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December 11, 1997

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Indian stumbles upon 'smart bombs' to cure cancer

US-based non-resident Indian Dr Raj Puri injected mice with an experimental 'smart bomb' for cancer and watched as huge tumours disappeared from their bodies within a few weeks.

Dr Puri discovered the potential cancer therapy in a tiny, little-known laboratory at the Food and Drug Administration at Bethesda. The US government has now given his invention to an Illinois biotechnology company that hopes to begin testing it in people with killer brain tumours and kidney cancer late next year.

The saga is unusual because the FDA is supposed to regulate drugs, not invent them. If this Interleukin-13 therapy ultimately works in people, Neopharm Inc will need FDA permission to sell it. And it comes at a time when the FDA's biotechnology laboratories are threatened by budget cuts.

Should they be discovering drugs? ''I don't think that's their job,'' said Alan Goldhammer of the Biotechnology Industry Organisation, one of the several trade groups that successfully pushed a legislation to block the FDA from using $ 10 million a year in industry fees to fund the labs.

Dr Puri's discovery was a surprise. He had run out of the immune system cells needed for an experiment and out of curiosity stuck breast cancer cells under the microscope instead.

Covering them were receptors for an immune substance called Interleukin-13. Amazed, he analysed brain tumours, kidney tumours and the AIDS-related Kaposi's Sarcoma and the solid tumours had large clusters of these magnet-like receptors, while healthy cells had very few.

Interleukin-13 travels straight to the receptors and latches on. Dr Puri essentially discovered a potential-guided missile: attach a cancer-killing drug to Interleukin-13 and the substance should carry the chemotherapy straight inside the tumour.

A series of studies published in distinguished medical journals showed it works in test tubes. Then Dr Puri tried treating sick mice. His eyes widened with excitement as he displayed for a reporter autopsy photos that show untreated mice covered in bloody tumours from Kaposi's Sarcoma next to healthy-looking treated mice.

''We have had tumours that were about 20 per cent of the body weight of the animal to completely disappear,'' he said.

Dr Puri asked long-time cancer researcher Dr Waldemar Debinski of the Pennsylvania State University to develop the tumour toxin, made from bacteria, that is attached to Interleukin-13. Dr Debinski said his separate experiments suggest low doses of the resulting drug can destroy in mice incurable brain tumours called glioblastomas.

Drugs that work in mice don't necessarily work in people.

''Still, it is quite a significant finding,'' said Dr Debinski, who envisions testing people with brain tumours within a year. In addition, Neopharm plans human testing against killer kidney cancer.

If the Interleukin-13 drug ultimately works, it could become the first medicine sold through this project and Dr Puri would get royalties.

Consequently, there's a real 'fire wall' to ensure Dr Puri has no say in the regulation of Neopharm, said Mark Elengold, who oversees Dr Puri's branch of FDA.

''As for discovering a new drug, that was serendipity,'' said Dr Puri, whose main job is helping approve medicines. ''To regulate cutting-edge research, you have to get your hands dirty... when you do that, who knows what you'll find?''

UNI

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