After being halted today at the market close, Tekmira (TSX:TKM) announced that the FDA had verbally confirmed it had modified the full clinical hold placed on its TKM-Ebola treatment, in light of the worst outbreak of the disease ever.
Shares of the company are up more than 8% on the Nasdaq after-market.
“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. The foresight shown by the FDA removes one potential roadblock to doing so,” said CEO Dr. Mark Murray. “This current outbreak underscores the critical need for effective therapeutic agents to treat the Ebola virus. 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.”
Earlier this week, there was speculation that American missionary Nancy Writebol had received Tekmira’s experimental Ebola drug, but the company denied that was the case. Writebol and another American, Dr. Kent Brantly, were infected at the same centre in Liberia. More recent takes suggests the experimental drug used was called ZMapp, but its manufacture told the AP that it would take months to produce even a small amount of that treatment.
Scrambling officials are likely looking towards Tekmira because its treatment successfully protected four monkeys who were given seven doses of the treatment after being infected with high-doses of Ebola in a 2010 study. Other treatment include an experimental flu drug from Fujifilm Holdings.
On Wednesday, the World Health Organization announced Wednesday that 932 Ebola-related deaths had been reported or confirmed. Dr. Tom Frieden, director of the U.S. Centers for Disease Control said the outbreak was the worst in history.
Burnaby based Tekmira, which was founded in 2005, is one of a handful of companies in the world developing therapies based on RNA interference, and the company is clearly an early leader in the space. RNA interference is a process that cells use to silence the activity of specific genes. The process works by blocking the molecular messengers of a a cell, rendering the cell useless. RNAi has already shown great potential with viruses such as HIV and Hepatitis C. Tekmira has three internal RNA interference product candidates; one to treat hypercholesterolemia, or elevated cholesterol, one for Ebola, and an anti-tumour drug in the treatment of cancer.
Shares of Tekmira on the TSX closed today up 6.6% to $15.61.