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 Research Updates
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CRAIG HOSPITAL IS AWARDED A GRANT TO BECOME THE TRAUMATIC BRAIN INJURY MODEL SYSTEMS NATIONAL DATA AND STATISTICAL CENTER
The U.S. Department of Education, Office of Special Education and Rehabilitative Services, National Institute on Disability and Rehabilitation Research (NIDRR) has announced that Craig Hospital has been named as the Traumatic Brain Injury Model Systems National Data and Statistical Center (TBINDSC). This is a $3.1 million 5-year grant. The TBINDSC is a central resource for researchers and data collectors within the Traumatic Brain Injury Model Systems (TBIMS) program.
The primary purpose of the TBINDSC is to advance medical rehabilitation by increasing the rigor and efficiency of scientific efforts to longitudinally assess the experience of individuals with traumatic brain injury (TBI). The TBINDSC provides technical assistance, training, and methodological consultation to 16 TBIMS centers as they collect and analyze longitudinal data from people with TBI in their communities, and as they conduct research toward evidence-based TBI rehabilitation interventions. Craig Hospital has been a NIDRR-designated TBI Model System since 1998.
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CRAIG NAMED AGAIN AS “MODEL SYSTEMS CENTER” FOR SPINAL CORD INJURY
Englewood, CO. July 25, 2006. The federal agency NIDRR- the National Institute on Disability and Rehabilitation Research has announced that Craig Hospital has once again been designated as a Spinal Cord Injury Model System for the next five years. The designation includes a $2.4 million grant to conduct research on spinal cord injury (SCI).
First designated as a SCI Model System Center in 1974, Craig is one of the only centers in the U.S. to be consecutively named since that time.
The main research project for this next funding cycle is a large randomized controlled clinical trial to study different clinical strategies for patients with tetraplegia (quadriplegia) to wean off of mechanical ventilators. Craig treats a large number of patients on ventilators and weaning is an important goal in improving the lives of these individuals and reducing costs to patients, families, insurance carriers and society. As one of the 14 Model System Centers, Craig will also contribute data to the aggregate National SCI Database in Birmingham, AL. As a long time Model Center, approximately ¼ of the total data in the National SCI database has come from Craig.
Daniel P. Lammertse, M.D. Craig’s Medical Director, and Susan Charlifue, PhD are the SCI Model System Project Co-Directors.
This uninterrupted Model Systems designation since 1974 demonstrates Craig’s continued worldwide leadership in spinal cord injury rehabilitation and research. Craig has also been a NIDRR Model Systems Center in the field of Traumatic Brain Injury (TBI) since 1998.
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Craig Hospital Receives NIH Award to Study Acupuncture
The National Institutes of Health, National Center for Complementary and Alternative Medicine has awarded Craig a two year grant to study acupuncture starting in September 2006. The primary purpose of this pilot study is to look at the science and methods of studying acupuncture in a rehabilitation setting. A secondary goal is to evaluate the potential of acupuncture to improve neurological recovery after spinal cord injury.
Participants in the study must be current in-patients at Craig Hospital and be less than six weeks post-spinal cord injury. The Principal Investigator, Dr. Amitabh Jha, says he expects to enroll 30 individuals during 18 months. “As a feasibility study, we are focused on methodological issues and plan to evaluate the possibility of conducting a larger multi-site study to look at treatment effectiveness in the future” says Dr. Jha. Interest in acupuncture in the treatment of SCI has increased in the last decade as more intriguing results have been published by international investigators.
This is the second NIH award to Craig Hospital. The first, awarded in September 2005, is an evaluation of massage to treat pain in people with SCI.
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TBI and Female Reproductive Functioning: Craig Hospital Awarded Research Grant
Craig Hospital was awarded a research grant from the Colorado Traumatic Brain Injury Trust Fund titled, “The Impact of TBI on Female Endocrine Functioning.”
David Ripley, MD is the principal investigator for this $50,000, one-year grant.
The study began July 1, 2005 and its objectives include:
- Compare the course of menstrual and reproductive functioning in women before
and after traumatic brain injury (TBI);
- Determine if the severity of TBI is associated with duration of amenorrhea;
- Determine if the duration of amenorrhea following TBI is associated with outcome;
- Determine if the duration of amenorrhea is longer after TBI than Spinal Cord Injury
(SCI); and
- Determine the feasibility of collecting serial hormonal testing, daily basal temperature,
menstrual diaries, demographic, injury severity, and reproductive cycle functioning.
Thirty women, between one and three years post-injury who received rehabilitation after TBI at Craig Hospital, will be interviewed to collect information about menstrual/reproductive functioning and outcomes. Demographic and injury severity data will be abstracted from their medical records. Additionally, five women admitted for inpatient rehabilitation will be recruited to collect serial hormonal levels, daily temperature, menstrual functioning and outcomes information. Data will be analyzed to determine the correlation between injury severity, menstrual functioning, and outcomes. Results of this pilot study will be used to plan a larger study to be submitted to the National Institutes of Health.
“This pilot project will lay the groundwork for future research into the impact of female steroid hormones on recovery following traumatic brain injury,” Dr. Ripley explains. “This has implications for treatment of both men and women. Hopefully, the information will be useful for ultimately identifying new therapies that will help people recover from TBI.
“Additionally, this will be the first project examining the impact of TBI on the function of the female reproductive cycle, an important issue in and of itself for the health of women following TBI.”
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Evaluating Massage Therapy
We recently received notice from the National Institutes of Health (NIH) that Craig has received a two-year grant to evaluate the efficacy of massage therapy on decreasing pain, reducing fatigue, decreasing analgesic medication use, and increasing participation in rehabilitation treatments among patients with spinal cord injury (SCI) during initial rehabilitation. The grant is for approximately $250,000.
“Pain is one of the most frequent and bothersome problems faced by people with SCI, and continued research in this area is important,” says Terry Chase, RN, ND, Patient/Family Education Program Coordinator, who will be principal investigator for the study.
Using a randomized controlled crossover design, the study sample will include 40 current SCI patients, age 16 and older. Eight Craig Hospital nurses will be trained to use compression-style massage versus light touch. C. A. Brooks, MSHA, of Craig’s Research department, will serve as the project manager.
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Clinical Research Update, Spring 2005
Dr. Falci is a graduate of Georgetown University Hospital of Medicine and completed his neurosurgical residency at Georgetown University Hospital in 1992. He received his undergraduate training at Princeton University. Dr. Falci initiated and designed the First Transplantation of Embryonic Nerve Cells for Spinal Cord Injury Project at the Craig Center for Spinal Cord Research in collaboration with the Spinalis SCI Research Unit, Karolinska Institute, Huddinge University Hospital in Stockholm, Sweden, and the department of Neurosurgery, University of Uppsala in Sweden.
Interview with Scott Falci, MD, Chief Neurosurgical Consultant, Craig Hospital
Dr. Falci, generally describe the scope of the work you are currently doing.
One-hundred percent of my practice is in rehabilitative neurosurgery for patients with spinal cord injury (SCI) to maintain and improve function of injured spinal cords. Along with my assistant, Charlotte Starnes, RN, we evaluate and surgically treat patients suffering from spinal cord tethering, cysts, syringomyelia, pain and spasticity to preserve feeling, movement, strength and function, and to irradicate pain. We perform approximately 150 of these surgeries per year, and are one of the largest practices of this kind in the U.S. We coordinate our evaluations and post-operative care and therapy with the physicians and interdisciplinary teams at Craig.
For Craig’s clinical trial site, I am also the chief neurosurgeon for Proneuron Biotechnology’s Phase II ProCord™ activated macrophage clinical trial. In addition I serve as Craig’s principal clinical collaborator in stem cell research with the Karolinska Institute in Stockholm, Sweden.
What advances are you making in the area of spinal cord injury pain?
In the course of my clinical neurosurgical practice over the past 13 years, I have learned a tremendous amount about the mechanisms of the pathophysiology of SCI pain and surgical interventions to alleviate SCI neuropathic pain. Some of the advances that we have made include the analysis and characterization of the electrical “signature” of normal SCI tissue, impaired tissue, dying tissue and dead tissue, and improvements in the Computer-Assisted Dorsal Root Entry Zone Microcoagulation procedure
(CA- DREZ). I believe these foundations in pathophysiology are vital for many
future surgical and pharmacological interventions in SCI.
How is the ProCord study going?
I am honored that Proneuron chose Craig to be the first U.S. trial site for Proneuron’s Phase II ProCord study, and I am proud to be the chief neurosurgeon at Craig for the study. FDA and IRB requirements prevent me from commenting on any clinical results, but I can say that I am pleased with what I am learning in the process about cellular interventions. Proneuron is about halfway through the trial and it is important that neurosurgeons and acute care SCI physicians continue to refer patients to Proneuron’s call center: 1-866-539-0767.
What is the nature of your collaboration with the Karolinska Institute in Stockholm?
I have been working with the Karolinska Institute for about 12 years now, first in surgical interventions for syringomyelia including fetal cells in adult patients with quadriplegia, and more recently in neuroscience stem cell research. The Karolinska Institute, which is home to the Nobel Prizes, also is home to about 2,000 MDs and PhDs who are working on research of all kinds. With regard to spinal cord injury, they have sophisticated basic science labs and animal labs. They also have a keen interest in SCI and in working with Craig.
We make a good team because I have the experience and expertise in human spinal cords, and we design our experiments together with the potential for eventual human application in mind. This collaboration between basic scientists and human neurosurgical scientists is unusual, but it’s important because there are major differences between animal and human spinal cords. The differences have significant implications as to where and how cellular and pharmacological interventions would be most effective in the spinal cord. Over the past several years we have learned the answers to such questions as:
- Can we establish self-perpetuating stem cell lines?
- How do undifferentiated stem cells develop into nerve cells?
- Will stem cells live in the spinal cord and make new connections?
- Do stem cells migrate, and how far, and how do they behave?
- What is the interaction between the immune system and stem cells?
- Do stem cells behave differently in acute vs. chronic SCI?
- Can stem cells be enhanced by various nerve growth factors?
- Can we deliver stem cells to rats and get functional return?
I know that this information is pretty technical for many readers, but when people ask why research takes so long, it is important to appreciate that all these pre-clinical questions have to be answered before we can safely begin human trials. However, having said that, we are hopeful that we will begin human clinical stem cell trials in the next two years. The funds raised at our annual PUSH Research Dinner fundraisers are helping us to achieve this goal, and contributions are greatly appreciated.
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Clinical Research Update, Fall 2004
Daniel P. Lammertse, MD, Craig Medical Director, ASIA President, and NIDRR SCI Model Systems President
Activated macrophage trial proceeds:
Craig began enrolling patients in an international, multi-center Phase II clinical trial of activated macrophage therapy for complete spinal cord injury in December 2003. The study, called ProCord™, is sponsored by Proneuron Biotechnologies. In this randomized-controlled trial of an experimental procedure, macrophages from the patient's own blood are injected into his or her injured spinal cord within two weeks of injury. Monocytes, which are a type of white blood cell, are processed with a patch of skin from the patient's inner arm. In turn, these cells are injected into the spinal cord at the lower boundary of the injury site. A sophisticated cell preparation facility was constructed at Craig to process the cells to the standards required by the FDA.
The research study is designed to determine whether this therapy can improve neurological outcomes by enhancing the immune system's role in the injury healing process. The project also will examine the safety of the therapy, which requires a neurosurgical procedure for injection of the prepared cells.
Craig was the second center to be approved for patient enrollment in the trial, joining Chaim Sheba Medical Center in Tel Hashomer, Israel, where the previous Phase I investigation of the experimental procedure was conducted. Four other SCI centers will come on board as experimental procedure facilities over the next year. Kessler Institute of Rehabilitation in New Jersey and The Mount Sinai Medical Center in New York will share a cell preparation facility and are nearly ready to enroll patients. The Shriners Hospitals for Children in Pennsylvania also is preparing for participation in the trial and will use the New Jersey facility for cell processing. The Shepherd Center in Georgia will be the clinical trial center for the southeastern U.S. and should be ready to enroll patients by early 2005.
The trial has a planned enrollment of 61 patients, two-thirds of whom will be randomly assigned to receive the experimental procedure. The remaining patients will be randomly assigned to a non-surgical control group, which will not receive the macrophage procedure. Both groups will have standard SCI rehabilitation and the same one-year followup for outcome data collection. For more information, see www.proneuron.com.
Additional studies:
Over the past several years, Craig Hospital has participated in a series of clinical trials sponsored by Acorda Therapeutics of the experimental drug Fampridine-SR, a sustained release version of the chemical 4-aminopyridine. This drug has been investigated in persons with spinal cord injuries and multiple sclerosis because of its ability to alter the properties of nerve cell membranes in a way that may improve impulse conduction through areas of nerve damage. Craig's involvement in this research began with a multi-center Phase II trial in 2000, and concluded with the Phase III trial that ran from 2002 through early 2004 and included 33 centers and enrolled 204 patients with chronic SCI. The Phase III trial was designed to measure the ability of the drug to improve spasticity in persons with chronic incomplete spinal cord injuries. A preliminary analysis of the data from the trial showed evidence of a positive treatment effect in reduction of spasms, but the results did not achieve statistical significance.
The Spinal Cord Injury Model System grant is funding four clinical research projects: to study the effectiveness of manual therapy in reducing incidence and severity of shoulder pain; to study neurological outcomes of patients undergoing surgery for treatment of progressive late myelopathy; to study the effectiveness of a shortened bed rest protocol after skin sore surgery; and to study the signs, symptoms, and management of perimenopause in women with SCI. For additional information about clinical research activities for SCI at Craig, contact Susie Charlifue, PhD, at 303-789-8306.
We also are conducting clinical research funded through our Federal Model Systems grant in Traumatic Brain Injury. In the new grant cycle we are conducting two clinical research studies: to investigate the effectiveness of the drug Modafinil for the treatment of fatigue and excessive daytime sleepiness in patients with TBI; and to study the effectiveness of social communication skills training. For additional information about these TBI Model Systems Grant projects, contact Cindy Harrison-Felix, PhD, at 303-789-8565.
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Macrophage clinical trial begins at Craig Hospital.
Study center at Craig first U.S. site to test ProCord™ (December 2003-November 2006
On December 8, 2003, Craig Hospital began enrolling individuals in an experimental study to further test a procedure that involves a type of white blood cell within 14 days of injury for certain patients with spinal cord injury.
This Phase II clinical trial of ProCord™, sponsored by Proneuron Biotechnologies, Inc. of Israel, was a randomized-controlled study involving patients with acute complete spinal cord injury who met study criteria. Utilizing Proneuron's processing cell center at Craig, the study center was the first U.S. site to test ProCord.
Following most types of tissue injury, white blood cells called macrophages quickly start to remove cell debris. These macrophages then secrete growth factors that help begin the healing process and promote regeneration. While this process occurs effectively in most tissues including peripheral nerves, it does not occur effectively in the spinal cord. However, discoveries in pre-clinical trials by Prof. Michal Schwartz of Israel's Weizmann Institute of Science suggested that specially treated macrophages promoted recovery from spinal cord injury. Based on these findings, Proneuron evaluated the safety and efficacy of ProCord in human trials. ProCord consists of macrophages isolated from the patient's own blood, activated through Proneuron's process, and then injected directly into the patient's injured spinal cord.
The study stopped enrolling in March of 2006 and completed all follow-up in November of 2006. No new patients are being enrolled. The Research Department at Craig Hospital is in the process of analyzing the data collected during the course of the study to evaluate the safety and efficacy of ProCord. We anticipate publishing these findings when the analyses are completed.
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PUSH Dinner Raises $614,000
March, 2004 - Eight-hundred people packed the Marriott Denver Tech Center on March 2 for Craig's third annual PUSH dinner to raise funds for spinal cord and traumatic brain injury research. This year's dinner chair was Tom Honig, Regional President and Chief Executive Officer of Wells Fargo Bank, and Peter Forsberg of the Colorado Avalanche hockey club presided as honorary chair. The event raised $614,000 to help fund a variety of pioneering research activities.
"We are grateful to so many people for their commitment and generosity," says
Denny O'Malley, Craig's President.
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PRESS RELEASE - Proneuron Biotechnologies Teams with Craig Hospital
in Denver to Expand IND Phase II Trial of ProCord
for the Treatment of Spinal Cord Injuries to the U.S.
Los Angeles, CA and Denver, CO, December 8, 2003 - Proneuron Biotechnologies, Inc. (www.proneuron.com), and Craig Hospital (www.craighospital.org) announced today that enrollment in Proneuron's IND Phase II trial of ProCord is now open to patients at Craig Hospital in Denver, Colorado. Proneuron is a leader in the development of treatments for patients with spinal cord injuries and other acute and chronic disorders of the central nervous system (CNS). Proneuron's processing Cell Center at Craig is the first U.S. site that will test ProCord, which consists of autologous activated macrophage therapy for a randomized controlled trial for patients with acute complete spinal cord injury (SCI) within 14 days of injury.
The trial commenced at Sheba Medical Center in Tel Hashomer, Israel, in September 2003. Following the necessary approvals, three additional sites located in the US will also study this experimental procedure including: the Mount Sinai Medical Center in NYC; Kessler Institute for Rehabilitation in West Orange, NJ and Shepherd Center in Atlanta, GA. This is the first step in implementing Proneuron's test of ProCord at multiple geographic clinical sites in their goal to commercialize operations in North America.
Daniel P. Lammertse, M.D., Medical Director of Craig Hospital and immediate past president of American Spinal Injury Association, expressed optimism for the potential of this treatment: "The Phase I trial suggests a positive treatment effect, giving clinicians hope that this may prove to be a helpful treatment in improving the outcomes of patients with spinal cord injury".
Following tissue injury, a type of white blood cell, called a macrophage, quickly starts to remove cell debris. These macrophages then start to secrete growth factors that promote a controlled inflammatory reaction to initiate the wound healing process. While this process occurs effectively in most tissues including peripheral nerves, it does not occur effectively in the CNS. Discoveries led by Prof. Michal Schwartz of the Weizmann Institute of Science have shown in pre-clinical studies that specially treated macrophages, however, promoted recovery from spinal cord injury (SCI). Based on these findings, Proneuron is now developing ProCord as a clinical product to treat patients with spinal cord injury. ProCord consists of macrophages isolated from the patient's own blood, activated through a proprietary process and then injected directly into the patient's injured spinal cord. It is crucial that the investigators are notified of a potential candidate within a few days of their spinal cord injury in order to give ample time for patients to enroll and participate in the 14-day window of the clinical trial.
"We are honored to collaborate with Craig Hospital, one of the top treatment centers in the world for spinal cord injury. We have established a working relationship together in the follow-up rehabilitation of some of the patients who participated in the Phase I trial. It is our hope that our newly established ability to offer our experimental treatment to patients in the U.S. will help us to better serve the patient population in the Americas," said Proneuron's V.P. of Clinical Development Dr. David Snyder.
Patient, Immediate Family of Patient and/or Physician inquiries:
24 hour a day Patient Recruitment Center:
Email: clinical.trial@proneuron.com
Telephone: 1 866 539 0767 (U.S. toll free) or 1 506 652 3486.
Fax: 1 866-214-7078
*Callers outside of the U.S., please use standard international dialing code
About Proneuron Biotechnologies
Proneuron Biotechnologies, Inc. is a privately held biopharmaceutical company developing products for the medical treatment of spinal cord injuries and other disorders of the central nervous system. Its products are based on proprietary technology for modulating the interaction between the nervous and the immune systems. The company is currently engaged in several clinical studies located in the U.S., Belgium and Israel. These include: a trial of Macrophage therapy for the treatment of spinal cord injuries and a trial of Cop-1 for the treatment of Huntington's disease (HD). In 2001, Proneuron entered into a strategic collaboration with Teva to develop and commercialize Cop-1 for various indications other than HD and ALS, which are being independently developed by Proneuron. The Company is also developing PN277 for the treatment of additional neurodegenerative diseases.
About Craig Hospital
Craig Hospital is one of the world's leading rehabilitation and research centers for spinal cord injury and traumatic brain injury and is designated by the National Institute of Disability Rehabilitation & Research (NIDRR) as a Model Systems Center for Spinal Cord Injury and Traumatic Brain Injury. Since 1956, Craig Hospital has treated approximately 24,000 patients with spinal cord injury and traumatic brain injury, more than any other single U.S. facility. In 2002, Craig treated patients from all 50 states in the U.S.
Media inquiries: Marjie Hadad, Marjie.hadad@proneuron.com; Marjie@netvision.net.il; +972-55-365-220
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PRESS RELEASE - Proneuron and Craig Hospital to Launch FDA Phase 2 Macrophage Clinical Trial
September, 2003 - Proneuron Biotechnologies, Inc., of Tel Aviv, Israel, has received FDA approval to begin a Phase 2 clinical trial with activated macrophages, and enrollment has begun in Tel Aviv. This experimental procedure involves the injection of macrophages derived from the patient's blood into his or her injured spinal cord, and is limited to complete ASIA A patients within 14 days of their injury. Phase 2's expansion to North America is expected around early December, at which time Craig Hospital will be the first clinical trial site in the U.S. to enroll patients. Daniel P. Lammertse, MD, Craig's Medical Director, will be the Principal Investigator, and Susie Charlifue, MA, in Research will be the Study Coordinator. Craig's participation in this project is consistent with our mission to promote the development of promising therapies to improve function after spinal cord injury. Referral calls for this experimental study should be made to the Proneuron Call Center at 866-214-7078. For more information about the study, including the inclusion/exclusion criteria for participation in the clinical trial, visit Proneuron's web site at www.proneuron.com.
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Clinical Research Update, Fall 2003
Susan Charlifue, PhD, Craig Hospital Research Supervisor
September, 2003 - Craig Hospital's ongoing clinical research aims are to improve treatment and function for people with spinal cord injury (SCI) and traumatic brain injury (TBI).
In the area of spinal cord injury, we presently are conducting two clinical trials of the drug Fampridine-SR in patients with chronic incomplete injury. This medication improves impulse conduction in damaged nerves in experimental animal models of SCI. The sponsor, Acorda Therapeutics, is trying to determine if this effect translates into clinical improvement in neurological function in patients with chronic spinal cord injury. The first trial is an extension of an earlier Phase 2 trial conducted at Craig two years ago. The second trial is a Phase 3 study (the final phase of research before application for FDA approval) of Fampridine-SR for spasticity in patients with chronic incomplete SCI. We completed enrollment in this experiment in the first quarter of 2003. The results of the Fampridine trials, which are being conducted at 80 centers in North America, will not be available for some time. If the drug is shown to be beneficial, it may be available by prescription as early as 2004.
The Spinal Cord Injury Model System grant is funding four clinical research projects.
In an attempt to determine if manual therapy can reduce the incidence and severity of shoulder pain in persons with tetraplegia, Dana Polonsky, PT, and Bev Parrott, PT, are leading a study of manual therapy for the treatment of shoulder pain. This trial includes individuals who are hospitalized at Craig for their initial rehabilitation, and more than half of eligible participants have been enrolled as of September 2003.
Scott Falci, MD, and Dan Lammertse, MD, are studying the neurological outcomes of patients undergoing surgery for treatment of progressive late myelopathy, a condition that can cause deterioration of function long after the initial injury in 5 to 10 percent of people with SCI.
Steven Snively, MD, and Gregory Buford, MD, are studying the effectiveness of a shortened bed rest protocol after skin sore surgery. The study has enrolled more than 70 individuals admitted to Craig Hospital for surgical treatment of a single, new skin sore. For many years, Craig used a five-week bed rest regimen after surgery to repair serious skin sores. This study will determine whether a new protocol of four weeks of bed rest is as effective as five weeks.
David Forschner, MD, Amy Dannels, ND, RN, and I are conducting a study to evaluate the signs, symptoms and management of perimenopause in women with SCI. In addition to defining perimenopause in women with SCI, this project also is examining the various treatments prescribed for the symptoms that are experienced by these women, and the impact of those treatments on the development or progression of osteoporosis. For additional information about clinical research activities for SCI at Craig, please contact me at 303-789-8306.
We also are conducting clinical research funded through our federal Model Systems grant in traumatic brain injury. As you know from the spring 2003 issue of Movin' On, our Traumatic Brain Injury Model System grant was renewed in October 2002 for an additional five years. In the new grant cycle we are conducting two clinical research studies. Alan Weintraub, MD, is leading a project investigating the effectiveness of the drug Modafinil for the treatment of fatigue and excessive daytime sleepiness in patients with traumatic brain injury. This study, which will enroll 60 outpatients with chronic TBI, is examining the use of this drug currently approved for the treatment of excessive daytime sleepiness associated with the condition know as narcolepsy. Our study will determine if this medication also has benefit for people with TBI. The TBI grant also is funding a study led by Cynthia Dahlberg, MA, CCC, to assess the effectiveness of social communication skills training in people with TBI. With a projected enrollment of 60 subjects, this study will determine whether a 12-week group treatment program using a problem solving approach can improve pragmatic communication skills for the participants. For additional information about these TBI Model Systems grant projects, contact Cindy Harrison-Felix, MA, in the Research Department at 303-789-8565.
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PRESS RELEASE - Proneuron Biotechnologies Announces a Phase II IND Study
of Macrophage Therapy (ProCord) for the Treatment of Complete Spinal Cord Injury
Study investigators must be notified of a patient within a few days of injury
Los Angeles, CA and Ness Ziona, Israel, September 23, 2003 - Proneuron Biotechnologies (www.proneuron.com), a leader in the development of medical treatments for spinal cord injuries and other disorders of the central nervous system, announced today it is now enrolling patients in a Phase II clinical trial of ProCord. ProCord consists of autologous activated macrophage therapy for the treatment of patients with acute complete spinal cord injury (SCI) within 14 days of damage.
Initially the treatment will be provided at Sheba Medical Center in Israel, the first of five locations to host this study. Following the necessary approvals, three additional sites located in the US will also enroll patients. These are: Craig Hospital in Denver, Colorado; Mount Sinai Hospital in NYC; and Kessler Institute for Rehabilitation in West Orange, NJ. A fifth site will be named later.
Following tissue injury, a type of white blood cell, called a macrophage, is quickly mobilized, and starts to remove cell debris. Macrophages then begin to secrete growth factors that promote a controlled inflammatory reaction, the initial phase of the wound healing process. While this process normally occurs in most tissues, including peripheral nerves, it does not occur in the CNS, including the spinal cord. Discoveries in pre-clinical studies, led by Prof. Michal Schwartz of the Weizmann Institute of Science, have shown that specially-treated macrophages promote recovery from SCI. Based on these findings, Proneuron is now developing ProCord as a clinical product to treat spinal cord injured patients. ProCord consists of macrophages isolated from the patient's own blood, activated through a proprietary process and then injected directly into the patient's injured spinal cord.
"The Phase I studies in Israel and Belgium treated patients worldwide. These studies showed positive results in an encouraging number of the patients; from complete loss of feeling and movement to recovery of some feeling and movement below the level of injury; i.e., American Spinal Injury Association (ASIA) grade A to ASIA grade B or ASIA grade C status. We hope that this current trial will lead to additional positive results that will ultimately enable us to offer a valuable treatment to patients," said Dr. Nachshon Knoller, Principal Investigator at Sheba Medical Center in Israel.
In the U.S. alone, there are an estimated 11,000 new spinal cord injuries per year. Causes include motor vehicle accidents, acts of violence, falls, sports and other occurrences. SCI trauma usually results in significant morbidity, including respiratory failure, bladder and bowel dysfunction, and complete loss of motor function.
The Phase II study will include 61 patients between the ages of 16 and 65 years old, all with complete spinal cord injury (ASIA grade A). The trial will be a multi-center, randomized-control trial. Controlled assessments will be made at six and 12 months.
"ProCord must be administered within 14 days of the injury. Therefore, it is crucial that the investigators in this trial are notified of a potential candidate within a few days of the incident in order to give ample time for Proneuron to conduct its proprietary procedures using the patient's own blood," said Dr. David Snyder, V.P., Clinical Development at Proneuron. "We hope that ProCord will continue to deliver promising results and ultimately fill a major unmet clinical need."
About Proneuron Biotechnologies
Proneuron Biotechnologies, Inc. is a privately held biopharmaceutical company developing products for the medical treatment of spinal cord injuries and other disorders of the central nervous system. Its products are based on a proprietary technology for modulating the interaction between the nervous and the immune systems. The company is currently engaged in several clinical studies in the U.S., Belgium and Israel. These include: a trial of Macrophage therapy (ProCord) for the treatment of spinal cord injuries and a trial of Cop-1 for the treatment of Huntington's disease (HD). In 2001, Proneuron entered into a strategic collaboration with Teva to develop and commercialize Cop-1 for various indications other than HD and ALS, which are being independently developed by Proneuron. Proneuron is also developing PN277 for the treatment of additional neurodegenerative diseases.
Patient, Immediate Family of Patient and/or Physician inquiries: 24 hour a day Call Center in the U.S.: 1-866-539-0767; Fax number: 1-866-214-7078. *Callers outside of the U.S., please use standard international dialing codes.
Press inquiries: Marjie Hadad, Marjie.hadad@proneuron.com; Marjie@netvision.net.il;
+972-55-365-220
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Los Angeles, CA and Denver, CO, June 25, 2003 - Proneuron Biotechnologies Inc. and Craig Hospital of Denver Colorado today announced the establishment of Proneuron's cell processing center in Denver. Following the successful completion of its IND approved phase I studies, this center will enable Proneuron, pending FDA approval, to start Phase 2 clinical trials and provide its proprietary autologous macrophage treatment (ProCord™) to complete spinal cord patients in the US within 14 days of their injuries. It is anticipated that following the necessary approvals, enrollment in the study will begin at Craig in the fall of 2003.
The Denver cell processing center in addition to Proneuron's collaboration with Progenitor Cell Therapy, L.L.C. in New Jersey are setting the fundamentals for Proneuron's operation in the US and shall serve the company both through the next stages of the clinical development and commercialization of ProCord™.
"Less than a year ago, we entered our collaboration with the Craig Hospital under the support of the BIRD Foundation. The Craig Hospital team has proven to be an ideal partner in our endeavors. With their clinical leadership and tremendous support, compounded by our initial promising clinical results, we are enthusiastically entering the next stages of our development of ProCord™.", said Nir Nimrodi, Proneuron's chief executive officer
Denny O'Malley, Craig Hospital's President of 29 years added: "Craig Hospital is very pleased to be part of this exciting collaboration with Proneuron. The Phase I Clinical trial has given us optimism that there is more to be learned in this next phase of research which could ultimately benefit people with spinal cord injuries. That is our goal - to help this population to whom we have devoted so much of our mission."
About Proneuron: Proneuron Biotechnologies Inc. is a privately held biopharmaceutical company developing products for the treatment of spinal cord injuries and other acute and chronic disorders of the central nervous system based on proprietary technology for modulating the interaction between the nervous and the immune systems. Proneuron has recently entered in to a strategic agreement with Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) to jointly develop a therapeutic vaccination for a number of neurological diseases including spinal cord injury. For more information about Proneuron and ProCord™, visit www.proneuron.com.
About Craig: Craig is one of the world's leading centers for the treatment of spinal cord injuries and traumatic brain injuries and Craig has treated over 23,000 SCI patients, the largest number of any single US facility. The hospital is designated by the National Institutes of Disability Rehabilitation & Research as one of just 16 model spinal cord injury centers and 17 model traumatic brain injury centers in the US. Additionally, Craig has been listed for thirteen consecutive years as one of the top US rehabilitation centers by U. S. News and World Report magazine.
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