Genital herpes treatment: Genocea Biosciences announce data from Phase II trials - Outbreak News Today | Outbreak News Today Outbreak News Today
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Cambridge, Mass. biopharmaceutical company, Genocea Biosciences, Inc., announced this week positive 12 month efficacy data from its Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes.

GEN-003 demonstrated sustained and statistically significant reductions compared to baseline in the rate of viral shedding 12 months after dosing across multiple dose groups as well as sustained efficacy at multiple dose levels across secondary endpoints measuring the impact on clinical disease. GEN-003 was safe and well tolerated by patients, with no serious adverse events related to the vaccine in the trial.

“We are very pleased with these data, which show that GEN-003 has strong and durable effects on both HSV-2 viral activity and genital herpes clinical disease, supporting our belief that GEN-003 could become a cornerstone treatment for patients affected by this serious disease. Specifically, a single course of treatment of GEN-003 may offer benefits similar to a full year of daily administration of oral antivirals – but with greatly improved convenience,” said Chip Clark, president and chief executive officer of Genocea. “We anticipate reporting virologic efficacy data for GEN-003 from our recently-initiated Phase 2b study in the third quarter of 2016, clinical efficacy data at 6 months post dosing around the end of 2016 and conducting our end of Phase 2 meeting with the FDA in the first quarter of 2017.”

“These 12 month data highlight the potential of GEN-003 to significantly enhance the genital herpes treatment landscape,”  said Lori A. Panther, M.D., MPH, infectious diseases specialist at Beth Israel Deaconess Medical Center and Assistant Professor of Medicine at Harvard Medical School.  “Because of the physical and psychological impact of this disease, both patients and treating physicians would be eager to use an effective treatment that more conveniently improves control of outbreaks. The reduction in viral shedding, which is thought to cause the epidemic spread of genital herpes, is also encouraging.”

Genocea has already advanced the two most promising doses, 60 µg per protein combined with either 50 or 75 µg of Matrix-M2TM adjuvant, from this Phase 2 dose optimization study into an ongoing Phase 2b efficacy trial. The efficacy of GEN-003 at these two dose levels over the course of the Phase 2 dose optimization trial is as follows:

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Inducing a T cell response against HSV-2 is critical to treating the clinical symptoms of disease and controlling transmission of the infection. GEN-003 is a first-in-class T-cell directed immunotherapy designed to elicit both a T cell and B cell (antibody) immune response. The immunotherapy was designed using Genocea’s ATLAS™ platform, which profiles the comprehensive spectrum of actual T cell responses mounted by humans in response to disease, to identify antigen targets that drive T cell response. GEN-003 includes the antigens ICP4 and gD2 along with Matrix-M2TM adjuvant, which Genocea licenses from Novavax, Inc. For more information about GEN-003, please visit http://www.genocea.com/platform-pipeline/pipeline/gen003-for-genital-herpes/.

Genital Herpes affects more than 400 million people worldwide and causes recurrent, painful genital lesions. It can be transmitted to sexual partners, even when the disease is asymptomatic. Current genital herpes therapies only partially control clinical symptoms and viral shedding, a process which drives disease transmission. Incomplete control of genital lesions and transmission risk, expense and the perceived inconvenience of taking a daily medication are hurdles for long-term disease management. Immunity through T cells is believed to be particularly critical to the control and possible prevention of genital herpes infections.

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5 Comments

  1. Elina says:

    Even though 90 percent of people have some form of herpes, the virus is heavily stigmatized. But the transition from “itchy annoyance” to shameful secret may not have been coincidental.

  2. JAMES says:

    Been diagnosed of herpes is just like been through hell but everything is posible. So amazing and i want to testify of the good work done by dr.Osas a very strong and powerful spell caster. dr.Osas has proved science and scientists wrong for believing and thinking that there is no cure for Herpes Virus but to be sincere this dr.Osas is so real and powerful. I never thought that this cure will work but this GREAT MAN has proved it to me and it has worked and still working perfectly. My Name is James Benand and i was diagnosed of the deadly disease called Herpes April 2016 and i thought that, this will be the end and there will be no hope. Speaking to anyone was always a problem because i was so worried and always in the state of unrest in fact i thought it was over until one blessed day when i was searching for help here on the internet, i came across a testimony about dr.Osas on how he helped a lady who was also infected with Herpes Virus, how he has also helped many others to get their loved ones back, and how he has also help others to cure HIV. At first i thought it was all a lie but i decided to give it a try since there was no option and, when i contacted this MAN he laughed and told me that, that is too small for him to handle but i was still in doubt, and he gave me a form to fill which I did, then he called me and told me that his gods required some items in which he will use in preparing the cure for me. He bought the items and prepared a cure for me, and instructed me on what to do and i OBEYED him completely as he told me. Then he sent a parcel to me through the courier delivery service. it was a holy water and a pure holy oil as described by dr.Osas. I took the holy water and the holy oil and after taking it, he told me to go for check up but I was still in doubt and was so afraid to go for the test but i took a bold step and believed that it is well, and i believed all what he has done and all that he has told me. So i went to the hospital for the test it was so amazing, awesome and exciting what seems to be impossible became possible, the VIRUS disappeared completely from my system quickly I called him and told him what happened he congratulated me and today i am a happy person again the way things use to be. Don’t you think that this testimony is worth sharing? I promise to tell the world about him and i will keep sharing this testimony till the end because many people has died of herpes and i want many people who believed that it is over to know that EVERYTHING IS POSSIBLE AND I WANT THEM TO GET HELP FROM THIS SPELL CASTER by contacting him on his email at dr.osascuringhome@gmail.com

  3. BENAND says:

    All these post about HERBAL MEDICINE and spell casters are scammers and fake trying to collect money all in the name of HERPES cure and when you contact them, they will be asking for your name, pictures, country, phone number, occupation and when you have given them all the information, they will be as king for money. I was once suffering from GENETIC HERPES and i spent a lot of money going from one herbal doctor to another but they all scam and take my money away until i came in contact with this powerful one called Dr.Osas who cured me from Herpes with his herbal medication , after doctor Osas has finished preparing the herbal medicine, he asked me to send him my residential address, so that he will send the herbal medicine to via D.H.L so i did. 2days later, i received the herbal medicine and i had to follow the instructions he gave to me on how i will apply it. 2weeks later i went to hospital for test and according to the test done by the Medical doctor Desmond, it stated that i was cured.
    So viewers be wise and beware of fake spell casters and fake herbal doctors, they are all over the internet trying to steal from poor people. I will drop you the email of this powerful herbal doctor just in case you wish to contact him for help. dr.osascuringhome@gmail.com.
    Dr OSAS CAN AS WELL CURE THE FOLLOWING DISEASES:-

    1. HERPES
    2. LASSA FEVER
    3. GONORRHEA
    4. HIV/AIDS
    5. LOW SPERM COUNT
    6. MENOPAUSE DISEASE
    7. EPILEPSY
    8. ASEPSIS
    9. CANCER
    10. ANXIETY DEPRESSION
    11. PREGNANCY PROBLEM
    12. SHORT SIGHTEDNESS PROBLEM
    14. Male menopause
    15. Menopause – male
    16. Menopause – peri
    17. Menstruation problems
    18. Mercury Poisoning
    19. Migraine
    20. Miscarriage
    21. Mites (demodex mites)
    22. Mites (scabies mites)
    23. Motion sickness
    24. Mouth ulcer
    25. MRSA
    26. Multiple sclerosis
    27. Muscle cramps
    28. Myodesopsia
    29. Stroke

  4. JAMES BENAND says:

    All these post about HERBAL MEDICINE and spell casters are scammers and fake trying to collect money all in the name of HERPES cure and when you contact them, they will be asking for your name, pictures, country, phone number, occupation and when you have given them all the information, they will be as king for money. I was once suffering from GENETIC HERPES and i spent a lot of money going from one herbal doctor to another but they all scam and took my money away until i came in contact with this powerful one called Dr.Cletus who cured me from Herpes with his herbal medication , after Dr.Cletus has finished preparing the herbal medicine, he asked me to send him my residential address, so that he will send the herbal medicine to via D.H.L so i did. 2days later, i received the herbal medicine and i had to follow the instructions he gave to me on how i will apply it. 2weeks later i went to hospital for test and according to the test done by the Medical doctor Desmond, it stated that i was cured.
    So viewers be wise and beware of fake spell casters and fake herbal doctors, they are all over the internet trying to steal from poor people. I will drop you the email of this powerful herbal doctor just in case you wish to contact him for help. Dr.Cletuscuringhome@gmail.com.
    Dr.Cletus CAN AS WELL CURE THE FOLLOWING DISEASES:-

    1. HERPES
    2. LASSA FEVER
    3. GONORRHEA
    4. HIV/AIDS
    5. LOW SPERM COUNT
    6. MENOPAUSE DISEASE
    7. EPILEPSY
    8. ASEPSIS
    9. CANCER
    10. ANXIETY DEPRESSION
    11. PREGNANCY PROBLEM
    12. SHORT SIGHTEDNESS PROBLEM
    14. Male menopause
    15. Menopause – male
    16. Menopause – peri
    17. Menstruation problems
    18. Mercury Poisoning
    19. Migraine
    20. Miscarriage
    21. Mites (demodex mites)
    22. Mites (scabies mites)
    23. Motion sickness
    24. Mouth ulcer
    25. MRSA
    26. Multiple sclerosis
    27. Muscle cramps
    28. Myodesopsia
    29. Stroke

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