|FDA Accepts NDA for AstraZeneca's Epanova; Stemcells Announces New Preclinical Data Demonstrating HuCNS-SC(R) Cells|
|By Staff and Wire Reports|
|Wednesday, 18 September 2013 19:23|
AstraZeneca (NYSE: AZN) announced that the US Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for EpanovaTM, an investigational compound for the treatment for patients with severe hypertriglyceridaemia (triglyceride levels greater than or equal to 500mg/dL). The NDA submission for Epanova was filed by Omthera Pharmaceuticals, now a wholly-owned subsidiary of AstraZeneca, as a 505(b)(1) application in July 2013. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA is 5 May 2014.
The US submission included data from pharmacokinetic and Phase III clinical studies to investigate the safety and efficacy profile of Epanova, a coated soft gelatin capsule containing a complex mixture of polyunsaturated free fatty acids derived from fish oils. In 2012, positive results were reported from two Phase III trials (EVOLVE and ESPRIT) examining the effectiveness of Epanova in lowering very high triglycerides, and in reducing non-HDL cholesterol in combination with a statin for patients with high triglycerides. Both trials were conducted under a Special Protocol Assessment with the US FDA.
StemCells, Inc. (Nasdaq: STEM) announced the publication of preclinical data confirming that the Company's proprietary HuCNS-SC cells (purified human neural stem cells) preserve photoreceptor cells and visual function in a widely used model of retinal degeneration. The data show not only that HuCNS-SC cells preserve the number of photoreceptors that would otherwise be lost, but also that the surviving photoreceptors appear healthy and normal, and maintain their synaptic connection to other important cells necessary for visual function. The study was published in Investigative Ophthalmology and Visual Science (IVOS), the journal of the Association for Research in Vision and Ophthalmology, and is available at (http://www.iovs.org/content/early/recent.) These results are highly relevant to disorders of vision loss, the most notable of which is age-related macular degeneration (AMD), which afflicts approximately 30 million people worldwide.
"This study demonstrates that, at the cellular and sub-cellular level, the surviving photoreceptors have all the components that characterize a healthy and normal photoreceptor, and they have the correct synaptic connections," said Nicolas Cuenca, PhD, Professor in the Department of Physiology, Genetics and Microbiology at the University of Alicante, Spain, and lead author of the paper. "The robust anatomical preservation of the photoreceptors and their synaptic connections most likely underlie the preservation of visual function.
"In addition, this study confirmed our preliminary hypothesis that HuCNS-SC cells phagocytose photoreceptor outer segments. The phagocytic activity of the HuCNS-SC cells restores a function normally performed by retinal pigmented epithelial (RPE) cells."
The Company is currently conducting a Phase I/II clinical trial in the dry form of AMD, the most prevalent form of the disease. The preclinical data underlying this Phase I/II clinical trial was previously published in the European Journal of Neuroscience (http://onlinelibrary.wiley.com/doi/10.1111/j.1460-9568.2011.07970.x/abstract). That data demonstrated that HuCNS-SC cells protect host photoreceptors (both rods and cones) and preserve vision in the Royal College of Surgeons (RCS) rat, a well-established animal model of retinal disease that has been used extensively to evaluate potential cellular therapies.
The Company's Phase I/II clinical trial in dry AMD is currently enrolling patients at the Byers Eye Institute at Stanford in Palo Alto, California, and at the Retina Foundation of the Southwest in Dallas, Texas. The Company recently dosed the first high-dose patient in the trial. To date, a total of five patients have been dosed in the 16-patient trial. Patients interested in participating in the clinical trial should contact the Byers Eye Institute at Stanford at (650) 498-4486 or the Retina Foundation of the Southwest at (214) 363-3911. The Company is working to open additional sites in the United States.
Amgen (NASDAQ: AMGN) and Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (HSR), in connection with Amgen's proposed acquisition of Onyx, was terminated early on Sept. 18, 2013, by the United States Federal Trade Commission.
Atossa Genetics, Inc.(NASDAQ: ATOS), The Breast Health Company™, announced today that it has entered into a nationwide distribution agreement with McKesson Medical-Surgical to sell and distribute Atossa's MASCT device and patient collection kits.
The NASDAQ OMX Group, Inc. (Nasdaq:NDAQ) announced today that trading of Benefitfocus, Inc. (Nasdaq:BNFT), a leading provider of cloud–based benefits software solutions, commenced on The NASDAQ Stock Market on Wednesday, September 18, 2013.
Hemispherx Biopharma, Inc. (NYSE MKT:HEB) will hold its Annual Meeting of stockholders on Friday, October 18, 2013, at 10 a.m. EDT, in Philadelphia, PA.
IPC The Hospitalist Company, Inc. (Nasdaq:IPCM), a leading national hospitalist physician group practice company, announced today that it has acquired the hospitalist-related assets of Metropolitan Pulmonary and Hospital Medicine, P.C. (MPHM).
Stanley T. Crooke, Ph.D., M.D., founder, CEO and chairman of the board of directors of Isis Pharmaceuticals, Inc. (NASDAQ: ISIS), has been awarded the 2013 Director of the Year Award for Companies in Transition. Each year the Corporate Directors Forum, a non-profit organization that promotes high standards of professionalism in corporate governance, recognizes directors for their high standards in corporate governance.
KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO) today announced the publication of Phase 1 study results for KB001, a first generation, anti-Pseudomonas aeruginosa (Pa) type III secretion system (TTSS) antibody, for use in patients with cystic fibrosis (CF).
Limitless Venture Group Inc's. (OTC Pink: LVGI) G.E.A.R sports Nutraceuticals subsidiary today announced it has signed a Letter of Intent with Australia's Flush Fitness to carry the entire G.E.A.R. line in both Australia and New Zealand.
MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that it has been selected to Georgia's 2013 Top 100 Public Companies.
Nanosphere, Inc. (NASDAQ: NSPH), a company enhancing medicine through targeted molecular diagnostics, today announced the closing of its previously announced underwritten public offering of 17,250,000 shares of its common stock at a public offering price of $1.75 per share, including 2,250,000 shares of common stock issued pursuant to the underwriters' exercise in full of their over-allotment option.
PLC Systems Inc. (OTCQB: PLCSF), a company focused on innovative medical device technologies, today reported that it has raised $1.75 million in gross proceeds through the sale of 29,166,668 shares of common stock at a purchase price of $0.06 per share and five-year warrants to purchase 29,166,668 shares of common stock at an exercise price of $0.08 per share.
Sunshine Heart, Inc. (Nasdaq:SSH) announced today that it has commenced an underwritten public offering of its common stock pursuant to its effective shelf registration statement previously filed with the U.S. Securities and Exchange Commission (SEC).