UPDATE 2-OncoGenex gets new fast-track status for cancer drug

* Gets additional fast-track status for OGX-011

* Says fast-track status based on mid-stage study data

* Analysts see partnership deal by year-end

* Shares up as much as 8 pct (Adds analysts' comment; updates share movement)

By Anand Basu

BANGALORE, Oct 6 (Reuters) - OncoGenex Pharmaceuticals Inc (OGXI.O) said U.S. health regulators granted an additional fast-track designation to its prostate cancer drug, OGX-011, in combination with first-line chemotherapy, sending its shares up about 8 percent.

The company had already received a fast-track status for second-line treatment with OGX-011 in combination with chemotherapy drug, docetaxel, for progressive metastatic prostate cancer following docetaxel.

Fast-track designation is designed to expedite the review of drugs to treat serious diseases and fill unmet medical needs. Usually, most drugs that are eligible for the designation are likely to receive a priority review.

With priority review status the U.S. Food & Drug Administration makes its decision on whether to approve a drug within six months, rather than the usual 10 to 12-month review period.

"There is positive bias towards timeline to approval if the company generates sufficient positive late-stage data to justify submitting their new drug application in the first place," Versant Partners analyst Douglas Loe said.

"But it implies nothing on the FDA's view on how well the drug will perform in pivotal clinical trials," he added.

The fast-track designation was based on data from a mid-stage study that suggested that the drug in combination with first-line docetaxel treatment may improve survival in patients with castrate-resistant prostate cancer.

In June, OncoGenex reached an agreement with the U.S. Food and Drug Administration, through the special protocol assessment process, to amend the design of a late-stage trial of the drug. [ID:nBNG481391]

PARTNERSHIP DISCUSSIONS

OncoGenex had said in May that it was seeking a partner to develop OGX-011, which is also being studied in lung and breast cancer.

"I think they are in the process of negotiating with a number of parties. We do expect a deal by the end of the year," Wedbush Morgan Securities analyst Gregory Wade said.

Agreeing with Wade, Versant's Loe said, "The fast track designation is one more positive factor in OncoGenex's favour for timely consummation of a co-development partnership on this drug."

Shares of the company, which went public last year through a reverse merger with Sonus Pharmaceuticals Inc, were up $1.90 at $36.64 in morning trade Tuesday on Nasdaq.

For the alerts double-click [ID:nWNAB6390] . (Editing by Aradhana Aravindan)