CoAxia Inc. of Maple Grove, MN, announced that the results of the SENTIS clinical trial - a worldwide, multi-center, randomized study of its NeuroFlo™ catheter were presented on Saturday, October 16th, by SENTIS Principal Investigator, Professor Ashfaq Shuaib at the 2010 World Stroke Congress in Seoul, South Korea. Professor Shuaib noted that SENTIS is the first randomized trial of an acute interventional treatment in ischemic stroke patients to signal safety and long term improvement in clinical outcomes. CoAxia is developing plans to submit trial results to the US FDA and exploring options to initiate marketing of the NeuroFlo technology in Europe, where it has previously received CE Mark.
Professor Shuaib, Director of Stroke Services, University of Edmonton Medical Center, described the SENTIS trial results as follows: whereas the NeuroFlo treatment did not achieve statistical significance in its primary efficacy measure, it did achieve the trial's primary safety endpoint and demonstrated numerous positive indications of both safety and benefit. He presented positive safety results in overall mortality and stroke-related mortality, and improved neurological outcomes, as measured by 90 day modified Rankin 0-2 scores, in early-presenting patients, mid-range stroke patients, and patients over 70 years of age.
The SENTIS trial included patients presenting with strokes up to 14 hours after symptom onset with baseline stroke severity NIHSS scores between 5 and 18. Patients were randomized 1:1 to either NeuroFlo treatment or standard medical care. Patients eligible for either intra-venous tPA (approximately 2-3% of stoke patients) or intra-arterial clot removal (< 1% of stroke patients) were excluded from the trial. The SENTIS endpoints included a range of neurological efficacy and safety measures assessed 90 days after symptom onset. These measures included the primary efficacy endpoint of a Return to Normal Neurological Status based on the NINDS Global Score, and secondary efficacy measures of Modified Rankin Scores (mRS 0-2 and Rankin Shift). Safety outcomes included the primary measure of total Serious Adverse Events and additional measures including Mortality and Symptomatic Intracranial Hemorrhage.
A summary of trial results (based on odds ratio comparisons of treatment and control groups) follows:
-- Primary Endpoints:
-- Efficacy: 1.17 odds ratio in the NINDS Global Score; p-value of 0.407
-- Safety: Statistically equivalent rate in Serious Adverse Events
Secondary/Additional Efficacy Endpoints using the Dichotomized Modified Rankin 0-2 Score:
-- 1.34 odds ratio; p-value of .202 in the entire SENTIS population
-- 1.95 odds ratio; p-value of 0.085 in patients who presented within 6 hours of symptom onset
-- 2.02 odds ratio; p-value of 0.045 in patients over the age of 70
-- 1.80 odds ratio; p-value of 0.055 in patients who present with baseline NIHSS stroke scores of 8 - 14
Secondary/Additional Safety Endpoints:
-- An all-cause mortality reduction with a 1.56 odds ratio; p-value of 0.133
-- A stroke-related mortality reduction with a 2.31 odds ratio; p-value of 0.016
-- No statistically significant increase in Serious Symptomatic Intracranial Hemorrhage rate in treatment patients vs. controls
Professor Shuaib commented, "SENTIS is the first trial of an interventional device treatment which signals a long term patient benefit and strong safety in such a diverse patient group one which is representative of the stroke patients we clinicians see every day. I believe that the NeuroFlo technology represents a significant step forward in stroke treatment especially for the many stroke patients who have no treatment options today."
Ischemic stroke is one of the largest causes of death and disability in the western world, affecting over 650,000 patients annually and responsible for $70B in annual costs for the long term care of stroke-disabled patients in the United States alone. Whereas in the US less than 5% of ischemic stroke patients are treated acutely, CoAxia believes that the NeuroFlo technology has the potential to address a much larger portion of the stroke population a significant potential benefit to stroke patients and the healthcare system.
Andrew M. Weiss, President and CEO commented, "CoAxia is grateful for the participation of stroke teams from the US, Canada, Europe and Israel - for their help in conducting this ground-breaking trial. While SENTIS did not achieve statistical significance in its primary efficacy measure, its signals of safety, mortality reduction and long-term benefit in large, meaningful stroke populations is very encouraging, and we plan to pursue efforts which will allow use of the NeuroFlo catheter in acute stroke."
CoAxia, Inc. is a venture-backed, privately held, clinical-stage company focused on providing perfusion augmentation therapies that improve outcomes for patients with cerebral ischemia resulting from stroke, vasospasm and other conditions.
Source: CoAxia, Inc
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quarta-feira, 20 de outubro de 2010
BioSante Pharmaceuticals Reaches Key LibiGel(R) Safety Study Enrollment Targe
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced enrollment of the 2,500th woman in the LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study. This important enrollment milestone triggers the first unblinded statistical analysis of cardiovascular events by the independent Data Monitoring Committee (DMC), which coincides with their fourth unblinded review of all adverse events. LibiGel is being developed for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is currently no FDA approved product. BioSante anticipates the submission of a new drug application (NDA) for LibiGel in 2011.
The DMC's unblinded statistical analysis will determine whether the current study enrollment of 2,500 is sufficient to prove statistically the relative safety of LibiGel compared to placebo after an average of 12 months of exposure is reached, or if enrollment will continue. To date, there have been only 14 adjudicated cardiovascular (CV) events, a rate of approximately 0.65 percent, and only seven diagnoses of breast cancer, a rate of approximately 0.32 percent, after approximately 2,300 women-years of exposure in the study. BioSante will remain blinded as to the distribution of the reported safety events between the active and placebo study arms.
If enrollment continues beyond 2,500 women, an additional unblinded statistical analysis will be conducted by the DMC each time a new cardiovascular event is adjudicated. At each of these analyses the trial potentially could be fully enrolled. If enrollment is not completed sooner, enrollment will continue until the study reaches its predetermined maximum of 4,000 women.
"This milestone gives BioSante our first opportunity potentially to declare completion of enrollment in the safety study," stated Michael Snabes, M.D., Ph.D., BioSante's senior vice president of medical affairs. "We have had an extremely low number of cardiovascular and breast cancer events to date, as well as three previous favorable DMC recommendations. We expect the study to demonstrate the safety of LibiGel in the treated population, regardless of whether the DMC stops enrollment at 2,500 women or we need to continue enrollment."
About the LibiGel Phase III Cardiovascular and Breast Cancer Safety Study
The Phase III LibiGel safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that will enroll between 2,500 and 4,000 women. The study will continue for a total of five years, however, BioSante can use the safety study data as part of an NDA submission after an average of 12 month exposure to LibiGel or placebo. BioSante anticipates the submission of a new drug application (NDA) for LibiGel in 2011.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study.
About LibiGel®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). The on-going Phase III efficacy trials are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after a once-daily pea-sized application on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
Source:
BioSante Pharmaceuticals, Inc.
The DMC's unblinded statistical analysis will determine whether the current study enrollment of 2,500 is sufficient to prove statistically the relative safety of LibiGel compared to placebo after an average of 12 months of exposure is reached, or if enrollment will continue. To date, there have been only 14 adjudicated cardiovascular (CV) events, a rate of approximately 0.65 percent, and only seven diagnoses of breast cancer, a rate of approximately 0.32 percent, after approximately 2,300 women-years of exposure in the study. BioSante will remain blinded as to the distribution of the reported safety events between the active and placebo study arms.
If enrollment continues beyond 2,500 women, an additional unblinded statistical analysis will be conducted by the DMC each time a new cardiovascular event is adjudicated. At each of these analyses the trial potentially could be fully enrolled. If enrollment is not completed sooner, enrollment will continue until the study reaches its predetermined maximum of 4,000 women.
"This milestone gives BioSante our first opportunity potentially to declare completion of enrollment in the safety study," stated Michael Snabes, M.D., Ph.D., BioSante's senior vice president of medical affairs. "We have had an extremely low number of cardiovascular and breast cancer events to date, as well as three previous favorable DMC recommendations. We expect the study to demonstrate the safety of LibiGel in the treated population, regardless of whether the DMC stops enrollment at 2,500 women or we need to continue enrollment."
About the LibiGel Phase III Cardiovascular and Breast Cancer Safety Study
The Phase III LibiGel safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that will enroll between 2,500 and 4,000 women. The study will continue for a total of five years, however, BioSante can use the safety study data as part of an NDA submission after an average of 12 month exposure to LibiGel or placebo. BioSante anticipates the submission of a new drug application (NDA) for LibiGel in 2011.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study.
About LibiGel®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). The on-going Phase III efficacy trials are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after a once-daily pea-sized application on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
Source:
BioSante Pharmaceuticals, Inc.
Ceregene Initiates A New Controlled Phase 2b Trial Of CERE-120 For Parkinson's Disease
Ceregene, Inc., a biopharmaceutical company, announced that enrollment has begun in a new double-blind sham surgery-controlled Phase 2b study evaluating CERE-120 in Parkinson's disease patients. CERE-120 is a gene therapy product that delivers the neurotrophic factor neurturin to degenerating or dying dopamine neurons. Data from the first Phase 2 clinical trial of CERE-120 are being published later this year in Lancet Neurology (to appear online October 21, 2010).
The launch of Phase 2 follows a fully enrolled Phase 1 portion that demonstrated early safety using an enhanced CERE-120 dosing regimen targeting the substantia nigra and putamen, two brain areas especially affected by Parkinson's disease. This study is enrolling at 11 major medical centers throughout the United States and includes investigators Drs. Mark Stacy and Dennis Turner at Duke University School of Medicine, Drs. Catherine Cho and Ron Alterman at Mount Sinai Medical Center, New York, and Drs. Stewart Factor and Nicholas Boulis at Emory University Hospital, who were all involved in treating the patients in the Phase 1 portion of this study.
Additional clinical sites include Columbia University Medical Center, NYC, NY; Beth Israel Medical Center, NYC, NY; University of Pennsylvania Hospital, Philadelphia, PA; University of Alabama, Birmingham, AL; Rush University Medical Center, Chicago, IL; Baylor College of Medicine, Houston, TX; University of California, San Francisco, CA and Stanford University School of Medicine, Palo Alto, CA.
"We are proud to play a key role in this potentially high-impact project," said Todd Sherer, Ph.D., vice president of research programs at The Michael J. Fox Foundation. "The Foundation continues to believe that trophic factors hold enormous potential to become transformative therapeutics for people with Parkinson's."
The first Phase 2 clinical trial of CERE-120, completed in November 2008, did not meet its pre-designated primary endpoint (Unified Parkinson's Disease Rating Scale- Motor Off at 12 months) although a clinically modest benefit was seen in improving motor performance and quality of life in Parkinson's disease patients, based on statistically significant differences in several secondary endpoints. Even greater improvement was seen following an analysis of all patients who were assessed under blinded conditions at 15 to 18 months post-treatment, including on the primary measure (UPDRS motor off at 18 months, p=0.025). Importantly, new scientific insight regarding degenerating dopamine neurons in the brains of advanced Parkinson's disease patients was gained from CERE-120-treated patients who died of unrelated causes, combined with the clinical results, led to important changes in CERE-120 dosing intended to significantly enhance its bioactivity and response to treatment. This revised dosing paradigm now targets both the terminals (or nerve endings) of the degenerating neurons in a site in the brain called the putamen, as well as the cell bodies of these neurons, located in another brain region called the substantia nigra.
"We are pleased to initiate a new controlled Phase 2b study that is statistically powered to demonstrate the efficacy of CERE-120," stated Jeffrey M. Ostrove, Ph.D., president and chief executive officer of Ceregene. "We continue to strongly believe that CERE-120 has the potential to improve the symptoms of Parkinson's disease while also delaying further disease progression, and may therefore represent a significant advancement in the treatment of patients for whom existing treatments inevitably fail as their disease progresses."
"This new, improved dosing approach we have developed to account for functional changes in Parkinson's disease neurons should assure that adequate neurturin protein is expressed throughout the degenerating nigrostriatal system. Our nonclinical studies suggest this may significantly enhance the biological effects and therefore the clinical benefit of CERE-120," stated Raymond T. Bartus, Ph.D., Ceregene's executive vice president and chief scientific officer.
"The revised CERE-120 dosing procedure appears safe, to date, and our investigators have been able to implement the dosing protocol with no surgical complications," added Joao Siffert, M.D., vice president and chief medical officer at Ceregene.
About CERE-120 and its Potential for Treating Parkinson's Disease
CERE-120 is composed of an adeno-associated virus (AAV) vector carrying the gene for neurturin, a naturally occurring protein known to repair damaged and dying dopamine-secreting neurons, keeping them alive and restoring normal function. Neurturin is a member of the same protein family as glial cell-derived neurotrophic factor (GDNF). The two molecules have similar pharmacological properties, and both have been shown to benefit the dopamine neurons in the substantia nigra that degenerate in Parkinson's disease. Degeneration of these neurons is responsible for the major motor impairments of Parkinson's disease. CERE-120 has been delivered by stereotactic injection to the terminal fields, i.e., the ends of the degenerating neurons, located in an area of the brain called the putamen. The cell bodies for these same neurons are located in a different area of the brain, called the substantia nigra, and the amended dosing regimen being employed in the ongoing Phase 2b trial calls for administration of CERE-120 to both the substantia nigra as well as the putamen. Once CERE-120 is delivered to the brain, it provides stable, long-lasting expression of neurturin in a highly targeted fashion.
About Parkinson's Disease
Parkinson's disease is a progressive movement disorder that affects a million people in the United States. Its main symptoms, stiffness, tremors and slowed movements and gait, are caused by a loss of dopamine-containing nerve cells in the substantia nigra, which project their axons to the putamen. Dopamine is a neurotransmitter involved in controlling movement and coordination, so Parkinson's patients exhibit a progressive inability to initiate and control physical movements. There is currently no treatment that can reverse the degeneration of these neurons, let alone cure Parkinson's disease.
Source: Ceregene, Inc
The launch of Phase 2 follows a fully enrolled Phase 1 portion that demonstrated early safety using an enhanced CERE-120 dosing regimen targeting the substantia nigra and putamen, two brain areas especially affected by Parkinson's disease. This study is enrolling at 11 major medical centers throughout the United States and includes investigators Drs. Mark Stacy and Dennis Turner at Duke University School of Medicine, Drs. Catherine Cho and Ron Alterman at Mount Sinai Medical Center, New York, and Drs. Stewart Factor and Nicholas Boulis at Emory University Hospital, who were all involved in treating the patients in the Phase 1 portion of this study.
Additional clinical sites include Columbia University Medical Center, NYC, NY; Beth Israel Medical Center, NYC, NY; University of Pennsylvania Hospital, Philadelphia, PA; University of Alabama, Birmingham, AL; Rush University Medical Center, Chicago, IL; Baylor College of Medicine, Houston, TX; University of California, San Francisco, CA and Stanford University School of Medicine, Palo Alto, CA.
"We are proud to play a key role in this potentially high-impact project," said Todd Sherer, Ph.D., vice president of research programs at The Michael J. Fox Foundation. "The Foundation continues to believe that trophic factors hold enormous potential to become transformative therapeutics for people with Parkinson's."
The first Phase 2 clinical trial of CERE-120, completed in November 2008, did not meet its pre-designated primary endpoint (Unified Parkinson's Disease Rating Scale- Motor Off at 12 months) although a clinically modest benefit was seen in improving motor performance and quality of life in Parkinson's disease patients, based on statistically significant differences in several secondary endpoints. Even greater improvement was seen following an analysis of all patients who were assessed under blinded conditions at 15 to 18 months post-treatment, including on the primary measure (UPDRS motor off at 18 months, p=0.025). Importantly, new scientific insight regarding degenerating dopamine neurons in the brains of advanced Parkinson's disease patients was gained from CERE-120-treated patients who died of unrelated causes, combined with the clinical results, led to important changes in CERE-120 dosing intended to significantly enhance its bioactivity and response to treatment. This revised dosing paradigm now targets both the terminals (or nerve endings) of the degenerating neurons in a site in the brain called the putamen, as well as the cell bodies of these neurons, located in another brain region called the substantia nigra.
"We are pleased to initiate a new controlled Phase 2b study that is statistically powered to demonstrate the efficacy of CERE-120," stated Jeffrey M. Ostrove, Ph.D., president and chief executive officer of Ceregene. "We continue to strongly believe that CERE-120 has the potential to improve the symptoms of Parkinson's disease while also delaying further disease progression, and may therefore represent a significant advancement in the treatment of patients for whom existing treatments inevitably fail as their disease progresses."
"This new, improved dosing approach we have developed to account for functional changes in Parkinson's disease neurons should assure that adequate neurturin protein is expressed throughout the degenerating nigrostriatal system. Our nonclinical studies suggest this may significantly enhance the biological effects and therefore the clinical benefit of CERE-120," stated Raymond T. Bartus, Ph.D., Ceregene's executive vice president and chief scientific officer.
"The revised CERE-120 dosing procedure appears safe, to date, and our investigators have been able to implement the dosing protocol with no surgical complications," added Joao Siffert, M.D., vice president and chief medical officer at Ceregene.
About CERE-120 and its Potential for Treating Parkinson's Disease
CERE-120 is composed of an adeno-associated virus (AAV) vector carrying the gene for neurturin, a naturally occurring protein known to repair damaged and dying dopamine-secreting neurons, keeping them alive and restoring normal function. Neurturin is a member of the same protein family as glial cell-derived neurotrophic factor (GDNF). The two molecules have similar pharmacological properties, and both have been shown to benefit the dopamine neurons in the substantia nigra that degenerate in Parkinson's disease. Degeneration of these neurons is responsible for the major motor impairments of Parkinson's disease. CERE-120 has been delivered by stereotactic injection to the terminal fields, i.e., the ends of the degenerating neurons, located in an area of the brain called the putamen. The cell bodies for these same neurons are located in a different area of the brain, called the substantia nigra, and the amended dosing regimen being employed in the ongoing Phase 2b trial calls for administration of CERE-120 to both the substantia nigra as well as the putamen. Once CERE-120 is delivered to the brain, it provides stable, long-lasting expression of neurturin in a highly targeted fashion.
About Parkinson's Disease
Parkinson's disease is a progressive movement disorder that affects a million people in the United States. Its main symptoms, stiffness, tremors and slowed movements and gait, are caused by a loss of dopamine-containing nerve cells in the substantia nigra, which project their axons to the putamen. Dopamine is a neurotransmitter involved in controlling movement and coordination, so Parkinson's patients exhibit a progressive inability to initiate and control physical movements. There is currently no treatment that can reverse the degeneration of these neurons, let alone cure Parkinson's disease.
Source: Ceregene, Inc
terça-feira, 19 de outubro de 2010
Estudo indica que DIU pode servir para tratar cancêr do endométrio
Dispositivos intrauterinos (DIUs), originalmente concebidos como contraceptivos, poderão ser usados para tratar e mesmo curar o câncer de endométrio, de acordo com um estudo italiano publicado on-line no periódico especializado Annals of Oncology no fim de setembro. A descoberta abre caminho para jovens mulheres que têm a doença, para quem a histerectomia significa o fim do sonho de ser mãe.
Um grupo de pesquisadores do Instituto Europeu de Oncologia, em Milão, descobriu que a aplicação do DIU, que libera progesterona sintética dentro do útero, combinado com uma injeção mensal do hormônio GnRH, durante um semestre, pode deter e reverter o crescimento do tumor em mulheres com menos de 40 anos. A progesterona sintética inibe o crescimento do tecido endometrial do útero, enquanto o GnRH interrompe a produção do estrogêneo, hormônio associado ao desenvolvimento do câncer de endométrio.
O estudo, porém, só foi realizado com mulheres com hiperplasia endometrial atípica, doença precursora do câncer, ou com tumor em estágio inicial, quando ainda não se espalhou para fora do endométrio. Entre 1996 e 2009, 39 pacientes entre 20 e 40 anos foram tratadas sendo que 34 mostraram-se aptas para participar do teste.
O DIU foi implantado durante um ano e, à medida que o câncer não cresceu ou diminuiu, os médicos retiraram o dispositivo, permitindo que as mulheres pudessem planejar uma gravidez. Depois da retirada do DIU, os pesquisadores acompanharam as pacientes a cada seis meses para checar se o câncer não havia voltado. Uma vez que satisfizeram o desejo de serem mães — não apenas uma vez, mas quantas vezes quiseram —, as pacientes foram, finalmente, submetidas à retirada do útero, para evitar que o tumor voltasse a longo prazo.
Das 20 pacientes com hiperplasia endometrial atípica, 95% responderam bem ao início do tratamento, embora quatro tenham piorado depois e voltado à terapia. Das 14 no estágio inicial do câncer, 57,1% tiveram resposta completamente positiva, 28% sofreram com a progressão da doença e duas pacientes que inicialmente foram bem pioraram depois. Ao fim da pesquisa, todas as mulheres continuavam vivas. Nove tiveram, ao todo, 11 gestações, e nove bebês nasceram.
Um grupo de pesquisadores do Instituto Europeu de Oncologia, em Milão, descobriu que a aplicação do DIU, que libera progesterona sintética dentro do útero, combinado com uma injeção mensal do hormônio GnRH, durante um semestre, pode deter e reverter o crescimento do tumor em mulheres com menos de 40 anos. A progesterona sintética inibe o crescimento do tecido endometrial do útero, enquanto o GnRH interrompe a produção do estrogêneo, hormônio associado ao desenvolvimento do câncer de endométrio.
O estudo, porém, só foi realizado com mulheres com hiperplasia endometrial atípica, doença precursora do câncer, ou com tumor em estágio inicial, quando ainda não se espalhou para fora do endométrio. Entre 1996 e 2009, 39 pacientes entre 20 e 40 anos foram tratadas sendo que 34 mostraram-se aptas para participar do teste.
O DIU foi implantado durante um ano e, à medida que o câncer não cresceu ou diminuiu, os médicos retiraram o dispositivo, permitindo que as mulheres pudessem planejar uma gravidez. Depois da retirada do DIU, os pesquisadores acompanharam as pacientes a cada seis meses para checar se o câncer não havia voltado. Uma vez que satisfizeram o desejo de serem mães — não apenas uma vez, mas quantas vezes quiseram —, as pacientes foram, finalmente, submetidas à retirada do útero, para evitar que o tumor voltasse a longo prazo.
Das 20 pacientes com hiperplasia endometrial atípica, 95% responderam bem ao início do tratamento, embora quatro tenham piorado depois e voltado à terapia. Das 14 no estágio inicial do câncer, 57,1% tiveram resposta completamente positiva, 28% sofreram com a progressão da doença e duas pacientes que inicialmente foram bem pioraram depois. Ao fim da pesquisa, todas as mulheres continuavam vivas. Nove tiveram, ao todo, 11 gestações, e nove bebês nasceram.
“O uso do dispositivo intrauterino nos permite enviar uma dose muito maior da progesterona sintética à superfície do endométrio do que seria possível por meio de uma pílula. “Acreditamos que esse é o tratamento ideal para jovens pacientes que podem não querer crianças imediatamente, mas gostariam de engravidar no futuro”, disse um dos autores do estudo, Lucas Minig.
Fonte: Correio Braziliense
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