Recurrence

GammaTile® Marks Milestone: 100th Patient Enrolled in Groundbreaking ROADS Phase 3 Clinical Trial for Newly Diagnosed Metastatic Brain Tumors

Retrieved on: 
Tuesday, April 9, 2024
RCT, Radiation, Brain, Completion, Progression-free survival, Risk, Patient, Lung, SRT, Neoplasm, Research, Indiana University, Breast, Doctor of Philosophy, MD, Quality of life, Trial of the century, Clinical trial, Melanoma, Recurrence, FDA, Craniotomy, Randomized controlled trial, Medical imaging

TEMPE, Ariz., April 9, 2024 /PRNewswire/ -- GT Medical Technologies, Inc. (GT MedTech), a medical device company with the mission of improving the lives of patients with brain tumors, today announced it has enrolled the 100th patient in its ROADS clinical study. ROADS, or Radiation One and Done Study, is the randomized control trial (RCT) designed to compare FDA-cleared GammaTile with stereotactic radiotherapy (SRT).

Key Points: 
  • ROADS, or Radiation One and Done Study, is the randomized control trial (RCT) designed to compare FDA-cleared GammaTile with stereotactic radiotherapy (SRT).
  • Patients enrolled in the ROADS clinical trial are randomized into two treatment groups following craniotomy with brain metastasis tumor removal: GammaTile implant at the time of surgery versus post-operative SRT.
  • Enrollment in the Phase 3 trial has now surpassed half of the 180 planned patients.
  • Our dedication to the ROADS trial is fueled by our mission to furnish the highest caliber of clinical evidence through randomized trial research.

Labcorp Announces Expansion of Precision Oncology Portfolio to Support Pharmaceutical, Biopharma, and Clinical Research in Advancing Drug Development Programs

Retrieved on: 
Monday, April 8, 2024
ACT, Gene, Biotechnology, Acceleration, LOH, CDX, Risk, Patient, NGS, Biomarker, Research, MSI, DNA, Cancer, Spacecraft, AACR, MRD, Recurrence, FDA, Health, Plasma, Neoplasm, Medicine, Pharmaceutical industry

BURLINGTON, N.C., April 8, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the strategic expansion of its precision oncology portfolio, solidifying its commitment to advancing cancer research and patient care on a global scale. The announcement underscores Labcorp's dedication to investing in scientific, diagnostic and laboratory innovations to support its pharmaceutical, biotechnology and clinical research partners in bringing groundbreaking therapies to market.

Key Points: 
  • The announcement underscores Labcorp's dedication to investing in scientific, diagnostic and laboratory innovations to support its pharmaceutical, biotechnology and clinical research partners in bringing groundbreaking therapies to market.
  • "Our portfolio expansion enhances our integrated services to empower our partners with the solutions and support they need to advance their development programs and make a lasting difference in patients' lives."
  • Labcorp recently announced the commercial availability of Labcorp Plasma Detect, the first clinically validated, tumor-informed, whole-genome sequencing circulating tumor DNA (ctDNA) MRD solution for research and investigational use.
  • Labcorp's deep scientific expertise and comprehensive solutions include specialized pre-clinical discovery, biomarker and companion diagnostics (CDx) development and post-commercialization capabilities.

Treace Celebrates 100,000 Lapiplasty® 3D Bunion Correction® Patient Milestone

Retrieved on: 
Monday, March 25, 2024
ABC, Hypoesthesia, Patient, Education, Foot, Bunion, Chronic pain, Quality of life, Life, Surgeon, Woman, Arthritis, Radio, Diving, Pain, Recurrence, Swelling, Parent

PONTE VEDRA, Fla., March 25, 2024 (GLOBE NEWSWIRE) -- Treace Medical Concepts, Inc. (“Treace” or the “Company”) (NasdaqGS: TMCI), a medical technology company driving a fundamental shift in the surgical treatment of bunions and related midfoot deformities through its flagship Lapiplasty® and Adductoplasty® Procedures, today announced that 100,000 patients have been treated with its patented Lapiplasty® 3D Bunion Correction® System.1 This milestone coincides with the first-ever National Bunion Day in the United States, which is being sponsored by Treace on April 16, 2024, and the launch of its new patient education and brand awareness campaign.

Key Points: 
  • “Achieving this important milestone is a testament to the tireless efforts of our team members and the trust of our surgeon customers and patients, all of whom have made our journey possible,” said John T. Treace, CEO and Founder of Treace.
  • “Since our initial surgical cases in 2015, Treace has been committed to educating people about surgical options that can provide lasting relief from bunion pain through our innovative procedures that are designed to minimize recovery time, reduce recurrence rates, and improve patient outcomes.
  • Today the Company also unveiled its latest campaign to continue to drive patient education and awareness of its Lapiplasty® Procedure.
  • Treace will premiere the “Future You” commercial on the finale of “The Bachelor” TV show on March 25, 2024 at 8:00 p.m. Eastern Time on the ABC network.

Atossa Therapeutics Provides Five-Year (Z)-Endoxifen Treatment Update on FDA-Approved "Expanded Access" Program for a U.S. Breast Cancer Patient

Retrieved on: 
Tuesday, March 19, 2024
Diagnosis, Growth, Ki-67, Neoadjuvant therapy, Mammography, Cancer, Expanded access, Woman, Neoplasm, Therapy, Breast cancer, CYP2D6, Safety, Axis, Osteoporosis, Hot, Recurrence, Tamoxifen, FDA, Enzyme inhibitor, PR, Pharmaceutical industry

Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.

Key Points: 
  • Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.
  • Over five years of adjuvant treatment, her daily (Z)-endoxifen treatment has been well tolerated, and there were no vasomotor symptoms commonly associated with standard of care adjuvant pharmaceuticals.
  • She remains cancer-free today and we are grateful to have been able to help her with a difficult treatment problem.”
    Diagnosis.
  • Under the FDA Expanded Access IND program, the use of Atossa's proprietary (Z)-endoxifen is restricted to this patient only.

Mainz Biomed Organizes HALLO DOC! Event to Highlight Innovations in Colorectal Cancer Treatment

Retrieved on: 
Tuesday, March 19, 2024
Diagnosis, Disease, Colorectal cancer, Incidence, Research, Cancer, Get Together, Recurrence, Medical device

BERKELEY, Calif. and MAINZ, Germany, March 19, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a leader in molecular genetics diagnostic solutions for early cancer detection, will be organizing the HALLO DOC!

Key Points: 
  • BERKELEY, Calif. and MAINZ, Germany, March 19, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a leader in molecular genetics diagnostic solutions for early cancer detection, will be organizing the HALLO DOC!
  • event, informing about colorectal cancer, cutting-edge research, new treatment modalities, and holistic therapeutic approaches.
  • This event will take place on March 20, 2024, in Berlin, Germany, aligning with the Colorectal Cancer Awareness Month.
  • Mainz Biomed has organized this event to shed light on new diagnostic methods, the importance of a comprehensive treatment approach, and the latest advancements in colorectal cancer research.

IMFINZI® (durvalumab) significantly improved overall survival and progression-free survival for patients with limited-stage small cell lung cancer in ADRIATIC Phase III trial

Retrieved on: 
Friday, April 5, 2024
Research, FDA, Clinical Trials, Biometrics, Health, Pharmaceutical, General Health, Science, Oncology, Lung cancer, Chemoradiotherapy, CRT, Small-cell carcinoma, Radiation, AstraZeneca, Survival, NSCLC, Immunotherapy, Disease, Infection, Carcinoma, Incidence, Progression-free survival, Patient, Warning, Doctor of Philosophy, Prednisone, Adrenocorticotropic hormone, Creatinine, Prognosis, PFS, Recurrence, ACTH, Administration, Pneumonitis, SCLC, Vaccine

Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.

Key Points: 
  • Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.
  • Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (
  • Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions.
  • Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.

Presentations at EADO Highlight Potential Impact of Castle Biosciences’ DecisionDx®-Melanoma and DecisionDx®-SCC Tests on the Management of Patients with Skin Cancer

Retrieved on: 
Thursday, April 4, 2024
Oncology, Health, Other Health, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Sentinel lymph node, SCC, Congress, Castle, Risk, Patient, Neoplasm, Research, NCCN, AJCC, National Comprehensive Cancer Network, Risk assessment, Lymph node, Carcinoma, Melanoma, Trial of the century, Recurrence, Metastasis, SLN, Medical imaging

Summary: The DecisionDx-Melanoma test has been validated to predict individual risk of SLNB positivity and five-year risk of recurrence and metastasis for patients with CM.

Key Points: 
  • Summary: The DecisionDx-Melanoma test has been validated to predict individual risk of SLNB positivity and five-year risk of recurrence and metastasis for patients with CM.
  • This study explored the cost-savings impact of using the DecisionDx-Melanoma test to guide risk-aligned clinical decision-making versus using the current melanoma staging standard, a patient’s AJCC stage.
  • Summary: The DecisionDx-SCC test uses a patient’s tumor biology to independently predict risk of regional or distant metastasis in patients with high-risk SCC.
  • These data demonstrate that DecisionDx-SCC improves the accuracy of risk assessment based solely on clinicopathological risk factors, leading to more appropriate risk-aligned management plans for patients with high-risk SCC.

New Survey Results from Cloudbreak Pharma Highlight Disease Burden, Need for Non-surgical Treatment Options for Underdiagnosed and Undertreated Ocular Disease

Retrieved on: 
Friday, April 5, 2024
Health, Clinical Trials, Research, Science, Pharmaceutical, Optical, Biotechnology, Diagnosis, Pterygium, Disease, Eye, Conjunctiva, Safety, Physician, ASCRS, Air conditioning, Conjunctivitis, Tavarua, Tearing, Contact, Dry, Volunteering, Wind, Efficacy, Ophthalmology, Pollen, Chronic, Irritation, Pharmacokinetics, Vision, HCP, Recurrence, Pharma, Food

“Simple tasks like putting in contact lenses, applying makeup and using a computer or phone are made significantly more difficult, if not impossible, for those with pterygium.

Key Points: 
  • “Simple tasks like putting in contact lenses, applying makeup and using a computer or phone are made significantly more difficult, if not impossible, for those with pterygium.
  • As ophthalmologists, we need to listen closely to our patients and coordinate with optometrists to fully understand the impact of pterygium.
  • More information about this trial is available here: Safety and Efficacy of CBT-001 Ophthalmic Solution in Patients With Pterygium .
  • The survey was designed with multiple-choice questions, rating questions and open-ended questions.2

REJOICE-Ovarian01 Phase 2/3 Trial of Raludotatug Deruxtecan Initiated in Patients with Platinum-Resistant Ovarian Cancer

Retrieved on: 
Wednesday, April 3, 2024
Pharmaceutical, Health, Oncology, Clinical Trials, MSD, DXD, CDH6, Survival, Glomus tumor, Patient, Merck & Co., SGO, MD, Society, Senior, MRK, Safety, Gynecologic Oncology (journal), Recurrence, ADC, Daiichi Sankyo, Annual general meeting, Pharmaceutical industry

The phase 2 portion of the trial will be conducted to identify the dose of raludotatug deruxtecan to be used in the phase 3 part of the trial, which will evaluate raludotatug deruxtecan versus investigator’s choice of chemotherapy.

Key Points: 
  • The phase 2 portion of the trial will be conducted to identify the dose of raludotatug deruxtecan to be used in the phase 3 part of the trial, which will evaluate raludotatug deruxtecan versus investigator’s choice of chemotherapy.
  • Raludotatug deruxtecan is an investigational specifically engineered potential first-in-class CDH6 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed with Merck.
  • “Raludotatug deruxtecan has shown promising activity in a phase 1 trial of patients with advanced ovarian cancer,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo.
  • “We look forward to working with our colleagues at Daiichi Sankyo to further evaluate the potential of raludotatug deruxtecan to provide a new treatment option for patients with platinum-resistant ovarian cancer.”

Natera and Alliance for Clinical Trials in Oncology Announce Activation of Alliance A032103 (MODERN): A Randomized, Phase II/III Adjuvant Trial in Urothelial Cancer

Retrieved on: 
Monday, April 1, 2024
Research, Genetics, Clinical Trials, Biotechnology, Biometrics, Health, Pharmaceutical, Science, Oncology, NCI, Checkmate, Hematology, Immunotherapy, Cystectomy, Colorectal cancer, Patient, DNA, National Cancer Institute, Nature, Bladder cancer, MD, Medicine, NTRA, National Institutes of Health, Nivolumab, MRD, Safety, Bangladesh Technical Education Board, Multimedia, Recurrence, FDA, Transitional epithelium, PD-1, Medical imaging

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, and the Alliance for Clinical Trials in Oncology, which is part of the National Clinical Trials Network (NCTN) funded by the National Cancer Institute (NCI), part of National Institutes of Health, today announced the launch of Alliance A032103 ( MODERN ), a randomized, phase II/III, biomarker-integrated trial.

Key Points: 
  • Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, and the Alliance for Clinical Trials in Oncology, which is part of the National Clinical Trials Network (NCTN) funded by the National Cancer Institute (NCI), part of National Institutes of Health, today announced the launch of Alliance A032103 ( MODERN ), a randomized, phase II/III, biomarker-integrated trial.
  • Alliance A032103 (MODERN) will utilize Signatera™, Natera’s personalized and tumor-informed molecular residual disease (MRD) test, to help guide personalized treatment based on molecular status in patients diagnosed with muscle-invasive urothelial cancer (MIUC) after radical cystectomy.
  • Patients will be divided into two cohorts based on an initial assessment of MRD status.
  • “We are grateful to collaborate with the Alliance on this important study.”