Daily Archives: May 25, 2020

Algernon Submits Investigational New Drug (IND) Application with U.S. FDA for Multinational Phase 2b/3 Human Study to Evaluate Ifenprodil for COVID-19

VANCOUVER, British Columbia, May 25, 2020 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company, is pleased to announce that it has submitted an Investigational New Drug (IND) application with the U.S. FDA for its planned multinational Phase 2b/3 study of its re-purposed drug NP-120 (Ifenprodil) as a potential therapeutic treatment for patients with COVID-19. Ifenprodil is an NMDA receptor antagonist.

The clinical study for Ifenprodil, 20 mg tablets, is entitled, “A Randomized Open Label Phase 2b/3 Study of the Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Confirmed COVID-19 Infected Hospitalized Patients.” As part of the multinational Phase 2b/3 COVID-19 clinical study, Algernon has already received clearance in Canada and has also filed for ethics approval in Australia.

“We have already started communicating with a number of U.S. based research institutions in advance, to make sure that we can move quickly with the U.S. part of the clinical trial, if approved,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals Inc. “We have identified strong interest to participate in the study and we look forward to starting the trial as soon as possible.”

The Company cautions that while it is preparing to begin Phase 2 clinical trials shortly, it is not making any express or implied claims that Ifenprodil is an effective treatment for acute lung injury (ALI), the COVID-19 virus, or any other medical condition at this time.

Phase 2b/3 Study Summary:

Once local ethics approvals have been received, the trial will begin as a Phase 2b study of an aggregate of 100 patients and with positive preliminary data, the clinical trial will move directly from a Phase 2b into a Phase 3 trial. The data will determine the number of expected patients needed to reach statistical significance in the Phase 3 trial.

Patients will be randomized in a one-to-one manner and will either be treated using an existing standard of care, or standard of care plus a 20mg dose of Ifenprodil taken three times a day for two weeks.

Over the testing period, doctors will observe whether there is an improvement in a number of secondary endpoints, including mortality, blood oxygen levels, time spent in intensive care and time to mechanical ventilation.

About NP-120 (Ifenprodil)

NP-120 (Ifenprodil) is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells and T-cells, neutrophils.

The Company believes NP-120 can reduce the infiltration of neutrophils and T-cells into the lungs where they can release glutamate and cytokines respectively. The latter can result in the highly problematic cytokine storm that contributes to the loss of lung function and ultimately death as has been reported in COVID-19 infected patients.

About Algernon Pharmaceuticals Inc. 

Algernon is a drug re-purposing company that investigates safe, already approved drugs for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

Algernon has filed new intellectual property rights globally for NP-120 (Ifenprodil) for the treatment of respiratory diseases and is working to develop a proprietary injectable and slow release formulation.

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com.

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CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.               

Vietnam named best COVID-19 fighter globally by Politico

The US news website Politico has ranked Vietnam the best performer worldwide in the fight against COVID-19.

 

The ranking is based on the COVID-19 impacts on public health and economic outcomes.

 

Politico has mapped the performance of 30 leading countries by plotting their health and economic outcomes and grouping them based on whether they have instituted light, moderate or severe restrictions.

 

Vietnam is a frontrunner regarding both public health and economic outcomes.

 

Vietnam had recorded only approximately 300 cases out of a population of 95 million, without any deaths, Politico said.

 

The country’s economy is predicted to grow by 2.7 percent in 2020, making it the overall best COVID-19 performer globally, it added.

 

Vietnam has so far confirmed 325 COVID-19 infections, including 185 imported cases. With no new cases reported on May 25 morning, the nation remained clear of transmissions of the disease for 39 consecutive days.

 

Source: Vietnam News Agency

 

Survey finds high domestic travel demand until year end

Close to 85 percent of respondents have said they have plans to travel from now until the year end, a survey by the Vietnam Tourism Advisory Board (TAB) has found.

 

Among them, 49.3 percent will travel for 2-3 days, 10.7 percent want to take a holiday longer than 7 days and 2.4 percent will go on a one-day tour, according to the survey.

 

Some 60.5 percent of the respondents said they plan to travel with their families, 29.1 percent will go with friends while 6 percent want to travel alone.

 

A majority, 51.7 percent, want to travel by plane while 20.3 percent said they will use their own cars.

 

The survey said that the most popular destinations were seaside resorts, followed by mountain resorts, eco-tourism sites and cities.

 

Source: Vietnam News Agency

Over 340 Vietnamese citizens return home from Japan

 

Over 340 Vietnamese citizens living in Japan were brought home safely on May 25.

 

The trip was arranged by Vietnamese and Japanese authorities, the Vietnamese Embassy in Japan, and national flag carrier Vietnam Airlines.

 

Passengers included children under 18, the elderly, the ill, pregnant women, workers whose visas and labour contracts had expired, and students. After landing at the NoiBai International Airport, they underwent health check-ups and were then quarantined.

 

On the outbound flight, Vietnam Airlines carried a batch of medical masks from the Vietnamese Government for the Japanese people.

 

Depending on Vietnamese citizens’ wishes, the quarantine capacity in localities, and the situation surrounding the pandemic, Vietnamese authorities, representative agencies overseas, and airlines will arrange more commercial flights to bring more Vietnamese home, in line with the Prime Minister’s directions.

 

Source: Vietnam News Agency

More than half of travel companies in HCM City reopen

Around 60 percent of travel companies in HCM City have resumed operating while the rest are expected to regain business in the fourth quarter of the year, according to the city’s Department of Tourism.

 

Travel companies specialising in inbound and bound markets, however, must wait to reopen when foreign tourists are allowed to enter the country again, according to Nguyen ThiAnhHoa, deputy director of the department.

 

Travel agencies are now focusing on domestic air travel as part of an effort to recover from the fall-out caused by COVID-19, Hoa said.

 

Most travel companies are seeking help from the Government’s relief package so they can remain in business.

 

The department has submitted to the State Bank of Vietnam’s HCM City branch a list of 50 travel firms in need of aid packages from the Government and banks.

 

Travel firms are coordinating with airlines, hotels and resorts, restaurants and tourist spots to develop tour stimulus packages discounted by 50-60 percent.

 

Tours from HCM City to the Central Highlands for two days, for example, have discounts of 500,000-1 million VND (21-42 USD) and are sold for 1-1.5 million VND (42-64 USD) per person.

 

Tours to destinations in the north are priced at 4.5 million VND (193 USD) per person, down from 7 million VND (300 USD).

 

Many travel companies have reported a rise in the number of domestic travel bookings in the past few days.

 

A Vietravel representative said there has been a surge in bookings for car and hotel services, but the number of tour package bookings remains modest.

 

Source: Vietnam News Agency

 

NA deputies to debate two draft laws, one draft resolution on May 25

Legislators will deliberate the draft Law on Mediation and Dialogue at Court on May 25 morning as part of the ninth session of the 14th National Assembly.

 

They will hear a report on revisions to the draft law based on feedback during previous discussion, to be presented by head of the NA’s Committee for Judicial Affairs Le ThiNga, and discuss online contentious contents of the document.

 

Also in the morning, Minister of Finance DinhTien Dung will present a proposal for the draft resolution on agricultural land use tax exemptions, and head of the NA’s Finance-Budget Committee Nguyen DucHai will deliver a verification report on the draft resolution.

 

The deputies will then engage in an online debate on the document.

 

During the afternoon session, the lawmakers are scheduled to continue with their discussion on the draft resolution.

 

They will devote most of the time in the afternoon to scrutising a report clarifying issues raised during previous discussions on the draft revised Youth Law and revising the draft based on acquired feedback. Some contentious contents of the document will be further tabled for debate.

 

At the end of the day, compilation and verification agencies will clarify some issues in the bill raised by the deputies during the discussion.

 

Source: Vietnam News Agency

 

Central Military Commission prepares for Army’s 11th Party Congress

 

The Central Military Commission held a conference in Hanoi on May 25 to collect feedback on draft documents to be submitted to the 11th Party Congress of the Vietnam People’s Army (VPA).

 

In his remarks, Party General Secretary and State President Nguyen PhuTrong, who is also Secretary of the Commission, said he appreciates the quality of the documents and asked delegates to candidly contribute opinions.

 

Apart from document preparation, the personnel tasks facing the Congress should also receive special attention, he said.

 

The draft political report stated that over the last five years the Commission and the Ministry of National Defence have fully performed their roles as strategic advisors of the Party and the State in military and national defence affairs.

 

It also highlighted the improved strength and combat preparedness of the VPA, along with reforms in training and drill work and effective defence diplomacy, which have contributed to defending the country and improving the position and prestige of the VPA and Vietnam in the international arena.

 

Conference delegates agreed on the content and basic orientations for the implementation of military and Party building tasks for the 2020-2025 tenure and the years to come.

 

Accordingly, the Party’s absolute and direct leadership of the VPA will be maintained and enhanced and greater efforts will be made to build a pure and strong Party Committee in the VPA and a revolutionary, regular, elite, and modern army.

 

The entire army will also maintain high combat preparedness to protect the country and contribute to ensuring a peaceful and stable environment for national construction and development.

 

Delegates shared views that personnel tasks must be prepared thoroughly at the Congress with a high sense of responsibility and democracy and be in line with procedures and principles.

 

Source: Vietnam News Agency