NEW PROVIDENCE, N.J. & DSSELDORF, Germany--(BUSINESS WIRE)--
Edge Therapeutics announced today positive preliminary results from the first human use of EG-1962, the Companys novel bioabsorbable nimodipine microparticle formulation for the prevention of delayed cerebral ischemia (DCI), a life-threatening complication of subarachnoid hemorrhage (SAH), typically resulting from a ruptured brain aneurysm or traumatic brain injury. There are approximately 90,000 patients in North America and Europe who are at risk for DCI, most of whom would be candidates for EG-1962.
Researchers at Heinrich-Heine-University Hospital in Dsseldorf, Germany conducted an open-label study to assess the safety and tolerability of EG-1962, which delivers therapeutic and sustained concentrations of nimodipine directly to the site of brain injury. Eleven patients were treated and 10 met pre-defined enrollment criteria, which included a low level of consciousness on admission to the emergency room and high hemorrhage volumes. Investigators found that there were no adverse events or other safety concerns related to EG-1962. Additionally, good clinical outcome, as measured by the Glasgow Outcome Scale (GOS) 30 days after SAH, was observed in all 10 patients who met the enrollment criteria. Based on similar patients treated in past clinical studies, researchers would have expected approximately half of these patients to suffer a poor outcome, such as death, persistent vegetative state or severe disability. An oral presentation of these data is scheduled during Vasospasm 2013, the 12th International Conference on Neurovascular Events after Subarachnoid Hemorrhage, on Fri., July 12, 2013 in Lucerne, Switzerland.
Our early clinical experience shows that one-time administration of EG-1962 has the potential to prevent a major cause of death or permanent disability after SAH, said Daniel Hnggi, M.D., principal investigator of the study and Vice Chairman of the Department of Neurosurgery at Heinrich-Heine-University. We are eager to participate in further research to investigate this promising and potentially life-saving therapy in our new investigator-initiated study under the auspices of the Bundesinstitut fr Arzneimittel und Medizinprodukte (BfArM, the German Institute for Drugs and Medical Devices).
The early clinical results and lack of side-effects with EG-1962 are striking, noted R. Loch Macdonald, M.D., Ph.D., Head of the Division of Neurosurgery and Keenan Endowed chair in Surgery at St. Michaels Hospital in Toronto, Ontario, Canada, and Chief Scientific Officer of Edge Therapeutics. Given these positive early results, EG-1962 may provide physicians with a powerful tool to reduce the risk of poor outcomes that threaten these already vulnerable patients.
Nimodipine is the standard of care for the prevention of DCI worldwide. However, many researchers believe currently approved oral and intravenous formulations of nimodipine deliver sub-optimal concentrations to the site of brain injury and have shown only modest efficacy in reducing poor outcomes after aneurysmal SAH. Previous efforts to administer higher doses of nimodipine have been limited by serious side effects such as hypotension.
Despite efforts to prevent DCI, many patients continue to suffer a secondary stroke or even death 3 to 14 days after their hemorrhage, said Brian Leuthner, President and CEO of Edge Therapeutics. The average age of patients who develop DCI is 50 years old and their complications are often catastrophic. There have been no approved therapies for DCI in almost 25 years, and we are hopeful that EG-1962 might one day become a new treatment option for these patients.
Edge announced earlier this month that the U.S. Food and Drug Administration (FDA) has accepted the Companys Investigational New Drug (IND) application for EG-1962. The opening of the lND will allow the company to begin enrolling patients in a Phase 1/2 clinical trial evaluating the safety and tolerability of EG-1962 for prevention of DCI. The multinational Phase 1/2 trial, expected to commence in the third quarter of 2013, is to be conducted separately from the Heinrich-Heine-University investigator-initiated study, and will include up to 96 patients in approximately 20 centers in North America and Europe.
About Delayed Cerebral Ischemia
Delayed cerebral ischemia (DCI) is a delayed, life-threatening neurological condition that occurs as a result of SAH, which is most commonly caused by aneurysmal SAH or traumatic brain injury (TBI). DCI is a major cause of death and disability in patients who are treated in the hospital for SAH.1,2,3 According to the World Health Organization and the International Brain Injury Association, at least two million people each year suffer conditions that put them at risk for DCI. DCI commonly affects the working population (average age 50 years old) and occurs in approximately one-third of patients during the first two weeks after SAH, often resulting in substantial disability or death.1
- Hyperbaric Chamber Therapy Brain Injury - May 7th, 2011 [May 7th, 2011]
- Treatment for Traumatic Brain Injury - May 9th, 2011 [May 9th, 2011]
- Atlanta Traumatic Brain Injury Treatment Emory - May 11th, 2011 [May 11th, 2011]
- Hyperbaric Oxygen Therapy Brain Injury Part 2 (Tbi) - May 20th, 2011 [May 20th, 2011]
- Mark, anoxi brain injury, physical therapy after stem cell treatment - May 21st, 2011 [May 21st, 2011]
- Hyperbaric Oxygen Therapy - May 21st, 2011 [May 21st, 2011]
- Bob Hahn Traumatic Brain Injury Recovery - May 23rd, 2011 [May 23rd, 2011]
- Mark, anoxi brain injury, after stem cell treatment at Tiantan Puhua Hospital Beijing - May 24th, 2011 [May 24th, 2011]
- New Beginnings community center for brain injury rehabilitation - May 30th, 2011 [May 30th, 2011]
- Traumatic Brain Injury - Part 1 - Dr. Robert Kohn, Neurologist - June 2nd, 2011 [June 2nd, 2011]
- Am I Brain Damaged? from traumatic brain injury - June 3rd, 2011 [June 3rd, 2011]
- SLI Wellness Center for Brain Injury Rehabilitation - June 11th, 2011 [June 11th, 2011]
- Update on Libya, Radiation in Japan, Tramatic Brain Injury treatment and more, 03/23/2011 - June 12th, 2011 [June 12th, 2011]
- Origami Brain Injury Rehabilitation Center - Finding Your Path - June 12th, 2011 [June 12th, 2011]
- Traumatic Brain Injury - Part 5 - Doctor Kohn, Chicago Neurologist - June 16th, 2011 [June 16th, 2011]
- The struggle to treat traumatic brain injury - June 17th, 2011 [June 17th, 2011]
- Traumatic Brain Injury Survivor Speaks about ProTECT trial at UC Health University Hospital - June 17th, 2011 [June 17th, 2011]
- Stem cell treatment for Brain Injury of Adrian - June 23rd, 2011 [June 23rd, 2011]
- Division of Vocational Rehabilitation Services for Traumatic Brain Injury (TBI) - June 24th, 2011 [June 24th, 2011]
- Hyperbaric Chamber Treatment Stroke and Traumatic Brain Injury TBI - July 4th, 2011 [July 4th, 2011]
- Traumatic Brain Injury - Part 2 - Dr. Robert Kohn, Neurologist - July 6th, 2011 [July 6th, 2011]
- Traumatic Brain Injury - Part 7 - Doctor Kohn, MD, Neurology, Neuropsychiatry - July 14th, 2011 [July 14th, 2011]
- Neurofeedback Training and Treatment at Healing Unleashed in Denver Colorado - July 15th, 2011 [July 15th, 2011]
- Alexis Verzal takes independent steps - July 18th, 2011 [July 18th, 2011]
- The New WalkAide System: Advanced Functional Electrical Stimulation (FES) for Treatment of Foot Drop - July 18th, 2011 [July 18th, 2011]
- Doctors Cool Newborn to Limit Brain Damage - July 19th, 2011 [July 19th, 2011]
- Traumatic Brain Injury - Part 6 - by Neurologist, Dr. Robert Kohn - July 24th, 2011 [July 24th, 2011]
- Brain injury and trauma treatment by homeopathy - July 31st, 2011 [July 31st, 2011]
- Traumatic Brain Injury - Part 4 - Dr. Kohn, Neuropsychiatrist / Neurologist - August 9th, 2011 [August 9th, 2011]
- Preserving Hope, Predicting Health - August 17th, 2011 [August 17th, 2011]
- Sask Brain Injury Association - August 19th, 2011 [August 19th, 2011]
- Cognition and Mild Head Injury by Dr. Muriel Lezak - August 21st, 2011 [August 21st, 2011]
- Brain injury_Shawna_ USA_before stem cell treatment 1.wmv - August 25th, 2011 [August 25th, 2011]
- Origami Brain Injury Rehabilitation Center - Recovery is a Journey - August 26th, 2011 [August 26th, 2011]
- Different types of Concussions by Dr. James Chesnutt.mov - August 30th, 2011 [August 30th, 2011]
- Brain injury_Shawna_ USA_after stem cell treatment 1.wmv - September 11th, 2011 [September 11th, 2011]
- With Brain Injuries, Soldiers Face A Battle For Care - September 23rd, 2011 [September 23rd, 2011]
- Tripler Medical Center Treats Traumatic Brain Injury (TBI) - September 24th, 2011 [September 24th, 2011]
- Sessions' Traumatic Brain Injury Amendment to DOD Appropriations - October 2nd, 2011 [October 2nd, 2011]
- Using Stem Cells for Treatment of TBI | Dr. Charles Cox | Research Trials - October 5th, 2011 [October 5th, 2011]
- Healing brain injuries - October 8th, 2011 [October 8th, 2011]
- Veterans Services at Origami Brain Injury Rehabilitation Center - - October 8th, 2011 [October 8th, 2011]
- Hope Beyond Trauma - October 9th, 2011 [October 9th, 2011]
- Traumatic Brain Injury - Part 3 - by Neurologist Dr. Robert Kohn - October 10th, 2011 [October 10th, 2011]
- Understanding and Improving Vocational Outcomes following Traumatic Brain Injury - Video - October 16th, 2011 [October 16th, 2011]
- LI facility dedicated to Terri Schiavo - Video - October 17th, 2011 [October 17th, 2011]
- Treating Traumatic Brain Injury with Neurotopia - featuring Holden McCray - October 18th, 2011 [October 18th, 2011]
- Brain Injury Survivors: Adriana Villar (Making a Difference: Story 1) - Video - October 21st, 2011 [October 21st, 2011]
- Fabio - brain injury - Video - October 23rd, 2011 [October 23rd, 2011]
- The Latest Developments in Traumatic Brain Injury Treatment - Video - October 25th, 2011 [October 25th, 2011]
- Stem Cell Treatments and Brain Damage Video of MRI of Brain Chambers WWW.STEMCELLREGENMED.COM - Video - October 29th, 2011 [October 29th, 2011]
- Military lags on promising treatment for brain-injured soldiers - Video - November 6th, 2011 [November 6th, 2011]
- Brian Moylan (TBI survivor) talking on treatment from the NHS - Video - November 10th, 2011 [November 10th, 2011]
- Brain Injury Experts at Madonna Rehabilitation Hospital - Video - November 12th, 2011 [November 12th, 2011]
- H200 Hand Rehabilitation System - Testimonials - Clinical Focus - Video - November 13th, 2011 [November 13th, 2011]
- Coping with Brain Injury: Robots and Rehabilitation - Video - November 16th, 2011 [November 16th, 2011]
- Traumatic Brain Injury Rehabilitation using MediTouch HandTutor - Video - November 18th, 2011 [November 18th, 2011]
- Brain Injury Treatment Success | College Station Chiropractor Dr. David Bailey - Video - November 30th, 2011 [November 30th, 2011]
- Hyperbaric Oxygen Therapy (HBOT) corrects brain-injury. - Video - December 7th, 2011 [December 7th, 2011]
- Story of a Traumatic Brain Injury Recovery with Hyperbaric Oxygen (Part1/4) - Video - December 8th, 2011 [December 8th, 2011]
- Hyperbaric Oxygen Therapy Brain Injury - Video - December 10th, 2011 [December 10th, 2011]
- Redwood Extended Care Facility - Brain Injury Services - Video - December 10th, 2011 [December 10th, 2011]
- What If... Brain Injury Rehabilitation - Video - December 17th, 2011 [December 17th, 2011]
- Dangers in Self Medication - Young Adults with Lyme Disease - Leo J. Shea, III, PhD - Video - December 18th, 2011 [December 18th, 2011]
- Reducing Severe Traumatic Brain Injury in the US - Video - December 19th, 2011 [December 19th, 2011]
- Traumatic Brain Injury - Part 8 - Dr. R. Kohn, MD, Neurology - December 21st, 2011 [December 21st, 2011]
- Brain injury rehabilitation using Wii recreational therapy - Video - December 24th, 2011 [December 24th, 2011]
- CNS President/CEO Dr. Mark Ashley discusses how research shapes brain injury rehabilitation - Video - December 29th, 2011 [December 29th, 2011]
- Albert James De Meillon-Traumatic Brain Injury-Part 1 - Video - January 1st, 2012 [January 1st, 2012]
- Hope Beyond Trauma_Janie Smith - Video - January 10th, 2012 [January 10th, 2012]
- Neurofeedback adhd - Video - January 11th, 2012 [January 11th, 2012]
- We are the World, We ARE The Children - Video - January 11th, 2012 [January 11th, 2012]
- New Hopes for Treating Traumatic Brain Injury - Video - January 11th, 2012 [January 11th, 2012]
- NeuroRestorative's Robin Ray Featured on ABC in Southern Illinois - Video - January 13th, 2012 [January 13th, 2012]
- Careers at Origami Brain Injury Rehabilitation Center - Video - January 26th, 2012 [January 26th, 2012]
- Chris Persel discusses what makes CNS a leader in brain injury rehabilitation - Video - January 27th, 2012 [January 27th, 2012]
- Care for catastrophic injuries, spinal cord and traumatic brain injury - Video - January 27th, 2012 [January 27th, 2012]
- Military Tests Pressurized Chamber to Treat TBI - Video - January 27th, 2012 [January 27th, 2012]
- Richmond Traumatic Brain Injury Attorneys Applaud White House Research Initiative Targeting Veterans’ Health Issues - January 28th, 2012 [January 28th, 2012]
- Protect Your Brain...Why? - Video - January 30th, 2012 [January 30th, 2012]