Rollcage Stage II

Long-term Survival Data from Longeveron’s ELPIS 1 Trial Presented at the 2023 Scientific Sessions of the American Heart Association

Retrieved on: 
Saturday, November 11, 2023
Lung, Safety, Hypoplastic left heart syndrome, Food, Rollcage Stage II, Transplant, US Foods, AHA, Mortality, Patient, HLHS, FDA, Survival rate, Trial of the century, American Heart Association, Survival, Growth, SVR, Poster, NHLBI, Pharmaceutical industry

MIAMI, Nov. 11, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN NASDAQ: LGVNR) (“Longeveron” or “Company”), a clinical-stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer’s disease and Aging-related Frailty, announced today that extended long-term follow-up data from the Company’s ELPIS I trial of Lomecel-BTM for patients with hypoplastic left heart syndrome (HLHS) is being presented as a poster at the annual Scientific Sessions of the American Heart Association (AHA), being held in Philadelphia, PA on November 11-13, 2023.

Key Points: 
  • The extended follow-up data on all patients enrolled in the study now includes monitoring for up to 5 years following treatment with Lomecel-BTM.
  • The average age at the time of the last follow-up visit was 4.5 years, with 2 patients being 5 years of age.
  • Historical results from outside studies have shown that children with HLHS have approximately 20% mortality by 5 years.
  • The ELPIS I trial ( NCT03525418 ) was an open-label, Phase 1b study designed to evaluate the safety of Lomecel-BTM in patients with HLHS.

ADCETRIS® (brentuximab vedotin) Plus Novel Immunotherapy Combination Delivers 100% Progression Free Survival at 12 months in Phase 2 Trial of Patients with Early Stage Classical Hodgkin Lymphoma

Retrieved on: 
Monday, December 11, 2023
Research, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, Doxorubicin, Safety, Toxicity, Rollcage Stage II, AVD, Progression-free survival, Progressive multifocal leukoencephalopathy, ADC, Febrile neutropenia, Brentuximab vedotin, Patient, Research and development, PFS, Bleomycin, DOR, PML, Hodgkin lymphoma, PD-1, CHL, Lymphoma, Vinblastine, Dacarbazine, Development, Nivolumab, Survival, Massachusetts General Hospital, ADCETRIS, Immunotherapy, Society, Inc., Hospital, Ima Hogg, Pharmaceutical industry, Vaccine, Medical device, Birth control, Seagen

This is the first time 12-month PFS results were presented for the treatment combination, which avoids use of vinblastine and bleomycin in patients with early stage cHL.

Key Points: 
  • This is the first time 12-month PFS results were presented for the treatment combination, which avoids use of vinblastine and bleomycin in patients with early stage cHL.
  • The PFS rate was 100% (95% CI: 100, 100) at 12 months and 97% (95% CI: 90.3, 99.1) at 18 months.
  • Among 56 efficacy-evaluable patients, 95% had an OR (95% CI: 85.1, 98.9) and 89% had a CR (95% CI: 78.1, 96.0).
  • The estimated PFS rate at 24 months was 88% (95% CI: 75.7, 94.6), with a median follow-up of 24.2 months (95% CI: 23.4, 26.9).

First results from PEGASUS trial reported at ESMO show promise for use of liquid biopsy to guide adjuvant treatment of colon cancer

Retrieved on: 
Monday, October 23, 2023
Science, Other Science, Biometrics, Oncology, Health, Medical Devices, Genetics, Clinical Trials, Patient, Cohort (statistics), Liquid biopsy, III, Congress, MD, Doctor of Philosophy, Circulating tumor DNA, Helmy Eltoukhy, PEGASUS, GH, Biology, Recurrence, MRD, Cancer, ISS, Toxicity, Neoplasm, Rollcage Stage II, DNA, Pharmaceutical industry, Medical imaging

One of the first prospective studies using liquid biopsy, the PEGASUS trial includes 135 patients recruited from 11 cancer centers in Italy and Spain.

Key Points: 
  • One of the first prospective studies using liquid biopsy, the PEGASUS trial includes 135 patients recruited from 11 cancer centers in Italy and Spain.
  • Initial results show that 34% of patients with a positive liquid biopsy result after surgery had the cancer return, while only 10% of patients with a negative result experienced a relapse.
  • Approximately 40% of patients converted from ctDNA-positive to ctDNA-negative after treatment, suggesting treatment efficacy of chemotherapy for some patients.
  • “A shift from the current paradigm of one-size-fits-all chemotherapy toward a new paradigm of tailored therapies is not the only expected impact of the PEGASUS trial.

BeiGene Announces the Phase 3 RATIONALE 315 Trial Met Primary Endpoints of Major Pathological Response Rate and Event-Free Survival for Tislelizumab Plus Chemotherapy in Patients with Resectable Non-Small Cell Lung Cancer (NSCLC)

Retrieved on: 
Tuesday, October 17, 2023
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, Other Science, Science, Oncology, SSE, Congress, NSCLC, Abstract, Tislelizumab, BeiGene, BGNE, CEST, ESMO, EFS, Rollcage Stage II, Neoadjuvant therapy, European Society for Medical Oncology, PCR, European Society of Gynaecological Oncology, Patient, MPR, Medical imaging, Dentistry, Pharmaceutical industry

The tislelizumab plus chemotherapy regimen also showed a statistically significant improvement in pathological complete response (pCR), the key secondary endpoint, after neoadjuvant therapy versus chemotherapy.

Key Points: 
  • The tislelizumab plus chemotherapy regimen also showed a statistically significant improvement in pathological complete response (pCR), the key secondary endpoint, after neoadjuvant therapy versus chemotherapy.
  • In the study, 56.2% of NSCLC patients treated with tislelizumab in combination with chemotherapy before surgery achieved MPR, compared to 15.0% of patients treated with chemotherapy alone (difference: 41.1%; 95% CI: 33.2-49.1, p
  • "Lung cancer remains the most common type of cancer and the leading cause of cancer-related death worldwide.
  • These results add to the growing evidence suggesting the potential benefits of tislelizumab in treating patients with NSCLC.”

Merck Announces Pivotal KEYNOTE-671 Trial Meets Dual Primary Endpoint of Overall Survival (OS) in Resectable Stage II, IIIA or IIIB Non-Small Cell Lung Cancer (NSCLC)

Retrieved on: 
Tuesday, October 10, 2023
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, MSD, Congress, MRK, NYSE, Lung cancer, Food, Research, NSCLC, MPR, SCLC, OS, Prescription Drug User Fee Act, Society, American Society of Clinical Oncology, Survival, Disease, ESMO, Merck & Co., EFS, Carcinoma, Head, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, European Society for Medical Oncology, ASCO, PCR, PDUFA, Rollcage Stage II, Patient, Pharmaceutical industry, Merck

The safety profile of KEYTRUDA was consistent with that observed in previously reported studies; no new safety signals were identified.

Key Points: 
  • The safety profile of KEYTRUDA was consistent with that observed in previously reported studies; no new safety signals were identified.
  • “This is a significant milestone in the treatment of resectable non-small cell lung cancer, as it represents the first Phase 3 study to show a statistically significant overall survival benefit for these patients with stage II, IIIA or IIIB (T3-4N2) non-small cell lung cancer.
  • Merck has an extensive clinical development program in lung cancer and is advancing multiple registration-enabling studies, with research directed at earlier stages of disease and novel combinations.
  • Key studies in earlier stages of NSCLC and small cell lung cancer (SCLC) include KEYNOTE-671, KEYNOTE-091, KEYNOTE-867, KEYLYNK-012, KEYVIBE-006 and KEYLYNK-013.

New Neoadjuvant Trial Confirms the Predictive Utility of MammaPrint® + BluePrint®

Retrieved on: 
Thursday, September 28, 2023
Blueprint, Lymphedema, Surgical oncology, Neoadjuvant therapy, NCT, Neoplasm, Cancer, Woman, Breast, Gene expression profiling, MS, MINT, TAD, Annals of Surgical Oncology, MD, Patient, Lymph, Risk, Rollcage Stage II, Health, III, Breast cancer, Medical imaging, MammaPrint

IRVINE, Calif. & AMSTERDAM, Sept. 28, 2023 /PRNewswire/ -- Agendia®, Inc., a global leader in innovative genomic technology and diagnostic tests, announced today the publication of the Multi-Institutional Neoadjuvant Therapy MammaPrint Project I (MINT) trial, a prospective study designed to evaluate the utility of molecular profiling alongside traditional pathologic and clinical prognostic factors in predicting the response to neoadjuvant chemotherapy (NCT) in patients with locally advanced breast cancer (LABC).

Key Points: 
  • This is the first neoadjuvant study to show that nodal downstaging in response to neoadjuvant therapy can be predicted by MammaPrint + BluePrint, Agendia's advanced genomic assays.
  • The MINT trial represents a collaboration of leading institutions and researchers dedicated to advancing breast cancer treatment.
  • It reaffirms the commitment of the scientific and medical communities to improve patient care and outcomes through cutting-edge research.
  • For more information about Agendia, visit www.agendia.com and follow Agendia on Facebook , Twitter ,  and LinkedIn .

Gracell Biotechnologies Reports Updated Clinical Data for FasTCAR-T GC012F for High-Risk, Newly Diagnosed Multiple Myeloma, Demonstrating 100% Stringent Complete Response Rate

Retrieved on: 
Wednesday, September 27, 2023
IIT, ASH, CD19, SCR, International, CRS, Multiple myeloma, DOR, B-cell maturation antigen, Cancer, MRD, Cytokine release syndrome, Patient, Graceling, IMS, Autoimmune disease, Poster, Rollcage Stage II, Society, III, ORR, BCMA, Safety, Grade 2, Vaccine, Pharmaceutical industry, Medical device, Hematology

The abstract (P-136) was presented as a poster at the 20th International Myeloma Society (IMS) Annual Meeting in Athens, Greece.

Key Points: 
  • The abstract (P-136) was presented as a poster at the 20th International Myeloma Society (IMS) Annual Meeting in Athens, Greece.
  • GC012F demonstrated a 100% overall response rate (ORR) and a 100% MRD- sCR rate among 19 transplant-eligible, high-risk NDMM patients as of the data cutoff date of August 1, 2023.
  • The data also showed that GC012F was well-tolerated with no new safety signals observed in this frontline application of CAR-T therapy.
  • We are delighted to report that in this study, all 19 NDMM patients treated by GC012F achieved MRD- sCR with favorable safety.

DoMore Diagnostics And Proscia Partner To Inform Personalized Treatment Decisions For Colorectal Cancer Patients

Retrieved on: 
Wednesday, August 30, 2023
Laboratory, Partnership, IVDR, CRC, IVDD, Deep learning, Marie Cassidy, Intelligence, Large intestine, II, Congress, Rollcage Stage II, Hospital, MD, Patient, Colorectal cancer, European, Neoplasm, Ecosystem, Research, Lancet, III, Disease, Medical imaging, Medical device, EU, Pathology

OSLO and PHILADELPHIA, Aug. 30, 2023 /PRNewswire-PRWeb/ -- DoMore Diagnostics, a leader in deep learning precision diagnostics for digital pathology, and Proscia®, a leading provider of digital and computational pathology solutions, have partnered to help pathologists predict outcomes for colorectal cancer (CRC) patients. The collaboration paves the way for integrating artificial intelligence (AI)-powered clinical decision support into routine pathology workflows, unlocking new insights that can guide increasingly precise treatment decisions and ensure patients receive optimal care.

Key Points: 
  • "We look forward to adding Histotype Px Colorectal to our ecosystem to help Proscia users make increasingly personalized diagnoses that can ultimately reduce overtreatment for more patients."
  • - Stephan Fromme, Proscia's Head of Strategic Alliances
    CRC is the third most common and second most deadly cancer worldwide[1].
  • "We have proven that Histotype Px Colorectal can offer valuable insight to guide personalized treatment decisions and help improve patient outcomes," said Torbjørn Furuseth, MD, CEO and Co-founder of DoMore Diagnostics.
  • We look forward to adding Histotype Px Colorectal to our ecosystem to help our users make increasingly personalized diagnoses that can ultimately reduce overtreatment for more patients."

Longeveron Announces Achievement of Surpassing 50% Enrollment Threshold in Phase 2 ELPIS II Study of Lomecel-B™ in Hypoplastic Left Heart Syndrome

Retrieved on: 
Friday, August 11, 2023
Heart, Opinion, National Heart, Lung, and Blood Institute, Fast Track, Lung, Doctor of Philosophy, Hypoplastic left heart syndrome, Bangladesh Technical Education Board, Shimaa Hashad, System, NHLBI, Patient, Mortality, Rollcage Stage II, FDA, HLHS, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Potential, Treatment, Food, Safety, Pharmaceutical industry, MD

MIAMI, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, announced today the Phase 2 ELPIS II trial, funded by the National Heart, Lung, and Blood Institute (NHLBI) and using the Company’s Lomecel-B™ asset in Hypoplastic Left Heart Syndrome (HLHS), has surpassed the 50% enrollment threshold. Additionally, the trial has activated its eighth clinical site location – one additional site beyond the seven originally planned -- in order to try to expedite the completion of the trial enrollment.

Key Points: 
  • Additionally, the trial has activated its eighth clinical site location – one additional site beyond the seven originally planned -- in order to try to expedite the completion of the trial enrollment.
  • HLHS is a congenital birth defect in which the left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing.
  • Lomecel-B™ for HLHS has previously received Fast Track, Rare Pediatric Disease, and Orphan Drug Designations from the U.S. Food and Drug Administration (FDA).
  • ELPIS II is being funded by grants from the National Institutes of Health’s National Heart, Lung, and Blood Institute (NHLBI; Grant numbers UG3HL148318, U24HL148316), in collaboration with Longeveron.

Timbercreek Financial Announces 2023 Second Quarter Results

Retrieved on: 
Wednesday, August 2, 2023
TSX, LTV, Growth, Rollcage Stage II, Investment, Sale, Bank, Real estate

TORONTO, Aug. 02, 2023 (GLOBE NEWSWIRE) -- Timbercreek Financial (TSX: TF) (the “Company”) announced today its financial results for the three and six months ended June 30, 2023 (“Q2 2023”).

Key Points: 
  • TORONTO, Aug. 02, 2023 (GLOBE NEWSWIRE) -- Timbercreek Financial (TSX: TF) (the “Company”) announced today its financial results for the three and six months ended June 30, 2023 (“Q2 2023”).
  • Q2 2023 results were highlighted by strong interest income and a healthy mortgage portfolio.
  • Mortgage repayment activity was higher in the second quarter after a slower Q1 2023 and as a result, portfolio turnover increased to 11.6% compared with 8.4% in Q1 2023.
  • “The second quarter results showed significant year-over-year growth in our key financial measures, including a 22% increase in net investment income, 18% increase in earnings per share, and strong growth in distributable income, to $0.21 per share at a conservative payout ratio,” said Blair Tamblyn, CEO of Timbercreek Financial.