Cytokinetics Provides Additional Update and Revised Guidance For BENEFIT-ALS
(Thomson Reuters ONE) -
Protocol Amended to Preserve the Intended Scientific Value of the Clinical Trial
Patient Enrollment Expected to Conclude in 2013 and Results Expected in Early
2014
South San Francisco, CA, July 23, 2013 -Cytokinetics, Incorporated (Nasdaq:
CYTK) announced today an amendment to the protocol for 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). 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 recently announced that it had been 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. Following detection of
the error, the company took steps to ensure that no further incorrect study drug
assignments occurred and to correct the programming error in the electronic data
capture system controlling study drug assignment. In addition, the company
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.
Following interactions with regulatory authorities, Cytokinetics amended the
protocol for BENEFIT-ALS to enable increased enrollment to approximately 680
patients and to update the statistical methods section, in both cases with the
objective to maintain the originally intended statistical power of the trial.
To date, over 500 patients have been enrolled in BENEFIT-ALS. Enrollment is
expected to continue as the new protocol amendment becomes effective at
participating investigative centers. The company now expects to complete
patient enrollment in BENEFIT-ALS during the second half of 2013, with results
to be available in early 2014. These changes to BENEFIT-ALS are expected to
increase the direct clinical trial costs by approximately $5 million in 2013 and
2014.
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
earlier Phase IIa 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 the objectives of the protocol amendment for BENEFIT-ALS
to maintain the originally intended statistical power and preserve the intended
scientific value of the trial; the design, enrollment, conduct and results of
BENEFIT-ALS; the expected timing for the completion of enrollment and
availability of results from BENEFIT-ALS; the expected additional costs to
conduct 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: Cytokinetics
may not be able to enroll additional patients in BENEFIT-ALS until the 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#1717981]
Unternehmensinformation / Kurzprofil:
Datum: 23.07.2013 - 13:30 Uhr
Sprache: Deutsch
News-ID 280934
Anzahl Zeichen: 9950
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Business News
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"Cytokinetics Provides Additional Update and Revised Guidance For BENEFIT-ALS"
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