|Cytori has Placed Enrollment in Athena On Hold and Athena II Trials On Clinical Hold; MediciNova Announces Positive Results Of MN-001; Requests A Meeting With FDA|
|By Staff and Wire Reports|
|Tuesday, 05 August 2014 18:48|
Cytori Therapeutics (NASDAQ: CYTX) has placed enrollment in the ATHENA and ATHENA II trials on clinical hold and therefore anticipates that it will not be possible to complete enrollment of the ATHENA I trial prior to the end of 2014 as previously anticipated. The decision to place the trials on hold was based on a safety review of reported cerebrovascular events. Symptoms occurred in three patients, of which two patients' symptoms fully resolved within a short period of time and the third patient has had substantial resolution of symptoms. Such events had not been previously reported in Cytori's other cardiovascular trials and appear to be related in part to the medical co-morbidities in the treated population and the complex nature of the procedures involved in the trial.
The U.S. ATHENA and ATHENA II clinical trials are randomized, double-blind, placebo controlled studies designed to evaluate the safety and feasibility of adipose-derived regenerative cells (ADRCs™) in heart failure patients with ischemic heart disease who are already receiving maximal therapy with no options for revascularization. The procedure involves a fat harvest through small volume liposuction, cardiac catheterization, electromechanical mapping of the heart to determine where to inject ADRCs (or placebo), the actual ADRC (or placebo) injection and related data collection and monitoring activities.
Cytori has been working with the FDA, an independent Data Monitoring Committee (DMC), trial investigators and external expert consultants to fully understand any adverse events and to carefully define adjustments to the protocol intended to minimize risks to patients and to improve the benefit to risk profile of the study.
Adverse events are expected in trials in which participants suffer from advanced cardiac disease and protocol revisions during phase II safety and feasibility studies in compromised populations are common. Cytori is committed to refining the trial protocol as needed, to mitigate risks as much as possible. Updated information regarding enrollment projections will be communicated upon final protocol revisions and agreement amongst the investigators, the DMC and FDA as to the safety and feasibility of continuing the trial as amended.
MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq: MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced positive results from a second preclinical study that examined the potential clinical efficacy of MN-001 for the treatment of advanced NASH (nonalcoholic steatohepatitis with fibrosis).
This study used mice in more advanced stages of NASH as compared to the first study of MN-001 in a NASH mouse model. MN-001 administered orally once daily (10, 30, and 100 mg/kg) for 4 weeks, was evaluated in the STAM™ (NASH-HCC) mouse model of advanced NASH, as measured by histopathology, NAFLD activity score (NAS) and percent of fibrosis.
MN-001 showed anti-NASH and anti-fibrotic effects in the advanced NASH mouse model. NAFLD activity score was significantly reduced in the MN-001 treated group compared to the non-treated group (p<0.001). The reduction was observed consistently in all NAS components including hepatocyte ballooning score (p<0.001), lobular inflammation score (p<0.01), and steatosis score (p<0.05). Percent fibrosis area was also reduced in the MN-001 treated group (p<0.01). In addition, alpha-SMA-positive staining area was significantly reduced in the MN-001 treated group (p<0.001).
Based on these results in addition to the results of the first NASH mouse model study reported on January 14, 2014, MediciNova requested a meeting with FDA to finalize the trial design for a clinical study of MN-001 in NASH patients.
Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS), today announced that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 8,796,337, entitled "Composition and Method For Treating Neurological Disease."
Alder BioPharmaceuticals, Inc. (Nasdaq:ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics for the treatment of migraine, autoimmune and inflammatory diseases, today provided recent corporate highlights and reported its financial results for the second quarter ended June 30, 2014.
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a global provider or spinal fusion technologies, today announced it will present at the 34th Annual Canaccord Genuity Growth Conference on Wednesday, August 13, 2014 at 11:30 AM Eastern Time at the Boston Intercontinental Hotel.
Baxano Surgical, Inc. (Nasdaq:BAXS), a medical device company focused on designing, developing and marketing minimally invasive products to treat degenerative conditions of the spine affecting the lumbar region, today announced its financial results for the second quarter ended June 30, 2014.
Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a global provider of life science research and clinical diagnostic products, today announced financial results for the second quarter ended June 30, 2014.
Cerner Corporation (Nasdaq:CERN) and Siemens AG today announced they signed a definitive agreement for Cerner to acquire the assets of Siemens' health information technology business unit, Siemens Health Services, for $1.3 billion in cash.
Cerulean Pharma Inc. (Nasdaq:CERU), a leader in Dynamic Tumor Targeting™, today announced that it will provide an update on corporate activities for the second quarter of 2014 on August 12, 2014.
ChemoCentryx, Inc., (Nasdaq:CCXI), a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, announced today its financial results for the second quarter ended June 30, 2014.
Corium International, Inc. (Nasdaq:CORI) today announced that it will release third quarter fiscal year 2014 financial results on Tuesday, August 12, 2014 after the close of the U.S. financial markets.
DARA BioSciences, Inc. (NASDAQ: DARA), an oncology supportive care pharmaceutical company dedicated to providing health care professionals a synergistic portfolio of medicines to help cancer patients adhere to their therapy and manage side effects arising from their cancer treatment, today announced that it will release financial results for the second quarter ended June 30, 2014, after the close of the market on Tuesday, August 12, 2014.
Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that John McDermott, Chairman and Chief Executive Officer, is scheduled to present at the Canaccord Genuity 34th Annual Growth Conference in Boston, MA.
Health Insurance Innovations, Inc. (Nasdaq:HIIQ), today announced the appointment of Dirk Montgomery as Executive Vice President and Chief Financial Officer, effective September 2, 2014.
Icon Media Holdings, Inc.(OTC:ICNM), a Raleigh, NC-based technology company, announced today that it has opened its www.MMJ-X.COM website for beta testing and initial user interfacing.
Insulet Corporation (NASDAQ: PODD), the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, and DexCom, Inc (NASDAQ: DXCM), the leader in continuous glucose monitoring ("CGM") technology, today announced their intention to allow information from Dexcom's 5th generation CGM system to be identified, received and displayed on Insulet's new Bluetooth-enabled Personal Diabetes Manager ("PDM"), currently in development.
Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that it will host a conference call and a live webcast discussion at 8:30 a.m. Eastern Time on Tuesday, August 12, 2014, to discuss financial results for the second quarter ended June 30, 2014, and provide a business update.
The Hain Celestial Group, Inc. (Nasdaq:HAIN), a leading organic and natural products company, will conduct a conference call to discuss its 4th quarter and fiscal year 2014 financial results on Wednesday, August 20, 2014 at 8:30 AM Eastern Time.
LifeVantage Corporation (Nasdaq:LFVN) today announced preliminary financial results for the fourth quarter and the full fiscal year ended June 30, 2014.
MacroGenics, Inc. (Nasdaq:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases, today provided a corporate progress update and reported financial results for the quarter ended June 30, 2014.
MannKind Corporation (Nasdaq:MNKD) will release its 2014 second quarter financial results on Monday, August 11, 2014 and its management will host a conference call to discuss the second quarter financial results and other Company developments at 5:00 PM (Eastern Time) on August 11, 2014.
MedAssets (Nasdaq:MDAS) today announced that it will webcast its 2014 Investor Day meeting on Wednesday, August 13, 2014.
Medical Marijuana, Inc. (OTC Pink: MJNA) is pleased to announce that one of its investment portfolio companies, KannaLife Sciences, Inc., a bio-pharmaceutical and phyto-medical company, has been awarded its second license agreement by the National Institutes of Health (NIH) to develop a drug to treat a concussion syndrome called CTE using derivatives from medical marijuana. The license agreement is in effect through February, 2021.
Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it will present at the 34th Annual Canaccord Genuity Growth Conference being held August 13-14, 2014 at the InterContinental Hotel in Boston.
NanoString Technologies, Inc. (Nasdaq:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today reported financial results for the quarter ended June 30, 2014.
National Research Corporation (Nasdaq:NRCIA) (Nasdaq:NRCIB) today announced results for the second quarter of 2014.
NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today that management will participate in the following investor events in August and September 2014:
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, reported financial results for the quarter ended June 30, 2014.
Versartis, Inc. (Nasdaq:VSAR), an endocrine-focused biopharmaceutical company that is developing a novel, long-acting form of recombinant human growth hormone (rhGH), today announced financial results for the second quarter ended June 30, 2014.
Versartis, Inc. (Nasdaq:VSAR), an endocrine-focused biopharmaceutical company that is developing a novel, long-acting form of recombinant human growth hormone (rhGH), today announced that Jeffrey L. Cleland, PhD, Chief Executive Officer, is scheduled to present at the Canaccord Genuity 34th Annual Growth Conference to be held at the InterContinental Boston in Boston, Massachusetts.