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Clinical Trial News

P-BCMA-ALLO1 Granted FDA RMAT Designation for Relapsed/Refractory Multiple Myeloma

  • The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to P-BCMA-ALLO1 for relapsed/refractory multiple myeloma.
  • P-BCMA-ALLO1 is an investigational stem cell memory T-cell-based allogeneic CAR T-cell therapy currently in phase 1/1b clinical development.
  • Early phase 1 data showed promising efficacy and safety with quick off-the-shelf patient access and no graft-vs-host disease.
  • The RMAT designation underscores P-BCMA-ALLO1's potential to address unmet needs in heavily pretreated multiple myeloma patients.

P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma

NCT04960579RecruitingPhase 1
Poseida Therapeutics, Inc.
Posted 5/5/2022

Epitomee Medical's Novel Ingestible Capsule Receives FDA Clearance for Weight Management

  • Epitomee Medical's capsule, a drug-free device, has been cleared by the FDA for weight management in adults with a BMI of 25-40 alongside diet and exercise.
  • The capsule works by creating a sensation of fullness in the stomach, aiding in weight loss through a purely mechanical action within the GI tract.
  • Clinical trials demonstrated significantly better weight loss in the device group compared to the control, with 55.5% achieving at least 5% total body weight reduction.
  • The device showed a favorable safety profile, with no serious adverse device effects reported and better improvement in quality of life reported by patients.

Darolutamide Plus ADT Shows Promise in Metastatic Hormone-Sensitive Prostate Cancer

  • Darolutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiological progression or death by 46% in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
  • The ARANOTE trial data supports the expanded use of darolutamide in mHSPC patients, both with and without docetaxel, according to Bayer.
  • Consistent benefits in radiological progression-free survival (rPFS) were observed across patient subgroups, including high- and low-volume mHSPC.
  • Darolutamide, already approved for certain prostate cancer types, shows a favorable safety profile with low incidences of treatment-emergent adverse events.

Biotronik's Selectra 3D Catheter and Solia S Lead Gain FDA Approval for Left Bundle Branch Area Pacing

  • Biotronik received FDA approval for its Selectra 3D catheter and Solia S lead, making them the first stylet-driven system approved for Left Bundle Branch Area Pacing (LBBAP).
  • The approval is based on data from the BIO-CONDUCT trial, which demonstrated a 95.7% implant success rate and a 1.7% lead-related complication rate at three months.
  • The Solia S lead offers advantages over legacy leads, including the ability to continuously pace off the stylet during implantation, according to Dr. Larry Chinitz.
  • The system has been used in over 80,000 patients worldwide and supports the evolving technique of pacing the heart’s natural conduction system.

Racial and Ethnic Disparities Undermine Food Immunotherapy Trial Applicability

  • A systematic review highlights underrepresentation of Black and Hispanic/Latinx participants in food allergen immunotherapy (FOIT) trials, raising concerns about result generalizability.
  • The authors emphasize that inequitable research studies stem from structural and social determinants of health, particularly healthcare access and quality.
  • Multilevel interventions addressing health equity, innovative care models like telemedicine, and diverse research teams are crucial for inclusive FOIT research and practice.
  • Achieving health equity in FOIT requires ensuring access to standard allergy care and addressing upstream barriers to achieve equitable outcomes for all patients.

Quralis Completes First Healthy Volunteer Cohort Dosing in Phase 1 MAD Trial of QRL-101 for ALS

  • Quralis has finished dosing the first group of healthy volunteers in a Phase 1 clinical trial of QRL-101, an oral small molecule therapy for amyotrophic lateral sclerosis (ALS).
  • The Phase 1 multiple ascending dose (MAD) trial aims to evaluate the safety, tolerability, and pharmacokinetics of QRL-101 in approximately 60 healthy volunteers.
  • QRL-101 is designed to reduce motor neuron hyperexcitability, a key factor in ALS progression, by selectively opening Kv7.2/7.3 voltage-gated potassium channels.
  • Results from the trial, expected in early 2025, will inform the design of larger global clinical trials to assess QRL-101's efficacy in people with ALS.

A Study Evaluating Multiple Ascending Doses of QRL-101 in Healthy Participants

NCT06532396CompletedPhase 1
QurAlis Corporation
Posted 7/1/2024

A Study Evaluating Safety, Tolerability, and Pharmacokinetics of QRL-101 in Healthy Participants

NCT05667779CompletedPhase 1
QurAlis Corporation
Posted 12/22/2022

Epitomee Medical's Novel Capsule Receives FDA Clearance for Weight Management

  • Epitomee Medical's ingestible capsule has received FDA clearance as a prescription weight management solution for adults with a BMI of 25-40 kg/m².
  • The drug-free capsule works by creating a feeling of fullness in the stomach, aiding weight loss when combined with diet and exercise.
  • Clinical trials, including the RESET study, demonstrated significant weight loss and a favorable safety profile compared to the placebo group.
  • The device offers a novel approach to weight management, providing a non-injectable, easily administered option for a broader patient population.

Immunotherapy Shows Promise in Prostate Cancer with MMRd Mutation

  • Men with prostate cancer and the MMRd mutation experienced significantly extended progression-free survival with dual immunotherapy.
  • The disease control rate at six months in MMRd tumors was 81%, substantially higher than other mutation types.
  • Median progression-free survival in the MMRd group reached 32.7 months, a notable improvement compared to other groups.
  • These findings suggest that immunotherapy could be a beneficial treatment option for a subset of prostate cancer patients with specific genetic profiles.

Apple Watch Receives FDA Clearance for Sleep Apnea Detection Feature

  • Apple has gained FDA clearance for its new Apple Watch feature designed to detect sleep apnea, marking a significant advancement in consumer health technology.
  • The feature leverages the watch's sensors to monitor sleep patterns and identify potential indicators of sleep apnea, a condition affecting millions.
  • This clearance allows Apple to market the sleep apnea detection feature as a medical device, potentially increasing awareness and early diagnosis of the condition.
  • The new capability is expected to be available through a software update, expanding the Apple Watch's role in personal health monitoring.

FDA Approves Dupilumab for Adolescent CRSwNP and Lebrikizumab for Atopic Dermatitis

  • Dupilumab (Dupixent) has gained FDA approval as the first drug for adolescents aged 12-17 with chronic rhinosinusitis with nasal polyps (CRSwNP), addressing a critical unmet need.
  • Lebrikizumab (EBGLYSS) received FDA approval for treating moderate to severe atopic dermatitis in patients 12 and older, offering a new first-line biologic option.
  • ACIP recommends that all children and adolescents over 6 months receive at least one updated COVID-19 vaccine booster for the 2024-2025 season, enhancing protection against newer strains.
  • Research indicates that metabolic profiles could potentially identify infants at higher risk for sudden infant death syndrome (SIDS), opening avenues for targeted interventions.

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