APTORUM GROUP

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

Retrieved on: 
Wednesday, September 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 Further Positive Interim Results of the Phase 1 Clinical Trial of ALS-4 Targeting Staphylococcus aureus

Retrieved on: 
Monday, July 12, 2021
Biotechnology, Pharmaceutical, Health, Clinical trials, Medical specialties, Infectious diseases, Microbiology, Staphylococcaceae, Gram-positive bacteria, Bacterial diseases, Healthcare-associated infections, Pathogenic bacteria, Staphylococcus aureus, Staphylococcus, Methicillin, Kerry LaPlante, ALS-4, Aptorum Group, ALS-4, APTORUM GROUP

Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (Aptorum Group or Aptorum), a clinical-stage biopharmaceutical company, announces further positive results of its ongoing Phase 1 clinical trial for ALS-4 (a first in-class anti-virulence approach based small molecule targeting Staphylococcus aureus, including, but not limited to Methicillin Resistant Staphylococcus Aureus (MRSA)).

Key Points: 
  • Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (Aptorum Group or Aptorum), a clinical-stage biopharmaceutical company, announces further positive results of its ongoing Phase 1 clinical trial for ALS-4 (a first in-class anti-virulence approach based small molecule targeting Staphylococcus aureus, including, but not limited to Methicillin Resistant Staphylococcus Aureus (MRSA)).
  • In addition, no clinically relevant changes in respect of vital signs, electrocardiogram (ECG), clinical laboratory test results and physical examinations were observed compared to baselines.
  • Our SAD is still ongoing to gain additional insights as to the effect of food on bioavailability as well as pharmacokinetics.
  • 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 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: 
Monday, May 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 Enters into an Agreement with Exeltis to Develop Aptorum’s Novel Preclinical Candidate Targeting Woman’s Gynecological Conditions

Retrieved on: 
Thursday, May 6, 2021
Biotechnology, Pharmaceutical, Health, Clinical trials, Endometriosis, Menstrual cycle, Gynaecology, Exeltis, Aptorum Group, EXELTIS, APTORUM GROUP

This novel candidate is intended to target woman\xe2\x80\x99s health and gynecological conditions, such as endometriosis or related conditions.

Key Points: 
  • This novel candidate is intended to target woman\xe2\x80\x99s health and gynecological conditions, such as endometriosis or related conditions.
  • Under the Agreement, Aptorum Group will retain the development rights in other jurisdictions in the world, as well as the right to develop the novel candidate into a drug product.
  • Commercialisation of the product is subject to relevant regulatory approvals in their respective jurisdictions.\nDr.
  • Clark Cheng, Chief Medical Officer and Executive Director of Aptorum Group, commented: \xe2\x80\x9cEndometriosis is a systemic gynecological condition that is often painful and chronic, estimated to affect approximately 10% of reproductive-age women1.

Aptorum Group Enters Into Material Transfer and Exclusive Option-To-License Agreement with Yale University for Its Novel Immunomodulators Potentially Targeting Autoimmune and Oncology Diseases

Retrieved on: 
Thursday, April 22, 2021
Research, Clinical trials, Biotechnology, Health, University, Pharmaceutical, Science, Education, Oncology, Medical specialties, Clinical medicine, Medicine, Immunology, Autoimmunity, Sjögren syndrome, Aptorum Group, the Yale Office of Cooperative Research, Yale University, APTORUM GROUP, THE YALE OFFICE OF COOPERATIVE RESEARCH, YALE UNIVERSITY

The novel immunomodulators may potentially target autoimmune and oncology diseases, including but not limited to, rheumatoid arthritis, lupus and sclerosis, as well as a variety of cancers, all subject to further preclinical development and testing.

Key Points: 
  • The novel immunomodulators may potentially target autoimmune and oncology diseases, including but not limited to, rheumatoid arthritis, lupus and sclerosis, as well as a variety of cancers, all subject to further preclinical development and testing.
  • Upon exercising its option to license, Aptorum will undertake to develop and commercialize one or more of these novel immunomodulators, as supported by Yale.\nMr.
  • Ian Huen, Chief Executive Officer of Aptorum Group, commented: \xe2\x80\x9cAptorum is delighted to partner with Yale to validate and develop its novel class of immunomodulators.
  • Aptorum believes that these immunomodulators have the potential to advance first-in-class drug discovery and development of such drugs for potential autoimmune and oncology diseases in particular.