|Boston Scientific Says Lotus Meets Co-Primary Endpoints; Sangamo Presents Positive Data from Alzheimer's Disease Treatment|
|By Staff and Wire Reports|
|Friday, 15 November 2013 20:37|
Marking a major step forward in the evolution of Transcatheter Aortic Valve Implantation (TAVI) technology, the first two commercial implants of the Boston Scientific (NYSE: BSX) Lotus™ Valve System have taken place in a German hospital. Prof. Dr. med. Gerhard Schuler and Prof. Dr. med. Axel Linke, both considered TAVI pioneers, led the procedures at the Heart Center - University Hospital Leipzig, Germany. CE Mark approval for the Lotus Valve System was announced October 28, 2013 at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco.
The Lotus Valve System offers a unique and effective alternative treatment for patients with severe aortic stenosis at high risk of surgical valve replacement. It is a next-generation transcatheter aortic valve implantation (TAVI) device designed to give physicians total control throughout the TAVI procedure. The Lotus Valve is comprised of bovine pericardium and a nitinol frame with a central marker to aid in precise positioning. It features a novel Adaptive Seal™ technology to help minimize aortic regurgitation (leaking), a proven predictor of mortality. It is also the first device of its kind that can be fully retrieved, redeployed, or repositioned, including after full valve deployment and prior to release.
"The Lotus Valve System permits very precise positioning of the device and the Adaptive Seal minimizes potential paravalvular leakage," said Professor Schuler. "These are the key differentiating features of this new technology."
Primary endpoint data from the REPRISE II clinical trial were presented at TCT by Prof. Ian Meredith, principal investigator and director of MonashHeart at Monash Medical Centre, Melbourne, Australia. The data demonstrated that the Lotus Valve System was successfully implanted and correctly positioned in all 120 patients, and met the co-primary endpoints of mean aortic valve pressure gradient and all-cause mortality at 30 days. The valve produced impressive clinical results, with no valve malpositioning, migration, or severe embolization, low clinical event rates that were consistent with those reported for other valves, and negligible paravalvular aortic regurgitation at 30 days.
The Lotus Valve System comes pre-attached on a transfemoral delivery system and is inserted into the body through a small incision in the leg. Once delivered across the diseased aortic valve, the Lotus Valve System is deployed through a controlled mechanical expansion that is distinct from balloon-expandable or self-expanding valves.
"The controlled mechanical expansion and early functioning of the valve facilitate precise positioning on the first attempt, and the ability to fully or partially recapture the valve, if necessary, provides additional assurance that the valve will be ideally positioned at the end of the procedure," said Dr. Linke.
The Lotus Valve System is available at select centers in Europe with commercial site expansion accelerating as physicians and centers become fully trained. The valve is available in a 23mm and 27mm size, treating patients with aortic annulus sizes from 20mm to 27mm. The Lotus Valve System is an investigational device in the United States and Japan and is not available for sale in these countries.
"Completing our first commercial implants marks a key step forward in offering an advanced new technology in Europe. The Lotus Valve System has been designed to give the physician increased control during implantation and to help provide a more precise, predictable procedure," said Tom Fleming, vice president and general manager, Structural Heart, Boston Scientific. "We believe the Lotus Valve is an important treatment alternative for severe aortic valve disease patients at high risk for surgical valve replacement." To view and download an image of the Lotus Valve System, click here.
Sangamo BioSciences, Inc. (NASDAQ: SGMO) announced today the presentation of positive data from the Phase 1 clinical trial of CERE-110 (AAV-NGF), a gene therapy approach designed to deliver nerve growth factor (NGF) for the treatment of Alzheimer's disease (AD). This novel product was developed by Ceregene, Inc., which was recently acquired by Sangamo. The data were presented at the Sixth Clinical Trials on Alzheimer's Disease (CTAD) Meeting, which is being held in San Diego from November 14-16, 2013.
The data from this dose escalation study demonstrate that surgical delivery of CERE-110 to the brain results in the long-term expression of bioactive NGF, the therapeutic protein. Clinicians also observed apparent stabilization of brain cell metabolic activity in treated subjects, as determined by PET-scans measuring glucose use, which may reflect a slowing of cell deterioration. The treatment was well-tolerated at all dose levels.
"These early clinical data demonstrate that this therapeutic approach is feasible, well-tolerated and results in appropriate delivery of the therapeutic, NGF protein, to the intended target cells in the brain," said Paul Aisen, M.D., Project Director of the ongoing Phase 2 clinical trial of CERE-110 and director of the Alzheimer's Disease Cooperative Study (ADCS) at the University of California San Diego, a preeminent research consortium for testing new treatments for Alzheimer's disease. "We are very pleased to be involved in the Phase 2 clinical trial, which is a placebo-controlled study, and will enable further evaluation of the efficacy of CERE-110. Alzheimer's disease has few effective treatment options, and this therapy could help the over five million people in the U.S. currently living with the disease."
The Phase 2 clinical study of CERE-110 is being carried out in collaboration with the ADCS and is funded by a grant from the National Institute on Aging (NIA), part of the National Institutes of Health (NIH).
"We are very encouraged by the Phase 1 data from the CERE-110 study," stated Edward Lanphier, Sangamo's president and CEO. "These positive data supported the further testing of this novel approach in a Phase 2 clinical trial to evaluate efficacy. The Phase 2 study is fully-funded and fully-enrolled and currently in the two year follow-up phase. We look forward to presenting data from the clinical trial in 2015."
The data, which have been accepted for publication in Alzheimer's and Dementia, the official publication of The Alzheimer's Association (Rafii et al., 2013), were presented by Raymond Bartus, Ph.D., who led the preclinical and early clinical development of CERE-110.
It is well-documented that cholinergic nerve cells in the brain degenerate early in AD and are linked to initial memory loss and cognitive decline. Current therapies for AD include a class of small molecule drugs called cholinesterase inhibitors, which aim to preserve or enhance the chemical signaling in cholinergic nerves. However, these drugs have dose-limiting side-effects, do not change the underlying disease process or its progression, are effective for some but not all people, and may help only for a limited time.
Research in animal models suggests that growth factors, such as NGF, which promote nerve growth, nerve repair and protect nerves against damage, may improve AD symptoms and slow disease progression. However, delivery of proteins to the appropriate part of the brain, in a manner that enables them to have a therapeutic effect, has proved challenging due to the blood brain barrier. Gene therapy with AAV, combined with stereotactic surgery, enables delivery of the gene encoding a biologically active protein such as NGF to a precise location in the brain. The nucleus basalis of Meynert (NBM), a structure near the base of the brain, is considered to be the best target for delivery of a gene-based therapeutic for AD as its cells represent the primary source of cholinergic nerves projecting to the brain cortex. Thus, a single treatment of CERE-110 into this structure is expected to provide a safe long-term source of NGF protein that may protect and preserve cholinergic cells in the brains of AD patients and potentially slow disease progression.
Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of patient-specific, expanded multicellular therapies for the treatment of severe, chronic cardiovascular diseases, announced today that on November 14, 2013, the Company was notified that it has regained compliance with the NASDAQ Capital Market and its minimum market value of listed securities requirement.
Adherex Technologies Inc. (TSX:AHX) (OTCQB:ADHXF) today reported its financial results and recent developments for the third quarter ended September 30, 2013.
Adherex Technologies Inc. (TSX:AHX) (OTCQB:ADHXF) announced today that it intends to complete a non-brokered private placement (the "Offering") of 4,000,000 units for gross proceeds of US$1,600,000.
Advanced Medical Isotope Corporation (OTCBB:ADMD), a company engaged in the development, production and distribution of medical isotopes, today announced that the Company will host a teleconference to discuss its Third Quarter 2013 financial results and to provide a general business update on November 18, 2013.
AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG), a specialty pharmaceutical company, announced today that Frank Thomas, AMAG's chief operating officer, will present at the Jefferies 2013 Global Healthcare Conference in London on Thursday, November 21, 2013 at 8:00 a.m. GMT.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today that the French National Agency for Medicines and Health Products Safety (ANSM) has granted an Autorisation Temporaire d'Utilisation de cohorte (ATU cohort), or Temporary Authorization for Use, for patient sales of Vimizim for the treatment of Morquio A Syndrome.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today the U.S. Food and Drug Administration (FDA) posted briefing materials for the November 19, 2013 Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to review the Vimizim™ (elosulfase alfa) Biologics License Application (BLA).
First Choice Healthcare Solutions, Inc.(OTCQB: FCHS), a diversified holding company focused on delivering clinically superior, patient-centric, multi-specialty care through state-of-the-art medical centers of excellence, today announced its third quarter results for the three and nine months ended September 30, 2013.
Fuse Science, Inc. (OTCQB: DROP) announced today further advancements of its technology partnership with Macular Health, LLC.
Hyperion Therapeutics (Nasdaq:HPTX) announced today that the company is scheduled to present at the Jefferies 2013 London Healthcare Conference on Wednesday, November 20 at 9:20 a.m. GMT.
IsoRay, Inc. (NYSE MKT: ISR) (NYSE Amex: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications for the treatment of cancers of the brain, lung, head and neck, prostate and gynecological, announced its financial results for the quarter ended September 30, 2013.
MMRGlobal, Inc. (OTCQB: MMRF) CEO Robert H. Lorsch was interviewed November 14th on Clear Channel's business talk radio show The Traders Network hosted by Michael Yorba.
OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that it has started a multi-center Phase 1b clinical trial of its first-in-class Wnt-pathway-targeting antibody vantictumab (OMP-18R5) with docetaxel in non-small cell lung cancer (NSCLC).
Prosensa Holding N.V. (NASDAQ: RNA) the Dutch biopharmaceutical company focusing on rare diseases with a high unmet medical need, has been awarded Best Biotech Pipeline 2013 in the Rare & Orphan Advocacy and Research (ROAR) Awards.
Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) announced today that it has priced its previously announced offering of 5.625% senior unsecured notes due 2021 (the "Notes").
Vision-Sciences, Inc. (Nasdaq:VSCI) announced today that Howard Zauberman, Interim Chief Executive Officer and Keith Darragh, VP Finance, will host one-on-one meetings at the Brean Capital 2013 Life Sciences Summit on November 25, 2013.
Larry Oakley, founder of WallStreetCorner.com, selected NovaBay Pharmaceuticals, Inc. (NYSE MKT: NBY) as his featured stock pick on November 12, 2013.