Whitney McKnight

WASHINGTON – Nemolizumab, an anti-interleukin-31 receptor A monoclonal antibody, was shown to rapidly and consistently improve pruritus, dermatitis, and sleep disturbance in patients with previously uncontrolled moderate-to-severe atopic dermatitis in a phase II, randomized, double-blind, placebo-controlled trial.

“The patients notice that the itch is gone very quickly, sometimes within days, even before their dermatitis starts to heal,” said Dr. Jon M. Hanifin, one of the treatment’s investigators. “It’s very exciting.”

jancin

Dr. Hanifin, a researcher at Oregon Health & Science University, Portland, made his comments while presenting the data during the late-breaking clinical research session at this year’s annual meeting of the American Academy of Dermatology.

The novel treatment, currently known as CIM331 (Chugai) targets elevated levels of interleukin-31, a cytokine that has been implicated in the pathophysiology of atopic dermatitis (AD) and pruritus.

The multicenter, multi-dose study assigned 264 patients, primarily in their mid-30s, with moderate-to-severe AD, uncontrolled by topical treatments, to either placebo or 0.1 mg/kg, 0.5 mg/kg, or 2.0 mg/kg CIM331 every 4 weeks. The study completion rate was 82%.

Using a visual analog scale of 0 to 10, with 10 characterized as “the worst imaginable,” at week 12, patients in the three study groups reported −41.5%, −61.2%, and −60.5% reductions in pruritus vs. −20.1% for placebo (P less than .01 for all).

The “significant reductions” in itch began as early as week 1, particularly in the group treated with the 2-mg/kg dose. Dr. Hanifin said that the patients had a very high mean pruritis score, and some had as much as half of their body surface area affected by AD.

Rescue medications such as topical corticosteroids were not permitted until after at least 1 month of treatment. Patients given rescue therapies were required to have both itch and dermatitis. “This was kind of a tough thing to get through, but [patients] did okay,” Dr. Hanifin said.

Patients treated with the 0.5-mg/kg dose showed the most improvement from baseline in Eczema Area and Severity Index scores at week 12 at −44.6%, compared with −20.9% for placebo. Across the study arms, the proportion of static Investigator’s Global Assessment of 1 or less was 20.9% vs. 4.7% for placebo. Additionally, Dr. Hanifin said sleep latency in the study groups was improved by half and there was an increase in total overall sleep time.

CIM331 was well tolerated, with the most common adverse events being exacerbation of AD and nasopharyngitis. “The risk of immune suppression seemed to be low,” Dr. Hanifin said.

WASHINGTON – Nemolizumab, an anti-interleukin-31 receptor A monoclonal antibody, was shown to rapidly and consistently improve pruritus, dermatitis, and sleep disturbance in patients with previously uncontrolled moderate-to-severe atopic dermatitis in a phase II, randomized, double-blind, placebo-controlled trial.

“The patients notice that the itch is gone very quickly, sometimes within days, even before their dermatitis starts to heal,” said Dr. Jon M. Hanifin, one of the treatment’s investigators. “It’s very exciting.”

jancin

Dr. Hanifin, a researcher at Oregon Health & Science University, Portland, made his comments while presenting the data during the late-breaking clinical research session at this year’s annual meeting of the American Academy of Dermatology.

The novel treatment, currently known as CIM331 (Chugai) targets elevated levels of interleukin-31, a cytokine that has been implicated in the pathophysiology of atopic dermatitis (AD) and pruritus.

The multicenter, multi-dose study assigned 264 patients, primarily in their mid-30s, with moderate-to-severe AD, uncontrolled by topical treatments, to either placebo or 0.1 mg/kg, 0.5 mg/kg, or 2.0 mg/kg CIM331 every 4 weeks. The study completion rate was 82%.

Using a visual analog scale of 0 to 10, with 10 characterized as “the worst imaginable,” at week 12, patients in the three study groups reported −41.5%, −61.2%, and −60.5% reductions in pruritus vs. −20.1% for placebo (P less than .01 for all).

The “significant reductions” in itch began as early as week 1, particularly in the group treated with the 2-mg/kg dose. Dr. Hanifin said that the patients had a very high mean pruritis score, and some had as much as half of their body surface area affected by AD.

Rescue medications such as topical corticosteroids were not permitted until after at least 1 month of treatment. Patients given rescue therapies were required to have both itch and dermatitis. “This was kind of a tough thing to get through, but [patients] did okay,” Dr. Hanifin said.

Patients treated with the 0.5-mg/kg dose showed the most improvement from baseline in Eczema Area and Severity Index scores at week 12 at −44.6%, compared with −20.9% for placebo. Across the study arms, the proportion of static Investigator’s Global Assessment of 1 or less was 20.9% vs. 4.7% for placebo. Additionally, Dr. Hanifin said sleep latency in the study groups was improved by half and there was an increase in total overall sleep time.

CIM331 was well tolerated, with the most common adverse events being exacerbation of AD and nasopharyngitis. “The risk of immune suppression seemed to be low,” Dr. Hanifin said.

WASHINGTON – Nemolizumab, an anti-interleukin-31 receptor A monoclonal antibody, was shown to rapidly and consistently improve pruritus, dermatitis, and sleep disturbance in patients with previously uncontrolled moderate-to-severe atopic dermatitis in a phase II, randomized, double-blind, placebo-controlled trial.

“The patients notice that the itch is gone very quickly, sometimes within days, even before their dermatitis starts to heal,” said Dr. Jon M. Hanifin, one of the treatment’s investigators. “It’s very exciting.”

jancin

Dr. Hanifin, a researcher at Oregon Health & Science University, Portland, made his comments while presenting the data during the late-breaking clinical research session at this year’s annual meeting of the American Academy of Dermatology.

The novel treatment, currently known as CIM331 (Chugai) targets elevated levels of interleukin-31, a cytokine that has been implicated in the pathophysiology of atopic dermatitis (AD) and pruritus.

The multicenter, multi-dose study assigned 264 patients, primarily in their mid-30s, with moderate-to-severe AD, uncontrolled by topical treatments, to either placebo or 0.1 mg/kg, 0.5 mg/kg, or 2.0 mg/kg CIM331 every 4 weeks. The study completion rate was 82%.

Using a visual analog scale of 0 to 10, with 10 characterized as “the worst imaginable,” at week 12, patients in the three study groups reported −41.5%, −61.2%, and −60.5% reductions in pruritus vs. −20.1% for placebo (P less than .01 for all).

The “significant reductions” in itch began as early as week 1, particularly in the group treated with the 2-mg/kg dose. Dr. Hanifin said that the patients had a very high mean pruritis score, and some had as much as half of their body surface area affected by AD.

Rescue medications such as topical corticosteroids were not permitted until after at least 1 month of treatment. Patients given rescue therapies were required to have both itch and dermatitis. “This was kind of a tough thing to get through, but [patients] did okay,” Dr. Hanifin said.

Patients treated with the 0.5-mg/kg dose showed the most improvement from baseline in Eczema Area and Severity Index scores at week 12 at −44.6%, compared with −20.9% for placebo. Across the study arms, the proportion of static Investigator’s Global Assessment of 1 or less was 20.9% vs. 4.7% for placebo. Additionally, Dr. Hanifin said sleep latency in the study groups was improved by half and there was an increase in total overall sleep time.

CIM331 was well tolerated, with the most common adverse events being exacerbation of AD and nasopharyngitis. “The risk of immune suppression seemed to be low,” Dr. Hanifin said.

WASHINGTON – After 60 weeks of continuous therapy with the investigational drug ixekizumab, 722 patients who initially had moderate to severe plaque psoriasis had Psoriasis Area Severity Index (PASI) 75, 90, and 100 response rates of 87%, 78%, and 57%, respectively, based on study results presented by Dr. Andrew Blauvelt at the annual meeting of the American Academy of Dermatology.

Additionally, the rate of complete clearance or mild severity of plaque psoriasis based on the Physician Global Assessment measure was 79% in the study patients. Dr. Blauvelt said “these were tremendous results over time.”

The findings come from the open-label continuation study of ixekizumab in UNCOVER-3. At week 12 of that study, 722 ixekizumab-treated patients were continued on or converted to a regimen of 80 mg ixekizumab every 4 weeks.

In UNCOVER-3, all study participants initially received induction therapy with ixekizumab and then were randomized to placebo (193 patients), etanercept 50 mg twice weekly (382 patients), 80 mg ixekizumab every 4 weeks (386 patients) after a 160 mg starting dose, or 80 mg ixekizumab every 2 weeks (385 patients) after an initial 160 mg starting dose. After 12 weeks, patients entered open-label treatment with the study drug once every 4 weeks.

The long-term safety and tolerability profile was similar to the one seen during the induction period and cited in previously published data. Dr. Blauvelt, President of the Oregon Medical Research Center, said the finding was “good news, in that there were no unexpected safety signals [not already] seen with initial therapy.”

Ixekizumab is an IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokines, inhibiting interaction with the IL-17 receptor.

According to a spokesperson from Eli Lilly, sponsor of the UNCOVER trial and maker of ixekizumab, a decision from the U.S. Food and Drug Administration on whether to approve ixekizumab for use in psoriasis is expected during the first quarter of 2016.

Dr. Blauvelt is an advisor or consultant for and has received research grants from a wide variety of drug companies including Eli Lilly.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – After 60 weeks of continuous therapy with the investigational drug ixekizumab, 722 patients who initially had moderate to severe plaque psoriasis had Psoriasis Area Severity Index (PASI) 75, 90, and 100 response rates of 87%, 78%, and 57%, respectively, based on study results presented by Dr. Andrew Blauvelt at the annual meeting of the American Academy of Dermatology.

Additionally, the rate of complete clearance or mild severity of plaque psoriasis based on the Physician Global Assessment measure was 79% in the study patients. Dr. Blauvelt said “these were tremendous results over time.”

The findings come from the open-label continuation study of ixekizumab in UNCOVER-3. At week 12 of that study, 722 ixekizumab-treated patients were continued on or converted to a regimen of 80 mg ixekizumab every 4 weeks.

In UNCOVER-3, all study participants initially received induction therapy with ixekizumab and then were randomized to placebo (193 patients), etanercept 50 mg twice weekly (382 patients), 80 mg ixekizumab every 4 weeks (386 patients) after a 160 mg starting dose, or 80 mg ixekizumab every 2 weeks (385 patients) after an initial 160 mg starting dose. After 12 weeks, patients entered open-label treatment with the study drug once every 4 weeks.

The long-term safety and tolerability profile was similar to the one seen during the induction period and cited in previously published data. Dr. Blauvelt, President of the Oregon Medical Research Center, said the finding was “good news, in that there were no unexpected safety signals [not already] seen with initial therapy.”

Ixekizumab is an IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokines, inhibiting interaction with the IL-17 receptor.

According to a spokesperson from Eli Lilly, sponsor of the UNCOVER trial and maker of ixekizumab, a decision from the U.S. Food and Drug Administration on whether to approve ixekizumab for use in psoriasis is expected during the first quarter of 2016.

Dr. Blauvelt is an advisor or consultant for and has received research grants from a wide variety of drug companies including Eli Lilly.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – After 60 weeks of continuous therapy with the investigational drug ixekizumab, 722 patients who initially had moderate to severe plaque psoriasis had Psoriasis Area Severity Index (PASI) 75, 90, and 100 response rates of 87%, 78%, and 57%, respectively, based on study results presented by Dr. Andrew Blauvelt at the annual meeting of the American Academy of Dermatology.

Additionally, the rate of complete clearance or mild severity of plaque psoriasis based on the Physician Global Assessment measure was 79% in the study patients. Dr. Blauvelt said “these were tremendous results over time.”

The findings come from the open-label continuation study of ixekizumab in UNCOVER-3. At week 12 of that study, 722 ixekizumab-treated patients were continued on or converted to a regimen of 80 mg ixekizumab every 4 weeks.

In UNCOVER-3, all study participants initially received induction therapy with ixekizumab and then were randomized to placebo (193 patients), etanercept 50 mg twice weekly (382 patients), 80 mg ixekizumab every 4 weeks (386 patients) after a 160 mg starting dose, or 80 mg ixekizumab every 2 weeks (385 patients) after an initial 160 mg starting dose. After 12 weeks, patients entered open-label treatment with the study drug once every 4 weeks.

The long-term safety and tolerability profile was similar to the one seen during the induction period and cited in previously published data. Dr. Blauvelt, President of the Oregon Medical Research Center, said the finding was “good news, in that there were no unexpected safety signals [not already] seen with initial therapy.”

Ixekizumab is an IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokines, inhibiting interaction with the IL-17 receptor.

According to a spokesperson from Eli Lilly, sponsor of the UNCOVER trial and maker of ixekizumab, a decision from the U.S. Food and Drug Administration on whether to approve ixekizumab for use in psoriasis is expected during the first quarter of 2016.

Dr. Blauvelt is an advisor or consultant for and has received research grants from a wide variety of drug companies including Eli Lilly.

[email protected]

On Twitter @whitneymcknight

Depression is one of the top chronic illnesses treated by primary care practices, but providers may be ill-equipped to manage it, compared with other conditions such as asthma, heart failure, and diabetes.

In a new study, Dr. Tara F. Bishop and her colleagues write that their findings show that more attention should be given “to developing policies and incentives to increase the use of care management processes for depression in primary care.”

Drawing upon data collected in 2012 and 2013 from the National Study of Physician Organizations survey, the researchers assessed whether 1, 070 practices used at least one of five established care management processes across depression, asthma, heart failure, and diabetes. The practice sizes of the physicians surveyed varied, although academic faculty practices and those that had less than 33% primary care physicians were excluded (Health Aff. 2016;35[3]:394-400), Dr. Bishop, a health policy analyst affiliated with Cornell University, New York, and her colleagues wrote.

When compared against an overall mean score of 4.8 on a 20-point scale for care management, the mean score for depression was 0.8, which was significantly lower than the other three chronic conditions (P less than .001). This means that when depression was treated in primary care practices, less than one established management strategy was used.

Registries were the most common care management process employed for depression treatment, but at 30%, was much lower for depression than in the other conditions, which ranged from 33% to 52%. Patient education and patient reminders were virtually unused in depression (P less than .0001).

In addition to registries, the care processes evaluated were nurse care managers, quality data, patient reminders, and patient education provided by support staff. Diabetes scored the highest at 1.7 (standard error, 0.13). Asthma and heart failure each had a score of 1.1 (SE, 1.13 and .07, respectively). Also included in the primary analysis were characteristics such as the extent to which the practice operated according to value-based measures such as patient satisfaction and other external incentives, and the level of health information technology employed.

For a secondary analysis, Dr. Bishop and her colleagues drew from additional data collected from an earlier round of the survey, as well as 2007-2010 data from the National Study of Small and Medium-Sized Physician Practices. A noted limitation of the study was that while all data were derived from responses given by the one person from each practice surveyed who was deemed to be the most knowledgeable overall, this was not verifiably the case. In all, the investigators compared 83 practices from across the country of 20 or more physicians with 719 practices nationwide that had fewer than 20 physicians.

The profile of a typical primary care setting in which depression is treated that emerged from the data was a practice that had been established for at least 2 decades, with an average of 21 physicians (SE, 11.2), 81% of whom were nonspecialists. The mean pay-for-performance score was 0.85 (SE, 0.05), the mean health IT score was 7.22 (SE, 0.28), and the mean score for public reporting was 0.87 (SE, .03).

Among larger practices, when controlling for practice characteristics, diabetes care management was the only one to have increased significantly across the years examined: from 2.57 in 2006-2007 to 3.22 in 2012-2013. In practices with fewer than 20 physicians, there were no significant changes in the care management processes scores for any of the chronic care delivered. However, in all practice sizes, higher pay-for-performance scores were associated with the use of depression care management processes. Smaller, hospital-owned practices that offered multispecialty care and greater levels of health IT were associated with lower depression care management scores.

Additionally, Dr. Bishop and her colleagues found that scores for depression treatment positively correlated with a practice having been established longer, being in the South vs. the Northeast, and having higher health IT scores. Negative correlations were found for depression care management and a practice being multispecialty rather than primary care only, and the practice being in the Midwest vs. the Northeast.

It is unclear whether the minimal use of chronic care processes for depression is attributable to what the authors called “the historical separation between mental and physical health care” or other factors, Dr. Bishop and her colleagues wrote.

The Robert Wood Johnson Foundation funded the study. Dr. Bishop declared support from a National Institute on Aging career development award.

[email protected]

On Twitter @whitneymcknight

Depression is one of the top chronic illnesses treated by primary care practices, but providers may be ill-equipped to manage it, compared with other conditions such as asthma, heart failure, and diabetes.

In a new study, Dr. Tara F. Bishop and her colleagues write that their findings show that more attention should be given “to developing policies and incentives to increase the use of care management processes for depression in primary care.”

Drawing upon data collected in 2012 and 2013 from the National Study of Physician Organizations survey, the researchers assessed whether 1, 070 practices used at least one of five established care management processes across depression, asthma, heart failure, and diabetes. The practice sizes of the physicians surveyed varied, although academic faculty practices and those that had less than 33% primary care physicians were excluded (Health Aff. 2016;35[3]:394-400), Dr. Bishop, a health policy analyst affiliated with Cornell University, New York, and her colleagues wrote.

When compared against an overall mean score of 4.8 on a 20-point scale for care management, the mean score for depression was 0.8, which was significantly lower than the other three chronic conditions (P less than .001). This means that when depression was treated in primary care practices, less than one established management strategy was used.

Registries were the most common care management process employed for depression treatment, but at 30%, was much lower for depression than in the other conditions, which ranged from 33% to 52%. Patient education and patient reminders were virtually unused in depression (P less than .0001).

In addition to registries, the care processes evaluated were nurse care managers, quality data, patient reminders, and patient education provided by support staff. Diabetes scored the highest at 1.7 (standard error, 0.13). Asthma and heart failure each had a score of 1.1 (SE, 1.13 and .07, respectively). Also included in the primary analysis were characteristics such as the extent to which the practice operated according to value-based measures such as patient satisfaction and other external incentives, and the level of health information technology employed.

For a secondary analysis, Dr. Bishop and her colleagues drew from additional data collected from an earlier round of the survey, as well as 2007-2010 data from the National Study of Small and Medium-Sized Physician Practices. A noted limitation of the study was that while all data were derived from responses given by the one person from each practice surveyed who was deemed to be the most knowledgeable overall, this was not verifiably the case. In all, the investigators compared 83 practices from across the country of 20 or more physicians with 719 practices nationwide that had fewer than 20 physicians.

The profile of a typical primary care setting in which depression is treated that emerged from the data was a practice that had been established for at least 2 decades, with an average of 21 physicians (SE, 11.2), 81% of whom were nonspecialists. The mean pay-for-performance score was 0.85 (SE, 0.05), the mean health IT score was 7.22 (SE, 0.28), and the mean score for public reporting was 0.87 (SE, .03).

Among larger practices, when controlling for practice characteristics, diabetes care management was the only one to have increased significantly across the years examined: from 2.57 in 2006-2007 to 3.22 in 2012-2013. In practices with fewer than 20 physicians, there were no significant changes in the care management processes scores for any of the chronic care delivered. However, in all practice sizes, higher pay-for-performance scores were associated with the use of depression care management processes. Smaller, hospital-owned practices that offered multispecialty care and greater levels of health IT were associated with lower depression care management scores.

Additionally, Dr. Bishop and her colleagues found that scores for depression treatment positively correlated with a practice having been established longer, being in the South vs. the Northeast, and having higher health IT scores. Negative correlations were found for depression care management and a practice being multispecialty rather than primary care only, and the practice being in the Midwest vs. the Northeast.

It is unclear whether the minimal use of chronic care processes for depression is attributable to what the authors called “the historical separation between mental and physical health care” or other factors, Dr. Bishop and her colleagues wrote.

The Robert Wood Johnson Foundation funded the study. Dr. Bishop declared support from a National Institute on Aging career development award.

[email protected]

On Twitter @whitneymcknight

Depression is one of the top chronic illnesses treated by primary care practices, but providers may be ill-equipped to manage it, compared with other conditions such as asthma, heart failure, and diabetes.

In a new study, Dr. Tara F. Bishop and her colleagues write that their findings show that more attention should be given “to developing policies and incentives to increase the use of care management processes for depression in primary care.”

Drawing upon data collected in 2012 and 2013 from the National Study of Physician Organizations survey, the researchers assessed whether 1, 070 practices used at least one of five established care management processes across depression, asthma, heart failure, and diabetes. The practice sizes of the physicians surveyed varied, although academic faculty practices and those that had less than 33% primary care physicians were excluded (Health Aff. 2016;35[3]:394-400), Dr. Bishop, a health policy analyst affiliated with Cornell University, New York, and her colleagues wrote.

When compared against an overall mean score of 4.8 on a 20-point scale for care management, the mean score for depression was 0.8, which was significantly lower than the other three chronic conditions (P less than .001). This means that when depression was treated in primary care practices, less than one established management strategy was used.

Registries were the most common care management process employed for depression treatment, but at 30%, was much lower for depression than in the other conditions, which ranged from 33% to 52%. Patient education and patient reminders were virtually unused in depression (P less than .0001).

In addition to registries, the care processes evaluated were nurse care managers, quality data, patient reminders, and patient education provided by support staff. Diabetes scored the highest at 1.7 (standard error, 0.13). Asthma and heart failure each had a score of 1.1 (SE, 1.13 and .07, respectively). Also included in the primary analysis were characteristics such as the extent to which the practice operated according to value-based measures such as patient satisfaction and other external incentives, and the level of health information technology employed.

For a secondary analysis, Dr. Bishop and her colleagues drew from additional data collected from an earlier round of the survey, as well as 2007-2010 data from the National Study of Small and Medium-Sized Physician Practices. A noted limitation of the study was that while all data were derived from responses given by the one person from each practice surveyed who was deemed to be the most knowledgeable overall, this was not verifiably the case. In all, the investigators compared 83 practices from across the country of 20 or more physicians with 719 practices nationwide that had fewer than 20 physicians.

The profile of a typical primary care setting in which depression is treated that emerged from the data was a practice that had been established for at least 2 decades, with an average of 21 physicians (SE, 11.2), 81% of whom were nonspecialists. The mean pay-for-performance score was 0.85 (SE, 0.05), the mean health IT score was 7.22 (SE, 0.28), and the mean score for public reporting was 0.87 (SE, .03).

Among larger practices, when controlling for practice characteristics, diabetes care management was the only one to have increased significantly across the years examined: from 2.57 in 2006-2007 to 3.22 in 2012-2013. In practices with fewer than 20 physicians, there were no significant changes in the care management processes scores for any of the chronic care delivered. However, in all practice sizes, higher pay-for-performance scores were associated with the use of depression care management processes. Smaller, hospital-owned practices that offered multispecialty care and greater levels of health IT were associated with lower depression care management scores.

Additionally, Dr. Bishop and her colleagues found that scores for depression treatment positively correlated with a practice having been established longer, being in the South vs. the Northeast, and having higher health IT scores. Negative correlations were found for depression care management and a practice being multispecialty rather than primary care only, and the practice being in the Midwest vs. the Northeast.

It is unclear whether the minimal use of chronic care processes for depression is attributable to what the authors called “the historical separation between mental and physical health care” or other factors, Dr. Bishop and her colleagues wrote.

The Robert Wood Johnson Foundation funded the study. Dr. Bishop declared support from a National Institute on Aging career development award.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – Research is honing in on the best dose for a therapeutic vaccine shown to reduce shedding of herpes simplex virus 2 in subjects with genital herpes infections, based on results presented at the annual meeting of the American Academy of Dermatology.

The vaccine could prove an alternative to antiviral therapy for infected patients.

In a phase II study of 310 HSV-2 infected adults, the subjects who received 60 mcg of recombinant HSV antigens gD and ICP4 and 75 mcg of Matrix M-2 adjuvant had the best response, which was a 58% reduction in viral shedding at 6 months, reported Dr. Zeena Nawas, a researcher at the Center for Clinical Studies in Houston.

The vaccine, GEN 003 (Genocea) is an HSV-2 protein subunit vaccine consisting of two recombinant T-cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D. The vaccine had a “profound and durable” effect on viral shedding and could become “the first therapeutic vaccine for genital herpes,” Dr. Nawas said.

Previously, Dr. Nawas and her colleagues demonstrated GEN 003 was associated with significant reductions in genital lesions and viral shedding. The new phase II data indicates a best dose combination of antigen and adjuvant for a vaccine candidate for future trials.

For the dose-finding study, seven cohorts were derived from 310 adults with symptomatic genital herpes. Subjects were randomly assigned to receive 30 mcg or 60 mcg each of the recombinant HSV antigens gD and ICP4, plus 25, 50, or 75 mcg of the Matrix M-2 adjuvant; one cohort received a placebo vaccine.

At 6 months after immunization, genital HSV-2 shedding was significantly reduced compared to baseline values in all vaccine groups who received 60 mcg of HSV-2 antigens. The highest reduction at 58% (P less than .0001) was observed in group given the 60/75 mcg dose. With the exception of the group given the 30/25 mcg dose, all study groups had a reduction from baseline measures in genital lesions that ranged from 43% to 69% (P less than .0001).

In response to a question from session comoderator Dr. Andrew Blauvelt, president of the Oregon Medical Research Center, Dr. Nawas said that the placebo group did not have any reduction in viral shedding, making the reductions in viral shedding “clinically and statistically significant. If we have less shedding, that means that the risk of transmission is way less.”Data used to determine the clinically significant correlation between shedding and transmission were derived frompreviously reported dataon antiviral therapies. Few participants across the cohort reported adverse events, according to Dr. Nawas. Myalgia, fatigue, and erythema at the injection site were the most common adverse events. The details of the studyare available at ClinicalTrials.gov. The study is sponsored by Genocea Biosciences, maker of GEN-003.

WASHINGTON – Research is honing in on the best dose for a therapeutic vaccine shown to reduce shedding of herpes simplex virus 2 in subjects with genital herpes infections, based on results presented at the annual meeting of the American Academy of Dermatology.

The vaccine could prove an alternative to antiviral therapy for infected patients.

In a phase II study of 310 HSV-2 infected adults, the subjects who received 60 mcg of recombinant HSV antigens gD and ICP4 and 75 mcg of Matrix M-2 adjuvant had the best response, which was a 58% reduction in viral shedding at 6 months, reported Dr. Zeena Nawas, a researcher at the Center for Clinical Studies in Houston.

The vaccine, GEN 003 (Genocea) is an HSV-2 protein subunit vaccine consisting of two recombinant T-cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D. The vaccine had a “profound and durable” effect on viral shedding and could become “the first therapeutic vaccine for genital herpes,” Dr. Nawas said.

Previously, Dr. Nawas and her colleagues demonstrated GEN 003 was associated with significant reductions in genital lesions and viral shedding. The new phase II data indicates a best dose combination of antigen and adjuvant for a vaccine candidate for future trials.

For the dose-finding study, seven cohorts were derived from 310 adults with symptomatic genital herpes. Subjects were randomly assigned to receive 30 mcg or 60 mcg each of the recombinant HSV antigens gD and ICP4, plus 25, 50, or 75 mcg of the Matrix M-2 adjuvant; one cohort received a placebo vaccine.

At 6 months after immunization, genital HSV-2 shedding was significantly reduced compared to baseline values in all vaccine groups who received 60 mcg of HSV-2 antigens. The highest reduction at 58% (P less than .0001) was observed in group given the 60/75 mcg dose. With the exception of the group given the 30/25 mcg dose, all study groups had a reduction from baseline measures in genital lesions that ranged from 43% to 69% (P less than .0001).

In response to a question from session comoderator Dr. Andrew Blauvelt, president of the Oregon Medical Research Center, Dr. Nawas said that the placebo group did not have any reduction in viral shedding, making the reductions in viral shedding “clinically and statistically significant. If we have less shedding, that means that the risk of transmission is way less.”Data used to determine the clinically significant correlation between shedding and transmission were derived frompreviously reported dataon antiviral therapies. Few participants across the cohort reported adverse events, according to Dr. Nawas. Myalgia, fatigue, and erythema at the injection site were the most common adverse events. The details of the studyare available at ClinicalTrials.gov. The study is sponsored by Genocea Biosciences, maker of GEN-003.

WASHINGTON – Research is honing in on the best dose for a therapeutic vaccine shown to reduce shedding of herpes simplex virus 2 in subjects with genital herpes infections, based on results presented at the annual meeting of the American Academy of Dermatology.

The vaccine could prove an alternative to antiviral therapy for infected patients.

In a phase II study of 310 HSV-2 infected adults, the subjects who received 60 mcg of recombinant HSV antigens gD and ICP4 and 75 mcg of Matrix M-2 adjuvant had the best response, which was a 58% reduction in viral shedding at 6 months, reported Dr. Zeena Nawas, a researcher at the Center for Clinical Studies in Houston.

The vaccine, GEN 003 (Genocea) is an HSV-2 protein subunit vaccine consisting of two recombinant T-cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D. The vaccine had a “profound and durable” effect on viral shedding and could become “the first therapeutic vaccine for genital herpes,” Dr. Nawas said.

Previously, Dr. Nawas and her colleagues demonstrated GEN 003 was associated with significant reductions in genital lesions and viral shedding. The new phase II data indicates a best dose combination of antigen and adjuvant for a vaccine candidate for future trials.

For the dose-finding study, seven cohorts were derived from 310 adults with symptomatic genital herpes. Subjects were randomly assigned to receive 30 mcg or 60 mcg each of the recombinant HSV antigens gD and ICP4, plus 25, 50, or 75 mcg of the Matrix M-2 adjuvant; one cohort received a placebo vaccine.

At 6 months after immunization, genital HSV-2 shedding was significantly reduced compared to baseline values in all vaccine groups who received 60 mcg of HSV-2 antigens. The highest reduction at 58% (P less than .0001) was observed in group given the 60/75 mcg dose. With the exception of the group given the 30/25 mcg dose, all study groups had a reduction from baseline measures in genital lesions that ranged from 43% to 69% (P less than .0001).

In response to a question from session comoderator Dr. Andrew Blauvelt, president of the Oregon Medical Research Center, Dr. Nawas said that the placebo group did not have any reduction in viral shedding, making the reductions in viral shedding “clinically and statistically significant. If we have less shedding, that means that the risk of transmission is way less.”Data used to determine the clinically significant correlation between shedding and transmission were derived frompreviously reported dataon antiviral therapies. Few participants across the cohort reported adverse events, according to Dr. Nawas. Myalgia, fatigue, and erythema at the injection site were the most common adverse events. The details of the studyare available at ClinicalTrials.gov. The study is sponsored by Genocea Biosciences, maker of GEN-003.

WASHINGTON – Research is honing in on the best dose for a therapeutic vaccine shown to reduce shedding of herpes simplex virus 2 in subjects with genital herpes infections, based on results presented at the annual meeting of the American Academy of Dermatology.

The vaccine could prove an alternative to antiviral therapy for infected patients.

In a phase II study of 310 HSV-2 infected adults, the subjects who received 60 mcg of recombinant HSV antigens gD and ICP4 and 75 mcg of Matrix M-2 adjuvant had the best response, which was a 58% reduction in viral shedding at 6 months, reported Dr. Zeena Nawas, a researcher at the Center for Clinical Studies in Houston.

The vaccine, GEN 003 (Genocea) is an HSV-2 protein subunit vaccine consisting of two recombinant T-cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D. The vaccine had a “profound and durable” effect on viral shedding and could become “the first therapeutic vaccine for genital herpes,” Dr. Nawas said.

Previously, Dr. Nawas and her colleagues demonstrated GEN 003 was associated with significant reductions in genital lesions and viral shedding. The new phase II data indicates a best dose combination of antigen and adjuvant for a vaccine candidate for future trials.

For the dose-finding study, seven cohorts were derived from 310 adults with symptomatic genital herpes. Subjects were randomly assigned to receive 30 mcg or 60 mcg each of the recombinant HSV antigens gD and ICP4, plus 25, 50, or 75 mcg of the Matrix M-2 adjuvant; one cohort received a placebo vaccine.

At 6 months after immunization, genital HSV-2 shedding was significantly reduced compared to baseline values in all vaccine groups who received 60 mcg of HSV-2 antigens. The highest reduction at 58% (P less than .0001) was observed in group given the 60/75 mcg dose. With the exception of the group given the 30/25 mcg dose, all study groups had a reduction from baseline measures in genital lesions that ranged from 43% to 69% (P less than .0001).

In response to a question from session comoderator Dr. Andrew Blauvelt, president of the Oregon Medical Research Center, Dr. Nawas said that the placebo group did not have any reduction in viral shedding, making the reductions in viral shedding “clinically and statistically significant. If we have less shedding, that means that the risk of transmission is way less.”Data used to determine the clinically significant correlation between shedding and transmission were derived frompreviously reported dataon antiviral therapies. Few participants across the cohort reported adverse events, according to Dr. Nawas. Myalgia, fatigue, and erythema at the injection site were the most common adverse events. The details of the studyare available at ClinicalTrials.gov. The study is sponsored by Genocea Biosciences, maker of GEN-003.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – Research is honing in on the best dose for a therapeutic vaccine shown to reduce shedding of herpes simplex virus 2 in subjects with genital herpes infections, based on results presented at the annual meeting of the American Academy of Dermatology.

The vaccine could prove an alternative to antiviral therapy for infected patients.

In a phase II study of 310 HSV-2 infected adults, the subjects who received 60 mcg of recombinant HSV antigens gD and ICP4 and 75 mcg of Matrix M-2 adjuvant had the best response, which was a 58% reduction in viral shedding at 6 months, reported Dr. Zeena Nawas, a researcher at the Center for Clinical Studies in Houston.

The vaccine, GEN 003 (Genocea) is an HSV-2 protein subunit vaccine consisting of two recombinant T-cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D. The vaccine had a “profound and durable” effect on viral shedding and could become “the first therapeutic vaccine for genital herpes,” Dr. Nawas said.

Previously, Dr. Nawas and her colleagues demonstrated GEN 003 was associated with significant reductions in genital lesions and viral shedding. The new phase II data indicates a best dose combination of antigen and adjuvant for a vaccine candidate for future trials.

For the dose-finding study, seven cohorts were derived from 310 adults with symptomatic genital herpes. Subjects were randomly assigned to receive 30 mcg or 60 mcg each of the recombinant HSV antigens gD and ICP4, plus 25, 50, or 75 mcg of the Matrix M-2 adjuvant; one cohort received a placebo vaccine.

At 6 months after immunization, genital HSV-2 shedding was significantly reduced compared to baseline values in all vaccine groups who received 60 mcg of HSV-2 antigens. The highest reduction at 58% (P less than .0001) was observed in group given the 60/75 mcg dose. With the exception of the group given the 30/25 mcg dose, all study groups had a reduction from baseline measures in genital lesions that ranged from 43% to 69% (P less than .0001).

In response to a question from session comoderator Dr. Andrew Blauvelt, president of the Oregon Medical Research Center, Dr. Nawas said that the placebo group did not have any reduction in viral shedding, making the reductions in viral shedding “clinically and statistically significant. If we have less shedding, that means that the risk of transmission is way less.”Data used to determine the clinically significant correlation between shedding and transmission were derived frompreviously reported dataon antiviral therapies. Few participants across the cohort reported adverse events, according to Dr. Nawas. Myalgia, fatigue, and erythema at the injection site were the most common adverse events. The details of the studyare available at ClinicalTrials.gov. The study is sponsored by Genocea Biosciences, maker of GEN-003.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – Research is honing in on the best dose for a therapeutic vaccine shown to reduce shedding of herpes simplex virus 2 in subjects with genital herpes infections, based on results presented at the annual meeting of the American Academy of Dermatology.

The vaccine could prove an alternative to antiviral therapy for infected patients.

In a phase II study of 310 HSV-2 infected adults, the subjects who received 60 mcg of recombinant HSV antigens gD and ICP4 and 75 mcg of Matrix M-2 adjuvant had the best response, which was a 58% reduction in viral shedding at 6 months, reported Dr. Zeena Nawas, a researcher at the Center for Clinical Studies in Houston.

The vaccine, GEN 003 (Genocea) is an HSV-2 protein subunit vaccine consisting of two recombinant T-cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D. The vaccine had a “profound and durable” effect on viral shedding and could become “the first therapeutic vaccine for genital herpes,” Dr. Nawas said.

Previously, Dr. Nawas and her colleagues demonstrated GEN 003 was associated with significant reductions in genital lesions and viral shedding. The new phase II data indicates a best dose combination of antigen and adjuvant for a vaccine candidate for future trials.

For the dose-finding study, seven cohorts were derived from 310 adults with symptomatic genital herpes. Subjects were randomly assigned to receive 30 mcg or 60 mcg each of the recombinant HSV antigens gD and ICP4, plus 25, 50, or 75 mcg of the Matrix M-2 adjuvant; one cohort received a placebo vaccine.

At 6 months after immunization, genital HSV-2 shedding was significantly reduced compared to baseline values in all vaccine groups who received 60 mcg of HSV-2 antigens. The highest reduction at 58% (P less than .0001) was observed in group given the 60/75 mcg dose. With the exception of the group given the 30/25 mcg dose, all study groups had a reduction from baseline measures in genital lesions that ranged from 43% to 69% (P less than .0001).

In response to a question from session comoderator Dr. Andrew Blauvelt, president of the Oregon Medical Research Center, Dr. Nawas said that the placebo group did not have any reduction in viral shedding, making the reductions in viral shedding “clinically and statistically significant. If we have less shedding, that means that the risk of transmission is way less.”Data used to determine the clinically significant correlation between shedding and transmission were derived frompreviously reported dataon antiviral therapies. Few participants across the cohort reported adverse events, according to Dr. Nawas. Myalgia, fatigue, and erythema at the injection site were the most common adverse events. The details of the studyare available at ClinicalTrials.gov. The study is sponsored by Genocea Biosciences, maker of GEN-003.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Better patient care means seeing to a patient’s overall health, according to Dr. Michael L. Kochman, chair of the American Gastroenterological Association’s Center for GI Innovation and Technology.

Dr. Kochman says that, thanks to recent innovations, different management strategies for certain diseases such as Barrett’s esophagus has meant gastroenterology has seen “rapid progress and significant change,” all of which are leading to better patient outcomes. Ablative techniques, for example, have helped reduce the number of thoracotomies performed in patients with Barrett’s.

Hear about other innovations in GI in this video. You can also visit the center’s website.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Better patient care means seeing to a patient’s overall health, according to Dr. Michael L. Kochman, chair of the American Gastroenterological Association’s Center for GI Innovation and Technology.

Dr. Kochman says that, thanks to recent innovations, different management strategies for certain diseases such as Barrett’s esophagus has meant gastroenterology has seen “rapid progress and significant change,” all of which are leading to better patient outcomes. Ablative techniques, for example, have helped reduce the number of thoracotomies performed in patients with Barrett’s.

Hear about other innovations in GI in this video. You can also visit the center’s website.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – Better patient care means seeing to a patient’s overall health, according to Dr. Michael L. Kochman, chair of the American Gastroenterological Association’s Center for GI Innovation and Technology.

Dr. Kochman says that, thanks to recent innovations, different management strategies for certain diseases such as Barrett’s esophagus has meant gastroenterology has seen “rapid progress and significant change,” all of which are leading to better patient outcomes. Ablative techniques, for example, have helped reduce the number of thoracotomies performed in patients with Barrett’s.

Hear about other innovations in GI in this video. You can also visit the center’s website.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – For those who seek to shape rather than react to the future of gastroenterology, attendance at the American Gastroenterological Association annual Tech Summit is essential.

While personalized medicine is poised to revolutionize medicine across the specialties, “We have some surprises upcoming in how we can really leverage and apply [personalized medicine] in gastroenterology,” says Dr. Michael L. Kochman, AGAF, chair of the AGA Center for GI Innovation and Technology.

Among new devices that will be featured at this year’s Tech Summit will be some from the bariatric and antireflux spaces, according to Dr. Kochman.

“Our ability to influence the future, rather than react to it is critical,” he says.

To learn more visit www.techsummit.gastro.org. Look out for the AGA’s Tech Summit report with videos and articles highlighting the most interesting talks from the summit.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – For those who seek to shape rather than react to the future of gastroenterology, attendance at the American Gastroenterological Association annual Tech Summit is essential.

While personalized medicine is poised to revolutionize medicine across the specialties, “We have some surprises upcoming in how we can really leverage and apply [personalized medicine] in gastroenterology,” says Dr. Michael L. Kochman, AGAF, chair of the AGA Center for GI Innovation and Technology.

Among new devices that will be featured at this year’s Tech Summit will be some from the bariatric and antireflux spaces, according to Dr. Kochman.

“Our ability to influence the future, rather than react to it is critical,” he says.

To learn more visit www.techsummit.gastro.org. Look out for the AGA’s Tech Summit report with videos and articles highlighting the most interesting talks from the summit.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – For those who seek to shape rather than react to the future of gastroenterology, attendance at the American Gastroenterological Association annual Tech Summit is essential.

While personalized medicine is poised to revolutionize medicine across the specialties, “We have some surprises upcoming in how we can really leverage and apply [personalized medicine] in gastroenterology,” says Dr. Michael L. Kochman, AGAF, chair of the AGA Center for GI Innovation and Technology.

Among new devices that will be featured at this year’s Tech Summit will be some from the bariatric and antireflux spaces, according to Dr. Kochman.

“Our ability to influence the future, rather than react to it is critical,” he says.

To learn more visit www.techsummit.gastro.org. Look out for the AGA’s Tech Summit report with videos and articles highlighting the most interesting talks from the summit.

[email protected]

On Twitter @whitneymcknight