CK Life, Swinburne team to trial ancient remedy as potential AIDS vaccine

CK Life Sciences, the biotech child of Asian business tycoon Li Ka Shing, will this month start an Australian trial of an AIDS vaccine drawn from ancient Chinese herbal remedies after inking a $600,000 deal with the Swinburne University Graduate School of Integrative Medicine last December.

Swinburne will conduct an extensive 12-24 month study to determine the efficacy of a Chinese herbal/yeast liquid preparation called CKBM-AO1 in raising the count of CD4 cells in AIDS patients.

CD4 -- or CD4+ T-lymphocytes -- cells belong to the group of T-cells comprising the human immune system. Because of the way they are structured, CD4 cells are especially vulnerable to the AIDS virus which eventually destroys victims' resilience to other diseases. People with under 200 cells/ul are classified as having AIDS.

CKBM-A01 will also be evaluated as a means of decreasing the HIV viral load in the plasma of HIV patients with intermediate immune deficiency, or CD4 cell counts between 200-500 ul, as well as advanced immune deficiency, or CD4 cell counts between 100-200 ul. Victoria's Macfarlane Burnet Research Institute will also assist in the testing and monitoring process.

Ginseng, wuweizu (Shisandra chinensis), jujube, hawthorn, soybean, and baker's yeast (saccharomyces cerevicae), all ingredients in the CKBM-A01 preparation, have been integral to traditional Chinese medicine for thousands of years.

CKLS said that in a recent trial of CKBM-AO1 among 200, mostly late-stage AIDS patients at Peking Union Medical College Hospital and Beijing You An Hospital last year CD4 cell counts had been shown to improve.

Buoyed by these results, CKLS announced late last year the formation of a dedicated AIDS research group to which it has committed an initial $HK370 million ($AUD78.2 million).

Luis Vitetta, director of the Swinburne University Graduate School of Integrative Medicine, said that a positive result for CKBM-A01 in Australia would be a catalyst for improved life expectancy amongst AIDS sufferers in the third world where the current highly active antiretroviral therapy (HAART) for HIV infected patients is not widely affordable.

"We have investigated the scientific literature of herbal materials employed in CK's product and determined that there is certainly potential for this product to do what it says it will," he said.

Recent data from the World Health Organisationand other sources estimates that as many as 20 million people have died of the disease with a further 40 million believed to be infected. Alarmingly high rates of infection in China has led to predictions that its epidemic will soon surpass even Africa's.

The stakes for finding a cure are very high, with the likes of Merck & Co, GlaxoSmithKline and Aventis Pasteur, as well as countless universities and Researchers, all in the hunt.

"HIV patients are a special group of people," Vitetta said. "The virus almost has a brain of its own; it's a retrovirus and can therefore escape detection."

The New York Times recently quoted Dr Tom Coates, director of the AIDS Research Institute at the University of California-San Francisco as saying: "Given the history of this field, I wouldn't place my money on anything -- it's a really difficult virus to stop."

Investors were far from forgiving of the disappointing data that emerged last month from Nasdaq-listed biotech VaxGen after the company conducted the biggest AIDS trial to date, for its AIDSVAX vaccine. Aside from suggesting some differences between racial groups, the data contributed little to the cause. On the day the data was released VaxGen stock fell $US6.16, or 47 per cent, to close at $US6.86 having fallen to as low as $US3. This for a stock that traded as high as $US23.25 last year.

Observers are eagerly awaiting the results of another big trial currently underway in Thailand, studying a possible treatment for IV drug users. For the Australian trial Swinburne will conduct an extensive analysis of CKBM-A01 over the next 12-24 months, examining such factors as its impact on quality of life as well as specific effects on the immune system. CKLS is hoping that a positive outcome will give further weight to the Chinese trial results and assist commercialisation of the treatment further down the track.

"CK came here to get credibility for their product," Vitetta said. "They had a small trial in China but they knew they needed to conduct a rigorous trial run if they were to get anywhere; they didn't come here to buy a result."

CKLS currently has a patent pending for CKBM-A01 in the US, where, Vitetta added, the group would have forked out five times as much to gain an independent evaluation of its treatment by a similar facility.

Swinburne's School of Integrative Medicine is seen as one of the world's most eminent centres for medical testing and evaluation, and was chosen by CKLS after an extensive evaluation of similar institutes throughout the US and Europe, a spokeswoman for the company said.

CKLS was spun off from its Hong Kong parent, property behemoth Cheong Kong Holdings, in an IPO in May last year, later going public on Hong Kong's Growth Enterprise Market (GEM), an adjunct to the Hong Kong Stock exchange set up in 1999 to facilitate the public listing of new economy companies and requiring relatively lax reporting standards.

Despite never turning a profit, CKLS is capitalised at around $2 billion and is the largest company on the GEM comprising around 16 per cent.

Local financial analysts have identified Australia's local scientific talent and highly respected research and testing standards as compelling reasons for Li Ka Shing to throw his anchor at Australia with many holding the view that the mere presence of CKLS would significantly raise the international profile of the local sector.

Last year senior Victorian state government officials met with CK executives in Beijing, where they are believed to have discussed provisions for the company setting up operations in Australia.

CK later confirmed to Australian Biotechnology News that CK executives had also met with Queensland Premier Peter Beattie in Brisbane, but would not comment on whether it was awaiting the outcome of a bidding war for tax breaks between the states before making any decisions.

Officials representing CK Life and the Victorian state government both declined to discuss details of negotiations.