On February 20, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported that it has received an independent assessment of the absence of cardiotoxicity in patients treated with Annamycin in both its US and European open label and single arm Phase 1 clinical trials (Press release, Moleculin, FEB 20, 2020, View Source [SID1234554627]). Data from the first 5 patients in the US and the first 9 patients in Europe were made available to an expert in chemotherapy who is affiliated with a leading cancer research institute in assessing cardiotoxicity. After review of this data, the independent expert concluded that he "does not see evidence of cardio-toxicity."
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)
The data made available included left ventricular ejection fraction (LVEF) as determined by echocardiograms, ECHO strain imaging, and Troponin levels. For a small population of patients, ECHO strains were not provided due to the limitations of delivery of such data by the clinical sites. "ECHO strain imaging" is a method in echocardiography (medical ultrasound) for measuring regional or global deformation of the myocardium (heart muscle). By strain rate imaging, the simultaneous function of different regions can be displayed and measured. Cardiac health biomarkers such as blood Troponin levels are considered an indicator of potential long-term heart damage.
"We are pleased to receive this independent assessment which further validates the absence of cardiotoxicity in patients to date of Annamycin," stated Wally Klemp, Chairman and CEO of Moleculin. "Currently approved anthracyclines are notoriously cardiotoxic, so demonstrating that Annamycin is not cardiotoxic, even in patients who have received more than the lifetime maximum cumulative anthracycline exposure established by the FDA, supports our claim that Annamycin is truly in a class by itself, and indeed a ‘Next Generation’ anthracycline." He continued, "We are excited to continue to demonstrate Annamycin’s excellent safety profile. We believe continuing to demonstrate the lack of cardiotoxicity, along with initial efficacy data shown while increasing the dosage to a therapeutic level, will make Annamycin an extremely promising new drug candidate."