Who/ where were the human guinea pigs?
GE
http://www.drugs.com/clinical_trials/tekmira-doses-first-subject-human-clinical-trial-tkm-ebola-16415.html
January 14, 2014
Tekmira Doses First Subject in Human Clinical Trial of TKM-Ebola
VANCOUVER, British Columbia, Jan. 14, 2014 (GLOBE NEWSWIRE) -- Tekmira Pharmaceuticals Corporation[http://images.intellitxt.com/ast/adTypes/icon1.png]<http://www.drugs.com/clinical_trials/tekmira-doses-first-subject-human-clinical-trial-tkm-ebola-16415.html#> (Nasdaq:TKMR) (TSX:TKM),
a leading developer of RNA interference (RNAi) therapeutics, today announced that it has dosed the first subject in a Phase I human clinical
trial[http://images.intellitxt.com/ast/adTypes/icon1.png]<http://www.drugs.com/clinical_trials/tekmira-doses-first-subject-human-clinical-trial-tkm-ebola-16415.html#> of TKM-Ebola, an anti-Ebola viral therapeutic that is being developed under a US$140 million contract with the U.S. Department of Defense.
"We are pleased to announce the first subject has been dosed in a Phase I clinical trial[http://images.intellitxt.com/ast/adTypes/icon1.png]<http://www.drugs.com/clinical_trials/tekmira-doses-first-subject-human-clinical-trial-tkm-ebola-16415.html#> evaluating the safety of a new LNP formulation for
our TKM-Ebola therapeutic. Building upon our compelling preclinical results, the Phase I data generated will guide our determination of the
appropriate dose of this drug for the potential use as a medical[http://images.intellitxt.com/ast/adTypes/icon1.png]<http://www.drugs.com/clinical_trials/tekmira-doses-first-subject-human-clinical-trial-tkm-ebola-16415.html#> countermeasure against this lethal hemorrhagic fever virus. We remain on
track to have data from this trial available in the second half of this year," said Dr. Mark J. Murray, Tekmira's President and CEO.
"Tekmira's leadership in the area of anti-viral therapy for hemorrhagic fever viruses - and the innovations generated by our TKM-Ebola program -
have formed a strong foundation for future RNAi-based anti-viral therapeutics, such as our earlier stage TKM-Marburg candidate," added Dr. Murray.
The TKM-Ebola Phase I clinical trial is a randomized, single-blind, placebo-controlled study involving single ascending doses and multiple ascending
doses of TKM-Ebola. The study will assess the safety, tolerability and pharmacokinetics of administering TKM-Ebola to healthy[http://images.intellitxt.com/ast/adTypes/lb_icon1.png]<http://www.drugs.com/clinical_trials/tekmira-doses-first-subject-human-clinical-trial-tkm-ebola-16415.html#> adult subjects.
Four subjects will be enrolled per cohort. There are four planned cohorts for a total of 16 subjects in the single dose arm, and three planned cohorts
for a total of 12 subjects in the multiple dose arm of the trial. Each cohort will enroll three subjects who receive TKM-Ebola, and one who will receive placebo.
About TKM-Ebola
TKM-Ebola, an anti-Ebola viral therapeutic, is being developed under a contract with the U.S. Department of Defense's Joint Project Manager[http://images.intellitxt.com/ast/adTypes/icon1.png]<http://www.drugs.com/clinical_trials/tekmira-doses-first-subject-human-clinical-trial-tkm-ebola-16415.html#> Medical
Countermeasure Systems (JPM-MCS), with a total contract value of approximately $140 million. Earlier preclinical studies were published in the medical
journal The Lancet and demonstrated that when siRNA targeting the Ebola virus and delivered by Tekmira's LNP technology were used to treat previously
infected non-human primates, the result was 100 percent protection[http://images.intellitxt.com/ast/adTypes/icon1.png]<http://www.drugs.com/clinical_trials/tekmira-doses-first-subject-human-clinical-trial-tkm-ebola-16415.html#> from an otherwise lethal dose of Zaire Ebola virus (Geisbert et al., The Lancet, Vol 375, May 29, 2010).
Tekmira's productive collaboration with the JPM-MCS was modified and expanded in 2013 to include significant advances in LNP formulation technology
since the initiation of the program in 2010.
About BioDefense Therapeutics (BD Tx)
This work is being conducted under contract with the US Department of Defense's (DoD) BioDefense Therapeutics (BD Tx), a Joint Product Manager within
the Medical Countermeasure Systems (JPM-MCS) Joint Project Management Office. A component of the Joint Program Executive[http://images.intellitxt.com/ast/adTypes/icon1.png]<http://www.drugs.com/clinical_trials/tekmira-doses-first-subject-human-clinical-trial-tkm-ebola-16415.html#> Office for Chemical and
Biological Defense, JPM-MCS aims to provide U.S. military forces and the nation with safe, effective and innovative medical solutions to counter chemical,
biological, radiological and nuclear threats. JPM-MCS facilitates the advanced development and acquisition of medical countermeasures and systems to
enhance our nation's biodefense response capability. For more information, visit www.jpeocbd.osd.mil .
--
You received this message because you are subscribed to the "USA-Africa Dialogue Series" moderated by Toyin Falola, University of Texas at Austin.
For current archives, visit http://groups.google.com/group/USAAfricaDialogue
For previous archives, visit http://www.utexas.edu/conferences/africa/ads/index.html
To post to this group, send an email to USAAfricaDialogue@googlegroups.com
To unsubscribe from this group, send an email to USAAfricaDialogue-
unsubscribe@googlegroups.com
---
You received this message because you are subscribed to the Google Groups "USA Africa Dialogue Series" group.
To unsubscribe from this group and stop receiving emails from it, send an email to usaafricadialogue+unsubscribe@googlegroups.com.
For more options, visit https://groups.google.com/d/optout.
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment