Patrick C. Kung, Ph.D.

President and CEO

PhytoCeutica, Inc. 5 Science Park, New Haven, CT 06511

 

Dr. Patrick C. Kung is the president and CEO of PhytoCeutica, Inc. Dr. Patrick C. Kung was a founder and Vice Chairman who took T Cell Sciences, Inc., public two years after its establishment; it is the predecessor of Avant Immunotherapies, Inc.; NASDAQ Symbol: AVAN. He served as Vice President of Research at Centocor, which was acquired by J & J for US$4.9 billion in 1999. He is the recipient of the 1991 Discoverers Award from PRMA for the first FDA approval of a monoclonal antibody, Orthoclone OKT3™ (Dr. Fu Kuen Lin, the Epogen’s discoverer got the same Award in 1994). Dr. Kung has brought numerous drug candidates from discovery to advanced stages of clinical trials and possesses extensive experience in raising start-up funds. He is also the co-inventor of CD4 typing for HIV patients. During his career, he negotiated over US$75 million deals with pharmaceutical companies in the US, Europe, Japan and the Greater China, including Syntex/Roche, Pfizer, SKB, Astra/Zeneca, Sun Ten Pharmaceutical, Ltd. and Yamanouchi. He has served on the boards of several companies, and is currently a Director of Ontogen Corp. in San Diego. Dr. Kung has been active in community services, serving as trustees in a secondary school, a community bank, and as President of the Division of BioPharmaceutical Sciences of Society of Chinese Bioscientists in America with over 2500 professionals. He received his Ph.D. from University of California, Berkeley and pursued a postdoctoral fellowship at M.I.T with Professor David Baltimore, a 1976 Nobel Laureate in Medicine.

 

Abstract:

Therapeutic treatment of cancers remains largely unmet. Many cancer patients are still using botanical products, which have not been supported by evidence of efficacy or safety. In contrast, there are over a dozen of botanical drugs, as defined by the FDA, are being developed for cancer therapy in developed countries. These botanical drugs are being tested in robust clinical trials as anti-tumor or adjuvant therapy in cancer. They may work in combination with chemotherapy or without.

When would the first botanical drug get approved by the FDA for cancer therapy? Although no one could predict the date, one may speculate what would be required for it to happen. To this end, we venture that A) foremost, the botanical drug should solve an urgent and unmet need; B) a developer can meet the ever-tightening quality control requirements and demonstrate the efficacy and safety of the botanical drug. Additionally, some insight into the mechanism of actions of the drug would be very helpful for gaining the approval.

During this presentation, we shall offer some examples to illustrate scientific approaches to develop a botanical drug for cancer therapy in terms of quality control, clinical trial design and theoretical considerations. The botanical drugs cited in the examples are aimed to ameliorate a life threatening toxicity of a chemotherapeutical agent or to increase the survival rate of patients with hepatocellular carcinoma. To this date, no therapies are available for either of these serious medical conditions.