30 May, 2008 - TAIPEI, Taiwan / New drug development company PhytoHealth Corp. (4108.TW) announced this week that it had begun a Phase II clinical trial in Taipei, Taiwan of its osteoporosis prevention drug candidate PHN031 for postmenopausal and osteopenic women, after recently receiving US FDA Investigational New Drug (IND) approval. 
 
The drug candidate PHN031 was developed from an extract of Rhizoma Dioscoreae, a variant strain of yam which was originally grown in the mountain area of Taiwan and used safely as food or for medicinal purposes in this country for several centuries.  
 
Being derived from botanical sources and with an established historical record of safe use, the new drug candidate is not requested to undertake usual Phase I clinical trials and may go straight to Phase II, according to FDA regulations. Approval was granted on October 10th of 2007. The clinical trial is being conducted in Taipei's Veteran's General Hospital, and 100 patients in total are enrolled. The duration of the study will be approximately nine months, with the study being completed by the end of this year. 
 
PhytoHealth's pharmacology studies on PHN031 showed anti-osteoporotic activity in animal models. Animal toxicology studies also indicated that PHN031 is well tolerated. Based on the toxicology studies carried out by PhytoHealth showing no toxic effects to date, and also the wild yam's long history of safe use as both food and traditional medicine, serious adverse reactions are not anticipated during PHN031's ongoing clinical trials. 
 
With osteoporosis resulting from an imbalance between two physiological processes--bone resorption by osteoclasts and bone formation by osteoblasts--PHN031 in pre-clinical studies induced osteoblastic bone formation by promoting osteoblastic progenitor cell proliferation and differentiation, as well as osteoblastic cell maturation and accelerating mineralization.  
 
With aging, the composition of bone marrow shifts to favor the presence of adipocytes, the increase in osteoclast activity, and the decline in osteoblast function, resulting in osteoporosis. In view of PHN031's novel mechanism of action in promoting bone formation that could compensate for or replenish accelerated postmenopausal bone loss, it has the potential to prevent as well as to treat osteoporosis.  
 
President of PhytoHealth, Dr. T.S. Jiang, hailed the start of this clinical trial as an important milestone for the company. "With PHN031 yielding such good pre-clinical safety and efficacy data to date, we expect that the Phase II clinical trial will be successful and confirm that we're well on the way to developing a safe and effective product not only treats but also prevents osteoporosis in women," remarked Jiang.  
 
The company plans to out-license the drug candidate while concurrently developing a health food product around the technology, while assessing the market acceptance of such a product and refining its commercialization strategy.

About osteoporosis 
Osteoporosis is a systematic skeletal disorder characterized by low bone mass and micro-architectural deterioration of bone tissue, with a consequential increase in bone fragility and susceptibility to fracture. Osteoporotic fractures cause substantial clinical and economic burden for society. According to the National Osteoporosis Foundation in the United States, there are 10 million people affected by osteoporosis and 34 million at risk of osteopenia. A predicted global increase in the elder population will result in a substantial increase in the prevalence of osteoporosis.  
 
Several chemical entities have been approved for the treatment of postmenopausal osteoporosis. These products include bisphosphonates with daily to monthly dosing formulations, selective estrogen receptor modulators, teriparatide, and strontium ranelate. Studies with these products demonstrated that the relative reduction of fracture risk does not differ between women with different levels of baseline risk of future fractures. Therefore, there is no rationale to make any distinction in the indication between treatment and prevention or between osteoporosis and established osteoporosis.  
 
As such, there is a great demand for new oestoporosis drugs, and the market size for such drugs has been estimated at over US$7.2 billion. (Source: "Osteoporosis: market driven by pipeline products," Datamonitor, 6 July 2007.)

About PhytoHealth Corp. 
Founded in 1998, PhytoHealth Corp. is a Taipei, Taiwan-based biotech company focusing on new drug development. PhytoHealth is developing new drugs for a range of therapeutic areas, including adjuvants for cancer and vaccine administration, cough treatment, osteoporosis, the complication of diabetes mellitus, motion sickness, hepatitis C, and pain control. Out of eight new drugs in development, seven are already undergoing clinical trials. The company is also developing seven generic / modified release dosage forms in the cardiovascular, neurological and infectious disease therapeutic sectors.  
 
PhytoHealth is a publicly-listed company, trading on Taiwan's OTC stock exchange (4108.TW), with its IPO on May 13, 2004. Its headquarters are located in Taipei and its research center is in the Nankang Biotechnology Plaza, east of Taipei city. The company is a member of MayWuFa Biopharm Group (1731.TW), ranked Taiwan's number one biopharmaceutical group by Business Weekly magazine in Taiwan. For more details, please visit the company website at www.phytohealth.com.tw.

Media contact: 
Jennifer Sung
Specialist / Pharmacist 
Business Development 
PhytoHealth Corporation 
5F 167 Fu Hsing N. Rd., Taipei 105, Taiwan 
Tel: +886-2-25453697 ext. 337  
Fax: +886-2-25140245 
jennifersung@phytohealth.com.tw
www.phytohealth.com.tw