AUGUSTA UNIVERSITY

Moleculin Biotech's Annamycin Shows Promise in Overcoming Treatment Resistance in AML

5 months ago

• Moleculin Biotech's Annamycin demonstrates the ability to overcome resistance to Venetoclax in acute myeloid leukemia (AML) based on preclinical and clinical data. • Preliminary clinical data from the MB-106 trial indicates a 60% complete remission rate in relapsed or refractory AML patients treated with Annamycin plus Ara-C. • Moleculin has received regulatory approval in Europe to begin recruiting for its Phase 3 MIRACLE trial, evaluating Annamycin in combination with Cytarabine for R/R AML. • The FDA has provided positive guidance on Moleculin's IND amendment, potentially accelerating the approval timeline for Annamycin in AML treatment.

Cretostimogene Shows Durable Responses in High-Risk Bladder Cancer

6 months ago

• Cretostimogene monotherapy demonstrated a 74.5% complete response rate at any time in patients with high-risk BCG-unresponsive NMIBC. • The median duration of response has not been reached but exceeds 27 months, indicating a sustained treatment effect. • The BOND-003 trial showed a favorable safety profile with no Grade 3 or higher treatment-related adverse events reported. • 97.3% of patients were free from progression to muscle-invasive bladder cancer at 12 months, highlighting the therapy's potential to prevent disease advancement.

FDA Approves Scemblix (asciminib) for Newly Diagnosed Chronic Myeloid Leukemia

7 months ago

• The FDA granted accelerated approval to Scemblix (asciminib) for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (CML) in the chronic phase. • The approval was based on the ASC4FIRST trial, which demonstrated a significantly higher major molecular response rate at 48 weeks with Scemblix compared to other tyrosine kinase inhibitors. • In the ASC4FIRST trial, the major molecular response rate at 48 weeks was 68% in the Scemblix arm versus 49% in the tyrosine kinase inhibitor arm. • Common side effects associated with Scemblix included rash, musculoskeletal pain, upper respiratory tract infection, fatigue, abdominal pain, headache, and diarrhea.

Predicting Response to rTMS: Early Symptom Improvement Key in Depression Treatment

7 months ago

• A recent study identifies early improvements in specific depressive symptoms as predictors of response to repetitive transcranial magnetic stimulation (rTMS). • Patients showing early improvement in initiative and emotional involvement are more likely to respond positively to rTMS treatment. • Longer depressive episode duration and a history of electroconvulsive therapy (ECT) are associated with lower odds of rTMS response. • The findings suggest that monitoring early symptom changes can help predict rTMS efficacy and personalize treatment strategies.

Hypofractionated Radiotherapy Shows Promise in Post-Prostatectomy and Localized Prostate Cancer Treatment

8 months ago

• A phase II trial (HYPORT-ES) demonstrates that hypofractionated postoperative radiotherapy is safe and effective for prostate cancer, showing a 93% biochemical control rate at three years. • Long-term data from a phase III trial indicates that dose-escalated hypofractionated radiation improves 10-year failure rates in localized prostate cancer, particularly in patients not receiving ADT. • Hypofractionation offers convenience and comparable or lower toxicity, potentially becoming a standard of care with advanced radiotherapy techniques and individual patient consideration. • Research suggests moderate hypofractionation is a safe option, with similar or lower toxicity levels and comparable oncologic outcomes, especially with modern radiation techniques.

UpFrontPSMA Trial: Lutetium-PSMA Plus Docetaxel Shows Promise in Metastatic Hormone-Sensitive Prostate Cancer

8 months ago

• The UpFrontPSMA trial demonstrated that adding lutetium-PSMA to docetaxel significantly improved undetectable PSA rates at 48 weeks in mHSPC patients. • The study also showed improvements in key secondary endpoints like PSA progression-free survival and freedom from castration resistance with the lutetium-PSMA combination. • Treatment with lutetium-PSMA did not increase overall toxicity or negatively impact quality of life, suggesting a potential role in mHSPC management. • The ongoing PSMAddition Phase III trial will further evaluate lutetium-PSMA's utility in mHSPC, potentially changing the standard of care.

Scemblix Receives Positive CHMP Opinion for CML Treatment After TKI Failure

3 years ago

• The CHMP has recommended Scemblix (asciminib) for treating Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML-CP) in adults after two or more tyrosine kinase inhibitors (TKIs). • Phase III ASCEMBL trial data showed Scemblix nearly doubled the major molecular response rate compared to bosutinib (25.5% vs. 13.2%) at 24 weeks. • Discontinuation rates due to adverse reactions were more than three times lower with Scemblix compared to bosutinib (5.8% vs 21.1%) in the ASCEMBL trial. • Scemblix, a STAMP inhibitor targeting the ABL myristoyl pocket, offers a novel mechanism to combat TKI resistance and intolerance in CML patients.