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Tekmira Sees Resolution to Ebola Drug Clinical Hold by Year-end

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NEW YORK (GenomeWeb) – Tekmira Pharmaceuticals this week provided an update on its investigational Ebola infection therapy TKM-Ebola, stating that it expects to provide US regulators with the information required to resume clinical testing of the drug by the fourth quarter of this year.

Meanwhile, the company is aiming to begin a Phase I study of its hepatitis B treatment TKM-HBV in 2015, and unveil its newest pipeline candidate by year-end.

Tekmira also released its financial results for the second quarter this week, posting a rise in net losses amid sharply increased research and development spending.

In July, Tekmira announced that the US Food and Drug Administration halted the multiple ascending dose portion of a Phase I study of TKM-Ebola in healthy volunteers until it received additional information about cytokine induction observed in those who had received the highest dose of the drug in the trial's single-dose arm.

Notably, none of the trial participants are receiving pre-medication to address siRNA-related immune responses — something that Tekmira had included in previous clinical studies of other drugs but does not intend to do with TKM-Ebola.

Earlier this month, the company said that the FDA had agreed to let the company provide the drug for use in Ebola-infected individuals in light of an outbreak of the disease in Africa. The hold on the clinical study, however, remains in place.

This week, Tekmira, which is amending the protocol of the clinical study to ensure the safety of its participants, said that it expects to have addressed the FDA's concerns by the fourth quarter.

As for TKM-Ebola's use in infected individuals, Tekmira said that "the regulatory framework to support its use in Africa has not yet been established," adding that "there can be no assurance that an appropriate framework for the use of this product will be found."

Meanwhile, the company said it continues to make progress with its TKM-HBV and expects to file an investigational new drug application or international equivalent for the agent in the second half of this year. Phase I testing is expected to begin in 2015.

Q2

For the three-month period ended June 30, Tekmira's net loss rose to $6.1 million, or $.28 a share, versus a year-ago loss of $3 million, or $.21 per share.

Contributing to the loss increase were climbing R&D costs, which rose to $9.3 million from $4.9 million, as well as a $1 million jump in general and administrative expenses to $1.8 million.

Revenues in the period fell to $1.8 million from $2.8 million.

At the end of June, Tekmira had cash, cash equivalents, and investments totaling $129.5 million.

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