Multicentre Double-blind Placebo-controlled Parallel Group Randomized Clinical Trial of Efficacy and Safety of Anaferon in the Treatment of Acute Respiratory Viral Infections

Purpose of the study:
• To obtain additional data on the efficacy and safety of Anaferon in the treatment of acute respiratory viral infections.

Start Date09 Oct 2018

Sponsor / Collaborator

Materia Medica Holding

NCT03301155

/ CompletedPhase 4

International Multicenter Double-bind Placebo-controlled Randomized Parallel-group Clinical Trial of Anaferon for Children Efficacy in Prevention of Influenza and Other Acute Respiratory Viral Infections in Children During the Peaks of Seasonal Morbidity

The objective of this study is to obtain additional data on the efficacy and safety of 12-week course of therapy with Anaferon for children for prevention of influenza and other acute respiratory viral infections in children during the peaks of seasonal morbidity.

Start Date03 Oct 2017

Sponsor / Collaborator

Materia Medica Holding

NCT03162458

/ CompletedPhase 3

Multicenter Double-blind Placebo-controlled Parallel Group Randomized Clinical Trial of Efficacy and Safety of Anaferon for Children Liquid Dosage Form in the Treatment of Acute Upper Respiratory Infections

Purpose of the study:
* To assess efficacy of Anaferon for children liquid dosage form in the treatment of acute upper respiratory tract infections.
* To assess safety of Anaferon for children liquid dosage form in the treatment of acute upper respiratory tract infections.

Start Date22 Jan 2015

Sponsor / Collaborator

Materia Medica Holding

100 Clinical Results associated with Interferon Gamma(Materia Medica Holding Research And Production Company)

100 Translational Medicine associated with Interferon Gamma(Materia Medica Holding Research And Production Company)

100 Patents (Medical) associated with Interferon Gamma(Materia Medica Holding Research And Production Company)

Literatures (Medical) associated with Interferon Gamma(Materia Medica Holding Research And Production Company)

01 Jun 2017·Antiviral researchQ2 · MEDICINE

RETRACTED: Efficacy of novel antibody-based drugs against rhinovirus infection: In vitro and in vivo results

Q2 · MEDICINE

Article

Author: Epstein, Oleg I ; Bartlett, Nathan W ; Petrova, Nataliia V ; Johnston, Sebastian L ; Edwards, Michael R ; Khaitov, Musa R ; Gogsadze, Leila ; Emelyanova, Alexandra G ; Bakhsoliani, Eteri ; Tarasov, Sergey A ; Walton, Ross P ; Aniscenko, Julia ; Gorbunov, Evgeniy A

Rhinoviruses (RVs) cause the common cold and are associated with exacerbations of chronic inflammatory respiratory diseases, especially asthma and chronic obstructive pulmonary disease (COPD). We have assessed the antiviral drugs Anaferon for Children (AC) and Ergoferon (containing AC as one of the active pharmaceutical ingredients) in in vitro and in vivo experimental models, in order to evaluate their anti-rhinoviral and immunomodulatory potential. HeLa cells were pretreated with AC, and levels of the interferon-stimulated gene (ISG), 2'-5'-oligoadenylate synthetase 1 (OAS1-A) and viral replication were analyzed. In a mouse model of RV-induced exacerbation of allergic airway inflammation we administered Ergoferon and analyzed its effect on type I (IFN-β), type II (IFN-γ) and type III (IFN-λ) IFNs induction, cell counts in bronchoalveolar lavage (BAL), cytokine (interleukin (IL)-4; IL-6) and chemokine (CXCL10/IP-10; CXCL1/KC) levels. It was shown that AC increased OAS1-А production and significantly decreased viral replication in vitro. Increased IFNs expression together with reduced neutrophils/lymphocytes recruitment and correlated IL-4/IL-6 declination was demonstrated for Ergoferon in vivo. However, there was no effect on examined chemokines. We conclude that AC and Ergoferon possess effects against RV infection and may have potential as novel therapies against RV-induced exacerbations of asthma.

01 May 2017·Journal of medical virologyQ4 · MEDICINE

Dose-dependent antiviral activity of released-active form of antibodies to interferon-gamma against influenza A/California/07/09(H1N1) in murine model

Q4 · MEDICINE

Article

Author: Emelyanova, Alexandra G. ; Epstein, Оleg I. ; Don, Еlena S. ; Gorbunov, Evgeniy A. ; Yakovleva, Natalia N. ; Petrova, Nataliia V. ; Tarasov, Sergey А. ; Nikiforova, Marina V. ; Morozov, Sergey G.

The assessment of dose-response is an essential part of drug development in terms of the determination of a drug's effective dose, finding the safety endpoint, estimation of the pharmacokinetic profile, and even validation of drug activity, especially for therapeutic agents with a principally novel mechanism of action. Drugs based on released-active forms of antibodies are a good example of such a target. In this study, the efficacy of the antiviral drug Anaferon for children (released-active form of antibodies to interferon-gamma) was tested in a dose-dependent manner (at doses of 0.13, 0.2, 0.4, 0.8 ml/mouse/day) in a murine model of acute pneumonia induced by influenza virus pandemic strain A/California/07/09 (H1N1). Administration of the drug at the two highest doses led to: a reduction in the virus infectious titer in lung tissue up to 4.2 lgEID50/20 mg of tissue; infected animals' life prolongation up to 6.7 days; an increase in the survival rate of up to 40% and a decrease in morphological signs of inflammation when compared to the control animals. In this study, the dose-response effect of Anaferon for Children was demonstrated on mice for the first time. This finding is especially important for drugs with a principally novel mechanism of action like drugs based on released-active forms of antibodies. J. Med. Virol. 89:759-766, 2017. © 2016 Wiley Periodicals, Inc.

01 Jun 2016·Acta neuropsychiatrica

Adjunctive use of interferon γ inducer for treatment of patients with schizophrenia

Article

Author: Vetlugina, Tamara Parfenovna ; Semke, Arkady Valentinovich ; Nikitina, Valentina Borisovna ; Nevidimova, Tatiana Ivanovna ; Lobacheva, Olga Anatolyevna ; Sergeeva, Svetlana Alexandrovna

Objective:

The present paper is devoted to evaluation of clinical and immunomodulatory effect of ultra-high dilutions of antibodies to human interferon γ, included in the complex therapy of patients with schizophrenia.

Materials and methods:

The study was carried out at the Mental Health Research Institute, Tomsk, Russian Federation. This double-blind, placebo-controlled randomised in parallel-group study enrolled 40 patients. As a part of complex therapy, patients from the main group (n=20) received anaferon, a drug containing ultra-high dilutions of affinity-purified antibodies to human interferon γ as the active pharmaceutical ingredient; patients from the comparative group (n=20) received placebo. Duration of the therapy was 30±5 days. Assessment of severity of symptoms and changes in them were made using clinical scales: Positive and Negative Syndrome Scale, Clinical Global Impression, Abnormal Involuntary Movements Scale. Spontaneous and phytohemagglutinin-induced production of interferon γ by immunocompetent cells in supernatants of 48 h whole blood culture of patients was measured by enzyme-linked immunosorbent assay (ELISA) method.

Results:

The reduction of interferon-producing potential by immunocompetent cells in comparison with reference normal value was shown in total group of patients (n=40) before combined therapy. During the treatment, increase of spontaneous interferon γ production and favourable changes in psychopathological symptoms as compared with placebo were shown in subjects receiving anaferon. It was found that favourable changes in clinical symptoms assessed using clinical scales with a high degree of confidence correlated with high level of spontaneous interferon γ production.

Conclusion:

Anaferon as a part of complex therapy of patients with schizophrenia contributes to enhancement of its efficacy acting via mechanism of psychoimmunomodulation.

News (Medical) associated with Interferon Gamma(Materia Medica Holding Research And Production Company)

09 Mar 2022

·eastgatebiotech.com

EastGate Biotech Discusses Their Phase 3 Clinical Trials and Recent Coronavirus Agreement

EastGate Biotech Discusses Their Phase 3 Clinical Trials and Recent Coronavirus Agreement Phoenix, Arizona–(Newsfile Corp. – February 5, 2020) – The Stock Day Podcast welcomed EastGate Biotech (OTC Pink: ETBI) (“the Company”), a company that focuses on innovative technological developments and produces and distributes innovative drug compounds and healthy nutraceuticals that are based on natural therapies absorbed by the body. CEO of the Company, Anna Gluskin, and President of the Company, Rose Perri, joined Stock Day host Everett Jolly. Jolly began the interview by asking Gluskin about the Company’s current projects, including Phase 3 clinical trials in Pakistan. Gluskin shared that the Company will be entering Phase 3 clinical trials for their product Insurgin, a liquid insulin mouth rinse solution. “The registration in Pakistan will give us a chance with another ten or eleven countries which recognize Pakistan registration,” explained Gluskin. “Every single step is getting us closer to distribution and registration in the region.” Gluskin then explained that the registration of the product is a lengthy process due to bureaucratic challenges, however, the Company expects this process to be completed within six months. The conversation then turned to the outbreak of the Coronavirus and its effect on the Company. Gluskin shared that the Company is currently working on a preventative and therapeutic solution for the Coronavirus, which would have a positive effect worldwide if successful. Jolly then commented on a recent press release regarding the marketing rights of Anaferon and asked about the capabilities of the drug. “Anaferon is an antibacterial and antiviral medication, which in some countries is considered non-medicinal,” explained Gluskin, adding that the Company’s primary goal is to distribute this drug to China to assist with the Coronavirus outbreak. Perri then expanded on the Company’s partnership in Pakistan. “They were established in 2002, so they have a long history already,” said Perri. “Their focus is on biology transfer,” she added. “The managing director has a real talent for analyzing trends in the healthcare business and finding innovative products,” said Perri. “What really excites me about our partnership is that we have the same common view – we believe innovation can be found anywhere in the world.” To close the interview, Gluskin expressed her confidence in the potential of the Company despite its small size and commented on the Company’s dedication to its investors. To hear EastGate Biotech’s entire interview, follow the link to the podcast here: https://audioboom.com/posts/7496606-eastgate-biotech-discusses-their-phase-3-clinical-trials-and-recent-coronavirus-agreement Investors Hangout is a proud sponsor of “Stock Day,” and Stock Day Media encourages listeners to visit the company’s message board at https://investorshangout.com/ About EastGate Biotech EastGate Biotech focuses on innovative technological developments and produces and distributes innovative drug compounds and healthy nutraceuticals that are based on natural therapies absorbed by the body. We utilize advanced nanotechnologies and alternative delivery systems that take difficult to deliver compounds and deliver them using our nanotechnology platform which ultimately increase the bioavailability to the body. Using our methods of delivery provides healthy alternatives to conventional pharmaceuticals that all-too-often create dangerous side-effects and unexpected consequences for those trying to attain and maintain a healthy lifestyle. EastGate’s wholly owned subsidiary Omni Surgery and Anti-Aging Centre is the first of many surgery centers to come under the Omni umbrella as we plan to roll up existing business under the Omni brand and expand our footprint globally. Cautionary statement on forward-looking information All statements, other than statements of historical fact, contained or incorporated by reference in this news release constitute “forward-looking information” or “forward-looking statements” within the meaning of certain securities laws, including the provisions for “safe harbor” under the United States Private Securities Litigation Reform Act of 1995 and are based on expectations, estimates and projections as of the date of this news release. The words “anticipates”, “plans”, “expects”, “indicate”, “intend”, “scheduled”, “estimates”, “forecasts”, “focus”, “guidance”, “initiative”, “model”, “methodology”, “outlook”, “potential”, “projected”, “pursue”, “strategy”, “study”, “targets”, or “believes”, or variations of or similar such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, or “should”, “might”, or “way forward”, “will be taken”, “will occur” or “will be achieved” and similar expressions identify forward-looking statements. Forward-looking statements are necessarily based upon a number of estimates and assumptions that are inherently subject to significant business, economic and competitive risks, uncertainties and contingencies. The risks, estimates, models and assumptions contained or incorporated by reference in this release, include those identified from time to time in the reports filed by EastGate with the SEC, which should be considered together with any forward-looking statement. EastGate undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. CONTACT: Rose Perri 1-647-692-0652 Email: information@eastgatepharmaceuticals.com Website: www.EastGateBiotech.com About The “Stock Day” Podcast Founded in 2013, Stock Day is the fastest growing media outlet for Nano-Cap and Micro-Cap companies. It educates investors while simultaneously working with penny stock and OTC companies, providing transparency and clarification of under-valued, under-sold Micro-Cap stocks of the market. Stock Day provides companies with customized solutions to their news distribution in both national and international media outlets. The Stock Day Podcast is the number one radio show of its kind in America. Stock Day recently launched its Video Interview Studio located in Phoenix, Arizona. SOURCE: Stock Day Media 602-441-3474

Phase 3

09 Mar 2022

·eastgatebiotech.com

EastGate Biotech Pakistan Expands its Collaboration in Advancing the Development of a New Vaccine Against COVID-19

Joint Venture Collaboration to also pursue antibiotic products to create a pipeline to fight various new strains of flu illnesses WEST CALDWELL, NJ and TORONTO, ON /NEWMEDIAWIRE/ February 18, 2020,/ EastGate Biotech Corp. (OTC: PINK: ETBI), a pharmaceutical company, that focuses on innovative technological developments specifically in insulin drug delivery for the treatment of Type 2 diabetes, announced today that the company along with its Joint Venture Partner EastGate Biotech Pakistan have agreed to move forward with the development of a new vaccine to combat Coronavirus COVID-19 in China and other affected around the globe. EastGate Biotech Pakistan has access to existing vaccine production companies; some of which already have experience with MERS coronavirus and who are presently conducting clinical studies of the COVID-19 vaccine. Discussions with these manufacturers are well underway. Initially, any agreement would involve the manufacturing scale of the vaccine to be supplied by the manufacturer. In anticipation of regulatory approval, EastGate Biotech Pakistan is also negotiating commercial manufacturing rights which will enable a smooth transition to larger-scale facilities in its Pakistani market. The role of EastGate Biotech would be to potentially register the vaccine for regulatory approval and engage partners in North America. “The development of vaccinations to both prevent and treat disease to help people worldwide will complement our distribution of Anaferon which is already included in our Joint Venture Agreement. As reported before, Anaferon has the potential to block the protease that the virus needs to replicate,” said Nasir Irfat of EastGate Biotech Pakistan. “Since the last SARS outbreak, we have been vigilant looking for other products to fight new viruses. Our collaboration with EastGate Biotech Corp. allows us to mine our network for new products like antibiotics, and then expand our distribution channels.” “The outbreak of new viruses is proving to be more complex and challenging to contain”, said Anna Gluskin, CEO of EastGate Biotech. “This makes prevention just as important as treatment, and there is room in the marketplace for new products that deal with these growing health concerns. We look forward to completing our licensing agreements with these companies and their innovative solutions.” “We share the same concern with health organizations on the size of the infected population and the fatalities from COVID-19” stated Bill Abajian, Chief Operating Officer of EastGate Biotech. “Illnesses that affect populations on a large scale not only have a personal impact on individuals and their families but also on national government management both in terms of personnel and budgetary controls. We are focused on pursuing technologies that will tackle chronic illnesses and are cognizant of the limited resources available to manage global health organizations.” About Anaferon Anaferon was originally developed in Russia where it saw its first widespread use for the treatment of acute viral and bacterial infections. Eventually, it was tested as prophylaxis in adults and children. Anaferon is part of a drug class called interferon. When a cell is infected with a virus it releases interferons also known as cytokines which are signaling proteins that essentially warn nearby cells to heighten their anti-viral defenses. When a cell is under viral attack, one of the cytokines released is Interferon-gamma (IFN-y) which is the primary activator of macrophages, natural killer cells, and neutrophils. Anaferon is a released-active form of antibody that targets the stimulation of INF-y and activation of the innate immune response. About Coronavirus COVID-19 COVID-19 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China.1 The origin of COVID-19 is uncertain and it is unclear how easily the virus spreads.2 COVID-19 is thought to be transmitted person to person through respiratory droplets, commonly resulting from coughing sneezing and close personal contact.3 Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals.4 For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath.5 It is believed that symptoms of COVID-19 may appear in as few as two days or as long as 14 days prior to exposure, and that symptoms in patients have ranged from non-existent to severe and fatal.6 There are currently no known anti-viral treatments effective at suppressing COVID-19.7 About EastGate Biotech EastGate Biotech focuses on innovative technological developments and produces and distributes innovative drug compounds and healthy nutraceuticals that are based on natural therapies absorbed by the body. We utilize advanced nanotechnologies and alternative delivery systems that make it difficult to deliver compounds and deliver them using our nanotechnology platform which ultimately increases the bioavailability to the body. Using our methods of delivery provides healthy alternatives to conventional pharmaceuticals that all-too-often create dangerous side-effects and unexpected consequences for those trying to attain and maintain a healthy lifestyle. EastGate’s wholly-owned subsidiary Omni Surgery and Anti-Aging Centre is the first of many surgery centers to come under the Omni umbrella as we plan to roll up existing business under the Omni brand and expand our footprint globally. Cautionary statement on forward-looking information All statements, other than statements of historical fact, contained or incorporated by reference in this news release constitute “forward-looking information” or “forward-looking statements” within the meaning of certain securities laws, including the provisions for “safe harbor” under the United States Private Securities Litigation Reform Act of 1995 and are based on expectations, estimates, and projections as of the date of this news release. The words “anticipates”, “plans”, “expects”, “indicate”, “intend”, “scheduled”, “estimates”, “forecasts”, “focus”, “guidance”, “initiative”, “model”, “methodology”, “outlook”, “potential”, “projected”, “pursue”, “strategy”, “study”, “targets”, or “believes”, or variations of or similar such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, or “should”, “might”, or “way forward”, “will be taken”, “will occur” or “will be achieved” and similar expressions identify forward-looking statements. Forward-looking statements are necessarily based upon a number of estimates and assumptions that are inherently subject to significant business, economic and competitive risks, uncertainties and contingencies. The risks, estimates, models, and assumptions contained or incorporated by reference in this release, include those identified from time to time in the reports filed by EastGate with the SEC, which should be considered together with any forward-looking statement. EastGate undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. CONTACT: Rose Perri 1-647-692-0652 Email: information@eastgatepharmaceuticals.com Website: www.EastGateBiotech.com SOURCE: EastGate Biotech Corp. References: 1. Novel Coronavirus 2019, Wuhan, China. (2020, January 29). Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/index.html 2. Novel Coronavirus 2019, Wuhan, China. (2020, January 24). Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/index.html 3. Novel Coronavirus 2019, Wuhan, China. (2020, January 29). Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/index.html 4. Novel Coronavirus 2019, Wuhan, China. (2020, January 29). Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/index.html 5. Novel Coronavirus 2019, Wuhan, China. (2020, January 29). Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/index.html 6. Novel Coronavirus 2019, Wuhan, China. (2020, January 29). Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/index.html 7. Novel Coronavirus 2019, Wuhan, China. (2020, January 29). Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/index.html

Vaccine

100 Deals associated with Interferon Gamma(Materia Medica Holding Research And Production Company)

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Indication	Country/Location	Organization	Date
Bacterial Infections	Russia	Materia Medica Holding	-
Virus Diseases	Russia	Materia Medica Holding	-

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03707912 (CTgov)	Phase 4	Viral respiratory infection	204	Anaferon (Anaferon)	tungeilrlr(nogbojrgao) = krozhquxox epeczaidgb (xgghkqhehu, 1.6) View more	-	02 Sep 2020
				Placebo (Placebo)	tungeilrlr(nogbojrgao) = fzcksovcfd epeczaidgb (xgghkqhehu, 1.5) View more
NCT03301155 (CTgov)	Phase 4	Viral respiratory infection \| Influenza, Human	1,036	Anaferon (Anaferon for Children)	yrrqzyxtqi(zylsbmeoxa) = iszrvdwjyr twgmvuplpl (hzyxknstuh, pgpeojopgc - nksdqnkyfz) View more	-	06 May 2020
				Placebo (Placebo)	yrrqzyxtqi(zylsbmeoxa) = qgvuwirsyv twgmvuplpl (hzyxknstuh, innwmmyfng - tdvszjpagl) View more
NCT02072174 (CTgov)	Phase 4	Acute respiratory infections \| Viral respiratory infection \| Influenza, Human	569	Anaferon (Anaferon for Children)	ayhjhspmgx(wljhagcnen) = vzzvbcgubu ayylwrkofx (ztsiabagpr, 1.4) View more	-	12 Jul 2019
				Anaferon (Placebo)	ayhjhspmgx(wljhagcnen) = etefzhxaic ayylwrkofx (ztsiabagpr, 1.3) View more
NCT03162458 (CTgov)	Phase 3	Acute upper respiratory infection	142	Anaferon (Anaferon for Children)	fxyaenhntw(mvdmlhamdl) = dymbvhvzfq sivkhkdhiv (bkmwhosgnv, 31.5) View more	-	03 Aug 2018
				Placebo (liquid dosage form) (Placebo)	fxyaenhntw(mvdmlhamdl) = ofhwgohncz sivkhkdhiv (bkmwhosgnv, 19.4) View more

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