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Daily Archives: March 13, 2020

Algernon Announces Filing of U.S. FDA Pre-IND Meeting Request for Ifenprodil Coronavirus Trial, Expanded Access, and Emergency Use

VANCOUVER, British Columbia, March 13, 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 is has filed its pre-IND (Investigational New Drug) meeting request with the U.S. FDA. This initiates formal communications with the U.S. FDA regarding development of the Company’s repurposed drug NP-120 (Ifenprodil) for the treatment and prevention of acute lung injury (ALI) and acute respiratory distress syndrome associated with COVID-19 (coronavirus) infection. The request for a pre-IND meeting was accompanied by the complete pre-IND briefing document.

In the application, the Company has requested direction regarding the use of Algernon’s planned new propriety injectable and slow release formulation as well as the use of the Company’s currently available Ifenprodil drug supply, for a US clinical trial on an emergency use basis. This filing also includes clarification of the expanded access pathway, also known as the “compassionate use” pathway.

The decision to file with the U.S. FDA, was made after a recent independent study found that Ifenprodil significantly reduced ALI and improved survivability in an animal study with Asian H5N1 infected mice by 40%. Asian H5N1 is the most lethal form of influenza known to date with an over 50% mortality rate. The drug was also previously shown in a separate study to prolong survival under anoxic (low oxygen) conditions, as might occur in patients with severely impaired lung function.

Ifenprodil H5N1 Animal Study Background:

A genome wide RNAi interference approach to identify genes that aid in the recovery of cell viability after H5N1 infection, lead to the identification of the NMDA receptor antagonist Ifenprodil, which when tested in an animal model of H5N1 infection showed:

  1. Markedly decreased leukocyte infiltration and lung injury scores in effected lungs
  2. Significantly ameliorated edema infected mouse lung tissue
  3. Significantly improved the survival of H5N1 infected mice by 40%

Study Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6906739/

“This is a very important step for the Company as we move forward on our strong belief, based on the data, that NP-120 (Ifenprodil) may be an effective treatment for coronavirus (COVID-19),” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals. “I would like to thank the entire Algernon team for all of the hard work and dedication this past week that went into preparing our pre-IND application. We will update the market shortly on the direction we receive from the U.S. FDA and based on circumstances, we are hoping for an expedited response.”

About NP-120 (Ifenprodil)

NP-120 (Ifenprodil) is an N-methyl-d-aspartate (NDMA) receptor glutamate receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB). Ifenprodil also exhibits agonist activity for the Sigma-1 receptor, a chaperone protein up-regulated during endoplasmic reticulum stress. Although the anti-fibrotic activity of Ifenprodil in IPF is not known, recent studies have suggested a link between both receptors and pathways associated with fibrosis.

Glutamate (Glu) is the main excitatory neurotransmitter which acts on glutamate receptors in the central nervous system (CNS) but overactivation of these receptors can cause several damages to neural cells including death. Recent studies show that the glutamate agonist N-methyl-d-aspartate (NMDA) can trigger acute lung injury (ALI). ALI is a direct and indirect injury to alveolar epithelial cells and capillary endothelial cell, causing diffuse pulmonary interstitial and alveolar edema and acute hypoxic respiration failure. ALI is characterized by reduced lung volume and compliance, and imbalance of the ventilation/perfusion ratio, inducing hypoxemia and respiratory distress and its severe stage (oxygen index <200) known as acute respiratory distress syndrome (ARDS). (1) Furthermore, pathological findings show that 64% of ARDS patients may have pulmonary fibrosis during convalescence (2).

NP-120 (Ifenprodil) was initially developed by Sanofi in the 1970’s in the French and Japanese markets for the treatment of circulatory disorders. The drug is genericized and sold in Japan and South Korea and is used to treat certain neurological conditions.

About Algernon Pharmaceuticals Inc. 

Algernon Pharmaceuticals is a clinical stage pharmaceutical development company focused on advancing its lead compounds for non–alcoholic steatohepatitis (NASH), chronic kidney disease (CKD) inflammatory bowel disease (IBD), idiopathic pulmonary fibrosis (IPF) and chronic cough.

Algernon has filed new intellectual property rights 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

The CSE does not accept responsibility for the adequacy or accuracy of this release.
Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release. The Canadian Securities Exchange has not in any way passed upon the merits of the proposed transaction and has neither approved nor disapproved the contents of this press release.

CAUTIONARY DISCLAIMER STATEMENT: No securities regulatory authority or stock 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.

(1) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5938426/
(2) https://www.ncbi.nlm.nih.gov/pubmed/19909524

Judge rebukes lawyer over grilling of witness

KUALA LUMPUR, March 12 – Lawyer Datuk Akberdin Abdul Kader, representing Datin Seri Rosmah Mansor in a corruption case involving a hybrid solar project for rural schools in Sarawak, was rebuked by High Court judge Mohamed Zaini Mazlan, who is presiding the case, for his way of “grilling” former Education Ministry (MOE) secretary-general Datuk Seri Alias Ahmad, who is a witness during cross-examination today.

“He (Alias) is not on trial here…mind yourself of the charges,” said the judge to Akberdin, who claimed that the 12th witness had interests in the RM1.25 billion hybrid solar project.

Earlier, Akberdin questioned on Alias’ action in personally contacting a former secretary at the Government Procurement Division of the Ministry of Finance (MOF), Datuk Othman Semail, to request for MOF to proceed with MOE’s application for approval of RM130 million in advance payment for the implementation of the hybrid solar project.

Akberdin: After receiving a letter dated April 19, 2017 from the MOF, I put it to you that you personally made a call to Datuk Othman asking for his good office to approve MOE’s application for advance payment of RM130 million.

Alias: About the call (to Othman), I agreed (making the call), but to talk about other matters, not about the RM130 million advance payment.

Akberdin: I put it to you that the response from Datuk Othman was that he held to the letter, he could not entertain your request because you did not follow procedures.

Alias: I disagree.

Akberdin: I put it to you that you took extra effort and initiative, to the extent of calling Othman because you had interest in the project.

Alias: I disagree.

During the previous proceeding, former secretary at the Asset Procurement and Management Division of MOE, Kamarudin Abdullah, had told the court that the letter dated April 19, 2017 was a from MOF to MOE which stated that the MOE’s request for approval of the advance payment of RM130 million was being looked into.

According to Kamarudin, MOF, also stated in the letter that to expedite the payment process, MOE would need to take action, like adhering to financial procedures and regulations and to expedite the process of signing a procurement contract with the contractor of the project, Jepak Holdings Sdn Bhd.

Rosmah, 68, is facing a charge of soliciting RM187.5 million and two counts of receiving a bribe of RM6.5 million from Jepak Holdings managing director Saidi Abang Samsudin through her former aide, Datuk Rizal Mansor as gratification for helping the company to secure the RM1.25 billion Hybrid Photovoltaic Solar System Integrated Project and Maintenance and Operation of Genset/Diesel for the 369 rural schools in Sarawak, through direct negotiation from the Education Ministry.

She allegedly committed the offences at three places, namely Lygon Cafe at Sunway Putra Mall in Jalan Putra here; her house at Jalan Langgak Duta, Taman Duta here, and at the Seri Perdana Residence, Persiaran Seri Perdana, Precinct 10, Putrajaya between January 2016 and Sept 7, 2017.

The hearing continues on April 6.

Source: BERNAMA News Agency

COVID-19: Selangor postpones all large-scale events

PELABUHAN KLANG, March 12 — Selangor has put on hold all its large-scale events, effective immediately.

Menteri Besar Datuk Seri Amirudin Shari said among postponed programmes were Selangor Land Carnival 2020 and Selangor Job Fair 2020 which were scheduled to be held this weekend.

“Following the declaration that COVID-19 is now a pandemic, all large-scale events will be postponed with immediate effect until the situation improved.

“The private sector is also advised to postpone non-critical programmes following the two-fold increase in COVID-19 infection currently, which has the potential to continue to spread,” he told reporters after visiting Westports Malaysia here today.

On the state assembly sitting anticipated to start this Monday for two weeks, Amirudin said it would be held as scheduled with a tightened precautionary measure.

Besides health check, hand sanitisers and face masks will be provided to all involved, he said.

Source: BERNAMA News Agency

COVID-19 : Nine new cases in Singapore, two linked to mosque gathering in Malaysia

SINGAPORE, March 12 – Singapore’s Ministry of Health (MOH) has confirmed nine more cases of COVID-19 infection in the republic, with two linked to a mass religious gathering at a mosque in Malaysia.

In a statement today, MOH said the cases involved male Singapore citizens, aged 29 and 48, both of whom had attended the gathering.

Both were confirmed to have COVID-19 infection this morning, and were currently warded in isolation rooms at the city-state’s National Centre for Infectious Diseases, it said.

With the new development, the COVID-19 tally in the republic now stands at 187.

Earlier, in KUALA LUMPUR, the Malaysian Health Ministry had confirmed that a Malaysian man had contracted COVID-19 at the mosque gathering in Malaysia’s federal capital.

Both were confirmed to have COVID-19 infection this morning, and were currently warded in isolation rooms at the city-state’s National Centre for Infectious Diseases, it said.

With the new development, the COVID-19 tally in the republic now stands at 187.

Earlier, in KUALA LUMPUR, the Malaysian Health Ministry had confirmed that a Malaysian man had contracted COVID-19 at the mosque gathering in Malaysia’s federal capital.

Source: BERNAMA News Agency

COVID-19: UiTM postpones convocation at all campuses

SHAH ALAM, March 12 — Universiti Teknologi Mara (UiTM) today decided to postpone its 92nd convocation ceremony scheduled for March 24 to April 16, at all campuses nationwide.

Vice-chancellor Emeritus Professor Datuk Dr Mohd Azraai Kassim said the decision was made after taking into consideration the COVID-19 report issued by the Ministry of Health (MOH) yesterday.

“Following the announcement of COVID-19 as a pandemic by the World Health Organisation, UiTM’s executive management at a special meeting today decided to postpone the convocation ceremony with immediate effect until a new date is announced.

“UiTM management needs to take proactive measures for the health and safety of all university and community members,” he said in a statement here today.

Mohd Azraai also expressed his appreciation for the support and cooperation of all parties in the decision on the postponement.

Source: BERNAMA News Agency

COVID-19: UiTM postpones convocation at all campuses

SHAH ALAM, March 12 — Universiti Teknologi Mara (UiTM) today decided to postpone its 92nd convocation ceremony scheduled for March 24 to April 16, at all campuses nationwide.

Vice-chancellor Emeritus Professor Datuk Dr Mohd Azraai Kassim said the decision was made after taking into consideration the COVID-19 report issued by the Ministry of Health (MOH) yesterday.

“Following the announcement of COVID-19 as a pandemic by the World Health Organisation, UiTM’s executive management at a special meeting today decided to postpone the convocation ceremony with immediate effect until a new date is announced.

“UiTM management needs to take proactive measures for the health and safety of all university and community members,” he said in a statement here today.

Mohd Azraai also expressed his appreciation for the support and cooperation of all parties in the decision on the postponement.

Source: BERNAMA News Agency

COVID-19: HTJS shortens visiting hours

SEREMBAN, March 12 — The Tuanku Jaafar Hospital Seremban (HTJS) has shortened its visiting hours after the World Health Organisation (WHO) declared the spread of COVID-19 as a pandemic, and the hike in cases in Malaysia.

State Health Department (Public Health) deputy director Dr Mohammad Faid Abd Rashid said a ban on bringing children under 12 years old to the hospital would also be tightened.

‘’The visiting hours have been shortened to 1 pm until 2 pm and 5 pm until 6.30 pm daily including general holidays and public holidays (Saturday and Sunday).

‘’The proactive measure is to prevent the spread of COVID-19 among visitors, patients and the staff of HTJS,’’ he said here today.

Source: BERNAMA News Agency