Tekmira Pharmaceuticals (TSX:TKM, Stock Forum) gained a fair amount of notoriety during the recent outbreak of Ebola in West Africa when it was speculated that the company had supplied its TKM-Ebola as an experimental treatment for two American aid workers infected with the virus.
That was not the case as the company was quick to quell those rumors, stating that its Ebola therapy, even though the furtherest along in the regulatory process, was still in Phase I clinical trials.
All that changed today when the company announced that the US Food & Drug Administration (FDA) verbally confirmed they have upgraded the status of TKM-Ebola Investigational New Drug Application (IND) from full clinical hold to partial clinical hold which would enable the potential use of TKM-Ebola in individuals infected by the virus.
According to the news release, the company is working in concert with the US Department of Defense's Medical Countermeasure Systems BioDefense Therapeutics (MCS-BDTX) Joint Product Management Office to develop TKM-Ebola.
Dr. Mark Murray, Tekmira Pharmaceuticals President and CEO, commented on the milestone, “We are pleased that the FDA has considered the risk-reward of TKM-Ebola for infected patients. We have been closely watching the Ebola virus outbreak and its consequences, and we are willing to assist with any responsible use of TKM-Ebola.”
He continued, “The foresight shown by the FDA removes one potential roadblock to doing so. This current outbreak underscores the critical need for effective therapeutic agents to treat the Ebola virus.”
Then he concluded, “We recognize the heightened urgency of this situation, and are carefully evaluating options for use of our investigational drug within accepted clinical and regulatory protocols.”
The release went on to note that the company remains on clinical hold in regards to the multi-ascending dose portion of the Phase I clinical study in healthy volunteers with TKM-Ebola, but it is working on an expedient resolution that would advance the drug for multiple ascending dose regimen evaluation.
Shares jumped 47.34% on the news to $23.00 per share.
Currently there are 22.1m outstanding shares with a market cap of $507.8 million.