief Science Officer, Origent Data Sciences.
“These data bring us one step closer to
prospectively validating the Origent predictive model using
datasets from BENEFIT-ALS and VITALITY-ALS,” said Jinsy Andrews,
M.D., Director of Neuromuscular Clinical Trials, Columbia
University and Medical Monitor for VITALITY-ALS. “We hope that
predictive algorithms arising from this research collaboration may
ultimately accelerate clinical trials in patients with ALS by using
virtual control arms.”
The objective of this phase of the research
collaboration was to develop a model that uses baseline patient
characteristics including the results of a screening visit to
predict SVC at subsequent times using the PRO-ACT (Pooled Resource
Open-Access ALS Clinical Trials) database, a platform that houses
the largest ALS clinical trials dataset. The database was used to
compare three different predictive models with the GBM algorithm
proving to outperform other models in predicting SVC. Using the GBM
model, the researchers demonstrated that 22 baseline
characteristics including FVC could be used to train a model that
predicts SVC at subsequent times. Additionally, the researchers
showed that baseline FVC and SVC were highly correlated measures of
vital capacity. Finally, the data identified and weighted the
predictive value of several variables, demonstrating that FVC at
baseline was the most important predictor of vital capacity at
subsequent times in patients with ALS.
About the Research
Partnership
Funded by Origent’s receipt of a grant from The
ALS Association, this joint research program is designed to enable
the first prospective validation of predictive models 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. 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, Cytokinetics’ completed Phase 2b trial of tirasemtiv,
a 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
data to be 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. Founded in 2013, Origent has become the market leader
in patient-level predictive modeling and has developed a number of
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 muscle troponin 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, subject to an option held
by Astellas Pharma Inc. Cytokinetics is also
collaborating with Astellas to develop CK-2127107, a fast skeletal
muscle activator, for the potential treatment of spinal muscular
atrophy, chronic obstructive pulmonary disease and
ALS. Cytokinetics is collaborating with Amgen
Inc. to develop omecamtiv mecarbil, a novel cardiac
muscle activator, for the potential treatment of heart
failure. 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 http://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
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