Synta, Developer of New Class of Cancer Drugs, Eagerly Awaits Results From Key Trial

1/27/09Follow @xconomy

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and he raised $75 million for a buyout in 2002 to start the company.

That got Synta started in its quest to build an independent biotech company. It added all the necessary skills, animal testing, clinical, regulatory affairs, intellectual property, legal, finance and manufacturing. The company went public in 2007. And it settled into a bet on a lead compound, elesclomol.

In multiple lab tests, this drug was found promising because it can boost the amount of free radicals inside cancer cells, without causing harm in healthy cells, Bahcall says. Essentially, cancer cells are thought to be on the verge of having so many free radicals that if pushed a little further, they will self-destruct.

Bahcell uses a handy analogy to explain how this works: “A cancer cell is like a car moving at 150 mph with a needle stuck in the red zone. A normal cell is like a car safely driving at 50 mph and the engine revving in the green zone. Our drug reaches inside there and cranks up the engine even more. If you do that with the cancer cell, you reach inside the engine like that it blows up, stalls out. If the car is safely moving at 50 mph, you crank up the engine you tap on the brake, and you’re fine.”

Synta chose melanoma as its first disease, because it’s one form of cancer that dances really close to the edge of having too many free radicals in cancer cells. But this same principle is thought to be at work in prostate cancer, breast, and ovarian cancer cells as well, Bahcall says.

Results from a mid-stage study of the drug for 81 patients with melanoma were encouraging. It found that patients on a combination of the Synta drug and paclitaxel were able to remain stable without their disease spreading for about twice as long as patients who got the paclitaxel alone (3.7 months, compared with 1.8 months). The results were better for patients who had gotten no prior chemotherapy, than for patients who had relapsed after an earlier round of chemo.

The bigger ongoing trial, called Symmetry, is designed the same way, Bahcall says. It is statistically designed to show that the Synta drug and paclitaxel keeps tumors from spreading for five months, compared with three months in the chemo-only control group, he says.

Investors appear to be in a wait-and-see mode for this trial, as shares fell 9 percent in 2008 (although that’s holding up better than a lot of biotech companies.) If the results are positive, Synta and its partner, GlaxoSmithKline will start gearing up to market the product. Given the history of failure of experimental melanoma drugs from New York-based Pfizer (NYSE: PFE), Princeton, NJ-based Medarex (NASDAQ: MEDX) and Berkeley Heights, NJ-based Genta, anything that reaches its endpoint will generate a lot of attention.

“It’s unlike any drug that’s ever been developed for cancer. When we have positive data, it’s going to be an explosion not only in the treatment of melanoma but also in the science,” Bahcall says. “This opens up a whole new field of science.”

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