An experimental medicine from Dendreon Corp improved survival in men with advanced forms of prostate cancer, the company said on Tuesday, bolstering chances of it becoming the first approved therapeutic vaccine for any type of cancer.
Shares of Dendreon (DNDN.O) more than tripled in heavy morning trading to as high as $22.10 as the study results suggested a revolutionary form of therapy is on the horizon for one of the most common cancers. Unlike traditional vaccines that prevent disease, the company's Provenge medicine treats it.
The Phase III clinical trial met the main study goal of improving survival, prompting Dendreon to say it will seek U.S. regulatory approval of Provenge in the fourth quarter.
"The successful outcome from the Phase 3 IMPACT study provides validation of the long-pursued goal of harnessing the human immune system against a patient's own cancer," Dendreon Chief Executive Mitchell Gold said in a statement.
Prostate cancer is the most common cancer in American men other than skin cancers, according to the American Cancer Society. About one in six men will be diagnosed with prostate cancer during his lifetime.
Paul Latta, an analyst with McAdams Wright Ragen, said Provenge stood to be a $200 million product if it is approved only in the advanced prostate cancer patient group, but could expand to a $1 billion blockbuster if it is expanded to men with earlier stages of the disease.
But Borho, whose New York investment firm owns 2.5 million shares of Dendreon, said Provenge's annual sales could reach several billion dollars.
"Dendreon has delivered the goods for sure, this is very exciting," Borho said.
STUDY RESULTS "UNAMBIGUOUS"
the study included 512 men with late-stage prostate cancer who have not benefited from drugs that sharply lower testosterone -- the male sex hormone that fuels progression of the cancer.
On a conference call with analysts, Gold said the trial's results were "unambiguous" and "robust" but the company deferred giving detailed data until a formal presentation on April 28 at the American Urological Association annual meeting in Chicago.
The Seattle-based company said the safety profile of Provenge appeared to be consistent with prior trials.
It would be the first approved cancer immunotherapy, meaning a drug to fight cancer by stimulating the immune system to attack cancer cells.
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