SAN DIEGO, Jan. 14, 2016 /PRNewswire-USNewswire/ -- Renova™ Therapeutics, a biopharmaceutical company developing gene therapy treatments for congestive heart failure and other chronic diseases, has hired Richard 'Mac' McCloskey, M.D., as Executive Vice President of Clinical Development.
An author of more than 100 peer-reviewed papers and editorials as well as three books, Dr. McCloskey has led an illustrious career in medical research and clinical practice. He has directed registration trials for Hoffman LaRoche and Centocor and was, most recently, Vice President of Scientific Affairs at Johnson & Johnson Development Corporation as well as a scientific adviser to Endo Pharmaceuticals.
As Executive Vice President of Clinical Development for Renova Therapeutics, Dr. McCloskey will be responsible for all clinical aspects of the company's trials, including preparation of trial synopses and protocols, review and approval of case report systems and safety reporting, and drafting of clinical trial endpoints. He will also ensure Renova Therapeutics meets all regulatory requirements for clinical trial safety reporting, and, as needed, will present trial data to regulatory agencies.
In this role, Dr. McCloskey will work closely with the Senior Vice President of Regulatory Affairs and Quality Assurance and will coordinate with the company's expert consultants on statistical analysis, trial planning and conduct. His immediate focus will be on Renova Therapeutics' lead investigational product RT-100, a single-dose gene therapy for the treatment of congestive heart failure, which recently completed a Phase 2 clinical trial.
"We're excited to have Mac join Renova as we progress further with our product pipeline," said Jack W. Reich, Ph.D., CEO and Co-founder of Renova Therapeutics. "His contributions in the medical field and in clinical development will be a tremendous asset to our team, as we continue to develop a portfolio of gene therapies for cardiovascular and metabolic diseases."
Dr. McCloskey received a master's in microbiology and an M.D. from the University of Rochester and completed his medical training at Duke University and the National Institutes of Health. He has been on the faculty of the University of Texas, the University of Pennsylvania and Jefferson Medical College, and he is an emeritus fellow of the American College of Physicians and the Infectious Disease Society of America.
His FDA-approved submissions include interferon, ceftriaxone, infliximab, abciximab, midazolam and injectable testosterone. He also contributed to the following as an academic clinical investigator: cefoxitin, thienamycin, cefotaxime, mezlocillin, ticarcillin, imipenem-cilastatin, cefmenoxime, amdinocillin, fleroxacin and ofloxacin.
To him, taking on this role is personal: "Having been treated for congestive heart failure by the single procedure of surgical aortic valve replacement, I have both a personal and scientific appreciation of the breakthrough potential of a single treatment for CHF," says McCloskey. "And the data derived so far for RT-100 demonstrates that potential."
About Renova Therapeutics
Renova™ Therapeutics is developing definitive, one-time gene therapy treatments to restore the health of people suffering from chronic diseases. The first two indications the company is pursuing are therapies for congestive heart failure (CHF) and type 2 diabetes, two of the most common and devastating chronic diseases in the world. The company's lead investigational product, RT-100, is a new type of treatment that delivers a therapeutic gene directly to damaged heart tissue during a routine outpatient procedure and has the potential to renew heart function in millions of patients with CHF. The company's product pipeline also includes a second-generation therapy for CHF patients and a groundbreaking therapy in pre-clinical stage for sufferers of type 2 diabetes. Renova Therapeutics was founded in 2009 and is led by an experienced management team in biopharmaceuticals and gene therapy. For additional information about the company, please visit www.renovatherapeutics.com.
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SOURCE Renova Therapeutics