Pengkhianatan G30S/PKI

AB Science receives Notice of Deficiency (NOD) from Health Canada for masitinib in the treatment of amyotrophic lateral sclerosis (ALS)

Retrieved on: 
Tuesday, December 13, 2022
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AB Science SA (Euronext - FR0010557264 - AB) today announced that it has received a Notice of Deficiency (“NOD”) for its masitinib New Drug Submission in the treatment of amyotrophic lateral sclerosis.

Key Points: 
  • AB Science SA (Euronext - FR0010557264 - AB) today announced that it has received a Notice of Deficiency (“NOD”) for its masitinib New Drug Submission in the treatment of amyotrophic lateral sclerosis.
  • This NOD means that Health Canada has requested the provision of additional information related to masitinib New Drug Submission.
  • The Response to a Notice of Deficiency is to be submitted within 90 calendar days from the date the NOD was sent.
  • AB Science will liaise with Health Canada to address the deficiencies, with the intention to resume the process within the allocated timeframe.

AB Science - Positive recommendation of the Data and Safety Monitoring Board to continue the Phase 2 study evaluating the antiviral activity of masitinib in Covid-19

Retrieved on: 
Wednesday, September 14, 2022
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AB Science SA (Euronext - FR0010557264 - AB) today announced continuation of the Phase 2 study evaluating the antiviral activity of masitinib in patients who have a confirmed diagnosis of COVID-19, following the recommendation of the Data and Safety Monitoring Board (DSMB).

Key Points: 
  • AB Science SA (Euronext - FR0010557264 - AB) today announced continuation of the Phase 2 study evaluating the antiviral activity of masitinib in patients who have a confirmed diagnosis of COVID-19, following the recommendation of the Data and Safety Monitoring Board (DSMB).
  • The DSMB indicated that there was no safety concern and recommended continuation of the study without restrictions.
  • AB Science currently has two on-going phase 2 clinical studies in COVID-19:
    Study AB21002, evaluating the antiviral activity of masitinib in patients with symptomatic mild to moderate COVID-19.
  • Study AB20001, evaluating the safety and efficacy of masitinib plus isoquercetin in hospitalized patients with moderate or severe COVID-19.

AB Science announces that Health Canada has started the review of New Drug Submission for masitinib in the treatment of ALS

Retrieved on: 
Thursday, May 26, 2022
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Under the NOC/c policy, Health Canada has a target of 200 calendar days maximum to review the application.

Key Points: 
  • Under the NOC/c policy, Health Canada has a target of 200 calendar days maximum to review the application.
  • As a reminder, Health Canada had granted in February 2022 authorization to file a new drug submission for masitinib in the treatment of amyotrophic lateral sclerosis (ALS) under the notice of compliance with conditions (NOC/c) policy.
  • Market authorization under the NOC/c policy allows Health Canada to provide earlier market access to potentially life-saving drugs.
  • Alain Moussy, co-founder and CEO of AB Science, said We welcome the decision of Health Canada to accept the masitinib registration dossier in ALS for review.

Rezolute Announces Positive Study Results for RZ402, an oral PKI being developed for DME

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Tuesday, February 22, 2022
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Results of the MAD study further validate and support the potential for once daily oral dosing and enable the company to initiate a Phase 2 proof-of-concept study later this year.

Key Points: 
  • Results of the MAD study further validate and support the potential for once daily oral dosing and enable the company to initiate a Phase 2 proof-of-concept study later this year.
  • By doing so, RZ402 may be able to prevent disease progression and treat vision loss for those suffering with DME, said, Raj Agrawal, MD, Vice President at Rezolute.
  • The MAD study results showed that RZ402 was generally safe and well-tolerated, including at higher doses than previously tested in the SAD study.
  • RZ402 is a selective and potent plasma kallikrein inhibitor (PKI) being developed as a potential oral therapy for the chronic treatment of diabetic macular edema (DME).

AB Science announces that Health Canada has granted authorization to file a New Drug Submission for masitinib in the treatment of ALS under the Notice of Compliance with Conditions (NOC/c) policy

Retrieved on: 
Monday, February 21, 2022
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AB Science SA (Euronext - FR0010557264 - AB) today announces that Health Canada has granted authorization to file a New Drug Submission for masitinib in the treatment of amyotrophic lateral sclerosis (ALS) under the Notice of Compliance with Conditions (NOC/c) policy.

Key Points: 
  • AB Science SA (Euronext - FR0010557264 - AB) today announces that Health Canada has granted authorization to file a New Drug Submission for masitinib in the treatment of amyotrophic lateral sclerosis (ALS) under the Notice of Compliance with Conditions (NOC/c) policy.
  • Market authorization under the NOC/c policy allows Health Canada to provide earlier market access to potentially life-saving drugs.
  • An assessment named Advance Consideration, performed by a Health Canada Adjudicating Committee, is necessary before being granted authorization to file under NOC/c policy.
  • The Adjudicating Committee has concluded that the request does fulfill the criteria for filing and advance consideration under the NOC/c policy.

AB Science to present on its Amyotrophic Lateral Sclerosis (ALS) development program at the 2022 ALS Drug Development Summit

Retrieved on: 
Monday, February 7, 2022
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AB Science SA (Euronext - FR0010557264 - AB) today announced that Professor Olivier Hermine, President of the Scientific Committee of AB Science, will deliver a presentation on the amyotrophic lateral sclerosis (ALS) masitinib development program to an audience of key opinion leaders and decision-makers in the field of ALS research and healthcare policy, at the up-coming ALS Drug Development Summit in Boston, USA (May 24-26, 2022).

Key Points: 
  • AB Science SA (Euronext - FR0010557264 - AB) today announced that Professor Olivier Hermine, President of the Scientific Committee of AB Science, will deliver a presentation on the amyotrophic lateral sclerosis (ALS) masitinib development program to an audience of key opinion leaders and decision-makers in the field of ALS research and healthcare policy, at the up-coming ALS Drug Development Summit in Boston, USA (May 24-26, 2022).
  • Additional information on the ALS Drug Development Summit can be found at the meeting website: https://www.als-drug-development.com/.
  • The development of masitinib in ALS is also supported by a well-demonstrated mechanism of action using a relevant model.
  • To date, masitinib has demonstrated positive Phase 2B/3 results in three neurodegenerative disorders, namely, amyotrophic lateral sclerosis (ALS) [2,3], Alzheimers disease [4], and progressive forms of multiple sclerosis [5].

AB Science granted authorization to initiate confirmatory Phase III trial of masitinib in progressive forms of multiple sclerosis by the Swedish Medical Products Agency

Retrieved on: 
Wednesday, February 2, 2022
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AB Science SA (Euronext - FR0010557264 - AB) today announces that it has been authorized by the Swedish Medical Products Agency, to initiate a Phase III study (AB20009) evaluating masitinib in patients with Primary Progressive Multiple Sclerosis (PPMS) or non-active Secondary Progressive Multiple Sclerosis (nSPMS).

Key Points: 
  • AB Science SA (Euronext - FR0010557264 - AB) today announces that it has been authorized by the Swedish Medical Products Agency, to initiate a Phase III study (AB20009) evaluating masitinib in patients with Primary Progressive Multiple Sclerosis (PPMS) or non-active Secondary Progressive Multiple Sclerosis (nSPMS).
  • To date, masitinib has demonstrated positive Phase 2B/3 results in three neurodegenerative disorders, namely, Alzheimers disease [1], amyotrophic lateral sclerosis (ALS) [2,3], and progressive forms of multiple sclerosis [4].
  • This confirmatory study follows successful completion of a first Phase 2B/3 study (AB07002) in primary progressive (PPMS) and non-active secondary progressive (nSPMS) multiple sclerosis.
  • Published 2021 Jul 19. doi:10.1177/17562864211030365
    [4] Vermersch P, Hermine O. Masitinib in primary progressive (PPMS) and non-active secondary progressive (nSPMS) multiple sclerosis: results from phase 3 study AB07002.

AB Science granted authorization to initiate confirmatory Phase III trial of masitinib in progressive forms of multiple sclerosis by the French Health Authority (ANSM)

Retrieved on: 
Monday, January 3, 2022
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AB Science SA (Euronext - FR0010557264 - AB) today announces that it has been authorized by the French Medicine Agency, ANSM, to initiate a Phase III study (AB20009) evaluating masitinib in patients with Primary Progressive Multiple Sclerosis (PPMS) or non-active Secondary Progressive Multiple Sclerosis (nSPMS).

Key Points: 
  • AB Science SA (Euronext - FR0010557264 - AB) today announces that it has been authorized by the French Medicine Agency, ANSM, to initiate a Phase III study (AB20009) evaluating masitinib in patients with Primary Progressive Multiple Sclerosis (PPMS) or non-active Secondary Progressive Multiple Sclerosis (nSPMS).
  • Professor Patrick Vermersch, MD, principal investigator of the study and Professor of Neurology at the University of Lille, France commented, We are very excited to initiate this confirmatory phase III study with masitinib in progressive forms of multiple sclerosis.
  • However, patients suffering from a progressive form of the disease currently account for approximately 50% of MS cases.
  • This confirmatory study follows successful completion of a first Phase 2B/3 study (AB07002) in primary progressive (PPMS) and non-active secondary progressive (nSPMS) multiple sclerosis.

AB Science publishes a Q&A press release, following-up on its June 28, 2021 press release relating to an agreement with historical shareholders

Retrieved on: 
Friday, August 6, 2021
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AB Science SA (Euronext - FR0010557264 - AB) publishes a Q&A press release, following-up on its June 28, 2021 press release relating to an agreement with historical shareholders.

Key Points: 
  • AB Science SA (Euronext - FR0010557264 - AB) publishes a Q&A press release, following-up on its June 28, 2021 press release relating to an agreement with historical shareholders.
  • Are these directors representatives of the historical shareholders mentioned in the AB Science press release?
  • 3. Who are the historical shareholders mentioned in the AB Science June 28, 2021 press release?
  • Among them, shareholders holding 5.1% of the share capital of AB Science were already in the concert in place within AB Science.