XyloCor Therapeutics, a clinical-stage biopharmaceutical company specializing in gene therapies for cardiovascular disease, has released positive 12-month data from the Phase 2 portion of its Phase 1/2 clinical trial (EXACT) evaluating the safety and preliminary efficacy of gene therapy candidate XC001 (encoberminogene rezmadenovec) in patients with refractory angina. The study demonstrated sustained improvements, including increased exercise duration and reduced chest pain and symptoms, adding to earlier positive findings at 3 and 6 months, highlighting XC001’s potential as a novel therapy for refractory angina.
Refractory angina poses a significant medical challenge for patients with chronic angina, experiencing symptoms despite optimal medical therapy and being ineligible for certain interventions. These patients currently lack treatment options, impacting their quality of life and leading to increased healthcare resource utilization.
XC001 is a one-time gene therapy designed to create new blood vessels in the heart, reducing ischemic burden and chest pain associated with refractory angina. The Phase 2 trial had a primary study period of six months, followed by a 12-month follow-up. At 12 months, patients showed sustained and significant increases in exercise duration, along with reduced chest pain episodes and nitroglycerin use. Cardiac imaging confirmed the therapy’s potential mechanism, indicating a sustained reduction in ischemic burden.
Thomas Povsic, M.D., Ph.D., National Principal Investigator for the study, expressed excitement about the continuous improvements seen at 12 months, signaling a promising advancement in gene therapy for cardiovascular disease. The robust mechanistic evidence supports XC001’s development and suggests potential long-term benefits with a single treatment.
Al Gianchetti, President and CEO of XyloCor, expressed confidence in transforming outcomes in cardiovascular disease based on the 12-month results, reinforcing their leading role in gene therapy for cardiovascular conditions.
Dedicated to developing best-in-class gene therapies for cardiovascular disease, XyloCor Therapeutics is also making progress with XC002, its second preclinical investigational product aimed at treating cardiac tissue damage resulting from heart attacks.
PackGene is a CRO & CDMO technology company that specializes in packaging recombinant adeno-associated virus (rAAV) vectors. Since its establishment in 2014, PackGene has been a leader in the AAV vector CRO service field, providing tens of thousands of custom batches of AAV samples to customers in over 20 countries. PackGene offers a one-stop CMC solution for the early development, pre-clinical development, clinical trials, and drug approval of rAAV vector drugs for cell and gene therapy (CGT) companies that is fast, cost-effective, high-quality, and scalable. Additionally, the company provides compliant services for the GMP-scale production of AAVs and plasmids for pharmaceutical companies, utilizing five technology platforms, including the π-Alpha™ 293 cell AAV high-yield platform and the π-Omega™ plasmid high-yield platform. PackGene’s mission is to make gene therapy affordable and accelerate the launch of innovative gene drugs. The company aims to simplify the challenging aspects of gene therapy development and industrialization processes and provide stable, efficient, and economical rAAV Fast Services to accelerate gene and cell therapy development efforts from discovery phase to commercialization.
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