University Of Leeds

Abbott's FreeStyle Libre CGM System Reduces Cardiovascular Hospitalization Risk in Diabetes Patients

7 days ago

• Abbott's FreeStyle Libre continuous glucose monitoring system is the first CGM shown to reduce cardiovascular complication severity in diabetes patients, with data showing a 78% reduction in heart-related hospitalizations for Type 1 diabetes patients. • The REFLECT program, comprising three real-world retrospective studies using Swedish registry data, demonstrated significant reductions in hospitalization risk for both Type 1 and insulin-treated Type 2 diabetes patients using the Libre technology compared to traditional blood glucose monitoring. • Patients with Type 1 diabetes who had no prior history of cardiovascular disease showed an 80% reduced risk of heart-related hospitalizations when using FreeStyle Libre, while those with prior cardiovascular disease history still saw a 49% reduction.

Novel Treatment Regimen Extends Myeloma Remission by Seven Months in UK Clinical Trial

8 days ago

• A phase 3 clinical trial led by the University of Leeds demonstrated that a second stem cell transplant followed by ixazomib maintenance therapy extends myeloma remission by seven months compared to standard care. • The ACCoRd trial treatment protocol combines autologous stem cell transplantation with targeted drugs thalidomide, dexamethasone, and ixazomib, offering patients improved quality of life compared to chemotherapy or long-term steroid use. • Ixazomib works by preventing protein breakdown in myeloma cells, causing toxic buildup while allowing healthy cells to grow, presenting a promising alternative for patients eligible for a second bone marrow transplant.

Reduced-Dose Radiotherapy Shows Promise for Early-Stage Anal Cancer Treatment

12 days ago

• The phase 2 PLATO-ACT4 trial demonstrated that reduced-dose intensity-modulated radiotherapy (IMRT) achieved comparable complete clinical response rates to standard dosing in early-stage anal cancer patients. • Patients receiving reduced-dose treatment experienced fewer grade 3+ toxicities (35% vs 46%), better treatment compliance, and improved sexual function scores at 6 months compared to standard dosing. • The breakthrough findings could transform clinical practice globally after 30 years of a "one-size-fits-all" approach, offering a shorter, kinder treatment option without compromising cure rates.

Novel Therapies Transform Rheumatology Landscape in Early 2025

3 months ago

• FDA regulatory actions in Q1 2025 include approval of Celltrion's denosumab biosimilars and Fast Track designation for CAR-T therapies targeting lupus, expanding treatment options for autoimmune conditions. • Breakthrough clinical data from the REGENCY trial demonstrates obinutuzumab's superior efficacy in lupus nephritis, while rosnilimab shows historic response rates in rheumatoid arthritis patients. • Novel approaches for difficult-to-treat conditions emerge with SAP-001 showing "best-in-class" results for refractory gout and transcranial magnetic stimulation providing sustained pain relief for fibromyalgia.

Phase 3 FINESSE Trial Launches to Evaluate Finasteride in Prostate Cancer Active Surveillance

3 months ago

• A new Phase 3 trial called FINESSE will evaluate whether finasteride can improve adherence to active surveillance in men with low and intermediate-risk prostate cancer. • The study will enroll 550 men across eight sites, randomizing patients to receive either standard active surveillance alone or with daily finasteride for two years. • The trial aims to address poor long-term compliance with active surveillance, with outcomes tracked for up to 10 years including disease progression, mortality, and quality of life measures.

Targeted Drug Combination Induces Remission in CLL Patients, Improving Survival and Quality of Life

5 months ago

• A phase III clinical trial, FLAIR, demonstrated that a combination of venetoclax and ibrutinib is more effective than chemotherapy for chronic lymphocytic leukemia (CLL). • The targeted drug combination significantly increased the time patients lived without cancer progression and improved overall survival, with over 95% in remission after three years. • The treatment was well-tolerated, resulting in fewer side effects and a better quality of life, especially for older patients who may not tolerate chemotherapy. • One patient, William Bennett, remains cancer-free nearly six years after starting the trial, highlighting the potential for long-term remission with this approach.

LEVI-04 Demonstrates Significant Pain and Function Improvement in Knee Osteoarthritis

6 months ago

• LEVI-04, a novel neurotrophin-3 inhibitor, significantly improved pain and function in patients with knee osteoarthritis (OA) compared to placebo in a phase 2 trial. • The study demonstrated statistical significance in primary and secondary endpoints at weeks 5 and 17, with over half of LEVI-04 treated patients experiencing at least a 50% pain reduction. • LEVI-04 was well-tolerated, showing no increased incidence of serious adverse events or joint pathologies, including rapidly progressive OA, compared to placebo. • The findings suggest LEVI-04's potential in treating OA pain and possibly other pain indications, warranting further investigation into its structure-modifying capabilities.

EP-104IAR Shows Promise for Knee Osteoarthritis Pain Relief in Phase 2 Trial

7 months ago

• Phase 2 trial data indicates EP-104IAR is safe and effective in reducing knee osteoarthritis (OA) pain for up to 14 weeks. • The SPRINGBOARD trial demonstrated a statistically significant improvement in WOMAC pain scores with EP-104IAR compared to the vehicle control group. • Treatment-emergent adverse events were similar between the EP-104IAR and control groups, with minimal effects on glucose and cortisol levels. • EP-104IAR's advanced formulation offers sustained pain relief and an improved safety profile, potentially advancing the standard of care for knee OA.

Study Reveals High Prevalence of Fibromyalgia in Post-COVID Musculoskeletal Pain Patients

7 months ago

• New research from Leeds Institute shows 72.2% of patients with post-COVID-19 musculoskeletal pain meet the clinical criteria for fibromyalgia syndrome, suggesting a strong link between viral infections and chronic pain conditions. • The study found that among 18 participants, myalgia affected 94.4% and widespread pain affected 77.8%, with symptoms persisting for an average of 27.9 months post-COVID infection. • Recent developments in AI-assisted diagnosis show promise, with a new large language model achieving 87% accuracy in distinguishing fibromyalgia from other chronic pain conditions.

Spider Venom-Inspired Drug Hi1a Advances to Clinical Trials for Heart Attack Treatment

8 months ago

• A drug derived from the venom of the K'gari funnel-web spider, Hi1a, is set to enter human clinical trials to treat heart attacks and protect donor hearts. • Hi1a has shown promise in preclinical studies by protecting heart tissue from damage caused by oxygen deprivation during heart attacks or donor heart retrieval. • The clinical trial, supported by $17.8 million in funding, will assess Hi1a's efficacy in improving patient survival, quality of life, and expanding the pool of viable donor hearts. • If successful, Hi1a could become the first drug to limit heart cell loss during an attack or protect donor hearts, addressing a significant unmet medical need.

NO-CUT Trial: Non-Operative Management Shows Promise in Rectal Cancer

8 months ago

• The NO-CUT trial reveals that non-operative management (NOM) following total neoadjuvant therapy (TNT) maintains distant relapse-free survival in pMMR locally advanced rectal cancer patients. • A clinical complete response (cCR) was observed in 26% of patients, allowing them to proceed with NOM, with 85% achieving organ preservation. • Circulating tumor DNA (ctDNA) analysis post-TNT predicts clinical response and distant relapse-free survival, potentially refining patient selection for NOM. • The 3-year distant relapse-free survival rate was 85.8% for ctDNA-negative patients versus 64.0% for ctDNA-positive patients (HR, 3.23; P = .035).

FDA Grants Fast Track Designation to MM-II for Osteoarthritis Knee Pain

8 months ago

• The FDA has granted Fast Track designation to MM-II, a non-opioid liposomal suspension, for treating osteoarthritis (OA) knee pain, potentially expediting its development and review. • Phase 2b trial data showed a single intra-articular injection of MM-II provided significant pain relief compared to placebo for up to 26 weeks in OA patients. • The Fast Track designation highlights the potential of MM-II to address the unmet need for effective and durable treatments for osteoarthritis, a prevalent degenerative joint disease. • MM-II demonstrated a greater than 50% improvement in knee pain from weeks 12 to 26, supporting its potential for accelerated regulatory approval.

Avacta's AVA6000 Shows Durable Responses in FAP-Positive Solid Tumors with Reduced Toxicity

8 months ago

• AVA6000 demonstrates encouraging efficacy with durable RECIST responses in patients with FAP-positive solid tumors, aligning with a favorable safety profile. • The pre|CISION™ technology enables tumor-specific doxorubicin release, reducing cardiac toxicity and other side effects compared to conventional doxorubicin. • Pharmacokinetic analysis reveals AVA6000 extends doxorubicin's half-life and limits its distribution into normal tissues, enhancing tumor exposure. • Clinical data supports the potential of AVA6000 to treat a broad range of solid tumor patient populations with unmet clinical needs.

Crestone's CRS3123 Shows Promise in Phase 2 Trial for C. difficile Infection

9 months ago

• Crestone's CRS3123 demonstrated comparable clinical cure rates to vancomycin in treating _Clostridioides difficile_ infection (CDI) in a Phase 2 trial. • The study revealed significantly lower CDI recurrence rates with CRS3123 compared to vancomycin at day 40 (4% vs. 23%). • CRS3123 was well-tolerated, with no serious treatment-emergent adverse events reported during the clinical trial. • NIAID exercised its option to provide $4.5 million in new funding for microbiome analyses and manufacturing process optimization of CRS3123.