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admin 13.06.2014

WASHINGTON — Federal health officials have approved a first-of-a-kind drug that uses the herpes virus to infiltrate and destroy skin cancer tumors. The Food and Drug Administration approved the injectable drug from Amgen for patients with hard-to-treat melanoma, the deadliest form of skin cancer that affects about 74,000 new patients annually.
The drug, Imlygic, is injected directly into tumor tissue, where it uses herpes as a Trojan horse to slip past and rupture cancer cells. Despite the drug’s groundbreaking approach, FDA officials stressed it has not been shown to extend life.
The FDA themselves called it a “first-of-its-kind” treatment this week when they approved a drug that uses the herpes simplex virus to help combat skin cancer.
The FDA-approved drug, Talimogene laherperepvec (to be sold under the brand name Imlygic), will be used on cancerous tumors that cannot be removed surgically — specifically, patients with hard-to-treat melanoma.
The modified herpes verus replicates within tumors and causes cell death by bursting the cells and releasing antigens that could promote an anti-tumor response.
Imlygic could potentially improve overall melanoma survival rates, but there hasn’t been research to support that just yet. Using an incurable virus to treat another disease is certainly not a run-of-the-mill approach, but it goes to show that creativity isn’t only critical for artistic endeavors. Imlygic (talimogene laherparepvec), a first-of-its-kind therapy, showed promise against lesions in the skin and lymph nodes in an early trial, the FDA said Tuesday. The drug is injected directly into tumors, where it replicates inside cancer cells, causing them to rupture and die. The agency’s approval is based on a study of 436 patients with advanced melanoma that could not be surgically removed. Decreases in tumor size that lasted for a minimum of six months were seen in about 16 percent of patients who received Imlygic, compared with about 2 percent of those who received the other treatment, the findings showed. Fatigue, chills, fever, nausea, flu-like symptoms and injection-site pain were the most common side effects reported among patients who received Imlygic.
Because Imlygic is a genetically modified herpes simplex 1 virus, it can also cause the kind of herpes infection that can lead to cold sores, so it shouldn’t be given to patients with weak immune systems or pregnant women, the FDA said. The material in this site is intended to be of general informational use and is not intended to constitute medical advice, probable diagnosis, or recommended treatments. This breakthrough treatment uses revolutionary research into genital wart treatment for lasting results. The serious effects of herpes go beyond the obvious physical discomfort to emotional suffering and even social isolation.
Recent research has uncovered that viruses, including herpes and genital warts, are positively-charged. Walden Bioresearch has developed a breakthrough method of applying a negative charge to areas affected by HPV and herpes: ozone. Our ozone treatment combines oxygen molecules and a powerful anti-viral agent to work in two ways. MedCity CONVERGE in Philadelphia July 12-13 focuses on healthcare innovation across all sectors.

The tests are meant to be used to diagnose such infections in people who are sexually active and on expectant mothers. It seems that anytime a new tool or technology is introduced, we inevitably apply it broadly, learning as we go that the tool has ideal applications.
The FDA has approved use of the finger-prick blood test kit for herpes developed by startup company Theranos. The company announced on Thursday, July 2, that they have received the approval letter and, according to them, this serves as a validation of their technology and approach to affordable blood testing that requires little amount of patient discomfort. The FDA comprehensively reviewed the system proposed by Theranos, which involved the highly computerized medium that aims to lessen human errors linked to the processing of the specimens.
Theranos has received numerous disapprovals from academic experts, citing the elusiveness of the company's methods of technology. Despite the statements of critics, the studies presented by Theranos, which involved 818 study participants, claim that the finger-prick test of either whole blood or plasma for HSV-1 developed by their company can be comparable, or at least be as reliable as the traditional venipuncture procedure approved by the FDA.
According to Holmes, the process of approval that the FDA conducts is rigorous, and the company voluntarily decided to undergo it because it believes that the laboratory testing the FDA has developed is of the highest quality.
The HSV-1 test developed by Theranos retails for about $9.07, which makes it one of 100 products that Theranos sells for less than $10. The drug combines a gene snippet meant to stimulate the immune system with a modified version of the herpes simplex virus — the kind that causes mouth cold sores.
It might strike you as strange since both oral and genital herpes are incurable, but in fact, viruses have been used since 1919 to treat disease. Imlygic is a genetically-modified version of the herpes simplex virus, and it’s administered through injections to the site of lesions. The studies have only looked at its effect on lesion sizes, but perhaps further research will produce even more exciting results. However, skin cancer is the most common form of cancer in the US as well as the leading cause of cancer-related deaths across the globe. Harper, executive vice president of research and development at Amgen (the drug company), said in a press release.
With the innovative minds working to transform current treatments and therapies, we can only imagine what the future holds for the medical field.
However, the therapy did not improve overall survival and it did not work if the cancer had spread to other parts of the body, the agency noted. Once the tumors have exploded, antibodies are released into the body that may trigger an immune response, the agency explained. After the first injection, a second dose is given three weeks later, followed by additional doses every two weeks for at least six months, until there are no remaining tumors to treat or other treatment is required, the FDA said in a news release. This year, about 74,000 Americans will be diagnosed with the disease and nearly 10,000 will die from it, according to the U.S.
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However, now you don’t have to let genital warts affect your confidence and your health.

Now, SOMOXAL Herpes Treatment uses new breakthrough research to destroy the herpes virus and give you back your confidence. Walden Bioresearch is putting an end to the negative effects of these conditions with a breakthrough treatment. Add a negative charge to the affected area and it actually destroys the virus and symptoms. We understand that these conditions can be a sensitive subject, so we wrap all purchases in plain packaging for your privacy. The clearance is specifically for the IgG Antibody to diagnose herpes simplex virus (HSV) types 1 and 2 assays for use on its cobas modular platforms that analyze the results. It provides clear steps to help you determine your top cybersecurity needs and priorities for a simple but effective approach. Food and Drug Administration (FDA) has given the green light for the finger-prick blood test for Herpes Simplex Virus 1 (HSV-1) developed by startup company Theranos Inc. In the approval issued by the FDA, the use of the Theranos' Nanotainer was also given the go signal. These researchers particularly emphasized that the essential data of how the company works in comparison to others have not been explained. In the commitment to guarantee health care providers and patients have access to correct health data, the company is hoping to continue its strong ties with the FDA for future endeavors, she added. Of the 436 study participants who had a tumor that couldn’t be surgically removed, 16.3 percent experienced a decrease in the lesion sizes on their skin and lymph nodes during the six month treatment course.
Despite the treatment’s cost and potential unwanted side effects, like nausea, fever, and flu, any new skin cancer treatment provides hope for the victims of the disease.
Registration or use of this site constitutes acceptance of our Terms of Service and Privacy Policy. Through this tube, blood samples may be drawn with very minimal pain because only a few drops of blood from the patient's finger are required for testing.
The tests are presently available at 42 branches of Walgreens in Arizona and one in California. We value your privacy and we will never sell or distribute your email or personal data to third party advertisers.
That number may not sound big, but a group who received a comparator therapy only experienced a 2.1 percent decrease, ScienceAlert reported. The entire Theranos system, including its analytical software and other devices, has been cleared for use.

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