HbO2 Therapeutics is a leader in the development of human and veterinary hemoglobin-based oxygen carriers (HBOCs), therapies that when intravenously administered, increase the oxygen-carrying capacity of blood. The Company has two core products: Hemopure® (HBOC-201) [hemoglobin glutamer - 250 (bovine), and Oxyglobin® [hemoglobin glutamer - 200 (bovine)] for human and veterinary use, respectively.
In 2001, Hemopure was approved in South Africa for the treatment of adult surgical patients who are acutely anemic, for the purpose of eliminating, delaying, or reducing the need for allogeneic red blood cells. In 2010, Hemopure was also approved in the Russian Federation for the treatment of acute, all-cause anemia.
Hemopure is an investigational new drug that is not approved by the FDA as being safe or effective for any use in humans, and therefore only available through a clinical trial, or expanded access (sometimes called compassionate use). In recent years, Hemopure has been used extensively across the US under the FDA’s Expanded Access Program (EAP), to treat patients with severe, life-threatening anemia for whom blood transfusion is indicated, but not an option, and who have exhausted all other treatment options. Reasons for not being transfused could include unavailability of compatible blood, conditions when blood transfusions are contraindicated, and patient refusal due to religious beliefs.
Oxyglobin is a veterinary therapy that has been approved in both the US and Europe for more than 20 years. The product is indicated to treat the clinical signs and symptoms of canine anemia by increasing plasma and total hemoglobin concentrations, thereby increasing arterial oxygen content. The first product of its kind to ever be approved in veterinary medicine. More than 240,000 units have been sold to date, and approximately 30 species treated off label. Our two products represent a body of knowledge resulting from more than 25 years of R&D, 22 clinical trials, and 250+ preclinical studies. Today, through innovative research and scientific collaboration, we strive to further their development and commercialization, in potential new applications where there exists a previously unmet medical need.
Chief Executive Officer
Mr. Zafirelis has more than 25 years of CEO experience in private and public companies, including start-up ventures and turnaround situations. He led the original team at Biopure that developed Oxyglobin®, the veterinary oxygen carrier, now approved by FDA and EMA. Previously he led two cardiac device (class 3) companies, Cardiac Assist (Tandemheart) and Medquest Products and has significant experience with regulatory agencies worldwide. Mr. Zafirelis has an MS in Chemistry and an MBA from the University of Southern California. He has also completed the Corporate Director Program at Harvard Business School.
Chief Financial Officer
Mr. Serov has over 20 years of experience in the Investment Banking industry. He spent most of his career in London running such groups as capital markets, structured products, and advisory. Mr. Serov has worked at Bankers Trust, Rose Square Capital, Dresdner Kleinwort Benson, and Renaissance Capital. Before joining Hemoglobin Oxygen Therapeutics, he was heading up coverage for corporate clients and financial institutions at Sberbank, the largest Russian bank. Mr. Serov has a BA in Mathematics and Economics from Connecticut College.
Senior Director, Process Development
Mr. Dawson has over 25 years of experience in the development and commercialization of Hemopure and Oxyglobin, and is leading the efforts to consolidate three manufacturing sites down to a single facility in Souderton, PA. He has held multiple positions in manufacturing operations and has an extensive skillset in all facets of production, maintenance, calibration, supply chain, process engineering, validation, environmental control, and aseptic fill finish. Brian was Director of Operations for both Biopure and OPK Biotech LLC, and has a BA from North Adams State College (Massachusetts College of Liberal Arts).
Greg Dubé, PhD
Vice President, Research and Development
Dr. Dubé has over 30 years of industry experience in drug R&D including leadership positions in large and small Pharma and biotech. Dr. Dubé is an expert in the physical, biochemical and pharmacological properties of HBOCs and has significant experience in the design and analysis of preclinical and clinical studies to evaluate them across a wide range of clinical indications, including donor organ perfusion, organ ischemia/reperfusion injury, hemorrhagic trauma/shock, anemia and heart failure. Dr. Dubé has a doctorate in pharmacology and cell biophysics from the University of Cincinnati College of Medicine and completed a postdoctoral fellowship at Duke University School of Medicine, Division of Cardiology.
Fantao Meng, PhD
Director, Research & Development
Dr. Meng is a Hemoglobin specialist with 20 years of research experience in developing hemoglobin-based oxygen carriers (HBOCS). In 2014, he received ORISE-advanced scientist fellowship from FDA, and worked in the Biochemistry and Vascular Laboratory at the Office of Blood Research and Review for 5 years. Previously he spent 10 years as post-doctoral fellow/instructor at Albert Einstein College of Medicine. He holds a PhD from the National Key Lab of Biochemical Engineering, Chinese Academy of Sciences, China.
Senior Director, Biostatistics & Data Management
Mr. Pitman has 20 years of broad-based pharmaceutical and healthcare US experience with a strong background in mathematics, statistics, and logistics. Previously he has taught courses in mathematics, logic, computer sciences and statistics at various colleges, including the University of Kharkov, Ukraine, Soviet Union. He earned a Master of Science with Honors in mathematics at Kharkov State University, USSR.
Director, Regulatory & Clinical Operations
Ms. Zafirelis has more than 24 years of pharmaceutical, biotech, and CRO experience. Having spent the majority of that time in smaller companies and startup environments, she has assumed a variety of cross functional roles and responsibilities, resulting in a comprehensive understanding of the regulatory landscape, and an ability to manage complex issues, across a wide range of therapeutic areas. She interacts directly with Regulatory Authorities in both the US and other jurisdictions, for both our human and veterinary products. Her background includes a BA from University of Massachusetts and a MBA from the University of Southern California