We offer
a long-term
strategy
against Corona

The Concept.

The Corona pandemic continues to pose a global threat; to date, only a small fraction of the total population has been vaccinated. Moreover, there is an immediate risk of further virus mutations.

With this in mind, DG-Nika AG research team developed a new approach to protect the world’s population from severe diseases - 2-DG (2-deoxy-D-glucose).

Similar to asthma sprays, 2-DG microparticles, from the glucose family, will be applied into the respiratory tract through the mouth. 2-DG blocks the energy demand of the infected host cells all the way into the lungs. The body’s immune system can thus actively fight the infection or keep it at low level.

Both, in vitro as well as tests on animals, have proven the scientific credibility of 2-DG.

The European Medical Agency (EMA) states that the proposed approach is comprehensible and should be pursued. The idea was patented in April 2020 and DG-Nika AG holds the worldwide exclusive rights to it. 2-DG inhaler should be available in the second half of 2021.

The Solution.

SARS-CoV-2 viruses from the Coronaviridae family are transmitted through the airways. They nest in the airways of the infected patients and then from there they spread within the whole body.

That is why we apply our solution right there; 2-DG is inhaled through an inhaler, just like an asthma spray. As soon as the substance enters the airways, it actively inhibits the growth and the reproduction of new viruses.

img Spray

The Theorie.

Glycosylation

2-DG does not only affect glycolysis but it also alters glycosylation of viral proteins. Glycosylation is required by viruses for proteins folding. The absence of proper glycosylation makes it for many viruses impossible to spread, including SARS-CoV-2.

The most important proteins affected by 2-DG are SPIKE (a proper spike is essential for cell infection) and ACE2 (which is the gate through which the virus enters the cell). This protein family is responsible for viral infection.

Inaccurately glycosylated SPIKE proteins do not allow infection of human cells. Moreover, the misfolded (misformed) SPIKE proteins will decompose and the remaining viral elements will not be able to turn into dangerous viruses.

2-DG may have a similar effect on other viruses, not just SARS-CoV-2. Degradation of proteins in ACE2 proves the prophylactic effect of 2-DG.

The infection is not possible, if the connection points, through which the viruses enter the cells in order to turn them into the host cells and to produce further viruses, do not fit into the viral spike.

img Glycosylation
img warburg-effect

Warburg effect

The Warburg effect refers to a change in the glucose metabolism observed in many tumour cells. The infected cells obtain the required energy mainly through glycolysis. A particular characteristic of the Warburg effect, also known as aerobic glycolysis, is that it occurs also in tumour cells which get a sufficient supply of oxygen. This type of energy generation is very inefficient due to an elevated glucose consumption of the affected cells.

This particular way of energy generation observed in the tumour cells occurs also in the virus infected cells (host cells). Researchers from Sweden and France were able to determine the increased need for energy in glucose in the affected cells.

A virus has a thin protective protein layer (capsid) which encloses its DNA; however, it doesn’t have own cells and is unable to metabolize. Therefore, it hijacks host cells in order to inject them with its own DNA, what triggers them to reproduce this DNA and the capsid.

Through our parallelly conducted cancer treatment research, we learnt about an effective substance, a glucose derivate, known as 2-deoxy-D-glucose (2-DG). What makes 2-DG unique, is that the infected cells identify it as glucose, because it uses the same signalling pathway. However, unlike in case of glucose, the metabolization of 2-DG ends with the phosphorylation phase.

That is why, we chose a different approach. A targeted disruption of cell’s metabolism and blocking of the glucose signalling pathways caused a massive reduction in virus production, as well as to apoptosis of infected host cells.

We use the same approach to attack the SARS-CoV-2 viruses (as well as other types of viruses).

We developed an inhalation formulation which contains 2-DG and which enters the airways in the same manner as viruses do. This means that we are able to reach the location (mentioned in numerous studies), which is mostly affected by the infected cells.

We carried out multiple tests on the epithelial cells of the respiratory tract and all of them show the prophylactic as well as the therapeutic effect of 2-DG.

Inhalation has many benefits – it works locally and doesn’t impact the whole organism. Unlike in case of the orally administered formulations, we do not need to apply a 10-times higher doses, in order to obtain a required 2-DG concentration in the lungs. This means that no adverse reactions were observed.

Since a virus strain mutates quickly, it is difficult to develop a long-lasting antidote. We attack the metabolism of the infected cells. This approach always works, regardless of the virus mutation.

For more information we have provided a list of the most popular publications, which support our statements.

1. "DNA Heats Up: Energetics of Genome Ejection from Phage Revealed by Isothermal Titration Calorimetry", Meerim Jeembaeva, Alex Evilevitch et al.; Journal of Molecular Biology, Vol. 395(5), pp 1079-87.

2. Lai, C.C., et al., Global epidemiology of coronavirus disease 2019 (COVID-19): disease incidence, daily cumulative index, mortality, and their association with country healthcare resources and economic status. Int J Antimicrob Agents, 2020. 55(4): p. 105946.

3. Deng, L., et al., Arbidol combined with LPV/r versus LPV/r alone against Corona Virus Disease 2019: A retrospective cohort study. J Infect, 2020. 81(1): p. e1-e5.

4. Liu, Y., et al., Viral dynamics in mild and severe cases of COVID-19. Lancet Infect Dis, 2020. 20(6): p. 656-657.

5. Woodward, G.E. and M.T. Hudson, The effect of 2-desoxy-D-glucose on glycolysis and respiration of tumor and normal tissues. Cancer Res, 1954. 14(8): p. 599-605.

6. Garriga-Canut, M., et al., 2-Deoxy-D-glucose reduces epilepsy progression by NRSF-CtBP-dependent metabolic regulation of chromatin structure. Nat Neurosci, 2006. 9(11): p. 1382-7.

7. Shao, L.R., J.M. Rho, and C.E. Stafstrom, Glycolytic inhibition: A novel approach toward controlling neuronal excitability and seizures. Epilepsia Open, 2018. 3(Suppl Suppl 2): p. 191-197.

8. Dwarakanath, B. and V. Jain, Targeting glucose metabolism with 2-deoxy-D-glucose for improving cancer therapy. Future Oncol, 2009. 5(5): p. 581-5.

9. Simons, A.L., et al., 2-Deoxy-D-glucose combined with cisplatin enhances cytotoxicity via metabolic oxidative stress in human head and neck cancer cells. Cancer Res, 2007. 67(7): p. 3364-70.

10. imons, A.L., et al., Enhanced response of human head and neck cancer xenograft tumors to cisplatin combined with 2-deoxy-D-glucose correlates with increased 18F-FDG uptake as determined by PET imaging. Int J Radiat Oncol Biol Phys, 2007. 69(4): p. 1222-30.

11. Zhao, Y., E.B. Butler, and M. Tan, Targeting cellular metabolism to improve cancer therapeutics. Cell Death Dis, 2013. 4: p. e532.

12. Raez, L.E., et al., A phase I dose-escalation trial of 2-deoxy-D-glucose alone or combined with docetaxel in patients with advanced solid tumors. Cancer Chemother Pharmacol, 2013. 71(2): p. 523-30.

13. Kurtoglu, M., et al., Under normoxia, 2-deoxy-D-glucose elicits cell death in select tumor types not by inhibition of glycolysis but by interfering with N-linked glycosylation. Mol Cancer Ther, 2007. 6(11): p. 3049-58.

14. Stein, M., et al., Targeting tumor metabolism with 2-deoxyglucose in patients with castrate-resistant prostate cancer and advanced malignancies. Prostate, 2010. 70(13): p. 1388-94.

15. Spivack, J.G., W.H. Prusoff, and T.R. Tritton, A study of the antiviral mechanism of action of 2-deoxy-D-glucose: normally glycosylated proteins are not strictly required for herpes simplex virus attachment but increase viral penetration and infectivity. Virology, 1982. 123(1): p. 123-38.

16. Leung, H.J., et al., Activation of the unfolded protein response by 2-deoxy-D-glucose inhibits Kaposi's sarcoma-associated herpesvirus replication and gene expression. Antimicrob Agents Chemother, 2012. 56(11): p. 5794-803.

17. Nakamura, K. and R.W. Compans, Effects of glucosamine, 2-deoxyglucose, and tunicamycin on glycosylation, sulfation, and assembly of influenza viral proteins. Virology, 1978. 84(2): p. 303-19.

18. Gualdoni, G.A., et al., Rhinovirus induces an anabolic reprogramming in host cell metabolism essential for viral replication. Proc Natl Acad Sci U S A, 2018. 115(30): p. E7158-E7165.

19. Pajak, B., et al., 2-Deoxy-d-Glucose and Its Analogs: From Diagnostic to Therapeutic Agents. Int J Mol Sci, 2019. 21(1).

20. Aft, R.L., F.W. Zhang, and D. Gius, Evaluation of 2-deoxy-D-glucose as a chemotherapeutic agent: mechanism of cell death. Br J Cancer, 2002. 87(7): p. 805-12.

21. Kuna, P., et al., Randomized equivalence trial: A novel multidose dry powder inhaler and originator device in adult and adolescent asthma. Allergy Asthma Proc, 2015. 36(5): p. 352-64.

22. Schmidt, M.F., R.T. Schwarz, and C. Scholtissek, Nucleoside-diphosphate derivatives of 2-deoxy-D-glucose in animal cells. Eur J Biochem, 1974. 49(1): p. 237-47.

23. Maehama, T., et al., Selective down-regulation of human papillomavirus transcription by 2-deoxyglucose. Int J Cancer, 1998. 76(5): p. 639-46.

24. Wang, Y., et al., Triggering unfolded protein response by 2-Deoxy-D-glucose inhibits porcine epidemic diarrhea virus propagation. Antiviral Res, 2014. 106: p. 33-41.

25. Bojkova, D., et al., Proteomics of SARS-CoV-2-infected host cells reveals therapy targets. Nature, 2020.

26. Vijayaraghavan, R., et al., Acute toxicity and cardio-respiratory effects of 2-deoxy-D-glucose: a promising radio sensitiser. Biomed Environ Sci, 2006. 19(2): p. 96-103.

27. Laszlo, J., et al., The effect of 2-deoxy-D-glucose infusions on lipid and carbohydrate metabolism in man. J Clin Invest, 1961. 40: p. 171-6.

28. Mohanti, B.K., et al., Improving cancer radiotherapy with 2-deoxy-D-glucose: phase I/II clinical trials on human cerebral gliomas. Int J Radiat Oncol Biol Phys, 1996. 35(1): p. 103-11.

29. Murugesan K. Gounder, H.L., Mark N. Stein, Susan Goodin, Joseph R. Bertino and Robert S. DiPaola, Phase I trial of 2-deoxyglucose for treatment of advanced solid tumors and hormone refractory prostate cancer: A pharmacokinetics (PK) assessment, in Proceedings of the 101st Annual Meeting of the American Association for Cancer Research. 2010: Washington, DC.

30. Singh, D., et al., Optimizing cancer radiotherapy with 2-deoxy-d-glucose dose escalation studies in patients with glioblastoma multiforme. Strahlenther Onkol, 2005. 181(8): p. 507-14.

31. Thompson, D.A., et al., Thermoregulatory and related responses to 2-deoxy-D-glucose administration in humans. Am J Physiol, 1980. 239(3): p. R291-5.

32. Zielinski, R., Fokt, I., Felix, E., Venugopal, R., Arumugam, J., Grela, K., Remiszewski, M., Skora, S., and W. Priebe. Preclinical evaluation of WP1122, a 2-DG prodrug and inhibitor of glycolysis. in Proceedings: Symposia on Cancer Research 2017 Cancer Metabolism. 2017. Houston, TX.

33. Kuprys-Lipinska, I., M. Kolacinska-Flont, and P. Kuna, New approach to intermittent and mild asthma therapy: evolution or revolution in the GINA guidelines? Clin Transl Allergy, 2020. 10: p. 19.

34. Bulbake, U., et al., Liposomal Formulations in Clinical Use: An Updated Review. Pharmaceutics, 2017. 9(2).

35. Gubernator, J., Active methods of drug loading into liposomes: recent strategies for stable drug entrapment and increased in vivo activity. Expert Opin Drug Deliv, 2011. 8(5): p. 565-80.

36. Rudokas, M., et al., Liposome Delivery Systems for Inhalation: A Critical Review Highlighting Formulation Issues and Anticancer Applications. Med Princ Pract, 2016. 25 Suppl 2: p. 60-72.

37. Cipolla, D., I. Gonda, and H.K. Chan, Liposomal formulations for inhalation. Ther Deliv, 2013. 4(8): p. 1047-72.

38. Kleemann, E., et al., Iloprost-containing liposomes for aerosol application in pulmonary arterial hypertension: formulation aspects and stability. Pharm Res, 2007. 24(2): p. 277-87.

39. Delgado, T., et al., Induction of the Warburg effect by Kaposi's sarcoma herpesvirus is required for the maintenance of latently infected endothelial cells. Proc Natl Acad Sci U S A, 2010. 107(23): p. 10696-701.

40. Stohrer, R. and E. Hunter, Inhibition of Rous sarcoma virus replication by 2-deoxyglucose and tunicamycin: identification of an unglycosylated env gene product. J Virol, 1979. 32(2): p. 412-9.

41. Datema, R. and R.T. Schwarz, Interference with glycosylation of glycoproteins. Inhibition of formation of lipid-linked oligosaccharides in vivo. Biochem J, 1979. 184(1): p. 113-23.

42. Gagneur, A., et al., Coronavirus-related nosocomial viral respiratory infections in a neonatal and paediatric intensive care unit: a prospective study. J Hosp Infect, 2002. 51(1): p. 59-64.

Prophylactic use

Causes errors in ACE2 glycosylation.

In this situation, this protein cannot bind to SPIKE SARS-CoV-2 and thus the virus cannot infect cells.

img Beschreibung: Prophylaktischer Effekt

Expert opinion

Franck Gallardo, PhD,

"2-DG is a very interesting product that deserves thorough evaluation as an anti-SARS-CoV-2 candidate."

2-DG induces a strong decrease in the production of infectious SARS-CoV-2 particles. Effect is impressive on TCID50 calculation.

According to the last report “Evaluate antiviral activity of 2-DG on infection and replication of SARS-CoV-2 in primary bronchial epithelial cells (PBEC)”, 2-DG induces a dose dependent decrease in SARS-CoV-2 virus production on primary human bronchial epithelial cells with low concentration. The effect is confirmed using RT-qPCR readout. 2-DG is a very interesting product that deserves thorough evaluation as an anti-SARS-CoV-2 candidate.

Franck Gallardo holds a Ph.D. in biochemistry from the Faculty of Medicine of the Université de Montréal, Qc, CANADA. In 2012 he founded NeoVirTech and in 2014 he received the Innovative Company Award from the French Ministry of Higher Education and Research as well as The French Agency for Innovation (BPI France) in 2013 and in 2016. In 2019 NeoVirTech was elected by Pharma Tech Outlook Magazine as a Top10 Drug Discovery and Development Consulting/Services Companies in Europe.

img Franck Gallardo, PhD
img Michał Witt, Prof. PhD

IHG PAS team

2-DG is a promising compound and deserves further investigation in the context of developing safe protection against SARS-CoV-2. Testing the effect of 2-DG on cells and cilia in the cultures of human respiratory epithelia is an important step to assure safe administration of the product.

Michał Witt, Prof. PhD.

Since 2016, the Director of the Institute of Human Genetics, Polish Academy of Sciences (IHG PAS) in Poznań. For many years the head of the Department of Molecular and Clinical Genetics at the IHG PAS. In 1987-1990, a postdoc at the University of Michigan Medical School, Ann Arbor, USA. In 1994 and 1996 – visiting professor at the National Institutes of Health (NIH) in Bethesda, USA. In 1999-2015, deputy director for scientific affairs at the International Institute of Molecular and Cell Biology in Warsaw. Author of numerous papers published in recognized scientific journals. Manager or coordinator of numerous grant projects: participated in European grants: HealthProt, BestCilia, BeatPCD. For many years, medical practitioner in the field of clinical genetics. Involved in the process of creating a Polish reference center for the diagnosis of primary ciliary dyskinesia.

Research and scientific interests: molecular genetics of genetic diseases of the respiratory system (cystic fibrosis, primary ciliary dyskinesia); molecular aspects of hemato-oncological diseases and bone marrow transplantation; ethical and legal aspects of genetic research.

Since 2020, prof. Witt and his coworkers (below) are involved in the 2-DG testing in ciliated epithelium in collaboration with DG-Nika-AG.

Ewa Ziętkiewicz, Prof. PhD.

Associated with the Institute of Human Genetics, Polish Academy of Sciences in Poznań since 1981; PI at the Department of Molecular and Clinical Genetics, professor since 2013. In 1989-2001, postdoc, then assistant professor at the Sainte Justine Hospital Research Center of the University of Montreal in Canada. Author of 68 papers published in recognized scientific journals, PI in many Polish grant projects; participant in several European grants (HealthProt, BestCilia, BeatPCD). Involved in the process of creating a Polish reference center for the diagnosis of primary ciliary dyskinesia.

Research and scientific interests: epidemiology and diagnostics of rare diseases, molecular basis of cilia function and ciliopathies, genetic and epigenetic diversity of human populations, evolution of the human genome.

Zuzanna Bukowy-Bieryłło, PhD.

A graduate of biology at the University of Silesia in Katowice. PhD student at the Institute of Biochemistry and Biophysics of the Polish Academy of Sciences, and at the Aarhus University in Denmark within an European 5th Framework Programme. Associated with the IHG PAS in Poznan since 2009, assistant professor in the Department of Molecular and Clinical Genetics the since 2012. Author of 22 papers published in recognized scientific journals, participant or PI in Polish grant projects, participant in several European grants (HealthProt, BestCilia, BeatPCD). Involved in the process of creating a Polish reference center for the diagnosis of primary ciliary dyskinesia.

Research and scientific interests: primary ciliary dyskinesia and cilia biology, methods of analysis of respiratory epithelial cells (primary epithelial cell cultures for ciliogenesis, high-speed videomicroscopy, immunofluorescent staining of ciliary proteins).

Alicja Rabiasz, M. Sci.

A graduate of biology at Adam Mickiewicz University in Poznan. Since February 2017, a PhD student at the Department of Molecular and Clinical Genetics at the IHG PAS, Poznan. Author of 2 papers published in recognized scientific journals, PI in the grant project from Polish National Science Center. Actively engaged in diagnostic activities of the COVID-19 lab at the IHG PAS.

Research and scientific interests: dysfunction of motile cilia, molecular basis of primary ciliary dyskinesia, elucidation of the role of novel genes potentially involved in the PCD pathogenesis using RNA interference method (RNAi) in ciliated flatworm (Schmidtea mediterranea).

About DG-Nika AG

DG-NIKA AG is a Swiss start-up company, which main objective is to effectively contain viral infections. We want to make a positive contribution by battling the Corona pandemic.

We have been working with a multinational team of scientists who are coordinated from Switzerland.

Georg Wander, CEO

Georg Wander is the CEO of DG-Nika AG.

After completing his education in banking and business administration, for many years he held leading positions in Germany, Luxembourg, Portugal, and South Asia.

Throughout his career as a business consultant, he was introduced to the concept of alternative energy, which resulted in many years of successful involvement in the fields of wind energy and photovoltaics.

In recent years, he developed a deep interest in modern cancer treatment research. Currently, he has been involved in the 2-DG project.

img Georg Wander

Scientific Advisors.

img Piotr Kuna, Prof. PhD, MD

Piotr Kuna, Prof. PhD, MD

Chairman of the II Department of Internal Medicine at the Medical University of Łódź.

Professor Kuna is involved in numerous international collaboration network and International Research Projects including ARIA, MASK, SHARP, ISAR, 3TR. Prof. Kuna’s research interest focuses on advancing our knowledge on the pathogenesis of respiratory and allergic diseases, with special interest in severe asthma and COPD.

Piotr Rieske, Prof. PhD

"The chances of finding the optimal dose of the drug in the final product, without approaching the toxicity limit, are very high.”

I have conducted several experiments in order to study the effects of 2-DG on the airway epithelial cells and to understand their mechanisms of action.

The "therapeutic window", which was tested under various conditions, is at least 50; this means that the chances of finding the optimal dose of the drug in the final product, without approaching the toxicity limit, are very high.

Piotr Rieske, Prof. PhD, is a medical analyst, biotechnologist, head of the Cancer Biology Department of the Medical University of Lodz, head of the Science and Research Laboratory of Celther Polska.

img Piotr Rieske, Prof. PhD
img Jerzy Gubernator, Prof. PhD

Jerzy Gubernator, Prof. PhD

"... a slightly modified glucose molecule [is] used as the Trojan Horse on cells infected with the SARS-CoV-2 virus."

Infectious diseases have always accompanied mankind. Sudden appearance and rapid human to human transmission make fighting them very difficult at times. Currently, humanity has to face a new threat in the form of the SARS-CoV-2 virus. The disease caused by the SARS-CoV-2 virus is new and at the moment no effective methods of fighting the effects of inflammation caused by viruses are known. The main problem caused by viruses is related to fibrotic injuries of the lungs, heart muscle, gastrointestinal tract and even brain damage leading to temporary or permanent intellectual disability. Since the epidemic began numerous clinical trials have been conducted around the world in which the possibility of using known antiviral drugs (remdesivir), vasodilators, corticosteroids, immune therapies, lipoic acid, bevacizumab, recombinant angiotensin-converting enzyme 2, hydroxychloroquine or chloroquine or different antibodies has been studied. To date only dexamethasone showed reduced mortality by one third for patients who are critically ill on ventilators and one fifth for those receiving supplemental oxygen. Contrary to expectations remdesivir failed to produce statistically relevant outcome.

In the present situation, enormous effort is put into the development of effective vaccines. At the moment, several dozen research centers and companies are developing various versions of vaccines, however, many specialists have doubts about the effectiveness of their action due to the observation that sick people again get SARS-CoV-2 after a period of about 3 weeks after the disease ceases. This may indicate the high antigenic variability of the virus, which may be much greater than that observed with the influenza virus.

Taking into account all these failures and doubts, other methods of fighting this virus are being sought. Currently, there is a lot of interest in the metabolic approach to fighting viruses. Quite unexpectedly, the metabolism of cells attacked by SARS-CoV-2 virus (as well as by other viruses) changes and being similar to that observed in cancer cells. To cope with the task of producing a huge amount of virus copies (a large number of virus DNA copies), the cell uses the same metabolic pathways as cancer cells. So, the so-called Warburg effect is observed, i.e., obtaining energy needed for rapid divisions and DNA synthesis almost exclusively by glycolysis from bypassing the oxidative phosphorylation. This requires a huge amount of glucose to be taken up and metabolized. It has been observed that both in the case of rapidly proliferating neoplastic cells and in cells infected with viruses, inhibition of the glycolysis process leads to the controlled death of these cells by apoptosis.

Paradoxically, the same glycolysis inhibitors can be used both in the fight against cancer and cells infected with SARS-CoV-2 viruses. Administration of a glycolysis inhibitor such as 2-DG into the environment leads to arrest of viral particle synthesis and death of the infected cell. At least in the theory this should stop the infection from spreading in the lung tissue rapidly.

DG-Nika AG has started research to exploit this relatively little-known phenomenon by using a slightly modified glucose molecule used as the Trojan Horse on cells infected with the SARS-CoV-2 virus. The glucose derivative itself shows little toxicity to healthy cells. As the disease develops in the lungs, it is possible to inhale the modified glucose into lungs to achieve its local concentrations enough to treat infected cells without exposing the whole organism. Such use of a long-known glycolysis inhibitor may turn out to be the best of the currently proposed solutions, in particular, as the company's employees calculated the amount of the substance needed to produce a therapeutic effect would fit on a pinhead. Will this amount be enough to show planned clinical trials, the completion of which will be expected by millions of people around the world.

Jerzy Gubernator, Prof. PhD, is a biotechnologist, the Head of Department of Lipids and Liposomes at the Faculty of Biotechnology and the director of Academic Center for Biotechnology of Lipid Aggregates in Wroclaw.

Ewelina Stoczynska-Fidelus, PhD, hab

has broad experience in molecular diagnostics and pharmacogenomic platform. Ewelina is the author of 32 scientific publications, 17 patent applications, 5 Grants and 4 patents.

Ewelina graduated from Molecular Genetics at the University of Lodz, Poland and gained her PhD in the Department of Tumour Biology at the Medical University of Lodz, where she held the position of an adjunct from 2014 till 2020. In 2008 she took part in a fellowship programme at the Temple University in Philadelphia (USA), where she conducted research on leukemic cells. She was distinguished in the third edition of scholarship programme for PhD students of the Fundacja na rzecz Nauki Polskiej (Foundation for Polish Science).

In 2020 she was appointed to the Head of Department of Molecular Biology. In 2015, she co-founded Personather Ltd., biotech company, where she is currently a Project Scientific Manager. Since 2009 she has been holding the position of PI/ Deputy CTO in Celther Polska LTD. She has 10 years of experience in cellular engineering and stem cells biotechnology (development of dozen R&D products including GE modified cells). She specializes in molecular oncology, especially glioblastoma (development of dozen GB models for in vitro testing) and has broad experience in molecular diagnostics and pharmacogenomic platform. Ewelina is the author of 32 scientific publications, 17 patent applications, 5 Grants and 4 patents.

img Ewelina Stoczynska-Fidelus, PhD, hab

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Cooperation

Logo Lekam

Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o. (pharmaceutical company)

LEK-AM Sp. z o.o. is one of the most dynamically developing pharmaceutical companies on the Polish market. It was established in 2000 and currently employs 440 people. It has the latest laboratory equipment and a highly qualified R&D team.

External link to the website of LEK-AM

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R&D Laboratory Personather Ltd.

Personather Ltd. Is an R&D laboratory which was established in 2015 in order to develop innovative anti-cancer therapies and diagnostic tools, based on the personalized medicine. Personather Ltd. develops absolutely original therapies which target only tumour cells. The team members have broad experience in designing anti-cancer therapies and in regenerative medicine (stem cells). The team of Personather Ltd. team works various scientific fields (i.e., bioinformatics, molecular and cellular biology, genetic engineering) and applies the latest technologies.

External link to the website of R&D Laboratory Personather Ltd.

Logo Medidest Enterprise Ptd.Ltd.

Medidest Enterprise Ptd.Ltd.

Medidest Enterprise Ptd.Ltd. is a company providing all-round service in the R&D field. Its field of expertise are the latest blockchain technologies, trademark protection and patent law and more.


Logo Celther Polska

Celther Polska

Celther Polska was established as a result of the activities in the field of cell therapy and the stem-cell research. Celther Polska specializes in computer modelling in clinical studies.

External link to the website of Celther Polska

Logo NeoVirTech

NeoVirTech

NeoVirTech is known for the high-resolution analysis of virus constructs in living cells. NeoVirTech developed customized ANCHOR TM- viruses and viral vectors for special applications in antiviral research, gene transfer, viral based vaccine development and oncolytic virotherapies. Their research also encompases the Sars-CoV2 virus. NeoVirTech offers a wide range of screening models for antiviral testing in both, humans and animals. They also provide screening services with models developed by customers (i.e., oncolytic or gene therapy products) and their internal compound libraries (280 FDA approved compounds/ EMEA approved compounds).

External link to the website of NeoVirTech

Logo BÜCHI Labortechnik AG

BÜCHI Labortechnik AG

BÜCHI Labortechnik AG has been a leading solution provider of the R&D laboratory technology, quality control and production, for over 80 years. They serve a wide range of industries, such as pharmaceutical, chemical, food and beverages, fodder, environmental analysis and academies.

External link to the website of BÜCHI

Institute Of Human Genetics

Institute Of Human Genetics


Institute Of Human Genetics

Research Laboratory SORBOLAB Sp. z o.o.[Ltd.]

Frequently asked questions.

please click a question to get the answer

What is 2-DG?
2-DG is a popular molecule from the glucose family.
How does 2-DG work?
As soon as 2-DG enters the body, it is being absorbed by energy-hungry cells, such as virus-infected host cells. These cells, however, are unable to metabolize 2-DG and, thus, they are prevented from generating energy. As a result, the virus reproduction by the host cell is massively restricted.
Does 2-DG kill the Corona virus?
No, so far there are no signs of any direct, lethal effect of 2-DG on viruses. The host cells are only being prevented from producing further viruses.
How to administer 2-DG?
Exact doses of 2-DG are sealed in plain capsules and blisters and administered via a matching inhaler.
When will 2-DG be available?
Our goal is to be market-ready in autumn 2021.
Who are the people behind DG-Nika AG?
A multinational team of scientists, coordinated from Switzerland.
How is DG-Nika AG financed?
The entire program is currently financed with private donations and investments. However, we are planning to invite third parties and public authorities, engaged in fighting the pandemic, to join one of our investment programs.
Who does the research on behalf of DG-Nika AG?
The information about the team members is available on our website. However, we continually reach out to the best specialists worldwide for scientific advice and also as contractors. We keep the development costs as low as possible in order not to unnecessarily increase the price of the final product.
What tests are being carried out?
The tests which are required to obtain the marketing authorization for our medicine are outlined in great detail by the legislator and monitored by regulatory authorities (Swissmedic, EMA, FDA, HSA etc.). Each of these authorizations apply to specific geographical areas. Since we are developing a brand-new medicine, many more tests are required to scientifically substantiate the hypotheses set up by our team.
What are the side effects of 2-DG?
We are pleased to say that to-date, we have not detected any side effects and based on the data analysis we do not expect any to occur. It is because of the fact that glucose is well tolerated (its annual production worldwide amounts to more than 20 million tons). Glucose can be found in the majority of foods and beverages.
Does 2-DG work in case of other viral infections?
Yes, because the proliferation characteristics of almost every virus are the same. Our medicine interrupts the viral replication and hence, it is effective for any kind of virus which spreads through mouth and nose, even the mutated ones.
Where is 2-DG manufactured?
2-DG is manufactured by a GMP-certified (Good Manufacturing Practice) company and in compliance with strict quality regulations. 2-DG forms the active substance in our medicine.
How can I invest in DG-NIKA AG?
At present we do not plan to sell shares. We are not interested in becoming a part of a large corporation; however, we plan a cooperation with one of the existing partners who is interested in organizing the pre-sale of our product. More information will be available on our website by the end of December.
From what age can I take 2-DG?
It has yet to be confirmed in clinical trials, but we do not see any reason for age restrictions. Nevertheless, it is important to understand that medicines for children in different development stages are subject to further strict regulations.
Can I take 2-DG during the pregnancy?
It has yet to be confirmed in clinical studies, but there are no reasons for such exclusions.
How frequently can I take 2-DG?
It always depends on the individual requirements. We distinguish between prophylaxis and healing of infected patients. We are currently running tests with different doses; however, we recommend to follow the dosage information on the package insert.
Will this medicine be covered by the health insurance companies?
At present this is not yet clear. We shall endeavour to make this option possible in order to make our product accessible to everyone.
How much will the medicine cost?
It is difficult to estimate due to the fact that the final research costs are not yet known. We anticipate that one inhalation would cost less than 1 euro, but ultimately the price might turn out to be 30- 50 cents more expensive. In any case, our medicine should be affordable for everyone.
Can the medicine be administered to adults age 65 and older?
There are no reasons for such assumptions; however, this can be confirmed only by the final results of our clinical trials.
Regarding the prophylaxis, when is the best time to take the medicine?
The in vitro studies showed that the early use can reduce the risk of infection by 72%. Inhalation of our drug two hours before going to an event (theatre, football game, disco) and after, minimizes the risk of infection. The second inhalation (after the event) prevents the infection in case, one had a contact with an infected person during the event. Two inhalation doses protect from contracting the virus. However, in case of infection, the medicine assures that the disease will have a mild course at best. Due to the fact, that the amount of viruses, which could cause an infection, was significantly reduced, the organism has enough time to develop its own antibodies - the same as in case of a vaccine and it is the best guarantee for safety.
Can the medicine be taken by vaccinated patients?
In principle, a vaccine should protect us from infection but no two people are exactly alike. That is why our bodies react differently on the vaccine (i.e, how long the protection lasts). In any case, an additional protection in form of 2-DG inhalation makes sense for those who work in areas with high infection risk or if the first infection symptoms are evident.
In principle, a vaccine should protect us from infection. Die individuellen Eigenschaften eines Menschen (jeder von uns ist ein bisschen anders) - Satz nicht vollstaendig That is why our bodies react differently on the vaccine (i.e, how long the protection lasts). In any case, an additional protection in form of 2-DG inhalation makes sense for those who work in areas with high infection risk or if the first infection symptoms are evident.
Can the medicine be taken by diabetics?
Yes. In fact, there is a credible study from Brazil, which describes local diabetes problem as a common disease. It was conducted by multiple universities and clinics, working together, and it proves that 2-DG has no harmful influence on people with diabetes.
Can the medicine be administered to people with asthma?
We believe that there are no grounds for excluding such patients, but it has yet to be confirmed in clinical trials.
Is the medicine available without a prescription?
We are trying to make it possible. However, it depends on each country's local regulations and will be determined by its authorities. .
Is the medicine available outside of Europe?
We are planning to license the production, so that our medicine would be available worldwide. In order not to compromise the high quality requirements imposed on medicines, the powder for the capsules will be manufactured solely in factories which are under our supervision. The "packaging" part can be carried out in every country and, if possible, it will also be performed by our partners in the third world countries in order to reduce the costs. We want to ensure that the medicine is available for as many people as possible, also in low-income countries.
Can the medicine be ordered online?
We are planning to work with a partner who intends to organize the pre-sale of our product. We will provide more information on our website by the end of January. Another option would be a cooperation with an online retail company which is authorized to sell pharmaceuticals.
Are genetically modified plants used for the production of 2-DG?
No, we do not use any genetically modified raw materials.
Do you use a human biological material in the production process?
No.
Were monkeys killed during the research?
We do not conduct research on primates. In general, we aim to avoid animal testing as much as possible.
Have the raw materials - BSE (mad cow disease) or TSE (encephalopathy) been tested?
All the raw materials are tested before the use and they never come in contact with these pathogens. They also do NOT come from sources which would suggest such contamination.
Were any virgin forests cleared in order to obtain the raw materials?
No.
How do I know that the medicine is authentic?
Our products are subject to strict regulations which are defined in the EU Commission Delegated Regulation 2016/161. They are protected against counterfeiting. Moreover, our methods are patented and any attempt to tamper with our product will lead to legal repercussions.
Does the medicine need to be stored at sub-zero temperatures?
No, our active substance is very stable and can be stored for several days at room temperature.
What is your approach?
Please see the information on our website. It contains information for general public as well as for experts. We provided a list of 150 publications which are directly related to our concept.
What is the function of 2-Deoxy-D-Glucose (2-DG)?
Please, see the information about Warburg effect on our website. 2-DG will be absorbed by energy-hungry cells so that they are not able to generate the required energy. In consequence, the viral production is stopped and the infected cells undergo apoptosis (they die).
What is the scientific value of a "strategy" which has not yet been tested?
This is the way how science works; a hypothesis will be established and then proven or overthrown through experiments. To-date, we were able to prove that a big part of our hypothesis is correct. The 2-DG effect on tumour cells is clear and the virus infected cells behave very much the same. In the past eight months, we were able to prove it in the in vitro studies with real Human Bronchial Epithelial Cells. Currently, we carry out experiments on mice and they also show the correctness of our approach.
You have stated, that till date no one has tried to administer (2-DG) via inhaler. Why?
It is relatively difficult to do it right and it requires a lot of experience and creativity. We and our partners in R&D were successful.
The medicine is concepted as a cure as well as a prophylaxis. What happens now? When exactly can it be used as a cure?
In multiple in vitro studies on infected HBEC with SARS-CoV-2 virus, we were able to prove that already low concentrations of 2-DG can lead to apoptosis of cells. This is called a therapeutic effect. On the other hand, in the further in vitro studies, we were able to prove that the human bronchial epithelial cells, which were pre-treated with non-toxic doses of 2-DG, show 72% lower infection risk. This is the prophylactic effect.
Could you provide a simple example (i.e., home remedy)? What prophylactic effects can be expected?
As mentioned above, we were able to prove both effects. Therefore, we assume that our medicine will be of help to people who work in areas with high risk of infection (i.e., healthcare personnel, nurses, doctors) as well as for those who have recently been infected. We do not claim that we can eliminate 100% of viruses, but our data confirms that 50%-70% of viruses can be stopped, depending on the severity of infection. This means that the body's immune system has enough time to produce its own antibodies. We ensure an almost symptom-free course of infection that never reaches the cytokine cascade phase. In case of an infection only a mild Covid-19 progression (also in case of flu) could occur and be fought with body's own antibodies, which protect us for a long period of time from renewed infection - as in the case of a vaccine.
How to administer the medicine?
Via inhaler.
Is the mask still required after taking the medicine?
Yes.
Would there still be a need for vaccination after taking the medicine?
No. However, we do not know yet, how long the protection of these vaccines will last. In case of a symptomatic infection, the vaccine will not work. We, on the other hand can help to tame the infection in every phase.
What is the difference between your approach and the vaccination?
See the answer above.

Press.

Timeline.

  • June

    Preparation of research publications considering the results

  • June

    Strategic alliances with investors

  • June

    Scientific Advice Follow-up with EMA

  • June

    Start of tests on the SARS-CoV-2 infected hamsters

  • June

    Completion of long-term-efficacy tests on Formulation 2 with no side effects

  • May

    Extensive testing of the slow-release-formulation

  • May

    Concluding an exclusivity agreement with a certified GMP active substance manufacturer

  • May

    Start of negotiations on a partnership with South Africa

  • May

    Start of negotiations on a partnership with Latin America

  • April

    Working on the GMP series of Formulation 1 with formulation specialists

  • April

    Completion of the long-term efficacy of Formulation 2

  • April

    Extension of cooperation with partners in Asia

  • March

    Preliminary discussions with EMA about a follow-up of a scientific advice

  • March

    Start of discussions with scientific cooperation partners from Asia

  • March

    Necropsy of the tested animals has proven safety of 2-DG

  • March

    Proof of the prophylactic effect of our active substance

  • March

    Planing of 1:1 tests on animals infected with SARS-CoV-2 virus in the II and III quarter of 2021

  • February

    Long-term studies on animals have proven safety of 2-DG in therapy

  • February

    Prophylactic effect of 2-DG has been proven

  • February

    Clarifying the hitherto unknown mechanisms of action of 2-DG; we are revolutionizing the current knowledge status quo about the antiviral effect of 2-DG

  • February

    Start of negotiations with multiple iglobal CRO candidates

  • January

    GMP quality tests on the active substance were completed

  • January

    First licenses for the future manufacturers and distributors

  • January

    The new DG-Nika AG website was launched

  • January

    Start of the drug pre-sale by Medidest Enterprise Ptd. Ltd.

  • January

    Start of the field testing of the second formulation

  • January

    Start of the second phase of animal studies

  • January

    Efficacy against other virus' types was established

  • January

    Production of the pilot series was successfully completed

  • December

    Start of the production of the pilot series in capsules

  • December

    Advanced planning of the clinical study

  • December

    Discovery and patenting of a further essential mechanism of action of 2-DG on virus production

  • December

    Successful safety tests of 2-DG application

  • December

    Positive assessment of the invention by EMA

  • December

    Positive 2-DG inhalation test results proved to cause NO allergic reactions

  • December

    Start of the second stage of the animal studies

  • November

    Registration of the product name

  • November

    First achievements - formulation with delayed release

  • October

    First computer model simulations

  • October

    Submission of the latest updates to EMA

  • October

    Proof of the prophylactic effect of 2-DG against SARS-CoV-2 viruses

  • October

    Positive results of the first test on animals

  • September

    Efficacy confirmation of the 2-DG testing onm the human PBEC cells

  • September

    Initiation of EMA procedures for the Scientific Advice

  • September

    First proof for the safety of the formulation in regards to the allergic reactions

  • August

    First tests conducted in Switzerland

  • July

    Beginning of works on the formulation

  • July

    First proof of efficacy against SARS-CoV-2

  • July

    First virus tests in specialized laboratory in France

  • July

    First attempts regarding the safety of the in vitro method

  • July

    First contact with EMA (European Medicines Agency)

  • July

    Participation in the first international conference on Covid-19

  • Juny

    First import of the active substance

  • April-June

    Recruting leading scientists for the project

  • April

    Submission of the patent application

  • March

    Corporate restructuring for the large-scale project

  • February-March

    First tests in specialized laboratory in Poland

  • January-February

    First in vitro trials regarding the Covid-19 project

  • Start of the research on 2-DG as an anti-cancer agent

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