|CorMedix Announces FDA IND Filing for Neutrolin; Zafgen Completes Enrollment Of Phase 2a Trial Of Beloranib|
|By David Fowler|
|Thursday, 25 September 2014 15:05|
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.
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."
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