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Tekmira to Present Cancer Drug Data at AACR, Aims for Phase II by Year-End

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Tekmira Pharmaceuticals this week said that it has completed the main part of a phase I study of the siRNA-based cancer drug TKM-PLK1, and is slated to present the trial’s results in two weeks at the American Association for Cancer Research’s annual meeting.

According to Tekmira President and CEO Mark Murray, the firm is also halfway through enrollment in a 10-patient expansion arm of the trial, with patients receiving the maximum tolerated dose of TKM-PLK1, and expects to release data from this part of the study before year end.
A phase II trial of the drug remains on schedule to begin in the second half of the year, Murray added, speaking during a conference call held to discuss Tekmira’s 2012 financial results.

TKM-PLK1 targets the cell cycle protein polo-like kinase 1 and is formulated with Tekmira’s proprietary lipid nanoparticle technology. Last summer, the company presented interim phase I data showing the agent to be well tolerated despite an “aggressive dosing regimen” (GSN 8/16/2012).

Meanwhile, Tekmira continues to work on a new formulation of its Ebola drug TKM-Ebola, which is being developed under a $140 million contract with the US Department of Defense.

Although the drug was already moved into phase I testing, Tekmira is tweaking it with an improved lipid nanoparticle, and still needs to submit the new formulation to the US Food and Drug Administration.

“It is expected that the LNP formulation work will be completed and submitted to the FDA in the second half of 2013 in order to conduct a phase I clinical trial,” Murray said during the call.

On the financial front, Murray noted that Tekmira is poised to receive two $5 million milestones related to a licensing arrangement with Alnylam Pharmaceuticals.

The first will be triggered by the initiation of phase III testing of Alnylam’s intravenous TR-mediated amyloidosis treatment ALN-TTR02, which uses Tekmira’s lipid nanoparticles. Alnylam has said that it anticipates beginning the pivotal study before year-end.

The delivery technology is also employed by Alnylam’s liver cancer drug ALN-VSP, and Tekmira said it will receive the other milestone payment once China’s Ascletis, which holds the Asian rights to the drug, begins human testing.

Tekmira CFO Ian Mortimer noted during the call that the company is currently engaged in technology transfer that will enable Ascletis to manufacture the drug for phase I trials.

“Once that work is complete, that will trigger the second $5 million milestone,” he said during the conference call.

Full Year Financials

For the 12-month period ended Dec. 31, Tekmira reported a net profit of $29.8 million, versus a year-ago loss of $9.9 million — a change the company attributed to its $65 million payout from Alnylam to end a longstanding legal battle between the companies over rights to the lipid nanoparticle technology (GSN 11/15/2012).

Revenues for the year were $14.1 million, down from $16.6 million in 2011, while research and development spending slipped to $18 million from $19.9 million.

General and administrative costs rose in 2012 to $8.1 million from $6.3 million in 2011, primarily as a result of the Alnylam litigation.

At the end of 2012, Tekmira had cash and cash equivalents totaling $46.8 million, which, along with expected income, should fund its operations into 2015.

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