Cel Sci Corporation (CVM)

[Fosco1]

Taïwan Feb 2018 Minutes

search for "multikine"

you'll have to translate or believe my word that the translation is :

"4. SF14218A (Fourth Report)
1) The company entrusted the director of the hospital's otolaryngology head and neck, Zhongyu Wang (???), to conduct {an open, randomized, multiple centres clinical trial to compare the use of Multikine (Leukocyte Interleukin, Injection) plus standard therapy (surgery + radiation therapy or surgery + radiation combined with chemotherapy) and the use of standard treatment in primary advanced squamous cell carcinoma of oral and soft palate cancer (program number: CS001P3; IRB number: SF14218).} By reviewing the registered clinical laboratory result, the case is listed on August 25, 2014, Zhong Rong Ren Zi Zi No. 1030020068 was approved.

2) The safety of the drug Multikine has not changed since the seventh safety review of the drug development report. A total of 208 deaths have been accumulated so far. During the reporting period, there were 75 deaths at home and abroad. This trial was suspended from September 26, 2016 and has been notified by the Institute for reference. It was released on August 10, 2017 during this report period. In addition, there were no new safety or efficacy issues related to drug treatment, and no SUSAR was involved.

3) A copy of the Multikine Drug Safety Development Report (Development Safety Update Report No. 8, Date of Report: 16 Mar 2018, for the reporting period from February 4, 2017 to February 3, 2018) is sent to you for reference."


What it says is that 208 events where reported in Feb 2018, 75 more than Feb 2017.

It is useful in the sense that it allowed to predict a date for 298, a date which contradicted all previous publications for an early end for the trial published by Cel-SCI ("early Q1" or Ergomed's "H1" 2019), also the number was under the expected number so good hint towards efficacy