Admedus (ASX:AHZ) has released very encouraging interim results from its Phase II clinical study for a Herpes Simplex Virus (HSV-2) therapeutic vaccine which showed a decrease in viral lesions in patients in the trial.
The trial blinded, pooled analysis of data was received from the first 20 patients to receive at least three vaccinations in the randomised, placebo–controlled HSV-2 vaccine Phase II study.
No safety issues were noted in this cohort of patients which is the primary endpoint of the Phase II trial. The data remains blinded to protect the integrity of the trial.
Significantly, there was a 90% decrease in viral lesions and outbreaks in trial patients, in the monthly rate versus baseline. A total of 14 patients also received the booster.
The average number of days HSV-2 was detected in patients was also reduced versus baseline.
Admedus CEO Mr Lee Rodne said, "We look forward to the next scheduled analysis, which will be more extensive and will be performed on unblinded data, giving us further insight into the data set. We anticipate this will be completed in the Q3 2016.”
Professor Ian Frazer said: “The initial data appears encouraging and we look forward to additional data from this study being released later this year.”
Prof Ian Frazer's company developed the next generation technology and which is now majority owned by Admedus.
Clinical Trial details
This prospectively designed, double blinded, placebo-controlled trial has randomised 44 patients to receive the Company’s COR-1 HSV-2 vaccine or placebo in a 3:1 ratio.
The primary endpoint of the study is safety.
The patients are divided into two treatment groups:
- Group 1 with 22 patients received a double inoculation split across both arms and
- Group 2 (22 patients) received the double inoculation into one arm.
The secondary endpoint and investigative endpoints included: various virological and immunological assessments such as occurrences of outbreaks (lesions), viral shedding, viral load, T-cell and antibody counts as well as safety.
Patients were assessed for monthly viral outbreaks and percentage of days where HSV-2 was detected in swabs taken from the patients relative to analogous pre-vaccination measurements as a baseline.
Post vaccination/booster virological assessments occurred over a time period of 45 days commencing seven days after the third administration (booster administrations) respectively.
This data is then compared to the baseline virological assessments of each patient occurring for a period of 45 days prior to any vaccination.
Admedus said at this point the data remains blinded and therefore no definitive conclusions can be made.
The company plans an analysis of the unblinded data from these 20 study participants to be performed during Q3 2016.
This will include assessment of the immunological endpoints including T cell response, as well as clinical and virological data.
To date, six patients have withdrawn from the trial for reasons unrelated to vaccine safety, some of whom received their vaccination.
Admedus said it anticipates all study groups to have completed their dosing, including booster, by Q4 2016 and full trial analysis data to be available by Q2 2017.
The World Health Organisation stated in October 2015 that 417 million people in the 15-49 age group are living with HSV-2.
As a result, a successful HSV-2 vaccine from Admedus could potentially address a market worth more than US$6 billion.
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