Sagittarius looking for licensing partners as bone fracture and osteoporosis prevention and treatment candidate SO101C passes Phase II trials

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Applied Clinical Trials

The Taipei, Taiwan-headquartered biotechnology and pharmaceutical company is now looking for international licensing partners to take the herbal-based product on to further clinical trials and subsequent commercialization.

TAIPEI, Taiwan – 16 August, 2005 – Bone fracture and osteoporosis prevention and treatment composition SO101C, discovered and developed by Sagittarius Life Science Corp., recently completed Phase II clinical trials, the company announced today. The Taipei, Taiwan-headquartered biotechnology and pharmaceutical company is now looking for international licensing partners to take the herbal-based product on to further clinical trials and subsequent commercialization.

Osteoporosis is a medical condition characterized by a loss of bone mass that occurs over time, leading to an increased risk of bone fractures, such as highly-debilitating hip joint fractures. According to the US National Osteoporosis Foundation, the disease strikes one out of every two women and one in four men over 50 in the US, and causes one fracture every 20 seconds nationwide. Worldwide, an estimated 200 million women and men suffer from osteoporosis, with 80 percent being women and 20 percent men.

With SO101C, Sagittarius has a composition designed to address these frightening statistics by strengthening bones and tempering the pain and dysfunction associated with aging and osteoporosis.

With Sagittarius having already filed a PTC patent for the product in 52 countries, including Taiwan, the US, Japan, Germany and mainland China, the company is now looking for R&D partners willing to take the product through to commercialization under a license agreement.

The recently completed Phase II clinical trial at China Medical University Hospital, in Taichung, central Taiwan, consisted of a three-month, double-blinded, randomized study of 67 postmenopausal women. Results from the government-sponsored trial indicated that SO101C increased bone mass density in the lumbar spine (3.55 percent) and femoral neck areas (5.36 percent) of these women. Furthermore, the bone resorption marker, serum NTx, increased at 6 weeks (11.92 percent up from baseline) and dropping back slightly after 12 weeks (7.92 percent up from baseline), while the bone formation marker, serum bone specific alkaline phosphatase, remained at the level of baseline at 6 weeks with an increased at 12 weeks (2.38 percent up from baseline). This suggests that SO101C behaves as a bone remodeling cycle modulator with an "activation of osteoclast to remove microlesion, then depression of osteoclast, and then activation of osteoblast to fill the excavation" modality.


"We believe–and these research results now indicate–that SO101C has great potential to be developed into an anti-ageing agent for the prevention and treatment of bone fractures and osteoporosis," commented Dr. S.Y. Liu, chief scientist and head of R&D at Sagittarius, and the one responsible for the composition's development.

"We are confident that further development of the composition will result in a highly-successful end product, a win-win situation benefiting any potential licensee," said Liu. SO101C had the added benefit of being a 100-percent natural product, as it was derived from GAP grown herbal material, she added.

In earlier in-vitro assay and animal studies conducted by Sagittarius, it was demonstrated that SO101C stimulated the proliferation and differentiation of rat osteoblasts. In ovariectomized rats, high turnover rates of bone metabolism were returned to normal levels as assessed by histomorphometry, and BMD and bone mechanical strength were also increased to normal levels after 70 days' treatment with SO101C. In a rabbit bone fracture study, SO101C facilitated the healing rate of the fracture significantly.

SO101C has been available in the US for the last two years as the branded herbal supplement Young Bones™, distributed and marketed by Sagittarius' US subsidiary Natural Bio Care. Research conducted in February 2004 in the US by renowned bone health specialist Dr. Susan Brown, through her non-profit research and educational organization Osteoporosis Education Project (OEP), suggested that taking the all-natural herbal supplement may strengthen the functions of the kidneys, spleen and pancreas and assist in bone mass generation, which together helped to combat osteoporosis and other bone diseases. Results suggested that the compound may build bone mineral density (BMD), and reduce the pain and dysfunction associated with osteoporosis. In the time that Young Bones™ has been on the market, it has shown to be a safe and popular osteoporosis-prevention product.

About Sagittarius Life Science Corp.

Sagittarius Life Science Corporation is a Taiwan-based biotechnology and pharmaceutical company whose mission is to develop Chinese herbal formulas that are effective, unique, safe and affordable. By addressing a variety of degenerative diseases and by combining state-of-the-art Western technology with the wisdom and knowledge of Traditional Chinese Medicine (TCM), we formulate remedies that can contribute to and make a positive difference in the health care of society at large. The company's key products include the anti-osteoporosis agent SO101C; the anti-angiogenesis agent ST104P; the immune booster ST188L; the transdermal patch for Alzheimers' disease SA201D; and the wound healing and skin care agent SS102T.