Acea looks to Brisbane, Australia to conduct"first in human" study.
Acea prepares for first in human clinical trials.
Acea is currently exploring sites in Australia to conduct its first clinical trial.
The first in human study will be for an oral formulation of Corifungin. There is a strong need in the market for a more potent, oral antifungal drug.
Australia was selected as a possible site for clinical trial due to its robust clinical facilities, its history of successful trials, and for the attractive tax advantages when compared to other locations.
Acea's First Time in Human (FTIH) study protocol will be for oral administration. A standard Phase I study will be conducted, consistent with FDA guidelines, to gain a better understanding of how well the doses are tolerated and the corresponding pharacokinetic markers.Following the Phase I, Acea will proceed into a very small Phase IIb study to test for effectiveness.
Josefino Tunac Ph.D.
Dr. Tunac is Chief Scientific Officer, co-founder of Acea Biotech, Inc. and discoverer of Corifungin.
Besides Acea, Dr. Tunac also continues his research activities at other pharmaceutical ventures. In 1987, Dr. Tunac founded a privately held pharmaceutical company, Fermical, Inc. (Ferndale, MI). Dr. Tunac discovered and developed a number of biotech-based drugs including infectious and chronic diseases. These drugs were used to start biotech companies including: Supergen, Inc. [NASDAQ:SUPG], Dublin, CA (anticancer drugs mitomycin C, pentostatin); Altaria Pharmaceuticals (Formerly JJ Pharma), Scottsdale, AZ (JJP-10/11 lipid modulator drugs and JJP-12 antiarthritic); Adevida Biotica, Corp., Oxford, MI (Adenzym™ to treat cellular 'corrosion'' Vintarex treatment for metabolic acidosis), Farmaceutix, LLC, Ferndale MI (diagnostics and therapies for vascular diseases).
Dr. Tunac invented and marketed the Tunair™ flask system (a laboratory culture flask now used worldwide) and the Airmentor™ (a novel bioreactor) for the manufacturing of biotech-based pharmaceuticals. Dr. Tunac was awarded “Entrepreneur of the Year” in 1995.
Dr. Tunac obtained his doctorate degree from the Waksman Institute of Microbiology, Rutgers University, NJ (the birthplace of antibiotics) where, as a graduate student, discovered his first antibiotic, Hydroheptin (the first water-soluble polyene macrolide). Merck & Co. (Rahway, NJ) hired Dr. Tunac and became instrumental in the discovery and development of commercially important compounds with multi-billion dollar sales, including avermectin, antiparasitic agent (Ivomec® Heartgard®); the thienamycin class of antibacterial antibiotic (Primaxin®).
Subsequently, Dr. Tunac was hired by Warner-Lambert/Parke-Davis (later bought by Pfizer) to direct its biotech program where he was responsible for the development of pentostatin (Nipent®), vidarabine (Vira-A®), and daunomycin (Daunorubicin®) and the discovery of a number of anticancer compounds. Dr. Tunac has more than twenty patents and patents pending covering a variety of new pharmaceuticals and biotech equipment. Dr. Tunac served as a consultant to the National Cancer Institute (NCI) and has more than 50 publications, presentations, and symposia, and is a member of the American Association for Cancer Research (AACR), the American Society of Microbiology (ASM), and the Society for Industrial Microbiology (SIM).
Milton K. Reeder, CEO
Mr. Reeder is Chief Executive Officer and co-founder of Acea Biotech, Inc. Mr. Reeder and Dr. Tunac have teamed up to bring Acea Biotech into the forefront of antimicrobial drug innovation.Mr. Reeder is a seasoned investor and business executive. He has been CEO of several private and public companies and managed those entities through growth and contraction cycles. His last public company was merged into ProLogis (NYSE:PLD) for $1.2 billion. Mr. Reeder is also CEO of Accent Capital Partners, LLC, a San Francisco-based investment-banking firm that he founded as well as CEO of Accent Capital Advisors, an NASD broker/dealer. Accent specializes in assisting young companies in a variety of industries. Mr. Reeder has been active in the financial community for over twenty-eight years. He has successfully completed over $3.0 billion in financial transactions including the public offering of common shares, preferred shares, investment grade rated debt as well as private offerings of equity securities. Mr. Reeder began his career as a CPA with Deloitte Touche after graduating from the University of Michigan School of Business.
James McKerrow, Ph.D, M.D.
Dr. McKerrow has assisted Acea in testing Corifungin against certain rare diseases. Dr. McKerrow is Distinguished Professor, Dean, Skaggs School of Pharmacy and Pharmaceutical Sciences. University of California, San Diego. Dr. McKerrow leads a consortium of academic and industry scientists dedicated to the discovery and development of new drugs for neglected tropical diseases (NTDs). This consortium, the Center for Discovery and Innovation in Parasitic Diseases, is focused on drug discovery and development through Phase I clinical trials. The Center pioneered the development of high-throughput screening assays for seven neglected diseases, ranging from single-cell protozoa like Trypanosoma brucei and Trypanosoma cruzi, to complex multicellular helminths (worms) like Schistosoma and Brugia. Over 30 companies have shared compound libraries with the Center. The Center includes expertise in structure-based drug design, encompassing both computational approaches and structure-guided medicinal chemistry, and maintains animal models of NTDs for proof of concept studies. Among its accomplishments, the Center discovered and developed a drug for Chagas’ disease through a successful pre-IND meeting with the FDA. The Center has also received Orphan-Drug Designation from the FDA for two drugs targeting NTDs in a “repurposing” screening campaign. Click HERE for his background.