FDA Approves Expansion of BIOTRONIK ProMRI® ICD Trial; Anavex Reports New Data Confirms Calcium Over-Expression May Cause Alzheimer's Print E-mail
By Staff and Wire Reports   
Thursday, 22 May 2014 19:05
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 22, 2014.
BIOTRONIK, a leading manufacturer of cardiovascular medical devices, announced today that the Food and Drug Administration (FDA) has approved a significant expansion of its ongoing ProMRI® trial. The approval will allow patients enrolled in Phase C of the trial to receive full-body scans, and for the first time include patients with DX implantable cardioverter defibrillators (ICDs) in the study.

In 2011, BIOTRONIK received CE mark approval and became the first company in the world with an ICD approved for use in a magnetic resonance imaging (MRI) scanner. The ProMRI® study is the next step in making this technology widely available in the U.S.

The unique BIOTRONIK DX ICD system provides physicians with the complete diagnostic capabilities of a dual-chamber ICD, including atrial sensing and advanced proven shock reduction algorithms with only a single lead. BIOTRONIK introduced DX technology in 2013 in the U.S., and it has been quickly adopted by electrophysiologists nationwide. Patients prefer implants with less hardware while physicians benefit from dual-chamber diagnostic data.

“With the DX system, I gain important diagnostic and therapeutic information. For my primary prevention patients with no dual-chamber pacing indication, the implant procedures are straightforward, and it makes sense to use as little hardware as possible,” said Harpreet S. Grewal, M.D., FACC, FHRS, at Richmond Cardiology Associates in Richmond, Virginia. “The potential to provide this therapy and have it approved for use in full-body MRI conditions adds clinical value.”

Phase C of the ProMRI® trial is the final phase in a series of ground-breaking MRI compatibility trials conducted by BIOTRONIK in rapid succession. Phase A and Phase B of the trial evaluated the safety of BIOTRONIK Entovis pacemaker systems during MRI scans. Phase A resulted in FDA approval on May 6, 2014 of Entovis systems for MRI scans with an exclusion zone. Phase B expanded the trial to evaluate the safety of Entovis pacemaker systems for full-body scans, including cardiac and thoracic spinal scans. Phase B is nearing completion and data will soon be submitted to the FDA.

“We are anxiously awaiting the day when this important diagnostic capability, up to now only available to pacemaker patients, can also benefit ICD patients,” said Kevin Mitchell, Vice President, Clinical Studies at BIOTRONIK, Inc. “BIOTRONIK is committed to extending its ProMRI® technology to as many patients as possible. We were the first company to offer ICD patients in the U.S. MRI access, and remain the only company that provides single-chamber pacemaker patients access to this diagnostic tool.”

Every year, about 200,000 patients in the U.S. are implanted with ICDs, and studies estimate that 50-75 percent of them will develop a clinical need for an MRI scan during their lifetime.1,2 MRI scans often provide improved diagnostic capabilities for certain diseases or conditions that cannot be adequately examined by X-ray, computerized tomography (CT) or ultrasound. The strong forces applied during an MRI scan can have a negative effect on both device and patient, and are usually contraindicated for pacemaker and ICD patients. With its ProMRI® technology, BIOTRONIK has developed a solution to enable all cardiac rhythm patients’ access to MRI scanning. ProMRI® technology is already used widely in Europe, including recent CE approval for MR Conditional full-body and 3.0 tesla scans with the Ilesto/Iforia ICD system.

The BIOTRONIK-sponsored trial (NCT01761162) has been in U.S. subject recruitment since March 2013.



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Anavex Life Sciences Corp. (OTCQB:AVXL),
a clinical-stage biopharmaceutical company developing novel drug candidates to treat Alzheimer's disease, other diseases of the central nervous system (CNS) and various types of cancer, welcomes new data published in the current issue of The Journal of Neuroscience that has favorable implications for ANAVEX PLUS, the Company's Alzheimer's disease drug candidate combination.

The scientific findings indicate that too much calcium signaling in neurons may be involved in causing Alzheimer's disease (AD). These calcium alterations can be modulated directly through the inositol triphosphate (IP3) receptor, representing a potential new therapeutic approach to treating AD. The findings indirectly confirm the therapeutic opportunity in Alzheimer's disease for ANAVEX PLUS, an agonist of the sigma-1 receptor (S1R), because the S1R acts as a calcium signaling modulator via IP3.

"Since we know from previous data that the sigma-1 receptor is directly involved in regulating intracellular calcium levels, these recent findings provide further confirmation of the potential for our drug candidate combination ANAVEX PLUS, which increases the expression of the sigma-1 receptor," said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. "These findings also provide added encouragement for the clinical trial of ANAVEX PLUS, which is scheduled to commence in 2014."

The Journal of Neuroscience report confirms that while normal calcium release is important for synaptic transmission and plasticity, too much is toxic. For the first time, by using a genetic approach, the authors showed that exaggerated neuronal calcium signaling can be normalized by decreasing the expression of IP3 protein by 50%. Importantly, this signaling modulation corrected significantly AD-like biochemical, electrophysiological and behavioral impairments observed in two different early and late-stage AD mouse models. The results indicate that the correction of exaggerated calcium signaling rescues the constitutive activation of this transcriptional pathway and dramatically reduces both hippocampal and cortical Amyloid-beta (Abeta) accumulation and hippocampal tau pathology, both hallmarks of AD.

Compelling evidence suggests that the changes in calcium signaling happen in the absence of or precede the appearance of Abeta plaques, indicating that it is an early event that could be a causative trigger of Alzheimer's disease.

According to the newly published report, the enhanced calcium release constitutes a good approximation event in vivo that contributes both to mild cognitive-like impairments and AD-like impairments in the respective animal models. The displayed abnormalities mirror those observed in presymptomatic patients where there is a family link to the disease and in patients suffering from mild cognitive impairment (MCI), a condition that commonly precedes AD.

Therefore, it is possible that environmental influences and genetic susceptibilities that alter calcium signaling play a role in the development of Alzheimer's disease.

The authors conclude that these results suggest that targeting the IP3 signaling pathway could be considered a potential therapeutic strategy for patients harboring mutations linked to AD.



Also Thursday:


Canyon Gold Corp. (OTCQB:CGCCD)
is pleased to announce the acquisition of 100% of the issued and outstanding shares of MARSHALL THOMSEN LTD., a British Columbia corporation entering the cannabis industry as a producer of cannabis products for distribution to the medical community.

Celator Pharmaceuticals, Inc. (Nasdaq:CPXX)
, a pharmaceutical company developing new and more effective therapies to treat cancer, today announced that Scott Jackson, Chief Executive Officer, will present an overview of the company at the Third Annual Marcum MicroCap Conference, New York, NY, on Thursday, May 29, 2014, at 2:00 p.m. EDT.

The Cooper Companies, Inc. (NYSE:COO)
will present at the William Blair 34th Annual Growth Stock Conference in Chicago, Illinois, on June 12, 2014.

EDAP TMS SA (Nasdaq:EDAP)
, the global leader in therapeutic ultrasound, today announced that the U.S. Food and Drug Administration (FDA) Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will review the Pre-Market Approval application for EDAP's Ablatherm-HIFU device for the treatment of localized prostate cancer on July 30, 2014.

Hemp, Inc. (OTC:HEMP)
today announced it has committed $1,000,000 to kick-start the search for an appropriate banking partner in Colorado and to perform due diligence thereof.

K2M Group Holdings, Inc. (Nasdaq:KTWO)
, a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced that the Company intends to release 2014 first quarter financial results after market close on June 4.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX)
announced today that the U.S. Food and Drug Administration has extended the initial Prescription Drug User Fee Act (PDUFA) goal date for its review of the Company's New Drug Application seeking marketing approval of ZerenexTM (ferric citrate) by three months. The new PDUFA goal date is September 7, 2014.

Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK)
today announced it will present clinical data on four novel antibody cancer therapeutics at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting, May 30-June 3, 2014 at McCormick Place in Chicago.

Rockwell Medical, Inc. (Nasdaq:RMTI)
, a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that it will participate at the 11th Annual Craig-Hallum Institutional Investor Conference on Wednesday, May 28, 2014 at the Minneapolis Marriott City Center Hotel, Minneapolis, MN.

Protea Biosciences Group, Inc. (OTCQB:PRGB)
announced that the Depository Trust Corporation (DTC) has approved its common stock for DWAC/FAST transfer through Island Stock Transfer, the Company's transfer agent.

RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL)
, an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage proprietary drugs for the treatment of inflammatory and gastrointestinal diseases and related conditions, today announced that the U.S. Food and Drug Administration has allowed the initiation of the Company's planned Phase III clinical study for the treatment of a new, undisclosed indication with RHB-102, an extended release oral pill formulation of the antiemetic drug ondansetron.

The Spectranetics Corporation (Nasdaq:SPNC)
today announced receipt of CE marking for the TightRail™ Rotating Dilator Sheath platform.

Symmetry Medical Inc. (NYSE:SMA)
, a leading global source of innovative medical device solutions, including surgical instruments, orthopedic implants, and sterilization cases and trays, announced today the sale of its UK based, Clamonta Ltd. subsidiary, which services the Aerospace machining industry, to The HLD Corporation Ltd. for £0.8 million (approximately $1.3 million).

TG Therapeutics, Inc. (Nasdaq:TGTX)
, today announced upcoming presentations of clinical data for TG-1101, the Company's next generation, glycoengineered anti-CD20 monoclonal antibody and for TGR-1202, the Company's novel, once-daily PI3k delta inhibitor, at the 19th Congress of the European Hematology Association (EHA), being held June 12 – 15, 2014 in Milan, Italy.

ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP)
, a biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced today results demonstrating the potent anti-tumor and anti-cancer stem cell (CTC) effects of Ad-RTS-IL-12 in a glioma (brain cancer) model, and in other preclinical and clinical settings.



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