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Clinical Trial News

InStatin to Study Inhalable Statin for Asthma and COPD Treatment

  • InStatin will conduct a non-GLP discovery study with Mountain West Research to assess the pharmacokinetics of its statin inhalant solution.
  • The study aims to optimize the targeted delivery of the active pharmaceutical ingredient (API) to the lungs, enhancing efficacy and bioavailability.
  • The research findings will guide the development of InStatin's respiratory solutions, in preparation for Phase 1 human trials.
  • Therma Bright, which holds a 17% stake in InStatin, anticipates the study will validate the potential of innovative lung delivery systems.

Peptide-Drug Conjugates (PDCs) Emerge as Promising Targeted Cancer Therapies

  • Peptide-drug conjugates (PDCs) are emerging as a novel class of cancer therapeutics, offering potential advantages over antibody-drug conjugates (ADCs) due to their smaller size and rapid internalization.
  • PDCs targeting SORT1, a transmembrane glycoprotein highly expressed in various solid tumors, demonstrate enhanced drug delivery and reduced off-target toxicity in preclinical studies.
  • Theratechnologies' SORT1+ Technology platform is advancing PDCs, with early clinical data showing durable disease stabilization and a unique mechanism of action in advanced solid tumors.
  • The versatility of PDCs allows for conjugation with diverse payloads, including radioisotopes, opening new avenues for targeted cancer treatment and potential development partnerships.

LEO Pharma's Delgocitinib Cream Receives FDA Filing Acceptance for Chronic Hand Eczema Treatment

  • The FDA has accepted LEO Pharma's New Drug Application for delgocitinib cream, a potential first-in-class treatment for chronic hand eczema (CHE) in the U.S.
  • Delgocitinib cream, a topical pan-JAK inhibitor, could become the first FDA-approved treatment specifically for adults with moderate to severe CHE.
  • The application is supported by Phase 3 DELTA 1 and DELTA 2 trial results, demonstrating significant efficacy and safety compared to a vehicle cream.
  • If approved, delgocitinib cream promises to address the high unmet need for CHE patients, offering a new option beyond traditional topical corticosteroids.

Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials

NCT04949841CompletedPhase 3
LEO Pharma
Posted 8/23/2021

Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema

NCT04871711CompletedPhase 3
LEO Pharma
Posted 5/10/2021

Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2)

NCT04872101CompletedPhase 3
LEO Pharma
Posted 5/25/2021

Antidepressant Escitalopram Shows Potential to Enhance Memory and Cognitive Function

  • A new study indicates that the antidepressant escitalopram (Lexapro) may improve memory and cognitive skills in patients.
  • The research links escitalopram's cognitive benefits to increased activity in the brain's 5HT4 serotonin receptor.
  • Cognitive tests showed improved recall ability in patients treated with escitalopram for eight weeks, correlating with enhanced 5HT4 receptor function.
  • Future research will explore drugs specifically targeting the 5HT4 receptor to treat cognitive impairments, regardless of depression symptoms.

Diabetes Medications Show Promise in Easing Gum Disease

  • A new study indicates that diabetes medications may help reverse gum damage associated with the disease, offering a potential dual benefit for patients.
  • Researchers in Japan observed improvements in gum health markers among type 2 diabetes patients undergoing intensive drug therapy, without any professional dental care.
  • The study highlights the importance of early diabetes management in preventing the onset and progression of periodontal disease, advocating for collaboration between medical and dental care.
  • Improvements in gum health, measured by reduced Periodontal Inflamed Surface Area (PISA) scores, correlated with improvements in overall health markers, such as blood flow and neuropathy.

Antengene's Xpovio Receives Thailand FDA Approval for Multiple Myeloma

  • Thailand FDA approves Xpovio (selinexor) for multiple myeloma, marking its availability in nine APAC markets.
  • Xpovio, a selective XPO1 inhibitor, is approved for use in combination with bortezomib and dexamethasone after one prior therapy.
  • The drug is also approved with dexamethasone after four prior therapies, addressing refractory cases.
  • Antengene anticipates further expansion in ASEAN, with potential approval in Indonesia expected in the second half of 2024.

UCLA Researchers Pioneer Organoid Platform for Personalized Sarcoma Treatment

  • UCLA researchers have developed a platform using patient-derived organoids to model sarcoma tumors, addressing the lack of personalized treatment options.
  • The platform successfully created organoids from 114 sarcoma samples, maintaining key characteristics of the original tumors for drug screening.
  • High-throughput drug screening identified potentially effective FDA-approved treatments for 59% of specimens, showing promise for personalized medicine.
  • A clinical trial (PREMOST) is underway to validate the platform's predictive power in osteosarcoma patients, potentially broadening drug use for rare cancers.

An Organoid-based Functional Precision Medicine Trial in Osteosarcoma

NCT06064682Recruiting
Jonsson Comprehensive Cancer Center
Posted 2/12/2024

Age-Related Biological Differences in Sarcomas Identified, Opening New Avenues for Targeted Therapies in Young Adults

  • Researchers have identified distinct protein profiles in soft tissue sarcomas between adolescent and young adult (AYA) patients and older adults, explaining disparities in survival outcomes.
  • The study pinpointed a splicing signature associated with metastasis-free survival in AYA sarcoma patients, potentially serving as a biomarker for risk stratification.
  • Findings highlight the need for age-specific studies and tailored therapies to improve outcomes and reduce overtreatment in AYA sarcoma patients.
  • The research suggests that targeting mitochondrial function and structural support proteins may offer novel therapeutic strategies for aggressive sarcomas in young adults.

Bajaj Healthcare Partners with European Firm to Develop Novel API for Clinical Trials

  • Bajaj Healthcare has entered into a development and supply agreement with a European entity for a new Active Pharmaceutical Ingredient (API).
  • The API will initially be supplied in small quantities to the EU partner for clinical trials exploring an alternative indication.
  • Revenue generation is contingent on positive outcomes from these clinical trials, with potential for larger-scale supply from Bajaj's FDA-approved facility.
  • This strategic partnership aims to explore new therapeutic applications, leveraging Bajaj Healthcare's manufacturing capabilities.

Medicare's $2 Drug List Model Could Benefit 38% of Beneficiaries with Modest Cost Savings

  • A new study reveals the Medicare High-Value Drug List Model could reduce out-of-pocket costs for 38.3% of beneficiaries, with median savings of $11 per year.
  • The proposed model would cap costs at $2 per month for 150 generic drugs, affecting 81% of Medicare beneficiaries who currently use these medications.
  • While savings are modest for most beneficiaries, researchers suggest the program could improve medication adherence and benefit patients through more consistent out-of-pocket costs.

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