StemCells ! Günstig wie nie ....
| eröffnet am: | 30.12.11 01:25 von: | Chalifmann3 |
| neuester Beitrag: | 25.04.21 01:39 von: | Katharinahczka |
| Anzahl Beiträge: | 107 | |
| Leser gesamt: | 36877 | |
| davon Heute: | 4 | |
bewertet mit 8 Sternen |
||
|
Seite:
1
|
2
|
||
13.02.13 05:10
#26
Chalifmann3
12 months data spinal cord trial
NEWARK, Calif., Feb. 12, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced that the twelve-month data from the first patient cohort in the Company's Phase I/II clinical trial of its proprietary HuCNS-SC® product candidate (purified human neural stem cells) for chronic spinal cord injury continued to demonstrate a favorable safety profile, and showed that the considerable gains in sensory function observed in two of the three patients at the six-month assessment have persisted. The third patient remains stable. A summary of the data was presented today by Martin McGlynn, President and CEO, at the 15th Annual BIO CEO & Investor Conference. By completing the twelve-month assessment, the first patient cohort has now completed the trial, and has entered into a separate follow-up study for long-term observation.
"The multi-segment gains observed in sensory function in two patients at six months have endured at the 12-month assessment. In addition, between the six- and 12-month evaluations, one patient converted from a complete to an incomplete injury," said Armin Curt, M.D., Professor and Chairman of the Spinal Cord Injury Center at Balgrist University Hospital, University of Zurich and principal investigator of the clinical trial. "Importantly, the persistence of these sensory gains at the 12-month evaluation was seen across more than one clinical measure. While much more clinical research needs to be done to demonstrate efficacy, the types of changes we are observing are unexpected and very encouraging given that these are patients in the chronic stage of complete spinal injury."
Mr. McGlynn added, "While we need to be cautious when interpreting data from a small, uncontrolled trial, to our knowledge, this is the first time a patient with a complete spinal cord injury has been converted to a patient with an incomplete injury following transplantation of neural stem cells. We are encouraged that the cells appear to convey clinical benefit in such severely injured patients. We are therefore hopeful that we will see similar or greater benefit in AIS B and C patients, who already have partial sensation and motor function below the level of injury which could be further augmented by cell transplantation."
Patients in the study's first cohort all suffered a complete injury to the thoracic (chest-level) spinal cord. In a complete injury, there is no neurological function below the level of injury, and sensory function of all three patients was stable before transplantation of the HuCNS-SC cells. All three patients were transplanted four to nine months after injury with a dose of 20 million cells at the site of injury. The surgery, immunosuppression and the cell transplants have been well tolerated by all the patients. There were no abnormal clinical, electrophysiological or radiological responses to the cells, and all the patients have remained neurologically stable through the first 12 months following transplantation. Positive changes in sensitivity to touch, heat and electrical stimuli were observed in well-defined and consistent thoracic regions in two of the patients, while no changes were observed in the third patient. Importantly, quantitative tests of specific sensory function, as well as electrophysiological measures of impulse transmission across the site of injury, show an association with the clinical examination, providing further objective confirmation of the sensory gains.
About the Spinal Cord Injury Clinical Trial
The Phase I/II clinical trial of StemCells, Inc.'s HuCNS-SC® purified human adult neural stem cells is designed to assess both safety and preliminary efficacy. Twelve patients with thoracic (chest-level) neurological injuries at the T2-T11 level are planned for enrollment, and their injuries must have occurred within three to twelve months prior to transplantation of the cells. In addition to assessing safety, the trial will assess preliminary efficacy based on defined clinical endpoints, such as changes in sensation, motor function and bowel/bladder function. The Company has dosed the first three patients, all of whom have injuries classified as AIS A, in which there is no neurological function below the injury level. The injuries are classified according to the American Spinal Injury Association Impairment Scale (AIS). The second and third cohorts will be patients classified as AIS B and AIS C, those with less severe injury, in which there is some preservation of sensory or motor function.
All patients will receive HuCNS-SC cells through direct transplantation into the spinal cord and will be temporarily immunosuppressed. Patients will be evaluated regularly in the post-transplant period in order to monitor and assess the safety of the HuCNS-SC cells, the surgery and the immunosuppression, as well as to measure any recovery of neurological function below the injury site. The Company intends to follow the effects of this therapy long-term, and each of the patients will be invited to enroll into a separate four year observational study after completing the Phase I/II study.
The trial is being conducted at Balgrist University Hospital, University of Zurich, a world leading medical center for spinal cord injury and rehabilitation, and is open for enrollment to patients in Europe, Canada and the United States. Enrollment for the second cohort is currently underway, and the first AIS B patient was enrolled and dosed late last year. If you believe you may qualify and are interested in participating in the study, please contact the study nurse either by phone at +41 44 386 39 01 or by email at stemcells.pz@balgrist.ch.
MFG
Chali
"The multi-segment gains observed in sensory function in two patients at six months have endured at the 12-month assessment. In addition, between the six- and 12-month evaluations, one patient converted from a complete to an incomplete injury," said Armin Curt, M.D., Professor and Chairman of the Spinal Cord Injury Center at Balgrist University Hospital, University of Zurich and principal investigator of the clinical trial. "Importantly, the persistence of these sensory gains at the 12-month evaluation was seen across more than one clinical measure. While much more clinical research needs to be done to demonstrate efficacy, the types of changes we are observing are unexpected and very encouraging given that these are patients in the chronic stage of complete spinal injury."
Mr. McGlynn added, "While we need to be cautious when interpreting data from a small, uncontrolled trial, to our knowledge, this is the first time a patient with a complete spinal cord injury has been converted to a patient with an incomplete injury following transplantation of neural stem cells. We are encouraged that the cells appear to convey clinical benefit in such severely injured patients. We are therefore hopeful that we will see similar or greater benefit in AIS B and C patients, who already have partial sensation and motor function below the level of injury which could be further augmented by cell transplantation."
Patients in the study's first cohort all suffered a complete injury to the thoracic (chest-level) spinal cord. In a complete injury, there is no neurological function below the level of injury, and sensory function of all three patients was stable before transplantation of the HuCNS-SC cells. All three patients were transplanted four to nine months after injury with a dose of 20 million cells at the site of injury. The surgery, immunosuppression and the cell transplants have been well tolerated by all the patients. There were no abnormal clinical, electrophysiological or radiological responses to the cells, and all the patients have remained neurologically stable through the first 12 months following transplantation. Positive changes in sensitivity to touch, heat and electrical stimuli were observed in well-defined and consistent thoracic regions in two of the patients, while no changes were observed in the third patient. Importantly, quantitative tests of specific sensory function, as well as electrophysiological measures of impulse transmission across the site of injury, show an association with the clinical examination, providing further objective confirmation of the sensory gains.
About the Spinal Cord Injury Clinical Trial
The Phase I/II clinical trial of StemCells, Inc.'s HuCNS-SC® purified human adult neural stem cells is designed to assess both safety and preliminary efficacy. Twelve patients with thoracic (chest-level) neurological injuries at the T2-T11 level are planned for enrollment, and their injuries must have occurred within three to twelve months prior to transplantation of the cells. In addition to assessing safety, the trial will assess preliminary efficacy based on defined clinical endpoints, such as changes in sensation, motor function and bowel/bladder function. The Company has dosed the first three patients, all of whom have injuries classified as AIS A, in which there is no neurological function below the injury level. The injuries are classified according to the American Spinal Injury Association Impairment Scale (AIS). The second and third cohorts will be patients classified as AIS B and AIS C, those with less severe injury, in which there is some preservation of sensory or motor function.
All patients will receive HuCNS-SC cells through direct transplantation into the spinal cord and will be temporarily immunosuppressed. Patients will be evaluated regularly in the post-transplant period in order to monitor and assess the safety of the HuCNS-SC cells, the surgery and the immunosuppression, as well as to measure any recovery of neurological function below the injury site. The Company intends to follow the effects of this therapy long-term, and each of the patients will be invited to enroll into a separate four year observational study after completing the Phase I/II study.
The trial is being conducted at Balgrist University Hospital, University of Zurich, a world leading medical center for spinal cord injury and rehabilitation, and is open for enrollment to patients in Europe, Canada and the United States. Enrollment for the second cohort is currently underway, and the first AIS B patient was enrolled and dosed late last year. If you believe you may qualify and are interested in participating in the study, please contact the study nurse either by phone at +41 44 386 39 01 or by email at stemcells.pz@balgrist.ch.
MFG
Chali
14.09.13 06:24
#27
Chalifmann3
Hier geht bald was .....
STEM ist weitaus günstiger zu haben als CUR:
Sep 12, 2013 9:00 AM EDT....Email0
Share0Print.....RELATED QUOTES..Symbol Price Change
STEM 1.73 +0.04
......NEWARK, Calif., Sept. 12, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced dosing of the first high-dose patient in the Company's Phase I/II clinical trial in dry age-related macular degeneration (AMD). The patient, the fifth overall in the 16-patient trial, was transplanted yesterday with one million HuCNS-SC(R) cells (purified human neural stem cells). The first four patients each received a dose of 200,000 cells. An independent Data Safety Monitoring Committee conducted a review of the trial data to date, and found no safety issues to preclude the trial from proceeding to the high dose.
"Advancing to the high dose, which is a five-fold increase from the low dose, is an important milestone in this trial," said Stephen Huhn, MD, FACS, FAAP, Vice President, CNS Clinical Research at StemCells. "Testing a cell dose of this magnitude in all the remaining patients planned for the trial will enhance our ability to assess the effect of the cells on visual acuity.
"Also, we are pleased to announce that we have received permission from the FDA to open three more U.S. trial sites in addition to the Retina Foundation of the Southwest and the Byers Eye Institute at Stanford, the two currently active centers. Expanding the number of sites will provide easier access to the trial for patients and help us achieve our goal of completing enrollment within the next nine months."
AMD afflicts approximately 30 million people worldwide and is the leading cause of vision loss in people over 55 years of age. Approximately 90 percent of AMD patients have the dry form of the disease, for which there are no approved treatments.
About the Clinical Trial
The Phase I/II trial is designed to evaluate the safety and preliminary efficacy of HuCNS-SC cells as a treatment for dry AMD. The trial is an open-label, dose-escalation study, and is expected to enroll a total of 16 patients. The HuCNS-SC cells will be administered by a single injection into the space beneath the retina in the most affected eye. Using both conventional and advanced state-of-the-art methods of ophthalmological assessment, patients will be evaluated at predetermined intervals over a one-year period to assess safety and signs of visual benefit. Patients will then be followed for an additional four years in a separate observational study.
The trial is currently enrolling at the Byers Eye Institute at Stanford in Palo Alto, California, and at the Retina Foundation of the Southwest in Dallas, Texas. Patients interested in participating in the clinical trial should contact the Byers Eye Institute at Stanford at (650) 498-4486 or the Retina Foundation of the Southwest at (214) 363-3911.
A summary of the Company's preclinical data underlying the trial was featured in February 2012 in the peer-reviewed European Journal of Neuroscience (http://onlinelibrary.wiley.com/doi/10.1111/...2011.07970.x/abstract). The data demonstrated that HuCNS-SC cells protect host photoreceptors and preserve vision in the Royal College of Surgeons (RCS) rat, a well-established animal model of retinal disease that has been used extensively to evaluate potential cellular therapies. Transplantation of HuCNS-SC cells into RCS rats significantly protected photoreceptors from degeneration. Moreover, the number of cone photoreceptors, which are responsible for central vision, remained constant over an extended period, consistent with the sustained visual acuity and light sensitivity observed in the study. In humans, degeneration of the cone photoreceptors accounts for the unique pattern of vision loss in dry AMD.
About HuCNS-SC Cells
StemCells' lead product candidate, HuCNS-SC cells, is a highly purified composition of human neural stem cells that are expanded and stored as banks of cells. The Company's preclinical research has shown that HuCNS-SC cells can be directly transplanted in the central nervous system (CNS) with no sign of tumor formation or adverse effects. Because the transplanted HuCNS-SC cells have been shown to engraft and survive long-term, this suggests the possibility of a durable clinical effect following a single transplantation. StemCells believes that HuCNS-SC cells may have broad therapeutic application for many diseases and disorders of the CNS, and to date has demonstrated human safety data from completed and ongoing clinical studies
MFG
Chali
Sep 12, 2013 9:00 AM EDT....Email0
Share0Print.....RELATED QUOTES..Symbol Price Change
STEM 1.73 +0.04
......NEWARK, Calif., Sept. 12, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced dosing of the first high-dose patient in the Company's Phase I/II clinical trial in dry age-related macular degeneration (AMD). The patient, the fifth overall in the 16-patient trial, was transplanted yesterday with one million HuCNS-SC(R) cells (purified human neural stem cells). The first four patients each received a dose of 200,000 cells. An independent Data Safety Monitoring Committee conducted a review of the trial data to date, and found no safety issues to preclude the trial from proceeding to the high dose.
"Advancing to the high dose, which is a five-fold increase from the low dose, is an important milestone in this trial," said Stephen Huhn, MD, FACS, FAAP, Vice President, CNS Clinical Research at StemCells. "Testing a cell dose of this magnitude in all the remaining patients planned for the trial will enhance our ability to assess the effect of the cells on visual acuity.
"Also, we are pleased to announce that we have received permission from the FDA to open three more U.S. trial sites in addition to the Retina Foundation of the Southwest and the Byers Eye Institute at Stanford, the two currently active centers. Expanding the number of sites will provide easier access to the trial for patients and help us achieve our goal of completing enrollment within the next nine months."
AMD afflicts approximately 30 million people worldwide and is the leading cause of vision loss in people over 55 years of age. Approximately 90 percent of AMD patients have the dry form of the disease, for which there are no approved treatments.
About the Clinical Trial
The Phase I/II trial is designed to evaluate the safety and preliminary efficacy of HuCNS-SC cells as a treatment for dry AMD. The trial is an open-label, dose-escalation study, and is expected to enroll a total of 16 patients. The HuCNS-SC cells will be administered by a single injection into the space beneath the retina in the most affected eye. Using both conventional and advanced state-of-the-art methods of ophthalmological assessment, patients will be evaluated at predetermined intervals over a one-year period to assess safety and signs of visual benefit. Patients will then be followed for an additional four years in a separate observational study.
The trial is currently enrolling at the Byers Eye Institute at Stanford in Palo Alto, California, and at the Retina Foundation of the Southwest in Dallas, Texas. Patients interested in participating in the clinical trial should contact the Byers Eye Institute at Stanford at (650) 498-4486 or the Retina Foundation of the Southwest at (214) 363-3911.
A summary of the Company's preclinical data underlying the trial was featured in February 2012 in the peer-reviewed European Journal of Neuroscience (http://onlinelibrary.wiley.com/doi/10.1111/...2011.07970.x/abstract). The data demonstrated that HuCNS-SC cells protect host photoreceptors and preserve vision in the Royal College of Surgeons (RCS) rat, a well-established animal model of retinal disease that has been used extensively to evaluate potential cellular therapies. Transplantation of HuCNS-SC cells into RCS rats significantly protected photoreceptors from degeneration. Moreover, the number of cone photoreceptors, which are responsible for central vision, remained constant over an extended period, consistent with the sustained visual acuity and light sensitivity observed in the study. In humans, degeneration of the cone photoreceptors accounts for the unique pattern of vision loss in dry AMD.
About HuCNS-SC Cells
StemCells' lead product candidate, HuCNS-SC cells, is a highly purified composition of human neural stem cells that are expanded and stored as banks of cells. The Company's preclinical research has shown that HuCNS-SC cells can be directly transplanted in the central nervous system (CNS) with no sign of tumor formation or adverse effects. Because the transplanted HuCNS-SC cells have been shown to engraft and survive long-term, this suggests the possibility of a durable clinical effect following a single transplantation. StemCells believes that HuCNS-SC cells may have broad therapeutic application for many diseases and disorders of the CNS, and to date has demonstrated human safety data from completed and ongoing clinical studies
MFG
Chali
24.09.13 18:59
#28
Chalifmann3
es geht los .....
StemCells, Inc. Announces New Preclinical Data Showing HuCNS-SC(R) Cells Preserve Visual Function by Keeping Photoreceptors Normal and Healthy
Press Release: StemCells, Inc. – Wed, Sep 18, 2013 9:00 AM
NEWARK, Calif., Sept. 18, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced the publication of preclinical data confirming that the Company's proprietary HuCNS-SC cells (purified human neural stem cells) preserve photoreceptor cells and visual function in a widely used model of retinal degeneration. The data show not only that HuCNS-SC cells preserve the number of photoreceptors that would otherwise be lost, but also that the surviving photoreceptors appear healthy and normal, and maintain their synaptic connection to other important cells necessary for visual function. The study was published in Investigative Ophthalmology and Visual Science (IVOS), the journal of the Association for Research in Vision and Ophthalmology, and is available at (http://www.iovs.org/content/early/recent.) These results are highly relevant to disorders of vision loss, the most notable of which is age-related macular degeneration (AMD), which afflicts approximately 30 million people worldwide.
"This study demonstrates that, at the cellular and sub-cellular level, the surviving photoreceptors have all the components that characterize a healthy and normal photoreceptor, and they have the correct synaptic connections," said Nicolas Cuenca, PhD, Professor in the Department of Physiology, Genetics and Microbiology at the University of Alicante, Spain, and lead author of the paper. "The robust anatomical preservation of the photoreceptors and their synaptic connections most likely underlie the preservation of visual function.
"In addition, this study confirmed our preliminary hypothesis that HuCNS-SC cells phagocytose photoreceptor outer segments. The phagocytic activity of the HuCNS-SC cells restores a function normally performed by retinal pigmented epithelial (RPE) cells."
The Company is currently conducting a Phase I/II clinical trial in the dry form of AMD, the most prevalent form of the disease. The preclinical data underlying this Phase I/II clinical trial was previously published in the European Journal of Neuroscience (http://onlinelibrary.wiley.com/doi/10.1111/...2011.07970.x/abstract). That data demonstrated that HuCNS-SC cells protect host photoreceptors (both rods and cones) and preserve vision in the Royal College of Surgeons (RCS) rat, a well-established animal model of retinal disease that has been used extensively to evaluate potential cellular therapies.
The Company's Phase I/II clinical trial in dry AMD is currently enrolling patients at the Byers Eye Institute at Stanford in Palo Alto, California, and at the Retina Foundation of the Southwest in Dallas, Texas. The Company recently dosed the first high-dose patient in the trial. To date, a total of five patients have been dosed in the 16-patient trial. Patients interested in participating in the clinical trial should contact the Byers Eye Institute at Stanford at (650) 498-4486 or the Retina Foundation of the Southwest at (214) 363-3911. The Company is working to open additional sites in the United States
MFG
Chali
Press Release: StemCells, Inc. – Wed, Sep 18, 2013 9:00 AM
NEWARK, Calif., Sept. 18, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced the publication of preclinical data confirming that the Company's proprietary HuCNS-SC cells (purified human neural stem cells) preserve photoreceptor cells and visual function in a widely used model of retinal degeneration. The data show not only that HuCNS-SC cells preserve the number of photoreceptors that would otherwise be lost, but also that the surviving photoreceptors appear healthy and normal, and maintain their synaptic connection to other important cells necessary for visual function. The study was published in Investigative Ophthalmology and Visual Science (IVOS), the journal of the Association for Research in Vision and Ophthalmology, and is available at (http://www.iovs.org/content/early/recent.) These results are highly relevant to disorders of vision loss, the most notable of which is age-related macular degeneration (AMD), which afflicts approximately 30 million people worldwide.
"This study demonstrates that, at the cellular and sub-cellular level, the surviving photoreceptors have all the components that characterize a healthy and normal photoreceptor, and they have the correct synaptic connections," said Nicolas Cuenca, PhD, Professor in the Department of Physiology, Genetics and Microbiology at the University of Alicante, Spain, and lead author of the paper. "The robust anatomical preservation of the photoreceptors and their synaptic connections most likely underlie the preservation of visual function.
"In addition, this study confirmed our preliminary hypothesis that HuCNS-SC cells phagocytose photoreceptor outer segments. The phagocytic activity of the HuCNS-SC cells restores a function normally performed by retinal pigmented epithelial (RPE) cells."
The Company is currently conducting a Phase I/II clinical trial in the dry form of AMD, the most prevalent form of the disease. The preclinical data underlying this Phase I/II clinical trial was previously published in the European Journal of Neuroscience (http://onlinelibrary.wiley.com/doi/10.1111/...2011.07970.x/abstract). That data demonstrated that HuCNS-SC cells protect host photoreceptors (both rods and cones) and preserve vision in the Royal College of Surgeons (RCS) rat, a well-established animal model of retinal disease that has been used extensively to evaluate potential cellular therapies.
The Company's Phase I/II clinical trial in dry AMD is currently enrolling patients at the Byers Eye Institute at Stanford in Palo Alto, California, and at the Retina Foundation of the Southwest in Dallas, Texas. The Company recently dosed the first high-dose patient in the trial. To date, a total of five patients have been dosed in the 16-patient trial. Patients interested in participating in the clinical trial should contact the Byers Eye Institute at Stanford at (650) 498-4486 or the Retina Foundation of the Southwest at (214) 363-3911. The Company is working to open additional sites in the United States
MFG
Chali
19.06.14 20:01
#29
MALAW
nö, JETZT gehts los
StemCells, Inc. Interim Results Show Improvement in Visual Function and Slowing of Disease Progression in Phase I/II Dry AMD Trial
Company to Host Webcast to Discuss Interim Data Today
NEWARK, Calif., June 19, 2014 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM) reported positive interim results from its Phase I/II clinical trial of the Company's proprietary HuCNS-SC® human neural stem cell platform in dry age-related macular degeneration (AMD) yesterday evening at the 12th annual meeting of the International Society for Stem Cell Research (ISSCR) in Vancouver, Canada.
Interim trial results show a 65 percent reduction in the rate of geographic atrophy (GA) in the study eye when compared to the expected natural history of the disease as well as a 70 percent reduction in the rate of GA when compared to the control eye.
GA is the progressive loss of two important retinal tissue layers, the photoreceptors and the retinal pigmented epithelium. This degeneration is the cause of vision loss in dry AMD.
Interim results also indicate improvements in visual function, as measured by the ability to distinguish shades of light versus dark, also referred to as "contrast sensitivity."
Contrast sensitivity was improved in four of the seven patients and remained stable in the other three patients.
The interim analysis is based on a minimum follow up of at least 6 months and demonstrates a favorable safety profile for administration of the HuCNS-SC cells into the sub-retinal space of the study eye.
"The interim data are very encouraging from two separate perspectives. First, the reduction in the rate of geographic atrophy suggests the HuCNS-SC cells are affecting the underlying cause of AMD. Secondly, the data demonstrates there are increases in contrast sensitivity, which is a vital aspect of visual function," said Stephen Huhn, M.D., FACS, FAAP, vice president, CNS clinical research and chief medical officer at StemCells, Inc. "Impacting the progression of GA and enhancing visual function could have a very meaningful impact on the quality of life for AMD patients and the results to date strongly support our plans to initiate a randomized, controlled, Phase II proof-of-concept trial later this year."
"These interim results have exceeded our expectations at this stage of the trial," said David Birch, Ph.D., chief scientific and executive officer of the Retina Foundation of the Southwest in Dallas, Texas. "These results are particularly interesting given that the first cohort of patients had significant visual impairment and baseline GA. The next cohort of patients will have less impairment and we look forward to learning even more as we analyze data from the patients in the second half of the trial."
StemCells, Inc. will host a conference call and webcast to discuss the interim results from the Phase I/II clinical trial of HuCNS-SC cells in dry AMD, after market close today, Thursday, June 19, at 4:30 p.m. Eastern Daylight Time (1:30 p.m. Pacific Daylight Time).
Interested parties are invited to listen to the call over the Internet by accessing the Investors section of the Company's website at www.stemcellsinc.com. Webcast participants should allot extra time before the webcast begins to register and, if necessary, download and install audio software.
Event: Interim Results from the StemCells, Inc. Phase I/II clinical trial in dry AMD
Date: Thursday, June 19, 2014
Time: 4:30 PM EDT (1:30 PM PDT)
Live webcast: http://www.media-server.com/m/acs/113baab16d15da4dd0c81018d65a272e
An archived version of the webcast will be available for replay on the Company's website beginning approximately two hours following the conclusion of the live call and continuing for a period of 30 days.
About Age-Related Macular Degeneration and Geographic Atrophy
An estimated 10 million people in the United States either have age-related macular degeneration (AMD) or are at substantial risk for receiving the diagnosis, according to the Foundation Fighting Blindness. AMD, a degenerative retinal disease that typically strikes adults in their 50s or early 60s and gradually progresses to destroy central vision, is the leading cause of blindness in adults over 55 years of age in the developed world. Age-related macular degeneration refers to a loss of photoreceptors (rods and cones) from the macula, the central part of the retina. Approximately 85-90 percent of AMD cases are the "dry" type of the disease, the advanced form of which is referred to as "geographic atrophy."
About the Trial
The Phase I/II trial evaluates the safety and preliminary efficacy of HuCNS-SC cells as a treatment for dry AMD. Patients with dry AMD had to have evidence of GA to be eligible for inclusion. The investigation is divided into two sequential cohorts. Subjects are enrolled into each cohort based on best-corrected visual acuity (BCVA), as determined by the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) acuity test. Patients with BCVA of less than or equal to 20/400 in the study eye were enrolled in Cohort I. Patients with less severe BCVA of 20/320 to 20/100 in the study eye are being enrolled in Cohort II. Cohort I consists of four subjects who were each transplanted with 200,000 stem cells, followed by four subjects who have each been transplanted with 1 million cells. Cohort II will consist of eight subjects who will undergo transplant with 1 million cells. The HuCNS-SC cells are administered by a single injection into the space behind the retina in the most affected eye. Patients' vision is being evaluated using both conventional and advanced state-of-the-art methods of ophthalmological assessment. Evaluations are being performed at predetermined intervals over a one-year period to assess safety and signs of vision improvement. Patients will be followed for an additional four years in a separate observational study.
The trial enrolled at five locations:
Retina Foundation of the Southwest, Dallas, Texas
Byers Eye Institute at Stanford, Stanford Hospital and Clinics, Palo Alto, CA
New York Eye and Ear Infirmary, New York, NY
Retina Research Institute of Texas, Abilene, TX
Retina-Vitreous Associates Medical Group, Los Angeles, California
More information about the StemCells Dry Age Related Macular Degeneration program can be found on the Company website at: http://www.stemcellsinc.com/Therapeutic-Programs/...nal-Disorders.htm
Additional information about the clinical trial is available at: http://www.stemcellsinc.com/Therapeutic-Programs/Clinical-Trials.htm and at the U.S. National Institutes of Health website at: http://www.clinicaltrials.gov/ct2/show/...temcells+inc+amd&rank=1
About HuCNS-SC Cells
StemCells, Inc. has demonstrated human safety data from completed and ongoing clinical studies of its proprietary HuCNS-SC cells. StemCells clinicians and scientists believe that HuCNS-SC cells may have broad therapeutic application for many diseases and disorders of the central nervous system (CNS). Because the transplanted HuCNS-SC cells have been shown to engraft and survive long-term, there is the possibility of a durable clinical effect following a single transplantation. The Company's preclinical research established that HuCNS-SC cells can be directly transplanted in the CNS with no sign of tumor formation or adverse effects. The HuCNS-SC platform technology is a highly purified composition of human neural stem cells that are expanded and stored as banks of cells.
About StemCells, Inc.
StemCells, Inc. is engaged in the research, development and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The Company's platform technology, HuCNS-SC® cells (purified human neural stem cells), is currently in clinical development as a potential treatment for a broad range of central nervous system disorders. The Company is conducting a Phase I/II clinical trial in chronic spinal cord injury in Switzerland, Canada and the United States, and has reported positive interim data for the first eight patients. The Company is also conducting a Phase I/II clinical trial in dry age-related macular degeneration (AMD) in the United States. In a Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children, the Company has shown preliminary evidence of progressive and durable donor-derived myelination in all four patients transplanted with HuCNS-SC cells. In addition, the Company is pursuing preclinical studies in Alzheimer's disease, with support from the California Institute for Regenerative Medicine (CIRM). StemCells also markets stem cell research products, including media and reagents, under the SC Proven® brand. Further information about StemCells is available at http://www.stemcellsinc.com.
Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, and is subject to the safe harbors created therein. These statements include, but are not limited to, statements regarding the prospect of the Company's HuCNS-SC cells to preserve vision; the prospect and timing of patient enrollment in the Company's clinical trial in dry AMD; and the future business operations of the Company. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management's current views and are based on certain assumptions that may or may not ultimately prove valid. The Company's actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including the fact that additional trials will be required to demonstrate the safety and efficacy of the Company's HuCNS-SC cells for the treatment of any disease or disorder; uncertainty as to whether the FDA or other applicable regulatory agencies or review boards will permit the Company to continue clinical testing in AMD; uncertainties regarding the timing and duration of any clinical trials; uncertainties regarding the Company's ability to recruit the patients required to conduct its clinical trials or to obtain meaningful results; uncertainties regarding the Company's ability to obtain the increased capital resources needed to continue its current and planned research and development operations; uncertainty as to whether HuCNS-SC cells and any products that may be generated in the future in the Company's cell-based programs will prove safe and clinically effective and not cause tumors or other adverse side effects; and other factors that are described under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2013, and in its subsequent reports on Forms 10-Q and 8-K.
Company to Host Webcast to Discuss Interim Data Today
NEWARK, Calif., June 19, 2014 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM) reported positive interim results from its Phase I/II clinical trial of the Company's proprietary HuCNS-SC® human neural stem cell platform in dry age-related macular degeneration (AMD) yesterday evening at the 12th annual meeting of the International Society for Stem Cell Research (ISSCR) in Vancouver, Canada.
Interim trial results show a 65 percent reduction in the rate of geographic atrophy (GA) in the study eye when compared to the expected natural history of the disease as well as a 70 percent reduction in the rate of GA when compared to the control eye.
GA is the progressive loss of two important retinal tissue layers, the photoreceptors and the retinal pigmented epithelium. This degeneration is the cause of vision loss in dry AMD.
Interim results also indicate improvements in visual function, as measured by the ability to distinguish shades of light versus dark, also referred to as "contrast sensitivity."
Contrast sensitivity was improved in four of the seven patients and remained stable in the other three patients.
The interim analysis is based on a minimum follow up of at least 6 months and demonstrates a favorable safety profile for administration of the HuCNS-SC cells into the sub-retinal space of the study eye.
"The interim data are very encouraging from two separate perspectives. First, the reduction in the rate of geographic atrophy suggests the HuCNS-SC cells are affecting the underlying cause of AMD. Secondly, the data demonstrates there are increases in contrast sensitivity, which is a vital aspect of visual function," said Stephen Huhn, M.D., FACS, FAAP, vice president, CNS clinical research and chief medical officer at StemCells, Inc. "Impacting the progression of GA and enhancing visual function could have a very meaningful impact on the quality of life for AMD patients and the results to date strongly support our plans to initiate a randomized, controlled, Phase II proof-of-concept trial later this year."
"These interim results have exceeded our expectations at this stage of the trial," said David Birch, Ph.D., chief scientific and executive officer of the Retina Foundation of the Southwest in Dallas, Texas. "These results are particularly interesting given that the first cohort of patients had significant visual impairment and baseline GA. The next cohort of patients will have less impairment and we look forward to learning even more as we analyze data from the patients in the second half of the trial."
StemCells, Inc. will host a conference call and webcast to discuss the interim results from the Phase I/II clinical trial of HuCNS-SC cells in dry AMD, after market close today, Thursday, June 19, at 4:30 p.m. Eastern Daylight Time (1:30 p.m. Pacific Daylight Time).
Interested parties are invited to listen to the call over the Internet by accessing the Investors section of the Company's website at www.stemcellsinc.com. Webcast participants should allot extra time before the webcast begins to register and, if necessary, download and install audio software.
Event: Interim Results from the StemCells, Inc. Phase I/II clinical trial in dry AMD
Date: Thursday, June 19, 2014
Time: 4:30 PM EDT (1:30 PM PDT)
Live webcast: http://www.media-server.com/m/acs/113baab16d15da4dd0c81018d65a272e
An archived version of the webcast will be available for replay on the Company's website beginning approximately two hours following the conclusion of the live call and continuing for a period of 30 days.
About Age-Related Macular Degeneration and Geographic Atrophy
An estimated 10 million people in the United States either have age-related macular degeneration (AMD) or are at substantial risk for receiving the diagnosis, according to the Foundation Fighting Blindness. AMD, a degenerative retinal disease that typically strikes adults in their 50s or early 60s and gradually progresses to destroy central vision, is the leading cause of blindness in adults over 55 years of age in the developed world. Age-related macular degeneration refers to a loss of photoreceptors (rods and cones) from the macula, the central part of the retina. Approximately 85-90 percent of AMD cases are the "dry" type of the disease, the advanced form of which is referred to as "geographic atrophy."
About the Trial
The Phase I/II trial evaluates the safety and preliminary efficacy of HuCNS-SC cells as a treatment for dry AMD. Patients with dry AMD had to have evidence of GA to be eligible for inclusion. The investigation is divided into two sequential cohorts. Subjects are enrolled into each cohort based on best-corrected visual acuity (BCVA), as determined by the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) acuity test. Patients with BCVA of less than or equal to 20/400 in the study eye were enrolled in Cohort I. Patients with less severe BCVA of 20/320 to 20/100 in the study eye are being enrolled in Cohort II. Cohort I consists of four subjects who were each transplanted with 200,000 stem cells, followed by four subjects who have each been transplanted with 1 million cells. Cohort II will consist of eight subjects who will undergo transplant with 1 million cells. The HuCNS-SC cells are administered by a single injection into the space behind the retina in the most affected eye. Patients' vision is being evaluated using both conventional and advanced state-of-the-art methods of ophthalmological assessment. Evaluations are being performed at predetermined intervals over a one-year period to assess safety and signs of vision improvement. Patients will be followed for an additional four years in a separate observational study.
The trial enrolled at five locations:
Retina Foundation of the Southwest, Dallas, Texas
Byers Eye Institute at Stanford, Stanford Hospital and Clinics, Palo Alto, CA
New York Eye and Ear Infirmary, New York, NY
Retina Research Institute of Texas, Abilene, TX
Retina-Vitreous Associates Medical Group, Los Angeles, California
More information about the StemCells Dry Age Related Macular Degeneration program can be found on the Company website at: http://www.stemcellsinc.com/Therapeutic-Programs/...nal-Disorders.htm
Additional information about the clinical trial is available at: http://www.stemcellsinc.com/Therapeutic-Programs/Clinical-Trials.htm and at the U.S. National Institutes of Health website at: http://www.clinicaltrials.gov/ct2/show/...temcells+inc+amd&rank=1
About HuCNS-SC Cells
StemCells, Inc. has demonstrated human safety data from completed and ongoing clinical studies of its proprietary HuCNS-SC cells. StemCells clinicians and scientists believe that HuCNS-SC cells may have broad therapeutic application for many diseases and disorders of the central nervous system (CNS). Because the transplanted HuCNS-SC cells have been shown to engraft and survive long-term, there is the possibility of a durable clinical effect following a single transplantation. The Company's preclinical research established that HuCNS-SC cells can be directly transplanted in the CNS with no sign of tumor formation or adverse effects. The HuCNS-SC platform technology is a highly purified composition of human neural stem cells that are expanded and stored as banks of cells.
About StemCells, Inc.
StemCells, Inc. is engaged in the research, development and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The Company's platform technology, HuCNS-SC® cells (purified human neural stem cells), is currently in clinical development as a potential treatment for a broad range of central nervous system disorders. The Company is conducting a Phase I/II clinical trial in chronic spinal cord injury in Switzerland, Canada and the United States, and has reported positive interim data for the first eight patients. The Company is also conducting a Phase I/II clinical trial in dry age-related macular degeneration (AMD) in the United States. In a Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children, the Company has shown preliminary evidence of progressive and durable donor-derived myelination in all four patients transplanted with HuCNS-SC cells. In addition, the Company is pursuing preclinical studies in Alzheimer's disease, with support from the California Institute for Regenerative Medicine (CIRM). StemCells also markets stem cell research products, including media and reagents, under the SC Proven® brand. Further information about StemCells is available at http://www.stemcellsinc.com.
Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, and is subject to the safe harbors created therein. These statements include, but are not limited to, statements regarding the prospect of the Company's HuCNS-SC cells to preserve vision; the prospect and timing of patient enrollment in the Company's clinical trial in dry AMD; and the future business operations of the Company. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management's current views and are based on certain assumptions that may or may not ultimately prove valid. The Company's actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including the fact that additional trials will be required to demonstrate the safety and efficacy of the Company's HuCNS-SC cells for the treatment of any disease or disorder; uncertainty as to whether the FDA or other applicable regulatory agencies or review boards will permit the Company to continue clinical testing in AMD; uncertainties regarding the timing and duration of any clinical trials; uncertainties regarding the Company's ability to recruit the patients required to conduct its clinical trials or to obtain meaningful results; uncertainties regarding the Company's ability to obtain the increased capital resources needed to continue its current and planned research and development operations; uncertainty as to whether HuCNS-SC cells and any products that may be generated in the future in the Company's cell-based programs will prove safe and clinically effective and not cause tumors or other adverse side effects; and other factors that are described under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2013, and in its subsequent reports on Forms 10-Q and 8-K.
20.06.14 23:57
#30
Eco1
Hi MALAW,
Was siehst/glaubst Du für ein Kursziele.
Eigentlich doch bei akuteller MK doch weit > 10$.
War mal investiert und habe leider schon vor einem Jahr verkauft mit nem kleinen Minus.
Überleg, jetzt einzusteigen, hab mich aber nicht mehr zu stark damit beschäftigt.
Wie ist dein EK und Deine Meinung?
Gruss, Eco1
Eigentlich doch bei akuteller MK doch weit > 10$.
War mal investiert und habe leider schon vor einem Jahr verkauft mit nem kleinen Minus.
Überleg, jetzt einzusteigen, hab mich aber nicht mehr zu stark damit beschäftigt.
Wie ist dein EK und Deine Meinung?
Gruss, Eco1
27.06.14 10:54
#32
LOLA-Prinzip
@Eco1: Kurse um die 5 USD aufwärts gut möglich!
Wie man am Langfrist-Chart erkennen kann, kriecht Stemcells wirklich am Boden. Die Krisenzeit (Rezession) hat viele Aktien stark gebeutelt. Eine technische Korrektur ohne weitere News wird meiner Meinung kommen, da die Investoren sich wieder eindecken werden. Bei Bio-Aktien geht es um viel Phantsie und Hoffnung. Weiß jemand, welche Präparate Stemcells hat und in welchen Phasen die sich aktuell befinden?
AAlle Angaben ohne Gewähr!
27.06.14 11:23
#33
LOLA-Prinzip
Clinical Development Programs
Habe mal selber gestöbert! Interessant!
02.07.14 15:34
#34
MALAW
neues Kursziel $7.00
Stemcells Now Covered by Brinson Patrick (STEM)
July 2nd, 2014 - 0 comments - Filed Under - by Mark Dietrich
Share on StockTwits
Stemcells logoBrinson Patrick started coverage on shares of Stemcells (NASDAQ:STEM) in a research note issued on Wednesday, TheFlyOnTheWall.com reports. The firm set an “outperform” rating and a $7.00 price target on the stock. Brinson Patrick’s price objective would suggest a potential upside of 250.00% from the company’s current price.
STEM has been the subject of a number of other recent research reports. Analysts at Maxim Group raised their price target on shares of Stemcells from $2.50 to $5.00 in a research note on Friday, June 20th. They now have a “buy” rating on the stock. Separately, analysts at Chardan Capital reiterated a “positive” rating on shares of Stemcells in a research note on Tuesday, June 17th.
Shares of Stemcells (NASDAQ:STEM) opened at 2.00 on Wednesday. Stemcells has a 52 week low of $1.15 and a 52 week high of $2.34. The stock’s 50-day moving average is $1.57 and its 200-day moving average is $1.43. The company’s market cap is $111.0 million.
Stemcells (NASDAQ:STEM) last posted its quarterly earnings results on Wednesday, May 14th. The company reported ($0.14) earnings per share (EPS) for the quarter, missing the consensus estimate of ($0.12) by $0.02. The company had revenue of $0.34 million for the quarter, compared to the consensus estimate of $0.24 million. During the same quarter in the previous year, the company posted ($0.17) earnings per share. On average, analysts predict that Stemcells will post $-0.60 earnings per share for the current fiscal year.
StemCells, Inc (NASDAQ:STEM) is engaged in the research, development, and commercialization of stem cell therapeutics and related enabling technologies for academia and industry.
July 2nd, 2014 - 0 comments - Filed Under - by Mark Dietrich
Share on StockTwits
Stemcells logoBrinson Patrick started coverage on shares of Stemcells (NASDAQ:STEM) in a research note issued on Wednesday, TheFlyOnTheWall.com reports. The firm set an “outperform” rating and a $7.00 price target on the stock. Brinson Patrick’s price objective would suggest a potential upside of 250.00% from the company’s current price.
STEM has been the subject of a number of other recent research reports. Analysts at Maxim Group raised their price target on shares of Stemcells from $2.50 to $5.00 in a research note on Friday, June 20th. They now have a “buy” rating on the stock. Separately, analysts at Chardan Capital reiterated a “positive” rating on shares of Stemcells in a research note on Tuesday, June 17th.
Shares of Stemcells (NASDAQ:STEM) opened at 2.00 on Wednesday. Stemcells has a 52 week low of $1.15 and a 52 week high of $2.34. The stock’s 50-day moving average is $1.57 and its 200-day moving average is $1.43. The company’s market cap is $111.0 million.
Stemcells (NASDAQ:STEM) last posted its quarterly earnings results on Wednesday, May 14th. The company reported ($0.14) earnings per share (EPS) for the quarter, missing the consensus estimate of ($0.12) by $0.02. The company had revenue of $0.34 million for the quarter, compared to the consensus estimate of $0.24 million. During the same quarter in the previous year, the company posted ($0.17) earnings per share. On average, analysts predict that Stemcells will post $-0.60 earnings per share for the current fiscal year.
StemCells, Inc (NASDAQ:STEM) is engaged in the research, development, and commercialization of stem cell therapeutics and related enabling technologies for academia and industry.
02.07.14 15:55
#35
MALAW
@ eco
sorry, aber ich hab keine ahnung, wohin das geht, aber andere s.o. wissen da besser bescheid...umsatz legt stark zu, vielversprechende pipline...also ich bin long und hoffe auf viel mehr...
gruss
gruss
02.07.14 16:34
#37
LOLA-Prinzip
Währungsrechner USD in EUR
http://www.oanda.com/lang/de/currency/converter/
02.07.14 16:51
#38
LOLA-Prinzip
Die Aktie ist kult und hier interessiert es keinen
Mich wundert es, das die Leute Aktien wie Geron, Viropharma, Stemcells heute kaum hier noch Aufmerksamkeit bekommen in den Threads...? Hatte deswegen auch in USA gekauft. Zum Glück sehen es die Amis anders...Auf alte Zeiten und fettes Plus im Depot!!:-) Viel Glück den investierten!
02.07.14 16:53
#39
nordküstenbau
Komisch
habe noch US85857B1008 im Depot, hat aber hiermit nichts zu tun? oder etwa doch??
02.07.14 18:49
#42
LOLA-Prinzip
+16,50%
Börse: Nasdaq
Aktuell: 2,33 USD
Zeit§02.07.14 18:31
Diff. Vortag: +16,50%
Tages-Vol.: 22,35 Mio.
Gehandelte Stück: 10,47 Mio.
Geld: 2,33
Brief: 2,34
Zeit: 02.07.14 18:31
Aktuell: 2,33 USD
Zeit§02.07.14 18:31
Diff. Vortag: +16,50%
Tages-Vol.: 22,35 Mio.
Gehandelte Stück: 10,47 Mio.
Geld: 2,33
Brief: 2,34
Zeit: 02.07.14 18:31
04.07.14 16:51
#43
LOLA-Prinzip
seit gestern abend stagnierte der kurs plötzlich?
Was ist da los, bisher kein Handel? Weiß da jemand mehr?
Kursdaten
Börse Nasdaq §
Aktuell§2,34 USD
Zeit§03.07.14 19:00
Diff. Vortag +2,18%
Tages-Vol.§12,25 Mio.
Gehandelte Stück 5,35 Mio.
Geld 2,27
Brief 3,47 §
Zeit§03.07.14 23:00
Spread 34,58%§
Geld Stk. 3.000
Brief Stk. 3.000
Kursdaten
Börse Nasdaq §
Aktuell§2,34 USD
Zeit§03.07.14 19:00
Diff. Vortag +2,18%
Tages-Vol.§12,25 Mio.
Gehandelte Stück 5,35 Mio.
Geld 2,27
Brief 3,47 §
Zeit§03.07.14 23:00
Spread 34,58%§
Geld Stk. 3.000
Brief Stk. 3.000
04.07.14 20:15
#47
LOLA-Prinzip
bin mal gespannt, wie es weiter geht...
kann mir vorstellen, das da bald etwas mehr schub rein kommt...lg
19.11.14 17:11
#50
1st.one
Upcoming Events
11/20/14 StemCells, Inc. Investor and Analyst Event
Thursday, November 20, 2014 12:00p.m. ET
Thursday, November 20, 2014 12:00p.m. ET
Seite:
1
|
1
|
2