Cardioxyl Pharmaceuticals achieves positive results in first clinical study of CXL-1020 for ADHF

Cardioxyl Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing novel therapeutic agents for the treatment of cardiovascular disease, today announced that it has achieved positive safety and tolerability results in the first clinical study of its lead drug candidate, CXL-1020, for the treatment of patients with acute decompensated heart failure (ADHF).  Each year in the United States, more than one million patients are hospitalized with acute heart failure.

Cardioxyl's Phase I/IIa placebo-controlled, double-blind, dose-escalation study was conducted at seven sites in the United States with affiliated heart failure specialty centers or academic medical centers. The Phase I/IIa study enrolled 28 subjects with chronic stable heart failure and involved 67 exposures of a sustained intravenous infusion across four cohorts. In the trial, CXL-1020 demonstrated an acceptable safety profile, an attractive pharmacokinetic profile, and was well tolerated by patients. The drug led to no serious adverse events, with patients tolerating doses up to 10 ug/kg/min. In addition, CXL-1020 clearly demonstrated statistically significant hemodynamic activity in patients with relevant underlying disease. More information on the trial results will be presented at upcoming scientific meetings.

"Cardioxyl is making significant clinical progress in the development of CXL-1020, an important treatment for patients with ADHF," said Chris Kroeger, M.D., President and Chief Executive Officer. "Results from our recently completed Phase I/IIa dose escalation study demonstrate that the drug has a very attractive safety profile and an important impact on cardiac and vascular function. We also believe that CXL-1020 is the only product in development that provides the ideal balance of blood vessel dilation combined with direct enhancement of cardiac diastolic and systolic function."

Dr. Garrie J. Haas, M.D., FACC, Section Director of Heart Failure/Transplant, and Medical Director of the Cardiovascular Clinical Research Organization, Professor of Medicine in the Division of Cardiovascular Medicine at The Ohio State University Medical Center and an investigator in the Cardioxyl Phase I/IIa trial stated, "There is currently a significant clinical need in the United States for a safe and effective therapy to treat the large population of hospitalized patients with heart failure. With its unique mechanism of action as compared to the limited options available on the market today, CXL-1020, if successful, will provide a novel and very useful new therapy for the treatment of these often severely ill patients."  

Cardioxyl Raises an Additional $15 Million in Funding

Cardioxyl also announced today that it has raised $15 million in funding from existing investors Aurora Funds and New Enterprise Associates (NEA).

Said Dr. Kroeger, "With this additional funding, Cardioxyl is well capitalized to execute on a Phase IIa trial for CXL-1020 and to continue development of our promising research portfolio. We are pleased to have the continued enthusiastic support of Aurora and NEA."