Maxim Analyst Issues Update On Tekmira's Ebola Research Development

In a report published Monday, Maxim Group analyst Jason Kolbert commented on Tekmira Pharmaceuticals Corp (NASDAQ: TKMR)'s ongoing research into the Ebola virus. Tekmira is part of an international consortium known as the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) to produce TKM-Ebola for clinical trials in West Africa.

Kolbert noted that the FDA has modified the partial clinical hold on TKM-Ebola to permit repeat dosing up to 0.24 mg/kg/day in healthy volunteers, but the hold remains in place for higher doses. In addition, a phase I study is expected to resume in several weeks with final data set for the second half of 2014.

TKM-Ebola has been on a clinical hold as the FDA previously requested safety data on ascending doses and appears that they are now comfortable in allowing the higher doses.

"What does this mean?" Kolbert wrote. "It's good news, TKM-Ebola so far appears to be safe with repeat and ascending dosing. RNAi therapy is likely not going to be a one-shot cure for acute infections like Ebola. Much like an oral anti-viral, RNAi may need to be given multiple times to achieve viral clearance."

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Kolbert concluded that the Ebola disease is highly infectious with a short incubation period and a high mortality rate. As such, TKM-Ebola should qualify to progress through the Animal Rule pathway (an FDA regulatory rule in which it marketing approval can be granted upon animal testing) just like similar products were approved to combat the bubonic plague and anthrax.

Shares remain Buy rated with a $27 price target.