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First Re-Engineered Virus to Earn FDA Approval As A Cancer Fighter

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Imlygic, a product of Amgen, was approved by FDA as the first genetically modified oncolytic viral therapy. Imlygic is a modified herpes simplex type 1 virus that replicates within tumors and releases a Protein called granulocyte-macrophage colony-stimulating factor. It's indicated to treat recurrent melanoma following surgery. GM-CSF kills tumors, which results in the spread of tumor-derived antigens that may stimulate the immune system, along with GM-CSF itself. Amgen says interestingly that the precise mechanism of action is unknown, a sure sign that the medicine lies at the frontiers of drug delivery. 

It's a major advance toward “a complete change in the game. For the first time the FDA has given the green light to a new form of cancer treatment—one that researchers hope might someday make chemotherapy, and its adverse side effects, a thing of the past.

As it turns out, the main key to this therapy, is viruses. If we try to go more specific we can say that it key to cancer treatment is the virus Herpes. 

FDA announced its approval of a “genetically modified live oncolytic herpes virus therapy” in which viruses are engineered specifically to hunt and kill the malignant cells associated with the skin cancer melanoma. The treatment—talimogene laherparepvec (“T-VEC”)—will be sold under the brand name Imlygic by BioVex Inc. and its parent company, Amgen. This is reportedly the first instance of a viral cancer treatment’s approval by the agency.

A treatment course with Imlygic consists of a series of injections into the melanoma lesions. After the initial injection, a second dose is administered three weeks later, followed by additional doses every two weeks for at least six months, unless other treatment is required or until there are no remaining injectable lesions to treat.

What makes this particular herpes virus special is its unique genetic engineering, which causes it to infect malignant cells while ostensibly avoiding healthy ones. In other words, it targets cancer, with minimal risk of giving a patient herpes, as we commonly know it (although, the FDA warns, some risk still remains for those with suppressed immune systems, or women who are pregnant). And while the agency does list several other potential side effects, such as fever, chills, and “flu-like symptoms,” these seem mild compared to the draining effect of current cancer treatments.

A published article describes the results of a large round of clinical testing of the procedure. It concludes that using the modified herpes virus did, in fact, shrink tumors and afford patients a marginally longer lifespan. The results weren’t groundbreaking—this is a treatment, and not a cure—but as the study’s authors write, “T-VEC represents a novel potential therapy for patients with metastatic melanoma.”

Herpes, as it turns out, could someday help save your life. It was a really smart move from the side of the researchers who thought of using smart viruses to treat other forms of cancer. The researchers see the FDA’s approval of Imlygic as an important milestone which will take us beyong melanoma.

As Mayo Clinic oncolytic virotherapy researcher Dr. Stephen Russell explained to The Guardian, the FDA’s approval of Imlygic opens the door to further research into the use of viruses to target diseased cells. He says: “We can’t prematurely claim that we’ve achieved our ultimate goal, because we haven’t; this really is a single step along that path. But it’s a very important and very significant step.”

Ultimately, the goal for many physicians is to end the need for physically—and often times psychologically—trying therapies such as chemo or radiation. 

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