Please refer below for
answers to shareholders’ question about the diabetic foot ulcer clinical trial.
1. Efficacy Analysis
Set: There were number of questions on whether or not to include two subjects
who met exclusion criteria in the efficacy analysis set.
Answer: According to
international guidelines, the analysis of clinical trial data should be
performed on two analysis sets; 1) a group of patients who have been enrolled
and received an investigational drug at least once (mITT; modified
intention-to-treat) and 2) a group of patients who have been enrolled, received
an investigational drug AND did not have major protocol violation (PP; per
protocol). In general, for clinical trial where superiority is required to be
demonstrated against placebo, primary analysis set should be the mITT set. By
the definition, for DFU-301 study, patients who meet the exclusion criteria
which suit the definition of major protocol violation, will be excluded from PP
set but will be included in mITT set.
2. DFU-301 top-line
result announcement schedule: There were questions asking exact top-line result
announcement schedule as it is often said that the bio-company do not usually
discloses top-line result on the target date and the results are always
announced later than promised date.
Answer: It is bitter to
hear that. We believe those of you who work in the bio industry may have full
understanding on possible causes of delay and the fact that time required in
data cleaning and performing analysis to have top-line result is very
trial and having top-line result announcement on the “target date” (“NOT promised date”) are not solely depending on devoted work of company"s employees.
Study investigator, research coordinators, and contracted data management and
stat. team must collaborate in collecting, reviewing, correcting and finally
completing the clinical study data to draw efficacy and safety conclusions.
Especially when it comes to phase 3 study where number of hospitals (clinical
study conducting sites) are involved, it is even harder to finalize the
clinical study data by the target date, as delay from one clinical study
conducting site will inevitably impacts the overall timeline. In addition, If
an event found during data cleaning requires approval of the ethics committee,
it also causes delay yet it is impossible to predict this delay until it
actually happens. In this context, many bio/pharma companies seems to disclose
top-line results later than the “target date” (not the promised date). Like all other clinical studies,
situations like aforementioned happens in DFU-301 as well, but definitely
company is putting all time and effort to abide by the target date.
3. Questions about
clinical trial results:
Answer: Until the
analysis is completed, the company cannot know the results, and we are waiting
for the results with the same sentiments as shareholders. There were also
questions asking company’s thought on whether or not DFU-301 result will
statistical significance or not, in comparison of the results of phase 2 . We
believe calculating success probability on arbitrary assumptions do not have
real value, but requires time and effort of the clinical team who will
otherwise focus on clinical study data cleaning.
4. The primary goal of
the company DFU project is to develop a good drug for diabetic foot ulcer. By
developing promising treatment of diabetic foot ulcer, the company would like
to provide good treatment option to the patient, as well as repay the
shareholders who have trusted and invested in Anterogen"s value.
Anterogen is conducting
clinical trials of DFU-301 (Wag 1 & 2) and DFU-302 (Wag 2) to achieve the
goal of developing a good treatment for diabetic foot ulcer.
As shareholders know,
the initial plan was to file a NDA(New Drug Application) after completing
both clinical trials of DFU-301 and DFU-302. Only in case when the DFU-301
clinical trial alone yields statistically significant results similar to phase
2 clinical trial, the company will file an NDA with DFU-301 data alone as the
company have repeatedly said.
If DFU-301 shows good
results and company is able to submit an NDA for market approval with one
clinical trial, it is a huge achievement and happiness to company as well as to
shareholders. But even if DFU-301 does not demonstrate statistically
significant results primarily owing to not sufficient number of Wag 2 patients
enrolled in DFU-301 study, the company still can prove the efficacy of the drug
with DFU-302 study, as initially planned. The true value of Anterogen shall be
remained as it is and was.
All information expressed herein are intended to provide answers to the
shareholders questions. Although best efforts are made to ensure that all
information is accurate and up to date, occasionally unintended errors may
occur. Each Individual is responsible for all the risks and financial resources
that you use and chosen in stock investment to our company.