Cytokinetics Provides Update on BENEFIT-ALS
(Thomson Reuters ONE) -
South San Francisco, CA, July 8, 2013 - Cytokinetics, Incorporated (Nasdaq:
CYTK) announced today an update on the conduct of BENEFIT-ALS (Blinded
Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv
in ALS). BENEFIT-ALS is a Phase IIb, multinational, double-blind, randomized,
placebo-controlled clinical trial designed to evaluate the safety, tolerability
and potential efficacy of tirasemtiv, a fast skeletal muscle troponin activator,
in patients with amyotrophic lateral sclerosis (ALS).
BENEFIT-ALS is currently designed to enroll up to 500 patients with ALS. To
date, over 450 patients have been enrolled in this study. The primary analysis
of BENEFIT-ALS will compare the mean change from baseline in the ALS Functional
Rating Scale in its revised form, or ALSFRS-R (a clinically validated instrument
designed to measure disease progression and changes in functional status), in
patients receiving tirasemtiv versus those receiving placebo.
Cytokinetics was recently informed by its data management vendor that a
programming error in the electronic data capture system controlling study drug
assignment caused 58 patients initially randomized to and treated with
tirasemtiv to receive placebo instead at a certain study visit and for the
remainder of the study. No patients randomized to placebo were dispensed
incorrect treatment. Cytokinetics and all clinical trial site personnel remain
blinded to the specific patients affected by the error.
Since the error was detected, the company has taken steps to ensure that no
further incorrect study drug assignments have occurred and the programming error
in the electronic data capture system controlling study drug assignment has been
corrected. In addition, the company recently convened an ad hoc meeting of
the study's Data Safety Monitoring Board (DSMB) to assess whether the error in
dispensing study drug had impacted the safety of the 58 affected patients.
After review of the relevant safety data from BENEFIT-ALS, the DSMB reported no
concerns regarding patient safety.
Cytokinetics is in communication with regulatory authorities regarding how best
to respond to the error in drug assignment in order to preserve the intended
scientific value of BENEFIT-ALS. The company continues to enroll patients in
the study under the current protocol and may amend the protocol to allow
increased enrollment. Following further communications with regulatory
authorities, Cytokinetics expects to provide updated guidance relating to the
conduct of BENEFIT-ALS, which may include revisions to the timing of publicly
available results from the study as well as to the projected costs of the
study.
About Cytokinetics
Cytokinetics is a clinical-stage biopharmaceutical company focused on the
discovery and development of novel small molecule therapeutics that modulate
muscle function for the potential treatment of serious diseases and medical
conditions. Cytokinetics' lead drug candidate from its cardiac muscle
contractility program, omecamtiv mecarbil, is in Phase II clinical development
for the potential treatment of heart failure. Amgen Inc. holds an exclusive
license worldwide to develop and commercialize omecamtiv mecarbil and related
compounds, subject to Cytokinetics' specified development and commercialization
participation rights. Cytokinetics is independently developing tirasemtiv, a
fast skeletal muscle activator, as a potential treatment for diseases and
medical conditions associated with neuromuscular dysfunction. Tirasemtiv is
currently the subject of a Phase II clinical trials program and 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 amyotrophic lateral sclerosis, a
debilitating disease of neuromuscular impairment in which treatment with
tirasemtiv produced potentially clinically relevant pharmacodynamic effects in
Phase II trials. Cytokinetics is collaborating with Astellas Pharma Inc. to
develop CK-2127107, a skeletal muscle activator structurally distinct from
tirasemtiv, for non-neuromuscular indications. All of these drug candidates
have arisen from Cytokinetics' muscle biology focused research activities and
are directed towards the cytoskeleton. The cytoskeleton is a complex biological
infrastructure that plays a fundamental role within every human cell. Additional
information about Cytokinetics can be obtained at www.cytokinetics.com.
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' discussions with regulatory authorities and
the outcomes of those discussions; potential amendments to the protocol for
BENEFIT-ALS, including potential changes in enrollment limits; the provision of
further guidance with respect to the timing of publicly available results from
BENEFIT-ALS and the projected costs of the study; the design, enrollment,
conduct and results of BENEFIT-ALS; the effectiveness of steps taken to prevent
further occurrences of incorrect study drug assignment; and the properties and
potential benefits of Cytokinetics' drug candidates. 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: if the
BENEFIT-ALS protocol is amended to increase enrollment, it will result in
increased time to enroll and complete the trial and increased costs to conduct
the trial, and Cytokinetics may not be able to enroll patients in the trial
above the current 500-patient limit until such protocol amendment is
implemented; Cytokinetics anticipates that it will be required to conduct at
least one confirmatory Phase III clinical trial of tirasemtiv in ALS patients
which will require significant additional funding, and it may be unable to
obtain such additional funding on acceptable terms, if at all; potential
difficulties or delays in the development, testing, regulatory approvals for
trial commencement, progression or product sale or manufacturing, or production
of Cytokinetics' drug candidates that could slow or prevent clinical development
or product approval, including risks that current and past results of clinical
trials or preclinical studies may not be indicative of future clinical trials
results, patient enrollment for or conduct of clinical trials may be difficult
or delayed, Cytokinetics' drug candidates may have adverse side effects or
inadequate therapeutic efficacy, the U.S. Food and Drug Administration or
foreign regulatory agencies may delay or limit Cytokinetics' or its partners'
ability to conduct clinical trials, and Cytokinetics may be unable to obtain or
maintain patent or trade secret protection for its intellectual property;
Cytokinetics may incur unanticipated research and development and other costs or
be unable to obtain additional financing necessary to conduct development of its
products; Cytokinetics may be unable to enter into future collaboration
agreements for its drug candidates and programs on acceptable terms, if at all;
standards of care may change, rendering Cytokinetics' drug candidates obsolete;
competitive products or alternative therapies may be developed by others for the
treatment of indications Cytokinetics' drug candidates and potential drug
candidates may target; and risks and uncertainties relating to the timing and
receipt of payments from its partners, including milestones and royalties on
future potential product sales under Cytokinetics' collaboration agreements with
such partners. For further information regarding these and other risks related
to Cytokinetics' business, investors should consult Cytokinetics' most recent
Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission.
Contacts:
Cytokinetics, Incorporated:
Joanna L. Goldstein
Manager, Investor Relations & Corporate Communications
(650) 624-3000
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Cytokinetics, Inc. via Thomson Reuters ONE
[HUG#1714722]
Unternehmensinformation / Kurzprofil:
Datum: 08.07.2013 - 13:30 Uhr
Sprache: Deutsch
News-ID 276247
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