CorMedix Announces FDA IND Filing for Neutrolin; Zafgen Completes Enrollment Of Phase 2a Trial Of Beloranib Print
By David Fowler   
Thursday, 25 September 2014 15:05
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 25, 2014.
CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious disease, is pleased to announce an Investigational New Drug application (IND) for Neutrolin® was submitted to the United States Food and Drug Administration (FDA) on Wednesday, September 24, 2014.

The IND includes a pivotal Phase 3 protocol for Neutrolin® in hemodialysis patients with a central venous catheter. The Phase 3 clinical trial is designed as a multi-center, randomized, controlled study conducted in the U.S. and Europe. Dr. Michael Allon, Professor, Department of Medicine, Division of Nephrology, University of Alabama, Birmingham will be the Study Chair of the Neutrolin® Phase 3 program. An IND goes into effect 30 days after FDA receives the IND, unless FDA provides notification that the IND is subject to a clinical hold.

Dr. Antony Pfaffle, Chief Scientific Officer at CorMedix stated, "The filing of our IND is an important incremental step that we believe will lead to the availability of Neutrolin® for patients in the US with central venous catheters. Neutrolin® is being developed to help prevent catheter-related infections and thrombosis. The active anti-infective ingredient in Neutrolin® is taurolidine, which has efficacy against both common and resistant forms of bacteria and fungi. Use of taurolidine has not been associated with the development of microbial resistance in humans."

Randy Milby, CEO of CorMedix would like to thank all the members of the regulatory team, and the scientific advisors who have helped prepare the IND, and wishes to express the company's appreciation to the FDA for its continued guidance in this important regulatory milestone for CorMedix.

Recently CorMedix reported the receipt of a broad label expansion in the entire European Union to include not only hemodialysis catheters, but also catheters used in chemotherapy, total parenteral nutrition and critical care settings. CorMedix is proud to continue to support Neutrolin® development and hopes to gain FDA approval to introduce the product in the US to prevent catheter-related infections and thrombosis.



 
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Zafgen, Inc. (Nasdaq: ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, announced the Company has completed enrollment of ZAF-221, a Phase 2a clinical trial of beloranib in the treatment of hypothalamic injury-associated obesity (HIAO). The objective of the study is to evaluate the efficacy and safety of beloranib in HIAO patients over four weeks of randomized treatment, followed by an optional four-week open-label extension. The trial includes 14 obese patients with radiographically confirmed hypothalamic damage who have been enrolled at four trial centers, two in the United States and two in Australia.

HIAO is most commonly caused by damage incurred during removal of a central nervous system tumor called craniopharyngioma, but can also result from less common types of hypothalamic injury. Craniopharyngioma is a rare form of benign brain tumor that occurs most commonly during childhood and infiltrates near the optic nerve, pituitary gland and hypothalamus. Following surgical resection and radiation treatment, hypothalamic dysfunction results in hyperphagia and significant obesity in approximately 50% of these patients, causing a variety of co-morbid conditions and a deteriorated quality of life.

"The completion of enrollment for the ZAF-221 trial represents an important step forward for both Zafgen and beloranib," said Thomas Hughes, Ph.D., Chief Executive Officer of Zafgen. "ZAF-221 will provide us with a first look in patients with HIAO to determine if beloranib has the potential to be a significant new treatment for patients afflicted with this life altering form of obesity. Zafgen expects to complete this study in the fourth quarter of this year."

The ZAF-221 trial consists of randomized, double-blind, placebo controlled, twice-weekly subcutaneous injections of 1.8 mg beloranib or placebo in 14 obese patients with radiographically confirmed hypothalamic damage. The primary outcome measure is change in body weight from baseline to the end of the randomized dosing period of four weeks. Secondary outcomes include changes in the patient's lipid profile, hs-CRP (a marker of systemic inflammation), sense of hunger, and quality of life.

"Currently, there is no marketed treatment available for hypothalamic injury-associated obesity. Patients often experience uncontrollable hunger, much like patients with Prader-Willi syndrome, which can result in hyperphagia and significant obesity," said Dennis Kim, M.D., Chief Medical Officer of Zafgen. "We have seen the therapeutic benefits of beloranib demonstrated in five clinical trials for multiple obesity-related conditions to date, and look forward to learning more from this study regarding beloranib's prospects as a potential treatment for HIAO patients."

 
 

Also Thursday:



Accelerate Diagnostics, Inc. (Nasdaq:AXDX), an in vitro diagnostics company dedicated to providing solutions for the global challenge of drug resistant organisms, today commended the Obama Administration's actions to combat antibiotic-resistant bacteria, and underscored two areas of critical importance.

AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today announced it will report financial results for its fiscal 2015 first quarter ended August 31, 2014, on Thursday, October 9, 2014, after the close of the U.S. financial markets.

Baxano Surgical, Inc. (Nasdaq:BAXS), a medical device company focused on designing, developing and marketing minimally invasive products to treat degenerative conditions of the lumbar spine, announced that the Company has completed a recent subordinated convertible note financing of approximately $1.5 million to extend its cash runway.

CAS Medical Systems, Inc. (Nasdaq:CASM), a leader in medical devices for non-invasive patient monitoring, today announced that Thomas M. Patton, President and Chief Executive Officer, will be participating in BTIG's Inaugural Emerging Technologies in Healthcare Diagnostics Symposium, to be held September 29 and 30 in New York City.

Celldex Therapeutics, Inc. (Nasdaq:CLDX) today announced the initiation of a pilot study of CDX-301 for the mobilization and transplantation of allogeneic hematopoietic stem cells in patients with hematological malignancies undergoing hematopoietic stem cell transplantation (HSCT).

Ekso Bionics Holdings, Inc. (OTCQB:EKSO), a robotic exoskeleton company, announced today that Nathan Harding, chief executive officer and co-founder, is a keynote speaker at the San Diego Convention Center Exhibit Hall for the American Health Information Management Association's 86th Convention on Monday September 29th, 8:50 am PDT. Health information management and technology professionals, government leaders and healthcare executives will gather in San Diego to address how health information management is transforming the healthcare industry.

Eternity Healthcare Inc. (OTC:ETAH), a medical device and diagnostic company with advanced technologies in Needle-Free Injection system, announced today that it has completed a new design of a Needle-Free Injection device.

Herborium® Group, Inc. (OTC Pink: HBRM), www.Herborium.com, a Botanical Therapeutics® Company and the provider of unique, all botanical, medicinal products  (Botanical Therapeutics®) announced today  that it's unique, all botanical, treatment for acne AcnEase®, has been featured at the BeautyPress Spotlight Event, on September 24th in New York City, as one of only 10 innovative products selected for exhibition at this event.

IPC The Hospitalist Company, Inc. (Nasdaq:IPCM), a leading national hospital medicine and post-acute physician group practice company, announced today that with the acquisition of Midland Hospitalists PLC in Midland it is continuing its investments in the acute and post-acute care marketplace in central Michigan.

Laboratory Corporation of America® Holdings (NYSE:LH) and LipoScience, Inc. (Nasdaq:LPDX), a provider of specialized cardiovascular diagnostic laboratory tests based on nuclear magnetic resonance (NMR) technology, today announced that they entered into a definitive merger agreement under which LabCorp would acquire LipoScience for a purchase price of $5.25 per share in cash, or a transaction value of $85.3 million which represents a total enterprise value of approximately $63 million.

Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative neuropsychiatric therapeutics, today announced that Edward F. Smith, Vice President and Chief Financial Officer of Marinus will present at the 21st Annual BioCentury Newsmakers Conference on Friday, September 26, 2014 at 3:00 p.m. (EDT) at the Millennium Broadway Hotel and Conference Center in New York.

Prosensa Holding N.V. (NASDAQ: RNA) today announced that Hans Schikan, Chief Executive Officer, will present a corporate overview at the NewsMakers in the Biotech Industry Conference on Friday, September 26 at 9:00am EDT and participate in a fireside chat at the Leerink Partners Rare Disease Roundtable at 1:05pm EDT in New York, NY.

Radius Health, Inc. (Nasdaq:RDUS), is a science-driven biopharmaceutical company developing new therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases including hormone responsive cancers, today announced that President and CEO, Robert Ward, will present an update on the Company at the BioCentury NewsMakers in the Biotech Industry Conference on Friday, September 26, 2014 at 2:00 p.m. Eastern Time at the Millennium Broadway Hotel & Conference Center in New York.

SAGE Therapeutics (Nasdaq:SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-threatening, rare central nervous system (CNS) disorders, today announced management will participate in the 2014 Leerink Partners Rare Disease Roundtable on Wednesday, October 1 at Le Parker Meridian Hotel in New York City.

Signal Genetics, Inc. (Nasdaq:SGNL), a commercial stage, molecular diagnostic company focused on providing innovative diagnostic services that help physicians make better-informed decisions concerning the care of their patients suffering from cancer, today announced the extension of its exclusive laboratory services agreements with the University of Arkansas for Medical Sciences (UAMS).

Trinity Biotech plc. (Nasdaq:TRIB), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced it has obtained the CE mark (i.e. European approval) for its Meritas point-of-care BNP test.

uniQure N.V. (Nasdaq:QURE), a leader in human gene therapy, today announced that its management will present at the Leerink Partners Rare Disease Roundtable Conference, October 1st, 2014, to be held at the Le Parker Meridien Hotel, New York City, NY, USA.

Zafgen, Inc. (Nasdaq:ZFGN)
, a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced that the Company has completed enrollment of ZAF-221, a Phase 2a clinical trial of beloranib in the treatment of hypothalamic injury-associated obesity (HIAO).



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