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A személyre szabott terápia legújabb lehetőségei a molekuláris onkológiában

New Options for Personalized Treatment in Molecular Oncology

Scientia et Securitas
Authors: Otília Menyhárt, Virag Vas, Balázs Győrffy, and László Buday

depletion as a potential treatment in glioma. Journal of Neurosurgery. 2020 132 (5):pp. 1313-1674. 10 Laetsch, T. W., DuBois S. G., Mascarenhas, L., Turpin, B., Federman

Open access

Monoklonális antitestek és egyéb biológiai terápiák a COVID–19 kezelésére

Monoclonal antibodies and other biologics for treatment of COVID-19

Scientia et Securitas
Author: Imre Kacskovics

., Cabeza, J., & Salmerón-Gercía, A. (2021) The relevance of monoclonal antibodies in the treatment of COVID-19. Vaccine, Vol. 9. No. 6. 557. https://doi.org/10.3390/vaccines9060557

Open access

Demencia prevenció: A korai diagnózistól a személyre szabott intervencióig

Dementia Prevention: From Early Diagnosis to Personalised Intervention

Scientia et Securitas
Authors: Annamária Manga, Menta Havadi-Nagy, Orsolya Székely, and Zoltán Vidnyánszky

., & Jiao, B. (2020) Epigenetics: Recent Advances and Its Role in the Treatment of Alzheimer’s Disease. Frontiers in Neurology, Vol. 11. 538301. 90

Open access

Zsigeri fájdalom, nocebo-hatások, placebo-analgézia

Visceral pain, nocebo-effects, placebo-analgesia

Scientia et Securitas
Author: György Bárdos

pharmaceutical treatments. Best Practice & Research Clinical Gastroenterology, Vol. 16. No. 6. pp. 869–883. 32 Kokkotou, E., Conboy, L. A., Ziogas, D. C

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A genetikai adatok szerepe a járványok elleni küzdelemben

Genetic data in the fight against pandemics

Scientia et Securitas
Authors: Ágnes Becsei, Orsolya Anna Pipek, Péter Pollner, and István Csabai

Összefoglaló. A COVID–19-járvány alatt bizonyossá vált, hogy az adattudományok, az adatok gyors megosztása és a nemzetközi összefogás a hatékony járványkezelés kulcsfontosságú eszközei. A járvány előtt létrejött Újonnan Felbukkanó fertőző betegségek Obszervatóriuma (Versatile Emerging infectious disease Observatory, VEO) nevű nemzetközi konzorcium célja egy olyan monitorozó rendszer kiépítése, amely a potenciálisan veszélyes kórokozókat még az előtt azonosítja, mielőtt azok tömeges megbetegedéseket okoznának, lehetőséget adva ezzel a gyors reagálásra. A járványok megelőzésére és kezelésére létrejött nemzetközi együttműködésekben, így a VEO-ban is a kórokozók, vagy a fertőzésnek kitett személyek genetikai szekvencia adatai kiemelkedő fontosságúak. Az ilyen típusú adatok kezelésével kapcsolatban az Európai Unióban többek között a Nagojai Jegyzőkönyv és a GDPR fogalmaz meg elveket, szabályokat.

Summary. Data science is proved to be a key tool in the fight against the ongoing COVID-19 pandemic, but it requires a huge amount of data shared between international research groups. The Versatile Emerging infectious disease Observatory (VEO) EU collaboration was established to generate and distribute high quality data for an evidence-based early warning system for emerging infectious diseases. Through an iterative process between data scientists, disease experts, social scientists and citizen scientists, a collaborative platform will be created for storing, secure sharing and analyses of traditional and new data sources. Next generation sequencing (NGS) has revolutionized genomic research. This versatile technology is broadly applicable to pathogens and human hosts. Rapid sharing of pathogen genetic resources, including physical samples of cultured pathogens and additionally genetic sequencing data of pathogens, is crucial in support of research and outbreak response. Access to genetic resources is regulated by the Nagoya protocol which is an internationally binding treaty to ensure equal sharing of benefits arising from the use of genetic resources. So far the Nagoya protocol has been applied only to biological samples, but digital data from genetic sequencing doesn’t necessarily fall under the treaty. Effects of diseases can differ based on genetic backgrounds, as certain gene variants may provide protection against or susceptibility to viral diseases. Human genomic data is an important resource for medical research. The General Data Protection Regulation (GDPR) lists identifiable human genetic data as sensitive, which is a subset of personal data. Sharing and analysis of this kind of data are strictly regulated and they are also subject to ethical challenges. These concerns become less pronounced when analyzing environmental samples like sewage. Samples collected from wastewater treatment plants can be used as pooled samples, containing naturally anonymized genetic information of the human population, near the wastewater treatment plant.

Open access
Scientia et Securitas
Author: György Miklós Keserű

Összefoglaló. A COVID–19-járvány egyre növekvő számú fertőzött betegének ellátása érdekében rövid időn belül szükség mutatkozott vírusellenes terápiás lehetőségekre. A gyors reagálás szempontját figyelembe véve erre a célra elsősorban más vírusok ellen már kifejlesztett vírusellenes szerek jöhetnek szóba. A magyar betegek ellátásbiztonsága szempontjából különösen fontos a hatóanyagok és gyógyszerkészítmények hazai gyártása. Ezt a cél tűzte ki a favipiravir, egy széles spektrumú antivirális hatóanyag hazai fejlesztése, amely sikeresen befejeződött, a gyógyszerkészítmény klinikai vizsgálata folyamatban van.

Summary. Increasing impact of COVID-19 on the healthcare system prompted the identification of potential antiviral therapies. Due to the immediate demand, known drugs were subjected to repositioning attempts. These drugs include agents inhibiting the viral entry into the host cells, drugs potentially blocking the release of the viral RNA from the endosomes, antivirals inhibiting the replication of the viral RNA and finally compounds that might prevent the assembly of the new virion. Since there is less experience with camostat and nafamostat, the entry inhibitors tested in Japan, and due to the ambiguous data collected with the endosome blocking chloroquine and hydroxyl-chloroquine, we focused on the actual antiviral treatment options for COVID-19 infections. In addition to favipiravir and remdesivir that were used early, at the onset of the pandemic, we discuss novel candidates including molnupiravir, a promising antiviral actually investigated in clinical trials. Considering the needs of Hungarian COVID patients and the security of supply as first priority, we selected favipiravir and developed a convenient process for the industry-scale production of the active pharmaceutical ingredient (API). At the end of this review we summarize the development and clinical investigation of favipiravir, a wide spectrum antiviral drug used for the treatment of mild and moderate COVID patients in Hungary in both ambulant and clinical settings. The Hungarian COVID Task Force set up two consortia, one for the development and the other for the clinical investigations of favipiravir. The objective of the favipiravir development consortium was to develop processes for the production of Favipiravir API and dosage forms. The consortium completed the pilot plant scale industrial production of the API and produced clinical samples for the upcoming trials. The selection and laboratory scale optimization of the synthesis route was performed at the Medicinal Chemistry Research Group of the Research Center for Natural Sciences. The laboratory scale synthesis was scaled up for pilot plant production at EVI plc and Gedeon Richter plc. GMP production was realized at the facilities of Gedeon Richter plc. Finished dosage forms were developed at Meditop Ltd who produced the clinical samples under GMP conditions. The clinical consortium is headed by the Hungarian section of the European Clinical Research Infrastructure Network (ECRIN) and organized two trials. One of these trials investigates favipiravir produced in Hungary while the other trial is performed with favipiravir produced in Japan. Both studies were approved by the Hungarian regulatory agency (OGYÉI) and are ongoing.

Open access

Az akadémiai-ipari együttműködések szerepe a gyógyszerfejlesztésben pandémia idején

Drug development collaborations between Academia and Industry in Pandemia

Scientia et Securitas
Author: György Miklós Keserű

Összefoglaló. Egészen az ezredfordulóig a gyógyszeripari kutatás-fejlesztés világszerte hagyományosan nagyvállalati keretek között folyt. Az elmúlt évtizedekben azonban ebben a szegmensben jelentős átrendeződések tapasztalhatók, ugyanis a korai kutatási és fejlesztési projektek sok esetben már az egyetemi-akadémiai, illetve kkv-szektorból indulnak. A szervezeti keretek mellett a fejlesztések szakmai tartalma is változott, a hagyományos kismolekulás gyógyszerek mellett egyre meghatározóbb szerep jut a biológiai terápiáknak, valamint a hatóanyagok fejlesztése mára összekapcsolódott a releváns diagnosztikumok fejlesztésével. A projektek finanszírozásában is fontos változások történtek, egyre jelentősebb szerep jut az állami KFI finanszírozásnak és a (kockázati) tőkebefektetéseknek. A gyógyszeripari K+F szakmai, szervezeti és finanszírozási kereteinek változása jelentősen felértékelte és szélesítette a korábban is meglévő akadémiai-ipari kapcsolatokat. Az együttműködések fontos szerepet játszanak a COVID–19 járványra adott válaszokban is, amit a magyar egyetemek, kutatóintézetek, kis- és középvállalatok, valamint gyógyszeripari nagyvállalatok részvételével indult kutatások igazolnak.

Summary. Until the turn of the millennium, pharmaceutical research and development worldwide had traditionally taken place in pharmaceutical companies. In recent decades, however, significant rearrangements have been witnessed, as early-stage research and development projects often start at the universities or the academic and SME sectors. In addition to the organizational framework, the professional content has also changed: in addition to traditional small molecule drugs, biological therapies are playing an increasingly important role, and the development of active ingredients is now linked to the development of relevant diagnostics. Important changes have also taken place in the financing of projects, with public RDI financing and (venture) capital investments playing an increasing role. Changes in the professional, organizational and funding frameworks for pharmaceutical R&D have significantly enhanced and broadened existing academic-industrial relations. Collaborations also play an important role in the responses to the COVID-19 epidemic, as evidenced by research involving Hungarian universities, research institutes, small and medium-sized enterprises, and large pharmaceutical companies. The first example is a collaboration of an academic research group and a spin-off company formed from this environment. Researchers of the Eötvös University (ELTE) and others working at the Research Centre for Natural Sciences (RCNS) applied phage display technology to discover new protease inhibitors. They established EvolVeritas Ltd, a spin-off company developing high affinity and high specificity inhibitors of the TMPRSS2 protease that is involved in the SARS-CoV-2 viral entry to host cells. In a parallel research program, the same consortium is working on new inhibitors of the MASP2 protease contributing to the coronavirus mediated activation of innate immunity, particularly the complement system. This latter approach would result in the effective control of microthrombosis events associated with serious COVID-19 infections. Both of the approaches are in the early preclinical phase and further investment would be needed to push these projects into clinical testing. The second example is a collaboration between an academic research group and an SME to reposition of azelastine, an approved antihistamine drug that was found to be effective in blocking SARS-CoV-2 mediated pathogenesis. After successful preclinical studies, the partners have now initiated clinical trials to demonstrate the efficacy of azelastine nasal drops in the prevention and treatment of COVID-19 infections. The third example is a collaboration of academic research groups, a SME and a pharmaceutical company. This consortium develops an antibody-like fusion protein therapeutics that can neutralize the SARS-CoV-2 virus. One component of the ACE2-Fc fusion protein is the relevant portion of angiotensin-converting enzyme 2 (ACE2) produced by recombinant technologies, which binds to the spike protein of the pathogen. The virus thus binds to the fusion protein instead of the ACE2 receptors in human cells. Another component is responsible for the long half-life of IgG, the so-called Fc region. The consortium confirmed that the ACE2-Fc fusion protein inhibits SARS-CoV-2 infection in cell culture, and prevents disease in experimental animals. Preclinical development and the preparation of the core documentation is ongoing, which will soon be submitted to the European Medicines Agency (EMA) to initiate clinical trials. The final example is a joint development project that involved a research group, an SME and two pharmaceutical companies. The objective of this program is process development and pharmaceutical formulation of favipiravir, a broad-spectrum antiviral with a treatment potential against COVID-19. The consortium completed the process development of the active pharmaceutical ingredient (API) and developed finished dosage formulations available for clinical testing. Clinical trials are ongoing that aim investigating safety and efficacy of favipiravir in COVID-19 infected patients. All of the examples described here demonstrate the power of collaborations that helped the participants to give diverse and effective responses to the unprecedented pandemic challenge of COVID-19. We believe that these experiences would encourage the members of the academic and industry community to formulate further collaborations to tackle the unmet medical need in our societies.

Open access

Gyorsreagálás a pandémiára, ellátásbiztonság

Rapid response to pandemia, supply security

Scientia et Securitas
Author: István Greiner

] Adenine C‑Nucleoside (GS-5734) for the Treatment of Ebola and Emerging Viruses. J. Med. Chem., Vol. 60. No. 5. pp. 1648–1661. 6 Szekanecz, Z

Open access

Összefoglaló. A klinikai orvosbiológiai vizsgálatok elkezdéséhez a kutatásban részt vevők biztonságát ellenőrző Egészségügyi Tudományos Tanács (ETT) kutatásetikai bizottságainak hozzájárulása szükséges. A járványt csak tudományos eredményekkel lehet legyőzni, ezért kitörésekor gyorsították a COVID–19 kutatási protokollok bírálatát. A koronavírus világjárvány szükségessé tett egy megváltozott kutatási adatkezelést is. A járványok megoldása a megelőzés. Bár a vírusellenes vakcinák adása hamar megkezdődött, ami jelentős tudományos teljesítmény, mégis tudományellenes hullám söpör végig a világon, és a kötelező védőoltások körüli jogi, etikai viták fellángoltak. Áltudományos érvelésekkel félrevezetnek embereket. Az ETT nemzeti kutatásfejlesztési programot javasolt a járvány következményeinek leküzdésére.

Summary. Biomedical research activities are subjects to prior professional-ethical approval. ETT (the Medical Research Council in Hungary) through its research-ethics committees ensures the safety of people and protects their interests and health in various clinical investigations and trials. Thus, science, ethics, and safety cannot be separated in biomedical research. The ETT operates three national ethics committees. The opinions of ethical bodies are binding; clinical and biomedical research may not be initiated without the consent of the relevant ETT committees. This is in line with international regulations. The ETT has published the “Codex of Bioethics. On the concepts and practice of biomedical research” on its website.

When the epidemic broke out, the ETT Presidency initiated immediate legislative changes that allowed for online meetings as well as digital consent to investigations, in addition to the previously exclusive personal ones. In the epidemic, time became the determining dimension, but this and the aim of the research could not be combined with such “lightening” that would endanger the safety and interests of the participants in the COVID studies. Thus, under the still strict requirements, the time for reviewing the COVID-19 protocols had to be radically shortened. However, the ETT research ethics committees also rejected submissions during the epidemic. A total of 171 COVID-19-related research protocols were approved in Hungary in 2020. The ETT Presidency initiated a national Research and Development program on infectious diseases, a call for scientific clinical R&D proposals on COVID-19, and also elaborated its priorities.

Throughout human history, the solution to epidemics has always been to prevent the spread of disease through vaccinations. The average production time for traditional vaccines is about 15 years, whereas in the year of the SARS-CoV-2 virus pandemic outbreak, mass vaccinations began with completely new coronavirus vaccines partly made using brand new molecular biology technology that had never been used before. Despite the tremendous professional scientific achievements, a wave of hostilities is sweeping across the world, and the ethos and successes of science, and scientific communities in research are being questioned when their roles are dominant and outstanding. The concept of compulsory vaccination has been arguably classified as a human right. With this, the world of vaccinations was tied to concepts that it really had nothing to do with. Arbitrary pairing and joint treatment of remote concepts favours the spread of fatal diseases such as measles and poliomyelitis, for which there are already vaccines. Meanwhile, pseudosciences are misleading the public.

The coronavirus pandemic has also necessitated changes in data management. The ETT has previously initiated a number of legal and professional proposals on health data management and access to research data, and has developed its own data protection rules following the introduction of the GDPR.

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Túl az etikán – a humán kutatások kockázatérzékenysége és pszichológiai aspektusai

Beyond ethics – risk sensitivity and psychological aspects of human research

Scientia et Securitas
Author: Valéria Csépe

Összefoglaló. A humán kutatások eredményeit bemutató közlemények számos adattal szolgálnak a megismerni kívánt jelenségre vonatkozóan. Általánosan elfogadott elvárás a vonatkozó etikai szabályok szigorú betartása, az előírt vizsgálati protokollok betartása. Az emberekkel végzett vizsgálatoknak azonban van egy olyan dimenziója, amelyre az etikai szabályok nem térnek ki, s amelyek a vizsgálati eredményeket, illetve azok reprezentativitását is befolyásolják. Ezek mindegyike a pszichológia vizsgálódási területéhez tartozik, legyen szó a pszichológiai kutatások etikai kérdéseiről, vagy az orvosbiológiai kutatások, orvosi beavatkozások, illetve azok elfogadásának pszichológiai aspektusairól. A tanulmány a pszichológia megváltozott etikai felfogásának rövid bemutatását követően a genetikai kutatások pszichológiai aspektusait és az egészség-magatartás kritikus kérdéseit elemzi. Az utóbbiak esetében a kockázatészlelés, valamint a bizalom, megbízhatóság pszichológiai modelljeiből kiindulva mutatja be az oltási hajlandóság és az oltásellenesség ismert pszichológiai faktorait.

Summary. Publications presenting the results of human research provide a wealth of data on the phenomenon to be explored. It is a generally accepted expectation to adhere strictly to the relevant ethical rules and to the required protocols. However, studies in humans have a dimension that is not fully covered by ethical rules and that also affects the studies’ results and their representativeness. All of these belong to the field of research in psychology, be it the ethical issues of psychological research or the psychological aspects of biomedical research, medical interventions, and their acceptance. Researchers of these and other scientific areas widely believe that science is morally neutral, that is, its task is the discovery of facts, the further development of the investigations’ tools and methods to perform correct analysis and draw reliable conclusions. However, research and development are characterized by a kind of moral neutrality, the essence of which is that the researcher not participating in the decisions on applications is neutral in general. This means that the curiosity driven research should not pay attention to risks associated with the use of results. However, many recent concerns related to the long-term effects of broadly applied inventions speaks for the need on consensus how the consequences could or should be forecasted.

Following a brief presentation of the changed ethical perception of psychology, I give some examples on the psychological aspects of genetic research and that of the critical issues in health behavior. Concerns psychological in nature have been articulated in the last decade and it became increasingly clear that genetic testing can also have psychological factors that must be considered. Moreover, the recent focus on psychological aspects of human research shed light on the complexity of health behavior, and questions have been raised about the known psychological factors of the human reactions to suggested therapies, especially those of the vaccination propensity, rejection, and anti-vaccination movements. Although there are only a few systematic studies on this issue, the proper solutions of the Covid-19 should consider the psychological aspects of the acceptance and rejection of vaccination. We may consider that the first waves of the Covid-19 epidemic created situations requiring altered psychological coping, to which psychological research responded primarily by examining the epidemiological situation, illness, and the resulting psychological aspects of lifestyle (treatment of social isolation, stress management, anxiety, depression). Therefore, scientific data on risk perception and psychological factors of vaccine acceptance may contribute to preparedness for globally predicted epidemics and decision-making processes.

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