A clinical study entails the testing of a pharmaceutical preparation or a method of treatment.
Clinical studies are usually divided into four phases:
- Phase I – The first time the pharmaceutical preparation is tested on people (healthy volunteers) primarily for safety and tolerability assessment.
- Phase II – The pharmaceutical preparation is tested on a larger group of patients to see if it has the desired effect and to determine the most effective dose.
- Phase III – The pharmaceutical preparation is tested on an even larger patient group.
- Phase IV – Is carried out after the pharmaceutical preparation has been launched on the market.
PEPTONIC medical has performed three randomized, double-blind, placebo controlled studies in which the effect of oxytocin for vaginal atrophy was tested.
The first study was performed in 2010-2011 and involved 68 patients. In this study, a formulation of 600 IU oxytocin or placebo was applied intravaginally daily for an initial two weeks and thereafter twice a week for 10 weeks.
The second study was performed in 2012 and involved 64 patients. Patients were treated daily with 100 IU, 400 IU oxytocin or placebo for 7 weeks.
These two studies demonstrated that Vagitocin® increased the number of cell layers in the vaginal mucosa and the rate of maturation of the cells in the vaginal wall. In addition, the symptoms were relieved. In fact, in the second study, 53% of the patients treated with 400 IU oxytocin were free of the most bothersome symptoms after only 7 weeks of treatment. In the placebo group, the corresponding figure was7%.
A third study was completed in Q3 2015. In this study, the oxytocin containing gel was stored in an aluminum tube instead of a glass syringe as in the previous two studies. Also, the study subjects were allowed to keep the tubes on room temperature (as opposed to refrigerator in the previous studies). The results of the study showed that treatment with oxytocin did not result in any improvement compared to placebo.
During the course of the study, a few subjects reported that the gel felt runny, which triggered a suspicion that the viscosity of the gel was lower than in previous studies. It was concluded that the combination of the aluminium tube and storage in room temperature was the cause. We then issued a recommendation to the remaining subjects to store the tubes refrigerated. Analysis of this sub-group, after the trial results were known, showed a significant reduction of the most bothersome symptom compared with placebo. Additional investigations also pointed at low viscosity being the culprit. This in turn resulted in too weak adhesion to the vaginal wall and an insufficient oxytocin dose.
These encouraging results and a strong belief that the causes of the low viscosity can be eliminated prompted the board to decide to repeat the study, of course, provided that financing could be secured. So it happened. In December a rights issue and a follow-on private placement brought SEK 27.7 m to the company (before issues costs). This is a clear sign of the strong confidence in the competence resting in the company among our shareholders.
Based on these results, PEPTONIC medical started a new phase IIb study in the spring of 2016, with results expected by the end of the year.