Welcome To The Mannkind HUB On AGORACOM

Edit this title from the Fast Facts Section

Free
Message: Russia finalises international tests of insulin’s new form – inhalation

"anyone else get the feeling these sites are just beginning enrollment based on the article's verbiage?"

OPC,

Yes, I did get that impression.However, according to Hakan the enrollment was going on there already in February.I felt better after learning that.

Hakan:

Enrollment in our pivotal Type 1 study, the MKC-171, is well underway. There are 42 U.S. sites that are operational, and having had successful experience with the clinical centers in Russia and Ukraine during earlier trials, we are utilizing some of those centers in the current studies. The Russian investigator meeting was held in December and the Ministry of Health has approved the protocol. The Russian site activation and recruitment have begun. Additional sites and recruitment in Ukraine will begin next.

The Type 1 trial has 3 arms, each scheduled to finish with 133 patients. 2 arms will deliver AFREZZA: 1 with the Dreamboat device, the other with the MedTone inhaler, as a bridge to our earlier trials. The third arm will use a rapid-acting analog and conventional injection therapy. All 3 cohorts will use Lancet as the basal insulin.

Our pivotal Type 2 study, the MKC-175, was initiated on schedule following the start of the Type 1 pivotal study. Site activation is well underway, with 35 U.S. sites already established and with additional sites currently being activated. The MKC-175 investigator meeting in Russia was held last week and Russian site activation and recruitment are now beginning. This is to be a superiority study in early-stage Type 2 patients failing on Metformin or Metformin plus another oral drug.

http://seekingalpha.com/article/385161-mannkind-s-ceo-discusses-q4-2011-results-earnings-call-transcript?find=russia&all=false

Share
New Message
Please login to post a reply