FIH

Arthex announces regulatory milestones met in its program to develop ATX-01 in Myotonic Dystrophy Type 1

Retrieved on: 
Wednesday, December 14, 2022
Chemistry, DM1, Industrial technology, Drug discovery, Scientific Advice Mechanism, Development, Food, IND, Muscle, EMA, Toxicology, Patient, Orphan drug, Myotonic dystrophy, Disease, FDA, Fatigue, CMC, CTA, MicroRNA, ODD, European Medicines Agency, Hypersomnia, Science, CDTI, Tissue, Food and Drug Administration Amendments Act of 2007, FIH, Centre for the Development of Industrial Technology, Pharmaceutical industry

Importantly, no red flags or concerns were raised regarding the toxicology or rationale to support a FIH study.

Key Points: 
  • Importantly, no red flags or concerns were raised regarding the toxicology or rationale to support a FIH study.
  • Myotonic dystrophy type 1 (DM1) is a highly disabling disease affecting more than one million people worldwide.
  • Arthex Biotech is a preclinical-stage drug development company focused on improving the lives of patients with high unmet medical needs.
  • Arthex Biotech's investors are Invivo Capital, AdBio Partners, and the Centre for the Development of Industrial Technology (CDTI).

SparingVision’s lead asset SPVN06 clears IND application in the US for the treatment of retinitis pigmentosa

Retrieved on: 
Thursday, December 1, 2022
Science, FIH, Professor, DSMB, RCD, Natural history, ANSM, Food, University, DNA, Epistasis, Gene, IND, University of Pittsburgh Medical Center, Safety, PDE6B, Toys "R" Us, Inc. v. Step Two, S.A, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PDE6A, Retina, Retinitis pigmentosa, Disease, RHO, CTA, IRD, AMD, Research, Quality of life, Severe cognitive impairment, Data monitoring committee, Oxidative stress, AAV, FDA, IRDS, Pharmaceutical industry, Vaccine, RP

SparingVision has also submitted a clinical trial authorisation (CTA) application to the French regulator (ANSM), which is currently under review.

Key Points: 
  • SparingVision has also submitted a clinical trial authorisation (CTA) application to the French regulator (ANSM), which is currently under review.
  • First safety data are anticipated in 2023 and the primary endpoint is expected to be reached in 2025.
  • With over 80 genes involved in RP, each with numerous causative mutations, we need to go beyond the gene-by-gene treatment approach.
  • SPVN06 has the potential to become the universal therapeutic solution that patients need, and we are excited for the next phase of development.

Tetra Bio-Pharma Provides Update on Patent Applications for Novel Therapeutic ARDS-003

Retrieved on: 
Tuesday, November 29, 2022
IP, FIH, TSX, Multimedia, PCT, United States Patent and Trademark Office, End organ damage, Pain, Safety, Insurance, Physician, Patent Cooperation Treaty, Solubility, Patient, Legislation, Plasma protein binding, Inflammation, Composition, Patent, TBP, News, COVID, Research, HU308, Sepsis, FRA, FDA, Generic drug, Pharmaceutical industry, Tetra

Tetra strengthens its intellectual property position with PCT and provisional patent applications for its innovative therapeutic, ARDS-003.

Key Points: 
  • Tetra strengthens its intellectual property position with PCT and provisional patent applications for its innovative therapeutic, ARDS-003.
  • MONTREAL, Nov. 29, 2022 /PRNewswire/ - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug discovery and development today announced the filing of three patent applications for its novel therapeutic, ARDS-003.
  • The Company filed a provisional patent application with the United States Patent and Trademark Office related to crystalline Onternabez and uses thereof.
  • Guy Chamberland, CEO and Chief Regulatory Officer at Tetra commented "This is a significant step in protecting our novel therapeutic, ARDS-003.

Clearmind Announces Initiation of CMND-100 Manufacturing Program to Address its Upcoming Clinical Trial

Retrieved on: 
Wednesday, November 23, 2022
FIH, CWY, Food, Safety, Acquisition, AUD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FSE, GMP, Patent, Good, Death, Research, Therapy, CSE, Clinical trial, New Drug Application, FDA, MEAI, Pharmaceutical industry

Following MEAI's synthesis development process, the compound is being produced under GMP (Good Manufacturing Process) conditions to comply with FDA requirements.

Key Points: 
  • Following MEAI's synthesis development process, the compound is being produced under GMP (Good Manufacturing Process) conditions to comply with FDA requirements.
  • The clinical batches production is made possible due to prior successful production of MEAI drug substance that was used in the Company's pre- clinical studies designed to evaluate the safety of its innovative compound.
  • "Clearmind continues its progress toward FIH clinical trial" said Dr. Adi Zuloff-Shani, Clearmind's Chief Executive Officer.
  • "Alcohol abuse is the third most-common preventable cause of death in the United States, where almost 6% struggle with this condition. "

Novotech Chairs BioCentury Summit Workshop on How to Build and Finance an East-West MRCT Strategy

Retrieved on: 
Friday, November 11, 2022
Clinical trial, FDi Magazine, US FDA, Gene, Plasma protein binding, Ownership, Cell, NDA, CRO, Marketing, MAH, Research, CTA, FIH, Drug development, NMPA, Cros, Pharmaceutical industry, Fine chemical, IND

Novotech has significant real-world experience in East-West MRCT strategy after more than 2 decades managing clinical research programs for biotechs across Asia Pacific and the US.

Key Points: 
  • Novotech has significant real-world experience in East-West MRCT strategy after more than 2 decades managing clinical research programs for biotechs across Asia Pacific and the US.
  • Commenting on Novotech's experience, Chief Commercial Officer Barry Murphy said the right drug development pathway supports investor attraction and a successful clinical program.
  • Strategies for an East-West MRCT include:
    - Companies should engage with the US FDA and NMPA early to confirm guidance on their clinical roadmap.
  • Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases.

Benitec Biopharma Releases First Quarter 2023 Financial Results and Provides Operational Update

Retrieved on: 
Thursday, November 10, 2022
IND, CTA, Research, Principal investigator, Principal, Company, GMP, Child development stages, Institutional review board, GDPR, IRB, Disclosure, Benitec Biopharma, Dispute board, RNA, General Data Protection Regulation, U.S. Securities and Exchange Commission, Argonaute, Oculopharyngeal muscular dystrophy, Drug discovery, Dysphagia, Oropharyngeal dysphagia, HDL-Atherosclerosis Treatment Study, HIV disease progression rates, Achievement, United, Privacy, CEC, REB, Phenotype, GLOBE, FIH, Organization, Behavior, Muscle, NASDAQ, Safety, Union, Clinical, Validation, Animal, Natural history, Insurance, Pharmaceutical industry, Medicine, Medical imaging, Mineral wool, Medical device, OPMD, EU

Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer of Benitec Biopharma.

Key Points: 
  • Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer of Benitec Biopharma.
  • In the Third Calendar Quarter 2022, Benitec submitted responses to the Central Ethics Committee (CEC) related to minor non-clinical queries.
  • BB-301 Phase 1b/2a Regulatory Updates:
    Investigational New Drug (IND) and Clinical Trial Application (CTA) filings are anticipated in the First Calendar Quarter 2023.
  • Total Revenues for the quarter ended September 30, 2022, were $0 compared to $0 for the quarter ended September 30, 2021.

Monopar Therapeutics Reports Third Quarter 2022 Financial Results and Recent Program Developments

Retrieved on: 
Thursday, November 10, 2022
Quality of life, GLOBE, Private Securities Litigation Reform Act, U.S. Securities and Exchange Commission, VOICE, Interim, Annual general meeting, American Society of Hematology, National University of Singapore, Research, FIH, Society, G&A, Therapy, Cancer, SEC, Oropharyngeal cancer, Company, Program, Clinical trial, Conference, Patient, Life, Security (finance), Mucositis, National university, ASH, COVID-19, LLC, Fine chemical, Pharmaceutical industry, Lithium, Verification and validation, BC

WILMETTE, Ill., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced third quarter 2022 financial results and summarized recent program developments.

Key Points: 
  • WILMETTE, Ill., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced third quarter 2022 financial results and summarized recent program developments.
  • Monopars collaborator, the Cancer Science Institute of Singapore at the National University of Singapore, has been testing MNPR-202 in preclinical cancer models with promising results.
  • Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients.
  • Monopar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Transcenta Presented Two Scientific Posters at SITC 2022 Annual Meeting

Retrieved on: 
Friday, November 11, 2022
China Media Group Headquarters, Transforming growth factor beta, DLT, Prevalence, Team Impulse, Nature, Mab, Syngenic, PK, Toxic epidermal necrolysis, Annual general meeting, Process, Immunotherapy, Research, Fucose, FIH, FCR, Adenocarcinoma, Neoplasm, TGF, Environment, Diagnosis, Primate, CDC, Cancer immunotherapy, HKEX, Interleukin 1 receptor, type II, PD-L1, News, Immunoglobulin G, Safety, IHC, PD-1, ICB, SITC, Social conditioning, Society for Immunotherapy of Cancer, Suzhou Industrial Park, Stomach, NK, Patient, Immune system, ADCC, Discovery, Therapy, FDA, Headquarters, Pharmaceutical industry, Vaccine, Medical imaging

SUZHOU, China, Nov. 10, 2022 /PRNewswire/ -- Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that it has presented two scientific posters at the 37th Society for Immunotherapy of Cancer's (SITC) Annual Meeting in Boston, MA, November 8-12, 2022.

Key Points: 
  • SUZHOU, China, Nov. 10, 2022 /PRNewswire/ -- Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that it has presented two scientific posters at the 37th Society for Immunotherapy of Cancer's (SITC) Annual Meeting in Boston, MA, November 8-12, 2022.
  • Claudin18.2 staining in 10% of the tumor cells at 1+ or above intensity was present in 216 (72%) tissue samples tested.
  • As of Aug 24, 2022, the first three dose cohorts have been completed and no DLT was observed.
  • Transcenta (HKEX: 06628) is a clinical stage biopharmaceutical company with fully integrated capabilities in antibody-based biotherapeutics discovery, research, development and manufacturing.

Saranas Announces Over 1,200 Patients Treated with the Early Bird® Bleed Monitoring System

Retrieved on: 
Wednesday, November 9, 2022
Surgery, Health, Medical Devices, CT, ST, Morristown Medical Center, Aortic valve, Femoral artery, MCS, Food, JAMA Cardiology, Adoption, FIH, Detection, Structural heart disease, Classification, Bleeding, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Mortality, Early Bird, Cardiology, Early, Length of stay, Patient, Physician, De novo, EVAR, The Early Bird, TAVR, FDA, Trial of the century, Medical imaging, Birth control

Saranas, Inc. announced today that over 1,200 patients have been treated with the Early Bird Bleed Monitoring System, the first and only FDA-approved bleed detection system.

Key Points: 
  • Saranas, Inc. announced today that over 1,200 patients have been treated with the Early Bird Bleed Monitoring System, the first and only FDA-approved bleed detection system.
  • The adoption of the Early Bird system is a testimony to physicians embracing the benefits of early bleed detection for their patients and practice.
  • The Early Bird Bleed Monitoring System includes a bleed detection array with integrated electrodes in a fully functional vascular access sheath.
  • First-in-Human Study of the Saranas Early Bird Bleed Monitoring System for the Detection of Endovascular Procedure-Related Bleeding Events.

Teon Therapeutics Announces First Patient Treated in Phase 1/2 Clinical Trial of TT-816, a Novel Oral Immune Checkpoint Inhibitor, in Patients with Advanced Solid Tumors

Retrieved on: 
Tuesday, November 1, 2022
Research, Venture Capital, Clinical Trials, Professional Services, Biotechnology, Health, Pharmaceutical, Science, Oncology, CB2, Ovarian cancer, CB1, CEO, GPCR, Inflammation, RCC, PD-1, Immunity, Lung, FIH, Clinical trial, FRCPC, Cancer, Brain, Renal cell carcinoma, Immunotherapy, Ovary, Immune system, Research, Safety, Hope, Company, Therapy, FACP, Pharmacokinetics, Patient, NK, NSCLC, Phase 1, Pharmaceutical industry, Vaccine, Teone Church

The study will include patients with advanced solid tumors with high unmet medical need who have not responded to the standard-of-care and may have no more treatment options.

Key Points: 
  • The study will include patients with advanced solid tumors with high unmet medical need who have not responded to the standard-of-care and may have no more treatment options.
  • As a novel checkpoint inhibitor with unique mechanisms of action, I am hopeful about the role of TT-816 in the treatment landscape.
  • The Phase 1/2 clinical trial is actively recruiting patients with advanced solid tumors in several sites.
  • Teon has an ongoing Phase 1/2 trial evaluating TT-816, a cannabinoid CB2 antagonist and a Phase1/2 trial evaluating TT-702, an A2B receptor-specific antagonist.