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Clinical Trial News

FDA Approves Anovo Robotic System for Ventral Hernia Repair

  • The FDA has granted 510(k) clearance to Momentis Surgical's Anovo robotic surgery platform for ventral hernia repair, expanding its application beyond gynecological procedures.
  • Anovo is the only robotic platform approved for minimally invasive abdominal hernia repair using a single entry incision, featuring robotic arms with 360-degree rotation.
  • The system's compact size and mobility make it suitable for both hospitals and physician clinics, potentially improving surgical outcomes and access to robotic-assisted surgeries.

Pentixapharm's Ga68-PentixaFor Receives EMA PRIME Status for Primary Aldosteronism Diagnosis

  • Pentixapharm's Ga68-PentixaFor, a novel radiodiagnostic agent, has been granted PRIME status by the EMA, potentially accelerating its approval for primary aldosteronism (PA).
  • Ga68-PentixaFor targets the CXCR4 receptor, highly expressed in aldosterone-producing tissue, offering a non-invasive alternative to adrenal venous sampling (AVS) for PA diagnosis.
  • The PRIME designation provides Pentixapharm with enhanced support from the EMA, including scientific advice and potential fee exemptions, to optimize drug development.
  • A Phase III pivotal study for Ga68-PentixaFor is scheduled to begin in 2025, marking a critical step towards obtaining marketing authorization for PA treatment.

GMRx2 Triple Combination Pill Shows Promising Phase III Results for Hypertension Treatment

  • A Phase III trial published in The Lancet reveals GMRx2, a novel triple combination pill, significantly reduces blood pressure compared to dual therapies.
  • GMRx2 half-dose achieved a 63% clinic BP control rate, while the standard dose reached 74%, surpassing dual combinations (53-61%) in hypertension management.
  • The triple combination therapy aligns with the latest European Society of Cardiology guidelines, advocating for increased use of combination therapies for hypertension.
  • George Medicines has submitted a New Drug Application to the FDA, potentially making GMRx2 the first approved triple combination for initial hypertension treatment.

KalVista's Sebetralstat Shows Promise in On-Demand Treatment of Hereditary Angioedema

  • KalVista Pharmaceuticals presented data at ACAAI 2024 highlighting sebetralstat's efficacy in treating hereditary angioedema (HAE) attacks.
  • A pooled analysis showed sebetralstat effectively treats laryngeal HAE attacks, which can be life-threatening due to airway obstruction.
  • The Phase 3 KONFIDENT trial data indicated a substantial reduction in HAE attack symptom burden with sebetralstat treatment.
  • An indirect treatment comparison suggested sebetralstat is comparable to intravenous rhC1-INH for on-demand HAE treatment.

Can-Fite BioPharma Advances Clinical Trials for Psoriasis, HCC, and NASH

  • Can-Fite BioPharma focuses on orally bioavailable small molecule therapeutics for cancer, liver, and inflammatory diseases.
  • Piclidenoson is in Phase III clinical trials for psoriasis, showing promise in treating this chronic skin condition.
  • Namodenoson is progressing through Phase III trials for hepatocellular carcinoma (HCC) and Phase IIb for non-alcoholic steatohepatitis (NASH).
  • The company's A3 adenosine receptor (A3AR) targeted platform offers innovative solutions with improved patient compliance via oral administration.

Capivasertib Plus Fulvestrant Shows Promise in PIK3CA-Altered Metastatic Breast Cancer

  • The CAPItello-291 trial demonstrated that capivasertib plus fulvestrant significantly improved progression-free survival (PFS) compared to fulvestrant alone in metastatic breast cancer patients.
  • In patients with AKT/PIK3CA/PTEN-altered tumors, the median PFS was 7.3 months with capivasertib plus fulvestrant versus 3.1 months with fulvestrant alone.
  • Capivasertib has a more manageable toxicity profile, particularly regarding hyperglycemia, compared to alpelisib, another PI3K inhibitor.
  • The on-off dosing schedule of capivasertib (4 days on, 3 days off) requires careful patient education and adherence monitoring to ensure optimal efficacy.

Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer

NCT04305496Active, Not RecruitingPhase 3
AstraZeneca
Posted 4/16/2020

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

NCT02437318CompletedPhase 3
Novartis Pharmaceuticals
Posted 7/23/2015

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments

NCT03056755CompletedPhase 2
Novartis Pharmaceuticals
Posted 8/29/2017

Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer

NCT03778931CompletedPhase 3
Stemline Therapeutics, Inc.
Posted 5/10/2019

FDA Delays Decisions on Amgen's Lumakras and Intercept's Ocaliva

  • The FDA has postponed the decision dates for Amgen's Lumakras supplemental application for metastatic colorectal cancer due to disappointing survival data.
  • Intercept Pharmaceuticals' Ocaliva's full approval for primary biliary cholangitis (PBC) also faces delay, pending further FDA review of its supplemental New Drug Application.
  • Ocaliva's application was previously met with skepticism from the FDA's Gastrointestinal Drug Advisory Committee, citing concerns over efficacy and safety data.
  • Both Lumakras and Ocaliva initially received accelerated approval but now face challenges in securing full approval due to mixed confirmatory data.

Piclidenoson Shows Positive Results in Canine Osteoarthritis Clinical Study

  • Vetbiolix reported positive results from a multicenter clinical study of Piclidenoson in dogs with osteoarthritis, showing significant improvement in clinical status.
  • The study met its primary endpoint, the Liverpool OsteoArthritis in Dogs (LOAD) questionnaire, and secondary endpoints, including pain assessment by pet parents.
  • Vetbiolix exercised its option for a full in-license agreement with Can-Fite, projecting $325M in income to Can-Fite over the next 10 years upon regulatory approval.
  • Piclidenoson, an A3 adenosine receptor agonist, demonstrated a dose and time-dependent inhibitory effect on LOAD and VAS scores in treated dogs.

Livionex's C-KAD Eye Drop Receives Positive FDA Feedback for Cataract Treatment

  • Livionex reports successful end-of-Phase 2 meeting with the FDA for C-KAD, a 2.6% EDTA ophthalmic solution, aimed at treating early-to-moderate cataracts.
  • The FDA has aligned with Livionex on key elements of the Phase 3 program, supporting a New Drug Application (NDA) filing for C-KAD.
  • Phase 1/2 trial data showed clinically and statistically significant improvement in visual function in the C-KAD group compared to placebo, with improved lens transparency.
  • C-KAD works by penetrating the eye to reduce lens clouding, addressing a significant unmet need for non-surgical cataract treatment options.

Cerus Highlights INTERCEPT Blood System Advancements at AABB 2024

  • Cerus Corporation presented data at the AABB Annual Meeting showcasing the benefits of INTERCEPT-treated blood products.
  • The ReCePI Phase 3 trial results indicated acute kidney injury outcomes following amustaline/glutathione pathogen-reduced red cells in cardiac surgery.
  • Studies highlighted the efficiency of INTERCEPT Fibrinogen Complex compared to traditional cryoprecipitate in laboratory settings.
  • Further research explored the implementation and impact of pathogen-reduced cryoprecipitate in managing postpartum hemorrhage and reducing operative transfusions.

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