|Cytokinetics Halted News Disseminated: Issues Update on BENEFIT-ALS; NeuroMetrix Announces Sleep Indication for SENSUS™|
|By Staff and Wire Reports|
|Monday, 08 July 2013 19:22|
Cytokinetics, Incorporated (Nasdaq: CYTK) announced 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.
NeuroMetrix, Inc. (NASDAQ: NURO), a medical device company focused on the treatment of the neurological complications of diabetes, reported the SENSUS Pain Management System became the first transcutaneous electrical nerve stimulator to receive 510(k) clearance (K130919) from the U.S. FDA for use during sleep.
SENSUS is a convenient and wearable non-invasive device that offers physicians and their patients a non-narcotic pain relief option as a complement to medications. The device is lightweight and can be worn during the day while remaining active. It is the only transcutaneous electrical nerve stimulator designed specifically for people with diabetes and chronic pain. The most common cause of such pain in people with diabetes is painful diabetic neuropathy (PDN), which affects up to 5 million people in the US alone. About half of patients with PDN suffer from sleep disturbances, which can aggravate their diabetes. With this expanded regulatory indication, the device may now be marketed for overnight use.
Under its draft guidance on transcutaneous electrical nerve stimulators for pain relief, the FDA requires that these devices carry a warning against use during sleep, primarily because of electrical hazards following dislodgement of electrodes. SENSUS utilizes a proprietary electrode peeling detection algorithm to address this risk.
“SENSUS is the first and only transcutaneous electrical nerve stimulator that specifically includes use during sleep within its 510(k) indications,” said Shai N. Gozani, M.D., Ph.D., President and Chief Executive Officer of NeuroMetrix. “We believe that growing recognition of the inter-relationship between chronic pain, such as painful diabetic neuropathy, and sleep disturbances is clinically important and represents a unique market position for SENSUS. We will build on this expanded indication by launching a series of novel sleep enabling features for SENSUS over the next 12 months.”
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