NEW YORK (GenomeWeb) – Amid the growing outbreak of Ebola virus in West Africa, investors been paying close attention to Tekmira Pharmaceuticals and its Phase I treatment for the hemorrhagic fever, putting the company's shares on a rollercoaster ride in recent months.
Since the World Health Organization first declared the outbreak on March 25, Tekmira's stock has sold as low as $8.91 and as high as $26.05, with more than 28 million shares trading hands on a single day.
Ebola has long been a focus for Tekmira, with the company and collaborators at the United States Army Medical Research Institute of Infectious Diseases reporting data in 2006 showing the lipid nanoparticle-delivered siRNAs could protect guinea pigs against lethal doses of the virus. A few years later, the partners published data demonstrating that similar protection could be achieved in non-human primates.
Buoyed by these results, in 2010 Tekmira officially added its Ebola therapy, dubbed TKM-Ebola, to its pipeline. Around that time, the company also received a contract worth up to $140 million from the US Department of Defense Chemical and Biological Defense Program to develop the drug through US Food and Drug Administration approval.
Since then, however, the road for TKM-Ebola has not been entirely smooth.
After initiating a Phase I study of the agent in healthy volunteers in early 2012, Tekmira's DoD contract was abruptly put on hold several months later as the agency evaluated its different programs amid budgetary constraints. On that news, shares of Tekmira fell nearly 10 percent to $2.98. In October, however, the DoD restarted the contract.
Tekmira then chose to scrap its existing version of TKM-Ebola in favor of a newer form that incorporated improved lipid-based delivery nanoparticles. It received the green light to move the enhanced product into Phase I testing in late 2013 and began enrolling healthy volunteers in January, at which point the company's shares were trading around $12.
Tekmira got a big shot in the arm in early March when the US Food and Drug Administration granted TKM-Ebola fast track designation, which provides a drug with an expedited review process. The news pushed the company's shares up more than 25 percent to $24.92.
After climbing even higher in the following weeks, Tekmira shares began a descent back to the low-to-mid teens during the late spring and early summer. By mid-July, shortly after Tekmira disclosed that the FDA had placed a hold on the Phase I trial of TKM-Ebola until the company provided additional safety data on the drug, they dipped below $10 for the first time since the study began.
With confirmed cases of Ebola in Africa nearing 1,000, earlier this month the FDA amended its clinical hold on TKM-Ebola to allow its use in infected individuals. Even though Tekmira cautioned that there is no regulatory framework in place for the drug to support its use in Africa, Wall Street responded positively to the development, sending Tekmira's stock up nearly 50 percent during the next day's trading to $20.70, with roughly 28.6 million being bought and sold.
During midday trading on Tuesday, Tekmira's shares were selling at around $19.