Tekmira Pharmaceuticals saw its stock leap today (Monday) after regulators agreed that its highly experimental Ebola drug can be used in patients who have or are thought to have contracted the deadly disease.
The Vancouver, Canada-based group said domestic and US health authorities have authorised an expanded access protocol for the drug, TKM-Ebola, which basically enables the treatment of seriously-ill patients who cannot take part in normal clinical trials.
“TKM-Ebola has been administered to a number of patients and the repeat infusions have been well tolerated,” said chief executive Mark Murray, but he also noted that “it must be kept in mind that any uses of the product under expanded access, does not constitute controlled clinical trials”.
“These patients may be infected with a strain of Ebola virus which has emerged subsequent to the strain that our product is directed against, and physicians treating these patients may use more than one therapeutic intervention in an effort to achieve the best outcome,” he cautioned.
Highs and lows
Nevertheless, the company’s share price, which has seen a lot of ups and downs in recent months relating to developments with its Ebola drug, had climbed 17% on the NasdaqCM in late-afternoon trading, as investors welcomed the news.
The stock took a hit after US officials placed TKM-Ebola on ‘clinical hold’ back in July, requesting data to clarify the mechanism of potential cytokine release and a modification to the protocol for the multiple ascending dose portion of the trial, but rallied again after this was reduced to a ‘partial’ hold in August to help pave the way for its potential use in Ebola-infected patients.
Tekmira is developing the an anti-Ebola RNAi therapeutic under a $140-million contract with the US Department of Defence, but it warned that supplies are limited.
Preclinical studies, published in the The Lancet, have shown that administering an siRNA targeting the Ebola virus via Tekmira's LNP technology to previously infected non-human primates resulted in 100% protection from an otherwise lethal dose of Zaire Ebola virus, raising hopes over its potential to fight the disease.