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Brussels, Belgium
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WATERTOWN, Mass., May 11, 2017 (GLOBE NEWSWIRE) -- Selecta Biosciences, Inc. (NASDAQ:SELB) today announced that patient dosing has commenced in a Phase 1 clinical trial to assess the safety, tolerability and pharmacodynamic profile of SELA-070, a nicotine vaccine candidate in development for smoking cessation and relapse prevention. The project is being funded primarily by an $8 million grant (#U01DA037592) from the National Institute on Drug Abuse (NIDA), part of NIH. Selecta’s Synthetic Vaccine Particles (SVP™) technology is designed to be a versatile platform and is being utilized in a series of programs aimed at inducing either antigen-specific immune tolerance or immune stimulation. SELA-070, an immune stimulation product candidate, delivers nicotine conjugated to the surface of nanoparticles that encapsulate immune stimulating agents. This second-generation product candidate is intended to induce a strong and durable immune response by triggering the production of a high level of anti-nicotine antibodies that bind to the nicotine inhaled by smokers, thus preventing nicotine from crossing the blood-brain barrier and triggering an addictive response. “Smoking continues to profoundly impact our society and remains as one of our greatest public health challenges,” said Werner Cautreels, Ph.D., CEO and Chairman of Selecta. “We are very proud and motivated to be teaming with NIDA on this trial to determine if SELA-070 might benefit the millions of smokers in the U.S. and worldwide who are seeking ways to overcome their addiction and improve their health.” Approved by the Federal Agency for Medicines and Health Products in Belgium, the Phase 1 trial is a double-blind, placebo-controlled, dose escalation study that is expected to enroll 48 smokers in Belgium. Patients will receive three injections of SELA-070 or a placebo over a period of 12 weeks followed by 8 weeks of monitoring. In addition to safety, the study will evaluate the vaccine’s potency through the measurement of concentrations of nicotine-specific antibodies. The Need for Smoking Cessation and Relapse Prevention Treatments According to Centers for Disease Control and Prevention (CDC), smoking causes 6 million deaths per year worldwide, and this figure is expected to increase to 8 million per year by 2030. For 2015, CDC estimated that: The CDC also reported in 2015 that 68% of U.S. smokers expressed interest in quitting, 55% had attempted to quit within the past year but only 7.4% were successful, demonstrating the need for additional and more effective treatment options. Selecta Biosciences, Inc. is a clinical-stage biopharmaceutical company that is focused on unlocking the full potential of biologic therapies by avoiding unwanted immune responses. Selecta plans to combine its tolerogenic Synthetic Vaccine Particles (SVP™) to a range of biologics for rare and serious diseases that require new treatment options. The company’s current proprietary pipeline includes SVP-enabled enzyme, oncology and gene therapies. SEL-212, the company’s lead candidate in Phase 2, is being developed to treat severe gout patients and resolve their debilitating symptoms, including flares and gouty arthritis. Selecta’s clinical oncology candidate, LMB-100, is in a Phase 1 program targeting pancreatic cancer and mesothelioma. Its two proprietary gene therapy product candidates are being developed for rare inborn errors of metabolism and have the potential to enable repeat administration. The use of SVP is also being explored in the development of vaccines and treatments for allergies and autoimmune diseases. Selecta is based in Watertown, Massachusetts. For more information, please visit http://selectabio.com and follow @SelectaBio on Twitter. Forward-Looking Statements Any statements in this press release about the future expectations, plans and prospects of Selecta Biosciences, Inc. (“the company”), including without limitation, the progress of the Phase I trial for SELA-070, statements regarding the ability of SELA-070 to achieve smoking cessation and relapse prevention, whether SELA-070 will induce a strong and durable immune response in smokers, whether SELA-070 triggers the production of a high level of anti-nicotine antibodies and ultimately prevents nicotine from crossing the blood-brain barrier, the company’s ability to unlock the full potential of biologic therapies, the company’s plan to apply its SVP platform to a range of biologics for rare and serious diseases, the potential treatment applications for products utilizing the SVP platform in areas such as enzyme therapy, gene therapy, oncology therapy, vaccines and treatments for allergies and autoimmune diseases, the potential of SEL-212 to treat severe gout patients and resolve their debilitating symptoms, the potential of the company’s two gene therapy product candidates to enable repeat administration, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including their uncertain outcomes, the unproven approach of the company’s SVP technology, undesirable side effects of the company’s product candidates, its reliance on third parties to manufacture its product candidates and to conduct its clinical trials, the company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, substantial fluctuation in the price of its common stock, a significant portion of the company’s total outstanding shares have recently become eligible to be sold into the market, and other important factors discussed in the “Risk Factors” section of the company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 28, 2017, and in other filings that the company makes with the SEC. In addition, any forward-looking statements included in this press release represent the company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The company specifically disclaims any obligation to update any forward-looking statements included in this press release.


WATERTOWN, Mass., May 11, 2017 (GLOBE NEWSWIRE) -- Selecta Biosciences, Inc. (NASDAQ:SELB) today announced that patient dosing has commenced in a Phase 1 clinical trial to assess the safety, tolerability and pharmacodynamic profile of SELA-070, a nicotine vaccine candidate in development for smoking cessation and relapse prevention. The project is being funded primarily by an $8 million grant (#U01DA037592) from the National Institute on Drug Abuse (NIDA), part of NIH. Selecta’s Synthetic Vaccine Particles (SVP™) technology is designed to be a versatile platform and is being utilized in a series of programs aimed at inducing either antigen-specific immune tolerance or immune stimulation. SELA-070, an immune stimulation product candidate, delivers nicotine conjugated to the surface of nanoparticles that encapsulate immune stimulating agents. This second-generation product candidate is intended to induce a strong and durable immune response by triggering the production of a high level of anti-nicotine antibodies that bind to the nicotine inhaled by smokers, thus preventing nicotine from crossing the blood-brain barrier and triggering an addictive response. “Smoking continues to profoundly impact our society and remains as one of our greatest public health challenges,” said Werner Cautreels, Ph.D., CEO and Chairman of Selecta. “We are very proud and motivated to be teaming with NIDA on this trial to determine if SELA-070 might benefit the millions of smokers in the U.S. and worldwide who are seeking ways to overcome their addiction and improve their health.” Approved by the Federal Agency for Medicines and Health Products in Belgium, the Phase 1 trial is a double-blind, placebo-controlled, dose escalation study that is expected to enroll 48 smokers in Belgium. Patients will receive three injections of SELA-070 or a placebo over a period of 12 weeks followed by 8 weeks of monitoring. In addition to safety, the study will evaluate the vaccine’s potency through the measurement of concentrations of nicotine-specific antibodies. The Need for Smoking Cessation and Relapse Prevention Treatments According to Centers for Disease Control and Prevention (CDC), smoking causes 6 million deaths per year worldwide, and this figure is expected to increase to 8 million per year by 2030. For 2015, CDC estimated that: The CDC also reported in 2015 that 68% of U.S. smokers expressed interest in quitting, 55% had attempted to quit within the past year but only 7.4% were successful, demonstrating the need for additional and more effective treatment options. Selecta Biosciences, Inc. is a clinical-stage biopharmaceutical company that is focused on unlocking the full potential of biologic therapies by avoiding unwanted immune responses. Selecta plans to combine its tolerogenic Synthetic Vaccine Particles (SVP™) to a range of biologics for rare and serious diseases that require new treatment options. The company’s current proprietary pipeline includes SVP-enabled enzyme, oncology and gene therapies. SEL-212, the company’s lead candidate in Phase 2, is being developed to treat severe gout patients and resolve their debilitating symptoms, including flares and gouty arthritis. Selecta’s clinical oncology candidate, LMB-100, is in a Phase 1 program targeting pancreatic cancer and mesothelioma. Its two proprietary gene therapy product candidates are being developed for rare inborn errors of metabolism and have the potential to enable repeat administration. The use of SVP is also being explored in the development of vaccines and treatments for allergies and autoimmune diseases. Selecta is based in Watertown, Massachusetts. For more information, please visit http://selectabio.com and follow @SelectaBio on Twitter. Forward-Looking Statements Any statements in this press release about the future expectations, plans and prospects of Selecta Biosciences, Inc. (“the company”), including without limitation, the progress of the Phase I trial for SELA-070, statements regarding the ability of SELA-070 to achieve smoking cessation and relapse prevention, whether SELA-070 will induce a strong and durable immune response in smokers, whether SELA-070 triggers the production of a high level of anti-nicotine antibodies and ultimately prevents nicotine from crossing the blood-brain barrier, the company’s ability to unlock the full potential of biologic therapies, the company’s plan to apply its SVP platform to a range of biologics for rare and serious diseases, the potential treatment applications for products utilizing the SVP platform in areas such as enzyme therapy, gene therapy, oncology therapy, vaccines and treatments for allergies and autoimmune diseases, the potential of SEL-212 to treat severe gout patients and resolve their debilitating symptoms, the potential of the company’s two gene therapy product candidates to enable repeat administration, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including their uncertain outcomes, the unproven approach of the company’s SVP technology, undesirable side effects of the company’s product candidates, its reliance on third parties to manufacture its product candidates and to conduct its clinical trials, the company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, substantial fluctuation in the price of its common stock, a significant portion of the company’s total outstanding shares have recently become eligible to be sold into the market, and other important factors discussed in the “Risk Factors” section of the company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 28, 2017, and in other filings that the company makes with the SEC. In addition, any forward-looking statements included in this press release represent the company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The company specifically disclaims any obligation to update any forward-looking statements included in this press release.


WATERTOWN, Mass., May 11, 2017 (GLOBE NEWSWIRE) -- Selecta Biosciences, Inc. (NASDAQ:SELB) today announced that patient dosing has commenced in a Phase 1 clinical trial to assess the safety, tolerability and pharmacodynamic profile of SELA-070, a nicotine vaccine candidate in development for smoking cessation and relapse prevention. The project is being funded primarily by an $8 million grant (#U01DA037592) from the National Institute on Drug Abuse (NIDA), part of NIH. Selecta’s Synthetic Vaccine Particles (SVP™) technology is designed to be a versatile platform and is being utilized in a series of programs aimed at inducing either antigen-specific immune tolerance or immune stimulation. SELA-070, an immune stimulation product candidate, delivers nicotine conjugated to the surface of nanoparticles that encapsulate immune stimulating agents. This second-generation product candidate is intended to induce a strong and durable immune response by triggering the production of a high level of anti-nicotine antibodies that bind to the nicotine inhaled by smokers, thus preventing nicotine from crossing the blood-brain barrier and triggering an addictive response. “Smoking continues to profoundly impact our society and remains as one of our greatest public health challenges,” said Werner Cautreels, Ph.D., CEO and Chairman of Selecta. “We are very proud and motivated to be teaming with NIDA on this trial to determine if SELA-070 might benefit the millions of smokers in the U.S. and worldwide who are seeking ways to overcome their addiction and improve their health.” Approved by the Federal Agency for Medicines and Health Products in Belgium, the Phase 1 trial is a double-blind, placebo-controlled, dose escalation study that is expected to enroll 48 smokers in Belgium. Patients will receive three injections of SELA-070 or a placebo over a period of 12 weeks followed by 8 weeks of monitoring. In addition to safety, the study will evaluate the vaccine’s potency through the measurement of concentrations of nicotine-specific antibodies. The Need for Smoking Cessation and Relapse Prevention Treatments According to Centers for Disease Control and Prevention (CDC), smoking causes 6 million deaths per year worldwide, and this figure is expected to increase to 8 million per year by 2030. For 2015, CDC estimated that: The CDC also reported in 2015 that 68% of U.S. smokers expressed interest in quitting, 55% had attempted to quit within the past year but only 7.4% were successful, demonstrating the need for additional and more effective treatment options. Selecta Biosciences, Inc. is a clinical-stage biopharmaceutical company that is focused on unlocking the full potential of biologic therapies by avoiding unwanted immune responses. Selecta plans to combine its tolerogenic Synthetic Vaccine Particles (SVP™) to a range of biologics for rare and serious diseases that require new treatment options. The company’s current proprietary pipeline includes SVP-enabled enzyme, oncology and gene therapies. SEL-212, the company’s lead candidate in Phase 2, is being developed to treat severe gout patients and resolve their debilitating symptoms, including flares and gouty arthritis. Selecta’s clinical oncology candidate, LMB-100, is in a Phase 1 program targeting pancreatic cancer and mesothelioma. Its two proprietary gene therapy product candidates are being developed for rare inborn errors of metabolism and have the potential to enable repeat administration. The use of SVP is also being explored in the development of vaccines and treatments for allergies and autoimmune diseases. Selecta is based in Watertown, Massachusetts. For more information, please visit http://selectabio.com and follow @SelectaBio on Twitter. Forward-Looking Statements Any statements in this press release about the future expectations, plans and prospects of Selecta Biosciences, Inc. (“the company”), including without limitation, the progress of the Phase I trial for SELA-070, statements regarding the ability of SELA-070 to achieve smoking cessation and relapse prevention, whether SELA-070 will induce a strong and durable immune response in smokers, whether SELA-070 triggers the production of a high level of anti-nicotine antibodies and ultimately prevents nicotine from crossing the blood-brain barrier, the company’s ability to unlock the full potential of biologic therapies, the company’s plan to apply its SVP platform to a range of biologics for rare and serious diseases, the potential treatment applications for products utilizing the SVP platform in areas such as enzyme therapy, gene therapy, oncology therapy, vaccines and treatments for allergies and autoimmune diseases, the potential of SEL-212 to treat severe gout patients and resolve their debilitating symptoms, the potential of the company’s two gene therapy product candidates to enable repeat administration, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including their uncertain outcomes, the unproven approach of the company’s SVP technology, undesirable side effects of the company’s product candidates, its reliance on third parties to manufacture its product candidates and to conduct its clinical trials, the company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, substantial fluctuation in the price of its common stock, a significant portion of the company’s total outstanding shares have recently become eligible to be sold into the market, and other important factors discussed in the “Risk Factors” section of the company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 28, 2017, and in other filings that the company makes with the SEC. In addition, any forward-looking statements included in this press release represent the company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The company specifically disclaims any obligation to update any forward-looking statements included in this press release.


WATERTOWN, Mass., May 11, 2017 (GLOBE NEWSWIRE) -- Selecta Biosciences, Inc. (NASDAQ:SELB) today announced that patient dosing has commenced in a Phase 1 clinical trial to assess the safety, tolerability and pharmacodynamic profile of SELA-070, a nicotine vaccine candidate in development for smoking cessation and relapse prevention. The project is being funded primarily by an $8 million grant (#U01DA037592) from the National Institute on Drug Abuse (NIDA), part of NIH. Selecta’s Synthetic Vaccine Particles (SVP™) technology is designed to be a versatile platform and is being utilized in a series of programs aimed at inducing either antigen-specific immune tolerance or immune stimulation. SELA-070, an immune stimulation product candidate, delivers nicotine conjugated to the surface of nanoparticles that encapsulate immune stimulating agents. This second-generation product candidate is intended to induce a strong and durable immune response by triggering the production of a high level of anti-nicotine antibodies that bind to the nicotine inhaled by smokers, thus preventing nicotine from crossing the blood-brain barrier and triggering an addictive response. “Smoking continues to profoundly impact our society and remains as one of our greatest public health challenges,” said Werner Cautreels, Ph.D., CEO and Chairman of Selecta. “We are very proud and motivated to be teaming with NIDA on this trial to determine if SELA-070 might benefit the millions of smokers in the U.S. and worldwide who are seeking ways to overcome their addiction and improve their health.” Approved by the Federal Agency for Medicines and Health Products in Belgium, the Phase 1 trial is a double-blind, placebo-controlled, dose escalation study that is expected to enroll 48 smokers in Belgium. Patients will receive three injections of SELA-070 or a placebo over a period of 12 weeks followed by 8 weeks of monitoring. In addition to safety, the study will evaluate the vaccine’s potency through the measurement of concentrations of nicotine-specific antibodies. The Need for Smoking Cessation and Relapse Prevention Treatments According to Centers for Disease Control and Prevention (CDC), smoking causes 6 million deaths per year worldwide, and this figure is expected to increase to 8 million per year by 2030. For 2015, CDC estimated that: The CDC also reported in 2015 that 68% of U.S. smokers expressed interest in quitting, 55% had attempted to quit within the past year but only 7.4% were successful, demonstrating the need for additional and more effective treatment options. Selecta Biosciences, Inc. is a clinical-stage biopharmaceutical company that is focused on unlocking the full potential of biologic therapies by avoiding unwanted immune responses. Selecta plans to combine its tolerogenic Synthetic Vaccine Particles (SVP™) to a range of biologics for rare and serious diseases that require new treatment options. The company’s current proprietary pipeline includes SVP-enabled enzyme, oncology and gene therapies. SEL-212, the company’s lead candidate in Phase 2, is being developed to treat severe gout patients and resolve their debilitating symptoms, including flares and gouty arthritis. Selecta’s clinical oncology candidate, LMB-100, is in a Phase 1 program targeting pancreatic cancer and mesothelioma. Its two proprietary gene therapy product candidates are being developed for rare inborn errors of metabolism and have the potential to enable repeat administration. The use of SVP is also being explored in the development of vaccines and treatments for allergies and autoimmune diseases. Selecta is based in Watertown, Massachusetts. For more information, please visit http://selectabio.com and follow @SelectaBio on Twitter. Forward-Looking Statements Any statements in this press release about the future expectations, plans and prospects of Selecta Biosciences, Inc. (“the company”), including without limitation, the progress of the Phase I trial for SELA-070, statements regarding the ability of SELA-070 to achieve smoking cessation and relapse prevention, whether SELA-070 will induce a strong and durable immune response in smokers, whether SELA-070 triggers the production of a high level of anti-nicotine antibodies and ultimately prevents nicotine from crossing the blood-brain barrier, the company’s ability to unlock the full potential of biologic therapies, the company’s plan to apply its SVP platform to a range of biologics for rare and serious diseases, the potential treatment applications for products utilizing the SVP platform in areas such as enzyme therapy, gene therapy, oncology therapy, vaccines and treatments for allergies and autoimmune diseases, the potential of SEL-212 to treat severe gout patients and resolve their debilitating symptoms, the potential of the company’s two gene therapy product candidates to enable repeat administration, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including their uncertain outcomes, the unproven approach of the company’s SVP technology, undesirable side effects of the company’s product candidates, its reliance on third parties to manufacture its product candidates and to conduct its clinical trials, the company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, substantial fluctuation in the price of its common stock, a significant portion of the company’s total outstanding shares have recently become eligible to be sold into the market, and other important factors discussed in the “Risk Factors” section of the company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 28, 2017, and in other filings that the company makes with the SEC. In addition, any forward-looking statements included in this press release represent the company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The company specifically disclaims any obligation to update any forward-looking statements included in this press release.


Weise M.,Bundesinstitut For Arzneimittel Und Medizinprodukte | Bielsky M.-C.,Medicines and Healthcare Products Regulatory Agency | De Smet K.,Federal Agency for Medicines and Health Products | Ehmann F.,European Medicines Agency | And 16 more authors.
Blood | Year: 2012

Biosimilar medicinal products (biosimilars) have become a reality in the European Union and will soon be available in the United States. Despite an established legal pathway for biosimilars in the European Union since 2005 and increasing and detailed regulatory guidance on data requirements for their development and licensing, many clinicians, particularly oncologists, are reluctant to consider biosimilars as a treatment option for their patients. Major concerns voiced about biosimilars relate to their pharmaceutical quality, safety (especially immunogenicity), efficacy (particularly in extrapolated indications), and interchangeability with the originator product. In this article, the members and experts of the Working Party on Similar Biologic Medicinal Products of the European Medicines Agency (EMA) address these issues. A clear understanding of the scientific principles of the biosimilar concept and access to unbiased information on licensed biosimilars are important for physicians to make informed and appropriate treatment choices for their patients. This will become even more important with the advent of biosimilar monoclonal antibodies. The issues also highlight the need for improved communication between physicians, learned societies, and regulators. © 2012 by The American Society of Hematology.


Hinsenkamp M.,Brussels University | Muylle L.,University of Antwerp | Muylle L.,Federal Agency for Medicines and Health Products | Eastlund T.,University of New Mexico | And 3 more authors.
International Orthopaedics | Year: 2012

Purpose: The use of bone and connective tissue allografts has grown rapidly and surpassed the use of autografts in many countries. Being of human origin, bone and tendon allografts carry the risk of disease transmission and complications have been reported. As part of the Project NOTIFY led by the World Health Organisation, an effort to improve recognition, reporting, tracking and investigation of adverse outcomes of allografts was initiated, achieving a comprehensive review of associated disease transmission and failures. Those involving the use of musculoskeletal allografts are reported here. A major objective is to involve orthopaedic surgeons in the improvement of the safe use of the musculoskeletal allografts. Methods: We reviewed the medical literature, requested reports from surgeons in selected professional organisations and informally surveyed tissue bank organisations and selected tissue bank professionals to discover reported and unreported cases of adverse outcomes. We analysed each case to decide the likelihood that the complication was truly allograft related. Results: The efficiency of the procedures involved in bone banking and bone and tendon allograft has improved significantly during the last three decades. The evolution of the incidence of reported adverse reactions and events reflects positively on the safety of transplanted tissues. Cases of bacterial and viral transmission by bone and tendon allografts occurred mainly with those that contained viable cells, were not processed to remove cells, or were not disinfected or sterilised. We documented cases of transmission of human immunodeficiency virus (HIV), hepatitis C virus (HCV), human T-lymphotropic virus (HTLV), unspecified hepatitis, tuberculosis and other bacteria. Reporting of these adverse outcomes has led to corrective actions and has significantly improved the safety of allograft use. However, it is probable that not all cases have been reported and investigated. Conclusions: Considering the high quality standards achieved in many countries, the best approach for further improvement in the safety of allografts is through a systematic reporting of all serious adverse reactions and events in the context of a global biovigilance programme. © 2011 Springer-Verlag.


Pauwels E.,Ghent University | Claeys D.,Ghent University | Claeys D.,Federal Agency for Medicines and Health Products | Martins J.C.,Ghent University | And 4 more authors.
RSC Advances | Year: 2013

Structural analysis of modified DNA with NMR is becoming ever more difficult with increasingly complex compounds under scrutiny for use in medical diagnosis, therapeutics, material science and chemical synthesis. To facilitate this process, we developed a molecular modeling approach to predict proton chemical shifts in sufficient agreement with experimental NMR measurements to guide structure elucidation. It relies on a QM/MM partitioning scheme and first principle calculations to predict the spatial structure and calculate corresponding proton chemical shifts. It is shown that molecular dynamics simulations that take into account solvent and temperature effects properly are of utmost importance to sample the conformational space sufficiently. The proposed computational procedure is applicable to modified oligonucleotides and DNA, attaining a mean error for the proton chemical shifts of less than 0.2 ppm. Here, it is applied on the Drew-Dickerson d(CGCGAATTCGCG)2 dodecamer as a benchmark system and the mispair-aligned N3T-ethyl-N 3T cross-linked d(CGAAAT*TTTCG)2 undecamer, illustrating its use as computational tool to assist in structure elucidation. For the proton chemical shifts in the cross-linked system our methodology yields a strikingly superior description, surpassing the predictive power of (semi-)empirical methods. In addition, our methodology is the only one available to make an accurate prediction for the protons in the actual cross-link. To the best of our knowledge, this is the first computational study that attempts to determine the chemical shifts of oligonucleotides of this size and at this level of complexity. This journal is © 2013 The Royal Society of Chemistry.


Sacre P.-Y.,Scientific Institute of Public Health | Sacre P.-Y.,University of Liège | Deconinck E.,Scientific Institute of Public Health | De Beer T.,Ghent University | And 5 more authors.
Journal of Pharmaceutical and Biomedical Analysis | Year: 2010

During this study, Fourier transform infrared spectroscopy (FT-IR), near infrared spectroscopy (NIR) and Raman spectroscopy were applied to 55 samples of counterfeit and imitations of Viagra® and 39 samples of counterfeit and imitations of Cialis®. The aim of the study was to investigate which of these techniques and associations of them were the best for discriminating genuine from counterfeit and imitation samples. Only the regions between 1800-400cm-1 and 7000-4000cm-1 were used for FT-IR and NIR spectroscopy respectively. Partial least square analysis has been used to allow the detection of counterfeit and imitation tablets. It is shown that for the Viagra® samples, the best results were provided by a combination of FT-IR and NIR spectroscopy. On the other hand, the best results for the Cialis® samples were provided by the combination of NIR and Raman spectroscopy (1400-1190cm-1). These techniques not only permitted a clear discrimination between genuine and counterfeit or imitation samples but also the distinction of clusters among illegal samples. This might be interesting for forensic investigations by authorities. © 2010 Elsevier B.V.


de Beer J.O.,Scientific Institute of Public Health | Naert C.,Federal Agency for Medicines and Health Products | Deconinck E.,Scientific Institute of Public Health
Accreditation and Quality Assurance | Year: 2012

Knowledge of the response function (y = f(x)) is essential in the validation of quantitative analysis methods as it describes the mathematical relationship between measurable responses and the concentrations or quantities of the analyte in the sample within a suitable range. The most common response function used is a straight line obtained by ordinary least squares (OLS) regression. Suitability of calibration lines obtained by OLS regression might be verified by calculation of a quality coefficient (QC mean). Mathematical modelling performed previously showed that with respect to critical limit values for g, which controls the symmetry of the prediction interval of the abscissa value obtained from the confidence intervals around the OLS calibration curve, a corresponding quality coefficient value exists as a quality performance parameter which is related to the spread of the abscissa values around their mean. In this paper, new mathematical models are developed to demonstrate to which extend also the number n of calibration points (x i,y i) defines the required value for the quality coefficient (QC mean) for different values of g. From these models, it could be established that the attribution of a critical limit value to QC mean as a performance parameter for straight line calibration cannot be arbitrary chosen but has to rely on the mathematical model relating QC mean, the g-value, the number n of calibration points and the spread of the x i-values around their mean. Practical measures for analysts are provided which tend to lower the g-value of straight calibration lines beneath critical values and enable to improve the quality of the calibration line applied for analysis, as demonstrated in an elaborated example. © 2012 Springer-Verlag.


Baldo A.,University of Liège | Mathy A.,University of Liège | Tabart J.,University of Liège | Camponova P.,University of Liège | And 5 more authors.
British Journal of Dermatology | Year: 2010

Background Microsporum canis is a pathogenic dermatophyte that causes a superficial cutaneous mycosis, mainly in cats and humans. Proteolytic enzymes, including subtilisins, have been postulated to be key factors involved in adherence and invasion of the stratum corneum and keratinized epidermal structures. Objectives To evaluate the importance of Sub3 as a M. canis virulence factor using a SUB3 RNA-silenced strain. Materials and methods The stability of a previously constructed RNA-silenced strain IHEM 22957 was tested in three different ways. The involvement of Sub3 in the adherence process was evaluated using a new ex vivo adherence model of M. canis arthroconidia to feline epidermis. In order to investigate the contribution of Sub3 in epidermal invasion, the pathogenicity of the SUB3 silenced strain was compared with that of the control strain in a guinea pig model of experimental M. canis dermatophytosis. Results The silenced strain was shown to be stable after four in vitro transfers and after the in vivo experimental infection. This strain has dramatic loss of adherence capacity to feline corneocytes when compared with the parental strain. In contrast, no significant differences were observed at any time during the infection between the control strain and the SUB3 silenced strain, indicating that Sub3 secretion is not required for invasion of epidermal structures. Conclusions RNA interference is a useful tool to evaluate pathogenic mechanisms of M. canis. For the first time, a role in pathogenicity could be attributed to a protease of a dermatophyte, namely Sub3 from M. canis, which is required for adherence to but not for invasion of the epidermis. © 2010 British Association of Dermatologists.

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