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Tekmira Pharma (TKMR) Updates on Highlights for Analyst, Investor Day; Completes TKM-PLK1 Enrollment Phase I/II

November 24, 2014 6:20 AM EST

Tekmira Pharma (Nasdaq: TKMR) announced an update from the Company's Analyst and Investor Day, which took place on November 21 in New York City. The event highlighted Tekmira's key products and clinical development plans, as well as corporate milestones for 2015 and beyond.

Key highlights from the meeting included the following:

  • The Company announced its first regulatory filing, in the form of a Clinical Trial Application (CTA) filed with Health Canada, to support its first TKM-HBV clinical trial.
    • Human trials are expected to commence in early 2015, progressing to chronically infected patients in a multi-dosing regimen in the second half of 2015
  • The Company introduced a new 'fourth generation' LNP, exhibiting significant increases in potency.
    • Two TKM-HBV product candidates will enter Phase I trials in early 2015. Both product candidates will employ the same RNAi triggers but differ based on the version of LNP used in delivery (i.e. third or fourth generation)
    • It is anticipated that proof-of-concept data for HBV surface antigen knockdown could potentially be available in 2015
  • Tekmira announced completion of patient enrolment in the Phase I/II trial of TKM-PLK1 for the treatment of Gastrointestinal Neuroendocrine Tumors (GI-NET) or Adrenocortical Carcinoma (ACC) tumors.
    • The Company remains on track to disclose interim data before the end of 2014
    • Final data for these studies is expected in mid-2015

"Tekmira has been at the forefront of the RNAi industry for the last decade, and 2014 has been a pivotal year for the Company as we continue to advance our pipeline of proprietary products to maximize value for our shareholders. In the year ahead, we intend to initiate and complete a Phase I study with TKM-HBV, participate in human clinical studies with TKM-Ebola-Guinea, release interim HCC data and full data for Phase I/II PLK1 trials in GI-NET and ACC, and file for an IND, or equivalent, for our next development candidate," said Dr. Mark J. Murray, Tekmira's President and CEO.



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