New Mesothelioma Treatment in Early Clinical Trial Stage

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Australian Researchers Report on New Mesothelioma Drug, SBP002

PERTH, AUSTRALIA — August 6, 2004 — Solbec Pharmaceuticals is developing a new drug, SBP002, to fight mesothelioma. Derived from the fruit of a native Australian weed known as “Devil’s Apple,” SBP002 contains solasodine glycosides, steroid–like compounds with sugar side chains. Early studies suggest that SBP002 can destroy mesothelioma tumors and boost immunity, Solbec reported.

In a study using animals, SBP002 attacked mesothelioma tumor cells. Professor Bruce Robinson and Dr. Richard Lake in the Department of Medicine at the University of Western Australia showed that SBP002 increased the quantity of tumor antigens in the lymph nodes, thereby producing a positive immune response. Unlike many other cancer treatments, SBP002 did not destroy lymphocytes, which are small white blood cells that play a major role in defending the body against disease. Instead, SBP002 may work by unlocking a receptor on the mesothelioma cell, then invading the cell and destroying it.

Solbec was allowed to provide SBP002 to some cancer patients, including those with mesothelioma, under the Therapeutic Good Administration’s Special Access Scheme (SAS), a government program in Australia. Results included reduced tumor sizes and growth rates, the company said.

Phase I clinical trials using SBP002 are now underway at Sir Charles Gairdner Hospital in Perth. In Australia, a Phase I clinical trial involves a small group of volunteers and has the purpose of determining the safety and appropriate dosage of a drug or medicine. So far, SBP002 use resulted in no serious side effects, according to company reports. Researchers are planning a Phase II trial at the hospital. Although still using a small number of patients, the Phase II trial will focus on how effective SBP002 may be as a mesothelioma treatment as well as on whether it is safe. (See Clinical Trials Explained for a summary of the types of clinical trials in Australia).

The Australian government has partly funded the research on SBP002. Solbec will also apply for “orphan drug status” for SBP002 in the United States. The Orphan Drug Program, which is administered by the federal Food and Drug Administration (FDA), promotes the development of products that are useful in the diagnosis or treatment of rare diseases. The “orphan drug status” designation usually allows a drug to be marketed faster, sometimes before a full FDA review. Special funding and tax benefits may also be involved.

Pemetrexed (ALIMTA^®) is the only drug that has ever been given orphan drug status for mesothelioma treatment. The FDA later fully approved the combination of ALIMTA^® plus cisplatin, a standard chemotherapy agent, for the treatment of pleural mesothelioma. For information about ALIMTA^® and other medications, see Chemotherapy. For information about your legal options as a mesothelioma patient, please feel free to contact us at Brayton Purcell. We have been handling cases involving mesothelioma and asbestos exposure for over 20 years and can provide support, information, and excellent advocacy.

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