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Sep 04, 2017 Regarding the status of the TREASURE exam On Friday, September 1 , we announced the announcement concerning the clinical trial ( TREASURE test) targeting cerebral infarction in Japan of somatic stem cell regeneration drug HLCM 051 . Notice on clinical trials for cerebral infarction in Japan (TREASURE test) of somatic stem cell regeneration drug HLCM 051
You may be worried about what it is like by interrupting the trial temporarily. I hope I can explain as much as possible. The place where this trouble was found is placebo (placebo). It is an intravenous preparation which does not contain active ingredients and resembles cell preparation (HLCM 051). Although it does not contain active ingredients, what is it is stated in the notification of clinical trials and submitted. However, this time we found that placebo preparations that were made at concentrations different from the concentrations of the constituents of the placebo described in the clinical trial report were distributed. Therefore, we have to temporarily suspend clinical trials because we need to rebuild the placebo manufactured at the correct concentration and distribute it again. If you are going to rebuild only the placebo formulation, why not just administer HLCM 051 in the meantime? You might think that. This clinical trial is a "placebo-controlled double-blind study". The patient is divided into two groups, one is administered with HLCM 051 and the other is administered with placebo. Whether the administered substance is HLCM 051 or placebo, also do not know the doctor who administered the patient, accumulate data such as efficacy and safety for each group, and compare the results with each other to make the investigational drug fair It is objectively evaluated. Because it is a method of comparing two groups, we can not proceed clinical trials with only HLCM 051 at hand.
Proper placebo formulation is already in production at a manufacturing consignment company in the US and it is expected to take about a month to ship after undergoing the procedure of quality inspection etc. on site after manufacture. After that, it will be delivered to the clinical trial facilities in Japan through a prescribed procedure, so it is expected that it will be necessary for one month to resume. Since administration to patients has not yet begun, there are also patients to whom this placebo formulation was administered, so safety problems and so on have not occurred. It has been nearly a year since submission of the report of the clinical trial, and I am feeling a lot hard to tell the progress, but on the other hand preparation for a clinical trial clinical trial is progressing steadily. We will restart sequentially as soon as the trial products are neat. We will seek further quality and product management from our affiliated Assassis, and we will work closely together to deliver new treatments, so please continue your continued support.