CUHK and CK Life Sciences jointly announce

Press Releases

29 August 2003

The Chinese University and CK Life Sciences jointly announce
the pre-clinical findings of an anti-cancer product

　　A series of in-vitro and in-vivo pre-clinical studies for an anti-cancer product developed by CK Life Sciences Int'l., (Holdings) Inc. ("CK Life Sciences") were conducted by the Biochemistry Department of The Chinese University of Hong Kong ("Biochemistry Department of CUHK"). Results demonstrate that the immune cells in mice will be activated and the human liver cancer cells in mice can be suppressed after the mice have been fed the product.

The pre-clinical findings have prompted the two parties to carry the research one step forward, and conduct clinical trials with the product.

The leader of the pre-clinical studies, Fung Kwok Pui, Professor of Biochemistry of CUHK, said, "CUHK is a great supporter of technology research and our Biochemistry Department is committed to excellence in both research and teaching. We are pleased that commercial entities like CK Life Sciences are devoted to developing new biotechnological medical products. We at CUHK will continue to evaluate such products to ensure better treatment for patients, and to contribute to the development of the biotechnology industry in Hong Kong."

"This trial collaboration with CK Life Sciences is a good example of cooperation between academic and commercial entities. It leverages on the rich resources of commercial corporation as well as the strong research capabilities of academic institutions. Not only would such cooperation speed up the pace of research, but also help to gain wider recognition for the study results," continued Professor Fung.

Hypothesis of CK Life Sciences' Anti-cancer products
According to Professor S F Pang, Vice President and Chief Technology Officer of CK Life Sciences, the Group's anti-cancer products are made up of natural ingredients, and do not have any side effects. These products fight against cancer cells in three different ways: 1) increase the activity of cancer suppressing substance which induce programmed cell death; 2) increase TNF-alpha secretion, leading to cell death; and 3) enhance the human immune system to combat cancer cells."

Three Distinctive Product Features
As pointed out by Prof Pang, CK Life Sciences' anti-cancer products have been developed based on the Group's proprietary yeast-based technology. Preliminary studies suggested the products have three distinctive features:

1. Improve immune system of cancer patients to combat the disease, reduce mortality rate, and promote recovery from chemotherapy and radiotherapy.

2. Not only do these products not produce side effects, they can lessen common side effects caused by chemotherapy and radiotherapy, such as nausea, alopecia, bleeding, edema and deterioration of immune system, resulting in better quality of life for the patients.

3. As the products are oral prescription, complications and pain arising from surgery and injection procedures can be avoided. Hospital stays can be reduced and medical costs decreased.

Results of Pre-clinical Studies Conducted by the Biochemistry Department, CUHK
Three sets of trials were conducted by the Biochemistry Department of CUHK to test the efficacy of CK Life Sciences' anti-cancer product in activating cytokine secreting cells and suppressing cancer cells. [Cytokines are small biological factors (in the range of 5-20 kD) that are released by cells and have specific regulatory effects on cell functions such as cell proliferation and programmed cell death (apoptosis)]:

1.	Trial Object:	Plasma samples of tumor-bearing mice
	Trial Method:	After feeding the anti-cancer product to the mice for 14 days, blood was drawn, plasma was prepared and cytokine levels were measured.
	Trial Result:	IL-6 in the sample increased 38%
	Remarks:	IL-6 is a cytokine. It is secreted from activated T cells and macrophages. It facilitates the B cells to differentiate into antibody-forming cells.
	Conclusion:	It is indicated that the product induces T cells to secret IL-6 and enhances the function of B cells in tumor-bearing mice.
2.	Trial Object:	Splenocyte culture of tumor-bearing mice
	Trial Method:	After feeding the anti-cancer product to the mice for 14 days, splenocyte were cultured and the secreted cytokines were measured.
	Trial Result:	IL-1β in the sample increased 70% No significant difference for IL-2 in the sample IL-4 in the sample increased 71% IL-6 in the sample increased 70% IFN-g in the sample increased 55%
	Remarks:	- IL-1β is a cytokine. Released by activated macrophage and natural killer cells, it is a potent immuno-modulator which mediates a wide range of immune and inflammatory responses including the activation of B and T cells. - IL-2 is a cytokine. Released by T helper cells, it facilitates T cell proliferation and differentiation, accelerates the growth of B cells, and activates monocyte and natural killer cells. - IL-4 is a cytokine. It is released from T cells and macrophages. It facilitates the B cells differentiation and induces antibody-forming cells. - IFN is a group of proteins, which strengthens anti-virus immune response. IFN have different forms. IFN-g is also known as immune interferon; it is released by lymphocytes.
	Conclusion:	It is indicated that the product can enhance the immune response and modulate the immune system.
3.	Trial Object:	Human hepatoma cells-bearing nude mice
	Trial Method:	Nude mice were fed with the anti-cancer product for 14 or 28 days, tumor volume and weight were measured.
	Trial Result:	14-day Treatment Group At 0.4 ml/day dosage – tumor volume decreased 26%, tumor weight reduced 17% At 0.8 ml/day dosage – tumor volume decreased 54%, tumor weight reduced 29% 28-day Treatment Group At 0.4 ml/day dosage – tumor volume decreased 36%, tumor weight reduced 52% At 0.8 ml/day dosage – tumor volume decreased 65%, tumor weight reduced 84%
	Conclusion:	It is indicated that the product can suppress human tumor growth in mice.

Professor Fung said, "The data from the pre-clinical studies indicates that the anti-cancer product developed by CK Life Sciences has the ability to strengthen the immune system in tumor-bearing mice and suppress the growth of tumors in mice in a time- and dose-dependent manner - an encouraging result indeed."

Product Development Progress
Up to date, a series of successful in-vitro and in-vivo pre-clinical trials have been carried out for the anti-cancer products developed by CK Life Sciences, and 18 anti-cancer product patent applications have been submitted to the US Patent and Trademark Office. In order to accelerate the research and development of its anti-cancer products, CK Life Sciences plans to implement a global trial program which spans six regions in four continents. Preparation for trials in Hong Kong, Mainland China and Australia are already in place, whilst those for trials in the US, Canada, and the UK are underway and are to begin later in the year.

"Following the encouraging pre-clinical trial studies, we plan to conduct a formal clinical trial for this product. Researchers from both CUHK and CK Life Sciences are working intensively on the project currently and we hope the clinical trials will begin this year. Both parties agree that effective cancer treatment products are in great demand as cancer cases are increasing globally. It is a pressing problem and we have to speed up the pace of research. Biotechnology is an effective tool in achieving this purpose," concluded Leung Ping Chung, Professor of Orthopaedics and Traumatology of CUHK.