Has anyone read about this trial?

[Guest guest]

This was in the Sunday Herald Sun (, Australia) yesterday.

HOPE ON LEUKEMIA

Test with new drug Impress

A n biotech company has developed a new drug for chronic myeloid

leukemia - a discovery that offers hope of a cure for the blood cancer.

ChemGenex Pharmaceuticals chief executive Dr Greg Collier said the drug,

omacetaxine, offered significant potential because it killed the stem cells

that caused chronic myeloid leukemia (CML).

Dr Collier said 80% of patients on the clinical trials conducted in

Australia, the US and Europe, no longer had cancer in the blood and one in

five no longer had cancer in the bone marrow.

International clinical trials confirm omacetaxine significantly increases

the survival rates of patients.

The drug may be available within months.

" This is excising because it targets those patients who have no other

option, " Dr Collier said.

ChemGenex said the drug was in final clinical trials and the company was

hopeful of approval by the US regulators the Food and Drug Administration

early next year.

The FDA has granted fast track status to omacetaxine because the drug is the

only treatment available to CML patients with a specific gene mutation.

CML is cancer of the blood cells. The bone marrow of patients with the

disease is replaced with malignant leukemia cells.

Three drugs are available to treat the disease, including Glivec, which has

been available in Australia since 2000.

Patients with the gene mutation T315I do not respond to existing treatments.

Omacetaxine targets those patients.

Prof Tony Schwarer at The Alfred is about to start two new clinical trials

as part of the global development plan of the drug, which he said fulfilled

a niche market for CML patients not responding to other drugs.

" There would be about 100 patients in Australia in this category, " Prof

Schwarer said.

He is recruiting for his two trials and said CML patients who had the gene

mutation or who were resistant to other therapies should speak to their

haematologists and then contact his office on 9899 4060.

" It is too early to say this drug is a cure, but it offers hope and is a

wonderful thing to come out of our local biotech industry, " he said.

Dr Collier said Glivec was a great breakthrough for CML even if it did not

kill residual disease in the bone marrow for some sufferers.

He said developing and securing approval for a new drug was hard, but that

ChemoGenex's progress confirmed local biotech companies could have a major

impact on the world stage.

" This is neither an easy nor an inexpensive process, " Dr Collier Said.

" We have been working towards getting omacetaxine approved for five years at

a cost of about $45 million.

About 400,000 people worldwide have CML.