A genetically modified version of herpes simplex virus type 1, the same virus that causes cold sores, shrank tumors of the deadly skin cancer melanoma in a clinical trial, according to Amgen, which is developing the experimental cancer treatment.
Patients in the trial were in the late stages of the disease, and were either being treated with a drug called GM-CSF or the new virus. Sixteen percent of the patients in the group that got the virus, known as talimogene laherparepvec, saw their tumors shrink completely or partially for at least six months. That compares to two percent of the control group. There was a trend toward the virus helping patients live longer, but the difference is not yet statistically significant. Amgen says that it may become so later this year, and those results are likely to be far more important in determining the future of the treatment.
Amgen purchased the company that developed the virus, Biovex, in 2011 for $425 million in cash and a commitment to pay up to $575 million if Biovex’s medicines hit certain milestones. If the Biovex anti-cancer virus is indeed a potent cancer fighter, it could help get investors excited about Amgen. It might also benefit Merck, because Amgen’s former research chief, Roger Perlmutter, has just agreed to take over running the research labs there, and this might reflect on his ability to make smart acquisitions.
In an interview in 2011, Perlmutter praised the Biovex researcher who had developed the virus. “Robert Coffin has done a really good job of developing this particular oncolytic virus,” he said. He told me that “you can’t doubt that the administration of the virus is having an effect” — I was skeptical — and promised “we kicked the tires on this very hard.”
Below is an excerpt from Amgen’s press release. Click the link to read the rest.
THOUSAND OAKS, Calif., March 19, 2013 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced top-line results from the Phase 3 trial in melanoma, which evaluated the efficacy and safety of talimogene laherparepvec for the treatment of unresected stage IIIB, IIIC or IV melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF).
The study met its primary endpoint of durable response rate (DRR), defined as the rate of complete or partial response lasting continuously for at least six months. A statistically significant difference was observed in DRR: 16 percent in the talimogene laherparepvec arm versus two percent in the GM-CSF arm. The analysis of overall survival (OS), a key secondary endpoint of the study, is event driven. A pre-planned interim analysis conducted with the analysis of DRR has shown an OS trend in favor of talimogene laherparepvec as compared to GM-CSF. The OS data is expected to mature in late 2013 in line with previous guidance.
“These are the first Phase 3 results of this novel approach to cancer therapy,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “A high unmet need exists in melanoma and we believe the innovative mechanism of action of talimogene laherparepvec may offer a promising approach for these patients.”
Source Article from http://www.forbes.com/sites/matthewherper/2013/03/19/modified-cold-sore-virus-shrinks-melanoma-tumors-amgen-says/
Modified Cold Sore Virus Shrinks Melanoma Tumors – Forbes
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