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    Modified Cold Sore Virus Shrinks Melanoma Tumors, Amgen Says:



    Matthew Herper, Forbes Staff

    I cover science and medicine, and believe this is biology’s century.

    Pharma & Healthcare

    3/19/2013 @ 7:20PM |1,496 views

    Transmission electron micrograph of herpes sim…

    Transmission electron micrograph of herpes simplex virus (Photo credit: Wikipedia)

    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.”

    via Amgen – Media – News Release.


    Melanoma Drug Succeeds in Late-Stage Trial:

    The New York Times:



    March 19, 2013

    A cancer drug based on a tumor-killing virus has for the first time succeeded in a late-stage clinical trial, giving a lift to a technology that has long tantalized doctors and researchers.

    Amgen, which is developing the drug, said late Tuesday that it had met the primary goal of a Phase 3 clinical trial in patients with advanced melanoma, the deadliest type of skin cancer.

    In the trial, 16 percent of the patients who had the treatment, called talimogene laherparepvec, or TVEC, experienced a significant shrinkage of their tumors that lasted at least six months. That compared with only 2 percent of the patients in a control group.

    Amgen said that while people getting TVEC were living longer, it was too early to say definitively whether the drug had improved survival, something that might be known late this year. A company spokeswoman said it was also too early to say if Amgen would file for regulatory approval based on the trial results.

    TVEC is a herpes simplex virus, the type that causes cold sores, that is modified in such a way that it replicates in fast-growing cancer cells but not healthy ones. It also contains an implanted gene for GM-CSF, a protein that stimulates the immune system.

    The drug is injected directly into skin tumors. As the virus replicates inside the cells, those cells produce GM-CSF.

    Eventually the replicating viruses cause the cell to burst, freeing the virus and the GM-CSF in the presence of tumor components. That is supposed to stimulate a systemic immune response that can kill cancer cells throughout the body.

    Amgen’s Phase 3 trial involved more than 400 patients. Two-thirds received TVEC injections directly into the tumors every two weeks. The other third received injections, not directly into the tumors, of GM-CSF.

    Dr. Antoni Ribas, a melanoma specialist at the University of California, Los Angeles, said that while it was encouraging that an oncolytic virus worked, TVEC might not be that successful as a melanoma drug.

    One reason, he said, is that only about one-third of advanced melanoma patients have tumors on or near the skin that can be injected, with others having tumors that have spread to places like the liver or brain.

    He also said the 16 percent durable response rate might not be that high and that the GM-CSF therapy used in the control arm would not typically be used to treat melanoma. Moreover, two significant drugs for melanoma were approved in 2011, raising the bar for a new treatment.

    “It’s a positive result but I’m sure not even Amgen is jumping up and down,” said Dr. Ribas, who has consulted for the company. “The field has changed so much in a short period of time.”

    Amgen obtained TVEC through its 2011 acquisition of Biovex, a privately held company in Woburn, Mass. Amgen agreed to pay $425 million initially and up to $575 million later if certain milestones were met.

    Onyx Pharmaceuticals, one of the first companies to try oncolytic viruses, eventually abandoned its effort in favor of more conventional drugs, though a copycat version of the therapy did win approval in China.

    Other companies pursuing such treatments include Oncolytics Biotech, Jennerex Biotherapeutics and Genelux.

    Catherine Poole

    I think what Dr. Ribas says is important. This looks like a viable treatment for those who have tumors you can inject. It will be interesting to see further results. Thanks for posting.

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