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Prohost Biotech - Thursday, June 12, 2014

We Mean: If Galena’s Therapeutic Cancer Vaccine Demonstrates It Can Save Thousands Of Lives, Would You Still Buy GALE While Galena Is Being Investigated By The SEC?

First: The Story Of The SEC Investigation

If you read all the versions posted on the Internet about this subject you will find the same limited information as that announced by Reuters on March 18, 2014. Reuters’ press release informed that Galena Biopharma  (GALE) fell as much as 21 percent after the company announced the SEC was investigating its dealings with an external investor-relations firm. Reuters story informed that Galena said in a regulatory filing that it has learned about the SEC probe in February. The company did not give any further details, but analysts said it was related to the hiring of investor-relations firm DreamTeamGroup in 2013.

According to Reuters, Adam Feuerstein, a columnist at The, alleged in February that several positive articles on Galena written by supposedly independent bloggers on Seeking Alpha had identical paragraphs stating that mid-stage trial results for Galena's experimental breast cancer vaccine Neuvax were well-received by analysts.

Reuters’ press release announced that an investor named Richard Pearson alleged in a blog posted on Seeking Alpha that he had been approached by DreamTeamGroup to write paid promotional pieces on Galena.

Galena issued a letter to shareholders accusing Feuerstein of having "an agenda" but acknowledged that it had previously engaged DreamTeamGroup. Galena said it had been in contact with the SEC staff and was cooperating with the investigation. The company also said that some shareholders had filed lawsuits alleging that its executives made false statements and questioning share sales by insiders.


NeuVax™ Therapeutic Cancer Vaccine Vs. The SEC Investigation

The investigation seems to be still ongoing in secrecy, as no news has surfaced anywhere about its details, which renders irrelevant accusing the firm of committing a crime. The same is said about the company’s innocence.

The question to be raised however is: Why attributing the stock rallying to the couple of articles stating that analysts are happy with the company’s therapeutic cancer vaccine and not to the good news announced by the firm? The good news is about the firm’s therapeutic cancer vaccine Neuvax (nelipepimut-S), its Therapeutic cancer vaccine, GALE-301 for ovarian and endometrial cancer and its drug GALE-401 (Anagrelide CR) for Essential Thrombocythemia (ET).  

Good news has been announced about Neuvax in each and every phase clinical trials. The vaccine has shown success in stimulating specific CD8+ cytotoxic T lymphocytes (CTLs). The activated specific CTLs recognize, neutralize and destroy HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci.  

Phase 2 trial results of the therapeutic vaccine are dubbed successful, as the vaccine achieved its primary endpoint of disease-free survival (DFS). Additionally the FDA granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT ongoing randomized.

It just does not make sense that having such promising news, Galena would still need a couple of amateurs bloggers to post articles stating that analysts liked the news. It is important to observe that none of the articles written by the firm's critics that keep reminding investors about the SEC investigation has dared doubting the good results of Neuvax published by Galena.   

On Tuesday, the Science Section of The New York Times published an article titled “Outsmarting Breast Cancer” written by Jane E. Brody. In this article, the author wrote: 

Knowing that the effectiveness of treatment is reduced once cancer has metastasized — that is, spread to other regions of the body — researchers are now testing creative ways to prevent such recurrences. One, a specially designed vaccine called NeuVax, is in the final stage of multinational clinical tests under the direction of Dr. Elizabeth A. Mittendorf, a surgical oncologist at M.D. Anderson.

The vaccine is made from a peptide, a small piece of a cancer protein, that is combined with an immune stimulant. Early results suggest that the vaccine can reduce the risk of recurrence by 50 percent among breast cancer patients whose tumors produce low levels of the protein HER2, a marker for more aggressive breast cancer.

Without the vaccine, such patients have a 20 percent chance of a recurrence, Dr. Mittendorf said. Rather than waiting to see if a patient’s cancer comes back, the vaccine is given at the time of initial treatment, when few if any cancer cells are present, she explained.”

Following the article’s publication, Galena’ stock managed to post modest gains. The stock didn’t stage a rally that's usually expected after such an article in The New York Time.  It was obvious that Gale is still under the constantly reminded pressure of the SEC investigation.

Some relevant questions to ask could be:

Is Roche conducting clinical trials with a combination of its blockbuster drug Herceptin with Galena’s vaccine Neuvax just for the sake of pleasing Galena?

Did the FDA grant NeuVax a Special Protocol Assessment (SPA) for Phase 3 PRESENT to mislead us?

Are we missing betting on a possible breakthrough vaccine that, according to the article’s statistics, would save the lives of thousands of HER2 breast cancer patients?

Will you bet on Neuvax if you feel it has good chance to become a successful life-saving vaccine even if the firm is under the SEC investigation for the reasons cited in the beginning of this article?

Are we living in a real World?   

FORWARD-LOOKING: Material presented here is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. Further, these are our 'opinions' and we may be wrong. We may have positions in securities mentioned in this article. You should take this into consideration before acting on any advice given in this article. If this makes you uncomfortable, then do not listen to our thoughts and opinions. The contents of this article do not take into consideration your individual investment objectives so consult with your own financial adviser before making an investment decision. Investing includes certain risks including loss of principal.

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