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Clinical Trial News

Sidney Hecht Honored for Pioneering Work Linking Chemistry and Biology to Combat Disease

• Sidney Hecht received the Arizona Bioscience Pioneer Award for Lifetime Achievement for merging biology and chemistry to improve human health. • Hecht's research at ASU's Biodesign Center focuses on mitochondrial disorders, particularly Friedreich’s ataxia, a genetic neuromuscular disease. • Hecht played a key role in developing Hycamtin, a chemotherapy drug for ovarian and lung cancer, and studied the anti-tumor agent Bleomycin. • His center has developed compounds that redirect electrons in dysfunctional respiratory chains, with one in clinical trials for Friedreich’s ataxia.

AngioDynamics Launches RECOVER-AV Trial for AlphaVac System in Pulmonary Embolism Treatment

  • AngioDynamics has initiated the RECOVER-AV trial to assess the AlphaVac F1885 System's safety and efficacy in treating acute, intermediate-risk pulmonary embolism (PE).
  • The multi-center, multi-national trial will enroll patients across Europe, evaluating the reduction in right ventricular/left ventricular (RV/LV) ratio post-procedure.
  • The study follows the APEX-AV trial in the U.S., which demonstrated the AlphaVac system's safety and effectiveness in improving right ventricular function and reducing clot burden.
  • The AlphaVac F1885 System received CE Mark approval in Europe, allowing AngioDynamics to expand its reach in treating PE, where prevalence is higher than in the U.S.

Mantle Cell Lymphoma Pipeline Shows Promise with Novel Targeted Therapies

• The Mantle Cell Lymphoma (MCL) pipeline is robust, featuring over 20 companies developing more than 22 therapies. • Key players like AbbVie and BeiGene are advancing novel drugs, including BTK inhibitors and Bcl-2 inhibitors, to improve MCL treatment. • Clinical trials are evaluating promising therapies such as Venetoclax, ADI-001, and Orelabrutinib across various phases. • Recent data highlights potential for combination therapies and novel mechanisms like BTK degradation in MCL treatment.

Cybin Advances CYB003 and CYB004 Clinical Programs for Mental Health Disorders

  • Cybin is set to initiate a Phase 3 study of CYB003 for Major Depressive Disorder (MDD) following a productive meeting with the FDA.
  • Twelve-month efficacy data from the Phase 2 study of CYB003 in MDD is expected in early Q4 2024, offering insights into long-term benefits.
  • Topline efficacy and safety results for CYB004 in Generalized Anxiety Disorder (GAD) are anticipated by year-end 2024 or early Q1 2025.
  • Cybin has strengthened its R&D team with the addition of Dr. Atul R. Mahableshwarkar and Dr. Tom Macek to lead the CYB003 and CYB004 programs, respectively.

FDA Clears Epitomee Capsule for Weight Management

  • The FDA has cleared the Epitomee capsule as an adjunct to lifestyle modification for weight management in adults with a BMI of 25 to 40 kg/m2.
  • The Epitomee capsule expands in the stomach to create a feeling of fullness, later disintegrating in the intestines for natural elimination.
  • Clinical trial data demonstrated significantly greater weight reduction with Epitomee compared to placebo (P < .0001) over 24 weeks.
  • A significant 55.5% of patients taking Epitomee achieved at least 5% body weight loss, demonstrating its effectiveness in weight management.

The Effect of Extended Use of the EPITOMEE CAPSULE (ELECT)

NCT04994769CompletedNot Applicable
Epitomee medical
Posted 8/31/2021

The Effect of Epitomee Capsule on Body Weight in Patients With Overweight and Obesity

NCT04222322CompletedNot Applicable
Epitomee medical
Posted 9/15/2020

GENFIT Reports Positive Financial Results in H1 2024 Driven by Iqirvo's U.S. Launch

• GENFIT reported €61.6 million in cash and equivalents as of June 30, 2024, excluding a €48.7 million milestone from Ipsen for Iqirvo's U.S. launch. • The company's revenues reached €59.0 million, boosted by the €48.7 million milestone payment invoiced in June 2024. • A positive opinion from the EMA for Iqirvo anticipates a final decision in H2 2024, potentially triggering a €26.5 million milestone upon pricing approval. • Phase 2 trial for VS-01 in Acute on-Chronic Liver Failure (ACLF) is progressing with protocol modifications to address recruitment challenges.

ESMO 2024: Key Breast Cancer Advances Highlighted

  • Final KEYNOTE-522 data confirmed pembrolizumab's benefit in neoadjuvant chemotherapy for early-stage triple-negative breast cancer, improving 5-year overall survival.
  • NATALEE trial's 4-year update showed ribociclib plus aromatase inhibition significantly improved invasive disease-free survival in high-risk, hormone receptor-positive early breast cancer.
  • DESTINY-Breast12 trial demonstrated trastuzumab deruxtecan's significant intracranial activity in HER2-positive metastatic breast cancer patients with brain metastases.
  • ICARUS-BREAST01 trial revealed promising objective response rates and progression-free survival with patritumab deruxtecan in HER3-positive, hormone receptor-positive, HER2-negative metastatic breast cancer.

Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)

NCT04221945Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 5/12/2020

A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

NCT03522246Active, Not RecruitingPhase 3
pharmaand GmbH
Posted 5/14/2018

Pre-operative Trial for Breast Cancer With Nivolumab in Combination With Novel IO

NCT03815890RecruitingPhase 2
The Netherlands Cancer Institute
Posted 10/4/2019

A Clinical Study of the Safety and Effectiveness of an Investigational Cell Therapy Given With and Without an Investigational RNA-based Vaccine in Patients With Organ Tumors

NCT04503278RecruitingPhase 1
BioNTech Cell & Gene Therapies GmbH
Posted 9/16/2020

Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44)

NCT02676349Active, Not RecruitingPhase 2
Institut de Cancérologie de Lorraine
Posted 10/13/2016

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)

NCT03036488Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 3/7/2017

Phase III Radium 223 mCRPC-PEACE III

NCT02194842Active, Not RecruitingPhase 3
European Organisation for Research and Treatment of Cancer - EORTC
Posted 10/1/2015

Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma

NCT04987203Active, Not RecruitingPhase 3
AVEO Pharmaceuticals, Inc.
Posted 9/9/2021

Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence

NCT03127995Active, Not RecruitingNot Applicable
UNICANCER
Posted 9/1/2016

Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054)

NCT02362594Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 7/16/2015

Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).

NCT04472429Active, Not RecruitingPhase 3
Incyte Corporation
Posted 1/12/2021

Chemotherapy Before Surgery and Radiation Therapy or Surgery and Radiation Therapy Alone in Treating Patients With Nasal and Paranasal Sinus Cancer That Can Be Removed by Surgery

NCT03493425RecruitingPhase 2
ECOG-ACRIN Cancer Research Group
Posted 3/12/2019

Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)

NCT04246177Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 5/22/2020

A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1

NCT04534205RecruitingPhase 2
BioNTech SE
Posted 1/7/2021

Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

NCT03732677Active, Not RecruitingPhase 3
AstraZeneca
Posted 11/16/2018

A Randomized Trial to Assess the Role of Imaging During Follow Up After Radical Surgery of High Risk Melanoma

NCT03116412RecruitingNot Applicable
Uppsala University
Posted 6/8/2017

A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

NCT03701334Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 12/7/2018

ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer

NCT05446298Active, Not RecruitingPhase 2
OncoC4, Inc.
Posted 12/22/2022

HARE-40: HPV Anti-CD40 RNA vaccinE

NCT03418480CompletedPhase 1
University of Southampton
Posted 4/11/2017

Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer

NCT04965766Active, Not RecruitingPhase 2
Gustave Roussy, Cancer Campus, Grand Paris
Posted 5/11/2021

A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer

NCT04739761Active, Not RecruitingPhase 3
AstraZeneca
Posted 6/22/2021

Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC

NCT03997123Active, Not RecruitingPhase 3
AstraZeneca
Posted 6/25/2019

Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

NCT04634877Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 1/10/2021

Pembrolizumab Approved for Mesothelioma; Patritumab Deruxtecan Shows Promise in NSCLC

  • FDA has expanded the approval of pembrolizumab (Keytruda) in combination with pemetrexed and cisplatin for previously untreated advanced/metastatic malignant pleural mesothelioma.
  • Patritumab deruxtecan demonstrated a statistically significant improvement in progression-free survival versus doublet chemotherapy in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer.
  • A novel three-drug regimen yielded an 80% response rate in a small study of patients with advanced chronic myelogenous leukemia or high-risk acute myeloid leukemia.

Regulatory Roundup: Key Approvals and Submissions in Late September 2024

  • Apellis received regulatory approval for its geographic atrophy treatment, offering a new option for patients facing this vision-threatening condition.
  • Glycomine secured orphan drug designation for its therapeutic aimed at addressing a rare metabolic disorder, potentially expediting its development.
  • Regulatory submissions and approvals spanned multiple companies, including Merck, Novartis, and Sanofi, highlighting continued pharmaceutical innovation.

Rezolute's Ersodetug Advances in Phase 3 for Hyperinsulinism; RZ402 Shows Promise in DME

• Rezolute's ersodetug receives FDA clearance to proceed with Phase 3 sunRIZE study in the U.S. for congenital hyperinsulinism (HI) treatment. • A Phase 3 study for ersodetug in tumor HI is slated to commence in the first half of 2025, expanding its clinical application. • RZ402 demonstrates positive Phase 2 results in diabetic macular edema (DME) patients, showing significant reduction in central subfield thickness. • Rezolute's financial position remains stable with $127.1 million in cash, despite an increased net loss due to higher R&D expenses.

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