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Press Release from Solbec

Anti-Cancer Drug Boost to the Immune System

Summary

  • University studies find SBP002 drug kills Mesothelioma tumours AND positively activates immune system
  • University studies meet three main criteria for immunological activity
  • The toxicity of SBP002 on the immune system was minimal when compared to other drugs used in combinational immunotherapy for the EFFECTIVE treatment of Mesothelioma.

Research studies have found that in the future, the deadly asbestos-related cancer, Mesothelioma, may be treated with an Australian drug that not only destroys existing tumours but has the ability to boost immunity against the disease.

The drug, SBP002, derived from a native weed called Devil’s Apple, is the lead compound of Perth based Biotechnology Company, Solbec Pharmaceuticals Ltd. Developments in the last week have been particularly promising.

Most recent studies undertaken by the University of Western Australia, Department of Medicine, Tumour Immunology Group have confirmed that SBP002 is able to positively activate the immune system.

The researchers, under the supervision of Professor Bruce Robinson and Dr Richard Lake have demonstrated that Solbec’s lead compound, SBP002, satisfies the three main criteria for immunological activity.

They have shown that

  • SBP002 effectively destroys mesothelioma tumour tissues in animals;
  • The killing of mesothelioma tissue by SBP002 actually increases the quantity of tumour antigens in the lymph nodes that drain the tumour. These antigens induce a positive immune response.
  • Most importantly, unlike most other cancer treatments, SBP002 does not destroy lymphocytes. Lymphocytes recognize the antigens and play a pivotal role in the immune response.

The researchers have reported “that the effect of SBP002 on the lymph organs (where lymphocytes are found) was minimal when compared to other chemotherapy regimes which have been used in combination with immunotherapy for the effective treatment of mesothelioma.”

“The fact that the three criteria occur together, makes this is a very exciting milestone,” said Solbec Managing Director, Stephen Carter. “We had some informal evidence that this was the case based on feedback from patients taking the drug under the Australian Special Access Scheme.”

“Now we have confirmation and can move on to further trials. While there is still more work to be done, the researchers are continuing to develop new methods of combinational therapy to maximize the immunological effect of SBP002.”

Mesothelioma is an extremely potent form of cancer that usually results in the patient’s death within 12-18 months of diagnosis. Current therapies are ineffective and are able to extend the patients life by only a few months. In Australia alone it is forecast that up to 60,000 people will succumb to the disease by the time it peaks in 2020. The figures in Europe and the USA are generally higher.

The low incidence of mesothelioma qualifies SBP002 for application for Orphan Drug Status administered by the Food and Drug Authority in the USA and Solbec is aggressively following this path. The work at the University of WA was partially funded by a Biotechnology Innovation Fund Grant from the Australian Government. SBP002 is also currently in Phase I clinical trials at Sir Charles Gairdner Hospital in WA to assess the safety of SBP002 for the treatment of advanced cancers, in particular mesothelioma and melanoma.

For further information contact: Stephen Carter Chief Executive Solbec Pharmaceuticals Ltd Phone +61 (0) 8 944 67555 Mobile + 61 (0) 412 154029 Hilarie Dunn Media Relations for Solbec Pharmaceuticals Ltd Phone +61 2 99093078 Mobile +61 414 357792

Background Information

Solbec Pharmaceuticals Ltd is listed on Australian Stock Exchange (code SBP).

Its lead compound is SBP002, a combination of two glycoalkaloids isolated from the fruit of Solanum linnaeanum, a weed more commonly know as Devil’s Apple. Currently the drug has completed its pre-clinical phase of trials as an anti cancer treatment. Human Phase 1 clinical trials are under way at Sir Charles Gairdner Hospital in WA in advanced cancer patients.

Solbec is focusing SBP002 research on treatment of mesothelioma and malignant melanoma which qualifies the drug for application for the fast track Orphan Drug Program in the USA. Under the Therapeutic Good Administration’s Special Access Scheme (SAS) in Australia, SBP002 has been administered to a number of cancer patients with encouraging results. These have included: increased well-being, tumour size reduction, reduced tumour growth rates, extended expected life span, and tumour eradication In previous studies carried out by the University of Western Australia, it was observed that SBP002-treated cells reduced the production of interlukin 6 (IL-6) when compared to the control and to cells treated with the anti-cancer drugs Gemcitabine and Docetaxol. IL-6 is known to be one of the chemicals produced by the body during disease that makes people feel unwell. IL-6 is also known to be involved in cancer cell proliferation. As well as a range of cancers, SBP002 may be useful for treating a range of IL-6 related diseases. These include inflammatory diseases such as rheumatoid arthritis, psoriasis and psoriasitic arthritis; microbial diseases such as HIV, chronic fatigue syndrome and malaria; heart disease such as cardiac myopathy; and other diseases such as Alzheimer’s disease, arteriosclerosis, thyroiditis and Castleman’s disease.

Solbec has lodged patents to cover this exciting aspect of the drug’s activity. Solbec is scheduled to commence Phase I Clinical trials for the treatment of Psoriasis in the third quarter 2004. Solbec has received an Australian Government grant of $196,000 through the AusIndustry Biotechnology Innovation Fund to carry out further research on SBP002. This research looked at the ability of SBP002 to boost the immune system.


 

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