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Tekmira May Name Third Drug Target, Aims to Release Data from Cholesterol Trial in 2010

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By Doug Macron

Tekmira Pharmaceuticals’ top official last week said that the company is actively working on selecting a target for its third drug candidate, but noted that it may not choose one until early next year.

“We are continuing to work on selecting our next … product candidate for development,” Tekmira President and CEO Mark Murray said during a conference call held to discuss the company’s third-quarter financial results. “This year, we’ve evaluated a number of oncology, metabolic, and infectious disease targets and have some exciting candidates in each of these areas.”

And while he had previously speculated that selection of a new target might occur in 2009, he noted during the call that the company remains focused on choosing “the right one [and that] … it may well be early next year before we decide which it is.”

Meanwhile, a phase I trial of the company’s first clinical candidate, the hypercholesterolemia treatment ApoB SNALP, is proceeding “as expected, and patient enrollment is on schedule,” Murray said. As such, “we are track to release data [from that study] in the first quarter of 2010.”

ApoB SNALP, an siRNA formulated with Tekmira’s stable nucleic acid-lipid particle technology, is designed to inhibit apolipoprotein B. In July, Tekmira announced it had begun a trial examining a single dose of the drug in about 30 patients with elevated low-density lipoprotein cholesterol (see RNAi News, 7/9/2009).

Each cohort will include four patients, three of whom will receive the drug and one of whom will receive a placebo.

”As with all phase I trials, the primary endpoints are safety and tolerability of the drug,” Murray said last week. “But we are also measuring LDL cholesterol in the subjects in this trial, so we may see early hints of biological activity indicative of efficacy.”

Study participants whose LDL cholesterol is reduced following treatment by 15 percent or more will be followed until their LDL cholesterol levels return to baseline, he noted. “This is very important pharmacodynamic data that will allow us to appropriately design subsequent clinical trials for ApoB SNALP, including a phase II repeat-dose efficacy trial.”

Murray also said that Tekmira is on track to file an IND for its second drug candidate, the cancer therapy PLK SNALP, before the middle of 2010, with a phase I trial beginning in the second half of that year.

Tekmira had previously expected to begin phase I testing of PLK SNALP, which is designed to silence the tumor-associated gene polo-like kinase 1, in 2009. But in March, the company said it had pushed this timeline back until 2010 in order to incorporate improvements in its drug-delivery technology into the drug (see RNAi News, 3/26/2009).

Third Quarter

In the third quarter, Tekmira’s net loss dropped to C$7.2 million ($6.9 million), or C$0.14 per share, from C$11.3 million, or C$0.26 per share, in the year-ago quarter. The company noted that its 2008 results included non-recurring costs associated with its merger with Protiva Biotherapeutics (see RNAi News, 6/5/2008).

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Revenues in the quarter, derived from research and development collaborations, licensing fees, and milestones, slipped to C$3.3 million from C$4.2 million, reflecting the amortization of up-front payments from partner Alnylam Pharmaceuticals into revenue at the end of 2008, Tekmira said. The only 2009 receipt from Alnylam has been a milestone payment of C$600,000.

Third-quarter R&D spending decreased to C$4.4 million from C$5.4 million in the year-ago quarter, which included non-recurring compensation-related charges. General and administrative costs in the quarter, meanwhile, dropped to C$900,000 from C$1.1 million.

As of Sept. 30, Tekmira had cash, cash equivalents, and short-term investments totaling C$26.9 million.

“At the start of 2009, we had estimated that our funds on hand, plus expected revenue, would be sufficient to continue our product development until the second half of 2010,” Tekmira CFO Ian Mortimer said during last week’s call. “We now expect our cash runway to extend until the second half of 2011.

“As in previous quarters, if we are able to generate partner revenue greater than what is contractually committed, we may be able to extend our cash even further,” he added.

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