Pharmacokinetics

NUCLIDIUM to Present Data from Three Clinical-Ready Precision Oncology Programs at the 36th Annual EANM Congress

Retrieved on: 
Tuesday, September 5, 2023
Science, Radiology, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, NETS, 18F, Half-life, EANM, PSMA, Survival, Cancer, Pharmacokinetics, University Hospital of Basel, FAP, Heterotrimeric G protein, Nuclear medicine, Radiopharmaceutical, Doctor of Philosophy, University Hospital of Zürich, Glomus tumor, European Association of Nuclear Medicine, Patient, PET/CT, Entrepreneurship, European Association for the Study of the Liver, Prostate cancer, Medical imaging

NUCLIDIUM today announced the presentation of pre-clinical and clinical translation data from three of the company’s precision oncology programs targeting epithelial tumours (KaliosTM), neuroendocrine tumours (TraceNETTM) and prostate cancer (NuriProTM) at the upcoming 36th Annual Congress of the European Association of Nuclear Medicine (EANM), 09-13 September 2023.

Key Points: 
  • NUCLIDIUM today announced the presentation of pre-clinical and clinical translation data from three of the company’s precision oncology programs targeting epithelial tumours (KaliosTM), neuroendocrine tumours (TraceNETTM) and prostate cancer (NuriProTM) at the upcoming 36th Annual Congress of the European Association of Nuclear Medicine (EANM), 09-13 September 2023.
  • The data, presented in two oral presentations and a poster presentation, support the advancement of these three programs into clinical translation.
  • The programs are part of NUCLIDIUM’s comprehensive pipeline of copper-based radiotheranostics based on its flexible CuTraceTM platform.
  • The positive pre-clinical data for the diagnostic candidates from three of our programs and the preparation for clinical translation represent an important step for NUCLIDIUM.

Addex ADX71149 Phase 2 Epilepsy Study Expected to Readout Data in Q2 2024

Retrieved on: 
Tuesday, September 5, 2023
Part 1, Epilepsy, Maintenance, IRC, Levetiracetam, PAM, ADX71149, Cohort, LR, Pharmacokinetics, Part, Trial of the century, Janssen Pharmaceuticals, Glutamic acid, Patient, Part Two, Seizure, Johnson & Johnson, Therapy, SIX, ClinicalTrials.gov, Safety, Pharmaceutical industry

Results evaluating the efficacy, safety and tolerability of ADX71149 in combination with levetiracetam or brivaracetam from patient Cohorts 1 and Cohort 2 are anticipated for the second quarter of 2024.

Key Points: 
  • Results evaluating the efficacy, safety and tolerability of ADX71149 in combination with levetiracetam or brivaracetam from patient Cohorts 1 and Cohort 2 are anticipated for the second quarter of 2024.
  • The primary efficacy endpoint of this study is time to baseline monthly seizure count.
  • Collaboration partner Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is responsible for the clinical development of ADX71149.
  • The primary objective of the study is to evaluate the efficacy of ADX71149 in combination with levetiracetam or brivaracetam using a time to baseline seizure count endpoint.

Oncorena's first patient treated with ONC175 (orellanine) in clinical phase I/II trial in patients with metastatic renal cancer and dialysis at Karolinska University Hospital in Stockholm, Sweden

Retrieved on: 
Monday, September 4, 2023
Policy by press release, CSO, Pharmacokinetics, Medicine, Trial of the century, Dialysis, Karolinska University Hospital, Patient, Phase, Safety, Pharmaceutical industry

LUND, Sweden, Sept. 4, 2023 /PRNewswire/ -- Oncorena announces first patient treated in the Phase I/II trial of the first-in-class compound, ONC175 (orellanine), in patients with metastatic renal cancer and dialysis.

Key Points: 
  • LUND, Sweden, Sept. 4, 2023 /PRNewswire/ -- Oncorena announces first patient treated in the Phase I/II trial of the first-in-class compound, ONC175 (orellanine), in patients with metastatic renal cancer and dialysis.
  • The first treatment was conducted on August 8 without any complication at the Center for Clinical Cancer studies at Karolinska University Hospital, Stockholm, Sweden.
  • "I am happy to announce first patient, first treatment in our clinical phase I/II trial, Oncorella-1, with ONC175 (orellanine).
  • The clinical study, Oncorella-1, is conducted at the Center for Clinical Cancer Studies at Karolinska University Hospital, Stockholm, Sweden.

Oncorena's first patient treated with ONC175 (orellanine) in clinical phase I/II trial in patients with metastatic renal cancer and dialysis at Karolinska University Hospital in Stockholm, Sweden

Retrieved on: 
Monday, September 4, 2023
Policy by press release, CSO, Pharmacokinetics, Medicine, Trial of the century, Dialysis, Karolinska University Hospital, Patient, Phase, Safety, Pharmaceutical industry

LUND, Sweden, Sept. 4, 2023 /PRNewswire/ -- Oncorena announces first patient treated in the Phase I/II trial of the first-in-class compound, ONC175 (orellanine), in patients with metastatic renal cancer and dialysis.

Key Points: 
  • LUND, Sweden, Sept. 4, 2023 /PRNewswire/ -- Oncorena announces first patient treated in the Phase I/II trial of the first-in-class compound, ONC175 (orellanine), in patients with metastatic renal cancer and dialysis.
  • The first treatment was conducted on August 8 without any complication at the Center for Clinical Cancer studies at Karolinska University Hospital, Stockholm, Sweden.
  • "I am happy to announce first patient, first treatment in our clinical phase I/II trial, Oncorella-1, with ONC175 (orellanine).
  • The clinical study, Oncorella-1, is conducted at the Center for Clinical Cancer Studies at Karolinska University Hospital, Stockholm, Sweden.

PepGen Announces Presentations at the 2023 Myotonic Dystrophy Foundation Annual Conference, Ottawa Neuromuscular Disease Meeting, and H.C. Wainwright 25th Annual Global Investment Conference

Retrieved on: 
Friday, September 1, 2023
PGN, Event, DM1, Pharmacokinetics, Preclinical development, Poster, Conference, Safety, Pharmaceutical industry, D.C

Ashling Holland, Director of Preclinical Development at PepGen, will be giving a talk titled “PGN-EDODM1 nonclinical data demonstrated mechanistic and meaningful activity for the potential treatment of myotonic dystrophy type 1 (DM1)”, at the 2023 Myotonic Dystrophy Foundation Annual Conference, on September 9, 2023, in Washington, D.C.

Key Points: 
  • Ashling Holland, Director of Preclinical Development at PepGen, will be giving a talk titled “PGN-EDODM1 nonclinical data demonstrated mechanistic and meaningful activity for the potential treatment of myotonic dystrophy type 1 (DM1)”, at the 2023 Myotonic Dystrophy Foundation Annual Conference, on September 9, 2023, in Washington, D.C.
    PepGen will also be making three poster presentations at the 2023 Ottawa Neuromuscular Disease Meeting, being held September 7-9, 2023, in Ottawa, ON, Canada.
  • In addition, James McArthur, Ph.D., President and CEO of PepGen will present at the H.C. Wainwright 25th Annual Global Investment Conference on Monday, September 11th at 10:30am ET being held in New York.
  • The corporate presentation made at the H.C. Wainwright conference will be webcast live on the Events & Presentations section of the Investor Relations section of PepGen’s website.
  • Title: FREEDOM-DM1: Nonclinical data support the Phase 1 study design to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of PGN-EDODM1 in adults with myotonic dystrophy Type 1 (DM1)

Cerevance Announces Presentation at the 22nd Society of Chemical Industry / Royal Society of Chemistry Medicinal Chemistry Symposium

Retrieved on: 
Thursday, August 31, 2023
Microglia, CNS, KCNK13, Pharmacokinetics, Central nervous system, Therapy, Safety, Chemical industry, Pharmacology, Cerev Del, Pharmaceutical industry

BOSTON, Aug. 31, 2023 (GLOBE NEWSWIRE) -- Cerevance, a private, clinical-stage drug discovery and development company focused on advancing novel, precision neuroscience therapeutics for central nervous system (CNS) diseases using the company’s proprietary Nuclear Enriched Transcript Sort sequencing (NETSseq) platform, today announced plans to present an oral presentation at the upcoming 22nd Society of Chemical Industry / Royal Society of Chemistry Medicinal Chemistry Symposium, taking place in Cambridge, United Kingdom, September 10 – 13th, 2023.

Key Points: 
  • BOSTON, Aug. 31, 2023 (GLOBE NEWSWIRE) -- Cerevance, a private, clinical-stage drug discovery and development company focused on advancing novel, precision neuroscience therapeutics for central nervous system (CNS) diseases using the company’s proprietary Nuclear Enriched Transcript Sort sequencing (NETSseq) platform, today announced plans to present an oral presentation at the upcoming 22nd Society of Chemical Industry / Royal Society of Chemistry Medicinal Chemistry Symposium, taking place in Cambridge, United Kingdom, September 10 – 13th, 2023.
  • Overview: The discovery of CVN293, from the NETSseq identification of KCNK13, an ion channel that exhibits highly specific expression in microglia, to the preclinical development efforts including in vitro and in vivo pharmacology, pharmacokinetics and safety will be presented.

Praxis Precision Medicines to Present Data from Epilepsy Portfolio at the 35th International Epilepsy Congress

Retrieved on: 
Thursday, August 31, 2023
Epilepsy, Central nervous system, Pharmacodynamics, SCN8A, Quality of life, CNS, SCN2A, Patient, Pharmacokinetics, Generalized tonic–clonic seizure, IEC, Pharmaceutical industry, Tolerability, Safety, Praxis

BOSTON, Aug. 31, 2023 (GLOBE NEWSWIRE) -- Praxis Precision Medicines , Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced that it will present data from two of its clinical-stage epilepsy programs at the upcoming 35th International Epilepsy Congress (IEC), to be held on September 2-6, 2023 in Dublin, Ireland.

Key Points: 
  • BOSTON, Aug. 31, 2023 (GLOBE NEWSWIRE) -- Praxis Precision Medicines , Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced that it will present data from two of its clinical-stage epilepsy programs at the upcoming 35th International Epilepsy Congress (IEC), to be held on September 2-6, 2023 in Dublin, Ireland.
  • “There remains a great unmet need in epilepsy for anti-seizure medications that restore quality of life to patients and their families, and we are committed to developing best-in-class treatment options for both rare and prevalent epilepsies,” said Marcio Souza, president and chief executive officer of Praxis.
  • “Data from our Phase 1 study of PRAX-628 for focal epilepsy support a potentially best-in-class safety profile that could address the limitations of existing therapies, such as poor tolerability and dose-limiting titration requirements.
  • We look forward to presenting data from this program along with data from our PRAX-562 program for children with SCN2A and SCN8A developmental and epileptic encephalopathies.”
    PRAX-562-101: A First-in-Human Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Food Effect of PRAX-562 in Healthy Volunteers
    PRAX-562-102: A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRAX-562 in Healthy Volunteers
    Safety, Tolerability and Pharmacokinetic Findings from a First-in-Human, Randomized, Double-Blinded, Placebo-Controlled Trial of Single and Multiple Ascending Doses of PRAX-628 in Healthy Participants

Jnana Therapeutics Presents Additional Data from Phase 1a Clinical Study of JNT-517 at SSIEM Annual Symposium

Retrieved on: 
Thursday, August 31, 2023
Science, Society, Phenylketonuria, Aminoaciduria, Pharmacokinetics, SLC6A19, RAPID, SAD, Jñāna, Dicarboxylic acid, DSM-IV codes, PKU, Phenylalanine, Plasma, Oregon Health & Science University, Oregon Health & Science University School of Dentistry, BID, MAD, Ageing, Medical genetics, Therapy, Safety, Pharmaceutical industry, Vaccine, Copper, Metabolism

BOSTON, Aug. 31, 2023 (GLOBE NEWSWIRE) -- Jnana Therapeutics, a clinical-stage biotechnology company leveraging its next-generation chemoproteomics platform to discover medicines for challenging-to-drug targets, today announced that additional data from its Phase 1a clinical trial of JNT-517 in healthy volunteers were presented at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium 2023. JNT-517 is a first-in-class, oral, allosteric inhibitor of the phenylalanine (Phe) transporter SLC6A19 that Jnana is developing for the treatment of phenylketonuria (PKU). The data were presented by Cary O. Harding, M.D., study investigator and Professor of Molecular and Medical Genetics at Oregon Health and Science University School of Medicine.

Key Points: 
  • JNT-517 is a first-in-class, oral, allosteric inhibitor of the phenylalanine (Phe) transporter SLC6A19 that Jnana is developing for the treatment of phenylketonuria (PKU).
  • The data were presented by Cary O. Harding, M.D., study investigator and Professor of Molecular and Medical Genetics at Oregon Health and Science University School of Medicine.
  • The Phase 1a study enrolled 64 healthy adults in a randomized, double-blind, placebo-controlled trial to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of JNT-517 across single (SAD) and multiple (MAD) ascending dose cohorts.
  • The ongoing Phase 1b study will assess the impact of JNT-517 on plasma Phe levels in individuals with PKU.

Longboard Pharmaceuticals to Present Data at Upcoming Medical Meetings

Retrieved on: 
Wednesday, August 30, 2023
Biotechnology, Health, Clinical Trials, ACCP, American College of Clinical Pharmacology, Development of the human body, DSM-IV codes, Medication, Plasma, Pharmacokinetics, Annual general meeting, IEC, Prolactin, Seizure, American College, QEEG, Pharmaceutical industry, Safety, Pharmacology

Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, today announced that it will present new and encore data at the 35th International Epilepsy Congress (IEC) and the American College of Clinical Pharmacology (ACCP) Annual Meeting.

Key Points: 
  • Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, today announced that it will present new and encore data at the 35th International Epilepsy Congress (IEC) and the American College of Clinical Pharmacology (ACCP) Annual Meeting.
  • Title: The PACIFIC Study: A Phase 1b/2a Study to Investigate the Safety, Tolerability, Pharmacology, and Exploratory Efficacy of LP352 in Subjects With Developmental and Epileptic Encephalopathies (#758)
    Title: Searching for Safer and More Effective Medications in the Management of Seizure Disorders: A 5-HT2C Superagonist (#754)
    Title: Evaluation of Prolactin as a Useful Pharmacodynamic Tool to Assess Engagement of Central 5-HT2C Receptors by LP352, a Potent and Selective 5-HT2C Agonist (#749)
    Title: A Phase 1 Study of 5-HT2C Superagonist LP352 Shows Robust Brain Penetration, a Strong Correlation Between Plasma and CSF Pharmacokinetics, and QEEG Changes Reflecting Receptor Engagement (#060)

Poxel Reports Cash and Revenue for the Second Quarter and First Half 2023 and Provides Corporate Update

Retrieved on: 
Wednesday, August 30, 2023
Health, Other Science, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Diabetes, ULF, Senior, Adrenoleukodystrophy, Prescription, Plasma, JPY, Patent, Patient, Serono, Merck, R, Estonia, POC, Pioglitazone, Sumitomo Group, Disease, Male, NASH, Pharmacokinetics, USD, EPO, Fatty liver disease, Leukodystrophy, Marshal of France, Rare, Kidney, Conference, Safety, Abstract, DPP4, ALD, JDS, Merck Serono, European Patent Office, Biomarker, DSM-IV codes, Communication, AMN, IRIS, Scientific communication, Sumitomo Pharma, United States patent law, SGLT2, VLCFA, European Patent Convention, Pharmacology, TZD, Pharmaceutical industry, Medical device, Cryptocurrency, Imeglimin, EUR, Euronext

These factors have resulted in a much higher increase in demand for TWYMEEG than expected by Sumitomo, and thus inventories are temporarily tight.

Key Points: 
  • These factors have resulted in a much higher increase in demand for TWYMEEG than expected by Sumitomo, and thus inventories are temporarily tight.
  • For the Sumitomo FY 2023, as a conservative assumption in line with Sumitomo’s forecast, Poxel expects to receive 8% royalties on TWYMEEG net sales.
  • On July 5th, Poxel was chosen as the winner of the 2023 edition of the I-nov contest for its program in ALD.
  • As of June 30, 2023, cash and cash equivalents were EUR 7.6 million (USD 8.2 million), as compared to EUR 13.1 million (USD 14.0 million) as of December 31, 2022.