The Prague Post Online: News: Cancer drug to get trials in ČR

December 5th, 2008

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Cancer drug to get trials in ČR

Hopes are high for treatment but analysts guard against optimism

By Ondřej Bouda
Staff Writer, The Prague Post
March 26th, 2008 issue

Six Czech hospitals will start testing a promising new treatment for lymph-node cancer and chronic lymphocytic leukemia this year. A quarter of new cancer patients each year in the Czech Republic (a reported 66,000) fall victim to these two types of the disease.

The new drug, developed by local researchers and tested in collaboration with the U.S. pharmaceutics company Gilead Sciences, is a unique medicine codenamed GS 9219. Unlike chemotherapy, this treatment — administered by infusion — does not destroy the whole immune system but targets only the tumor. This could mean quicker and more comfortable treatment without classic side effects such as hair loss and infections, according to a Gilead Sciences press release.

The treatment was first developed in 2005 by Czech scientist Antonín Holý at the Institute of Organic Chemistry and Biochemistry at the Czech Academy of Sciences, and further work was performed at the First Medical Faculty at Charles University in Prague. Gilead helped finish the research and is now applying for permission to start human testing in the Czech Republic, as the treatment was originally a Czech project.

“We are very proud of our achievement so far but lack the cash to complete the whole testing procedure ourselves,” said Zdeněk Havlas, director of the Institute of Organic Chemistry and Biochemistry. “We have worked with Gilead Sciences in the past, trying to cooperate as much as possible on different projects and this is the first time we’re working together on a cancer treatment.” He added that the cost of the project could reach $1 billion (16.2 billion Kč) before GS 9219 becomes commercially available, provided results are satisfactory.

Initial tests on animals in the United States have been very encouraging, with even one infusion producing promising results. Next comes the rigorous process of testing on Czech patients, which will be divided into three rounds starting this summer. During the first, which will require about 400 patients, the right dosage will be determined and side effects will be observed. Trial participants will have to meet several criteria: Apart from having the applicable type of cancer, they must be healthy, have demonstrated an insufficient response to conventional drugs and their life expectancy must be more than six months.

In phase two, the effect of the drug on tumors will be observed, and in phase three the new treatment will be compared with conventional methods. The whole process could take five to eight years and involve more than 2,500 patients, according to Dr. Pavel Klener, who will lead testing at the Institute of Hematology and Blood Transfusions in Prague. “Testing prospective drugs is a long process,” he said. “However, we have high hopes for this one and chose the best hospitals in the country for the trials.”

But Havlas guards against too much optimism.

“I’d like newspapers to be very cautious in reporting about this,” he said. “We don’t want to give false hope to terminally ill patients. Mladá fronta Dnes wrote a misleading article that to me seems highly unethical because it’s toying with vulnerable people. There is still a long way to go. However, initial results have been great and could be promising.”

If the new drug is successful, Havlas concedes, the reputation of Czech cancer research stands to gain a great deal.

Ondřej Bouda can be reached at obouda@praguepost.com

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