Cytokinetics Halted News Disseminated: Issues Update on BENEFIT-ALS; NeuroMetrix Announces Sleep Indication for SENSUS™ Print E-mail
By Staff and Wire Reports   
Monday, 08 July 2013 19:22
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 8, 2013.

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.”

Also Monday:

Stacy London, style expert and co-host of TLC’s “What Not to Wear,” today announced her partnership with AbbVie (NYSE:ABBV) on a new psoriasis campaign called Uncover Your Confidence.

Amarin Corporation plc (Nasdaq:AMRN) today announced that it is offering to sell 21,700,000 American Depositary Shares ("ADSs") in an underwritten public offering.

Anavex Life Sciences Corp. (OTCQB: AVXL) today announced the closing of $2.6-million in a private placement financing and conversion of liabilities and an agreement with institutional investor Lincoln Park Capital Fund, LLC ("Lincoln Park Capital") for a funding commitment of up to $10-million with an initial investment of $100,000.  

Arch Therapeutics, Inc. (OTCQB: ARTH), a life science company and developer of AC5™, a novel product aimed at controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care, is pleased to appoint Mr. Alan Barber as CFO and Mr. William M. Cotter as COO.

Assisted Living Concepts, Inc. (NYSE: ALC) today announced that substantially all state licenses to operate its assisted living facilities have been obtained by Aid Holdings, LLC ("Parent") in connection with the previously announced Agreement and Plan of Merger (the "Merger Agreement") dated as of February 25, 2013 among Parent, Aid Merger Sub, LLC ("Merger Sub") and ALC. Parent and Merger Sub are affiliates of TPG Capital, L.P.

DelMar Pharmaceuticals, Inc. (OTCQB: DMPI)
today announced that the Chinese Bureau of Foreign Experts has approved the application for a grant to Guangxi Wuzhou Pharmaceutical Company to support DelMar Pharma's collaboration with Guangxi Wuzhou Pharmaceutical Company, a subsidiary of publicly traded Guangxi Wuzhou Zhongheng Group Co., Ltd (SHG 600252).

GenScript, the world's largest provider of synthetic genes, has aided a leading biopharmaceutical company, Novavax, Inc. (NASDAQ: NVAX), in developing an avian influenza A/H7N9 vaccine candidate, by synthesizing three constructs containing genes that encode for key vaccine proteins in just 6 business days.

Insmed Incorporated (NASDAQ: INSM), a biopharmaceutical company focused on developing and commercializing an inhaled anti-infective to treat patients battling serious lung diseases that are often life-threatening, today announced that Will Lewis, President and Chief Executive Officer of Insmed, will be presenting a corporate overview at the 8th Annual JMP Securities Healthcare Conference on Wednesday, July 10th at 11:00 a.m. Eastern time at The St. Regis New York.

La Jolla Pharmaceutical Company (OTCBB: LJPC)
, a leader in the development of therapeutics targeting galectin proteins, announced today that the first patient was dosed in a randomized, single blind, Phase 2 clinical trial of GCS-100 for chronic kidney disease (CKD).

Luminex Corporation (Nasdaq: LMNX) today announced that it expects to report results for the second quarter of 2013 on Monday, July 29, 2013 after the close of trading.

MAKO Surgical Corp. (Nasdaq:MAKO), a medical device company that markets its RIO® Robotic Arm Interactive Orthopedic surgical platform, MAKOplasty® joint specific applications and proprietary RESTORIS® implants that together enable orthopedic surgeons to consistently, reproducibly and precisely treat patient specific osteoarthritic disease, today announced that Scott D. Flora and Jonathan T. "Jack" Lord, M.D. have joined the Company's Board of Directors.

Masimo (NASDAQ: MASI) announced today that the Joint Commission has issued a National Patient Safety Goal on Alarm Management to improve the safety of clinical alarm systems, requiring hospital leaders to establish alarm safety as a hospital priority and take specific actions to help avoid patient injuries and deaths related to alarms.

NeoMedigen Limited, a public company traded on the Bermuda Stock Exchange Main Board under Ticker Symbol NEOM:BH (BERMUDA: NEOM) announced today advancements in its bio-molecular technology and their relevance to obesity and aging skin.

Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP), a developer of oral drug delivery systems, announced today that the first patient has been enrolled in a Phase 2a trial of ORMD-0801, an orally ingestible insulin capsule, on patients with type 2 diabetes.

Predixion Software, a developer of collaborative predictive analytics solutions, announced today it has raised $20 million in Series C financing. Predixion's Series C includes two new strategic investors, Accenture (NYSE: ACN) and GE Ventures.

The President and CEO of SmartMetric, Inc. (OTCQB: SMME), Ms. Chaya Hendrick, said today that SmartMetric will be releasing for sale direct to the public using national syndicated radio.

Tauriga Sciences, Inc. (OTCQB:TAUG)
, a diversified life sciences company focused on proprietary biotherapeutics and diagnostics, novel medical devices and consumer healthcare businesses, has today announced that the Company anticipates that final packaged bamboo-based medical products will be available for commercial sale prior to the quarter's end.

Wound Management Technologies, Inc. (OTCQB: WNDM)
announced it has entered into a distribution agreement with Academy Medical, LLC, a veteran-owned distributor of medical products, to sell its CellerateRX line of products to the VA facilities across the country.

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

Add this page to your favorite Social Bookmarking websites
Digg! Reddit!! Mixx! Google! Live! Facebook! Technorati! StumbleUpon! MySpace! Yahoo!

blog comments powered by Disqus