Botanic Century's innovative drug development strategy is to explore the ancient traditional medicine for solutions for modern clinical difficulties, where there is no drug available or an existing drug has unacceptable side effects. With regard to the Chinese market, Botanic Century will independently apply for product licenses from the Chinese SFDA, at the same time, seeking alliances with international pharmaceutical companies to develop the international market or in-license their products for the Chinese market. Through our research, we have identified a number of drug candidates in the area of POI (Post-Operative Ileus), bacterial infections, diabetes and Hepatitis C. Besides these, our research efforts also concentrated on obesity and anti-oxidation.
TQS for Postoperative Ileus (POI)
POI is a near universal phenomenon after a major surgical process which could be exacerbated by surgical trauma, anesthetic and inflammations. It causes significant discomfort and prolonged hospital stay, consequently, postoperative morbidity. Approved by the FDA in May 2008 in the U.S., Alvimopan became the only commercially available drug for management of POI. As a μ opioid receptor agonist developed by GlaxoSmithKline and Adolor, Alvimopan was designed to block the negative effects of opioids on the gastrointestinal (GI) motility.
TQS is a highly purified single plant fraction that has shown a gastrointestinal (GI) motility promoting effect in preclinical studies. Although the mechanism of TQS is not clear, it appears to differ from that of alvimopan.
A clinical trial license on TQS for POI has been granted by China SFDA in April 2009. A double –blinded, randomized, parallel-dosed and multi-centered phase IIa clinical trial is planed to be finished by the first quarter of 2010. This product is expected to launch into Chinese market in 2012. A conservative estimate for the POI market in China is 120 billion Ren Min Bi per year.
BCL-6 for antibiotic resistant bacteria
Antibiotic resistant bacteria are an increasingly important public health concern. Due to the emergence of antibiotic resistant pathogens, many diseases have become more and more difficult to treat. Treating these infections often requires the use of more expensive or more toxic drugs and can result in longer hospital stays. With the sharp increase of so-called "super-bugs" such as MRSA in hospitals, there is a major need for new anti-bacterial treatments.
BCL-6 is a group of similar compounds isolated from a single TCM plant, that have been found in pre-clinical screening assays to have activity against major classes of infectious bacteria, such as MRSA that have acquired resistance to current front-line antibiotics.. Against other test organisms, BCL-6 has shown activity and it may therefore have potential as a botanic drug for skin infections or as an add-on therapy for antibiotic resistant bacterial infections.
Botanic Century has signed an agreement with Phynova PLC group for the co-development of BCL-6. Botanic Century will retain rights for China, while Phynova has rights for the rest of the world.
PYN18 for hepatitis C virus (HCV)
According to the WHO, HCV is comparable to a'' viral time bomb'' . The WHO estimates that about 200 million people are infected with HCV with a global 170 million chronic suffers at risk of developing liver cirrhosis and/or liver cancer which are the primary reasons for liver transplants. Only a minority of patients receive a long-term benefit from the treatments currently available. Many drop out or decline the treatment because of side effects. The unmet medical need remains very high and the market potential for a new effective treatment is substantial.
PYN18 is a single plant extract that has shown anti-viral activity against HCV in pre-clinical tests. Phynova recently screened several different fractions of this extract and found that one in particular showed very distinct activity against the hepatitis C virus in a surrogate viral replicon assay. In the assay, interferon alpha, which in combination with ribavirin is the current recommended treatment for HCV, was used as a control. PYN18 showed activity comparable to interferon in the assay.
Initially, Botanic Century worked as a contract research organization with Phynova for Manufacturing and Control (CMC) study of PYN18, but both company entered an agreement for co-development of this drug candidate last year. Under the agreement, BCCL will be responsible for the development and commercialization of PYN18 inside China.
BCL-5 for type II diabetes
Diabetes is the sixth leading cause of death listed on death certificates in the United States. People with diabetes have heart disease and stroke death rates about 2-4 times higher than adults without diabetes. Diabetes is also the leading cause of blindness, kidney disease, nerveous system disease, amputations and dental disease. There are about 21 million people in the United States and 45million people in China with diabetes. The total annual economic cost of diabetes in 2002 was estimated to be $132 billion in the US.
BCL-5 is a single plant extract that was first discovered as a glycosidase inhibitor in an in-vitro assay, then showed activity to increase glucose tolerance in preclinical tests. As a complex of many different chemicals, it is hoped it will have a comprehensive treatment effect on the diabetic patient. BCL-5 is undergoing further preclinical development at this time.
|
