Why Galena Biopharma Inc. Shares Spiked Higher

Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.

What: Shares of Galena Biopharma (NASDAQ: GALE  ) , a biopharmaceutical company focused on developing immunotherapeutic treatments for cancer, advanced as much as 10% earlier this morning after announcing the completion of enrollment in its Phase 2a study involving GALE-301 for ovarian and endometrial cancers.

So what: According to the press release, its phase 2a study, consisting of 45 total patients, will be an open label trial consisting of two arms of HLA-A2-positive patients and a control arm of HLA-A2-negative patients. GALE-301 will be administered in a series of six vaccinations given once per month, with patients receiving a booster inoculation at two subsequent six-month intervals. Galena anticipates a data readout from this study in about a year's time with its primary purpose being to measure immune response, time to cancer recurrence, and overall survival between treatment arms. In its phase 1 study of GALE-301, seven of 14 patients in the control arm had their cancer return, while four patients who completed the series had their cancer recur in the GALE-301 arm, as well as two during treatment. One patient was unable to complete the treatment course and dropped out. None of the patients receiving the 1,000 mg dose being tested in its phase 2a study have had a cancer recurrence.

Now what: Today's move is all about the excitement of a catalyst. Galena does have six separate clinical studies ongoing, but the wait between enrollment and data can take years, as in the case of its lead breast cancer adjuvant NeuVax. Simply getting an update from the company that's it's advancing another one of its clinical products into the next stage of development is enough to stir the pot and cause some of Galena's 26 million short-sellers to flee. Of course, the primary focus here should remain on NeuVax. In its final phase 2 study results at 60 months the company noted a 78% clinical reduction benefit in breast cancer recurrence for HER2-negative breast cancer patients that were treated with NeuVax as an adjuvant therapy. The allure of success is there, unfortunately small-cap oncology-focused biopharmaceuticals have had very poor luck in the past when trying to get a cancer drug approved by the Food and Drug Administration; so keep that in mind!

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  • Report this Comment On August 07, 2014, at 4:17 PM, Paulson545 wrote:

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