SACT-1

Aptorum Group Receives FDA Orphan Drug Designation for its SACT-1 Repurposed Drug For The Treatment of Neuroblastoma

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Jeudi, janvier 20, 2022
Research, Infectious Diseases, FDA, Clinical Trials, Health, Pharmaceutical, General Health, Other Science, Science, Euronext Paris, Survival, Research, Patient, Technology, Clinical trial, MYCN, SEC, Death, Infection, United, Lists of diseases, Therapy, Cancer, JT Group Limited, FDA, Prospectus, Pharmaceutical industry, Medical imaging, EU, Science, Neuroblastoma, IND, SACT-1, Neuroblastoma, Aptorum Group Limited, SACT-1, NEUROBLASTOMA, APTORUM GROUP LIMITED

Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (Aptorum Group or Aptorum), a clinical-stage biopharmaceutical company, is pleased to announce that the United States Food and Drug Administration (FDA) Office has granted Orphan Drug Designation to SACT-1, a repurposed small molecule compound for the treatment of patients with Neuroblastoma.

Key Points: 
  • Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (Aptorum Group or Aptorum), a clinical-stage biopharmaceutical company, is pleased to announce that the United States Food and Drug Administration (FDA) Office has granted Orphan Drug Designation to SACT-1, a repurposed small molecule compound for the treatment of patients with Neuroblastoma.
  • Aptorum Group plans to file an Investigational New Drug Application (IND) to commence a phase 1b/2a clinical trial for SACT-1 to test the drug in neuroblastoma patients in 2022.
  • SACT-1 is an orally administered repurposed small molecule drug to target neuroblastoma.
  • This press release does not constitute an offer to sell or a solicitation of offers to buy any securities of Aptorum Group.

Aptorum Group Announces Completion of Phase I Clinical Trials for ALS-4 and SACT-1, Small Molecule Drugs Targeted for Infections Caused by Staphylococcus Aureus and Neuroblastoma

Retrieved on: 
Lundi, janvier 10, 2022
Research, Infectious Diseases, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Aureus, Clinical trial, Vancomycin, Randomness, MRSA, SEC, Safety, Trial of the century, Nervous system, Single, US, JT Group Limited, Staphylococcus, Bacteria, Volunteering, Infection, Pharmacokinetics, Technology, Patient, World Health Organization, Brain, Neuroblastoma, Research, Adult, IND, ECG, Female, World, Methicillin, MAD, Staphylococcus aureus, Male, SAD, Lists of diseases, Euronext Paris, Vital signs, Prospectus, Therapy, Mortality, MYCN, Pharmaceutical industry, Science, EU, ALS-4, SACT-1, Aptorum Group Limited, ALS-4, SACT-1, APTORUM GROUP LIMITED

The safety data of the last SAD cohort (300mg) and MAD cohort (200mg twice a day for 14 days) are pending.

Key Points: 
  • The safety data of the last SAD cohort (300mg) and MAD cohort (200mg twice a day for 14 days) are pending.
  • SACT-1s first in-human clinical trial is a Phase 1, Open-label Randomized, Single Cross Over Bioavailability and Food Effect Study of SACT-1 in healthy adult volunteers.
  • Aptorum is pleased to announce the successful completion of the trial, during which no SAE were observed.
  • This milestone supports the focus of Aptorum Group to embark on the exciting Phase II clinical trials for ALS-4 and planned Phase Ib/2a clinical trials for SACT-1, subject to IND clearance.

Aptorum Group Limited Has Received IND Clearance From the US FDA to Initiate Clinical Trials for Repurposed Small Molecule Drug SACT-1 for the Treatment of Neuroblastoma

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Mercredi, septembre 15, 2021
Biotechnology, Health, Oncology, Clinical Trials, MYCN, FDA, Technology, Neuroblastoma, Prospectus, Patient, JT Group Limited, Research, Private Securities Litigation Reform Act, Nervous system, IND, Disease, Adult, Infection, Therapy, Brain, SEC, Euronext Paris, Lists of diseases, Pharmaceutical industry, SACT-1, Aptorum Group, SACT-1, APTORUM GROUP

Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (Aptorum Group or Aptorum), a clinical stage biopharmaceutical company focused on novel technologies including the targeting of oncological diseases, announced that the group has received clearance from the US FDA regarding the IND application to initiate clinical trials of SACT-1, an orally administered repurposed small molecule drug for the treatment of neuroblastoma.

Key Points: 
  • Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (Aptorum Group or Aptorum), a clinical stage biopharmaceutical company focused on novel technologies including the targeting of oncological diseases, announced that the group has received clearance from the US FDA regarding the IND application to initiate clinical trials of SACT-1, an orally administered repurposed small molecule drug for the treatment of neuroblastoma.
  • This milestone supports the focus of Aptorum Group in the United States and reflects the potential of our scientific rigor and novel approach of our products.
  • Neuroblastoma is a highly unmet solid tumor arising in the nervous system outside of the brain predominantly in pediatric patients.
  • The clinical behavior of neuroblastoma is highly variable with majority cases being highly aggressive.

Aptorum Group Announces Positive Interim Phase I Clinical Trial Progress for ALS-4 Targeting Staphylococcus aureus and Positive Pre-IND Progress for SACT-1 Targeting Neuroblastoma

Retrieved on: 
Lundi, mai 24, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Medical specialties, Infectious diseases, Microbiology, Bacterial diseases, Healthcare-associated infections, Staphylococcaceae, Gram-positive bacteria, Pathogenic bacteria, Staphylococcus aureus, ALS-4, SACT-1, Aptorum Group, ALS-4, SACT-1, APTORUM GROUP

In addition, no relevant clinical changes in respect of vital signs, ECG, clinical laboratory test results and physical examinations were observed compared to the relevant baseline.

Key Points: 
  • In addition, no relevant clinical changes in respect of vital signs, ECG, clinical laboratory test results and physical examinations were observed compared to the relevant baseline.
  • On this basis, the remaining ALS-4 Phase I study will continue to progress and as of this date, Cohort C (100mg) studies have been initiated.
  • SACT-1, a repurposed drug candidate for the treatment of neuroblastoma, has completed its Pre-IND meeting with the US FDA.
  • As part of Aptorum Groups Acticule infectious disease platform, ALS-4 is a novel first-in-class orally administered small molecule drug based on an anti-virulence approach targeting staphylococcus aureus including MRSA.

Aptorum Group Announces Further Positive Data on SACT-1 Against Neuroblastoma and Other Potential Tumor Types

Retrieved on: 
Mardi, septembre 1, 2020
Biotechnology, Pharmaceutical, Health, Oncology, RTT, Brain tumor, Neuroblastoma, Cancer, Organ systems, Causes of death, SACT-1, Aptorum Group Limited

This further supports our earlier in vitro observation that SACT-1 promotes tumor DNA damage and tumor cell death.

Key Points: 
  • This further supports our earlier in vitro observation that SACT-1 promotes tumor DNA damage and tumor cell death.
  • As a result, in addition to treating neuroblastoma, SACT-1 may have potential applications in the treatment of other cancers.
  • Aptorum Group is pursuing therapeutic projects in orphan diseases, infectious diseases, metabolic diseases, womans health and other disease areas.
  • Aptorum Group assumes no obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.