Roth Still Positive on Galena Biopharma (GALE) Following GALE-301 FBP Presentation; Issues Commentary

Roth Capital keeps Galena Biopharma (Nasdaq: GALE) at Buy with a price target of $7 following a recent presentation of GALE-301 Folate Binding Protein (FBP) vaccine data.

Ahead of the bell Monday, Galena said, Overall, 30 patients were enrolled in the Phase 1 trial. Of 14 control patients, 7 (50%) have recurred. Of 16 vaccinated patients, 4 (25%) have recurred after completing the primary vaccine series (PVS), 2 (12.5%) recurred prior to completing the PVS, and one patient withdrew. Of note, no recurrences have been seen in the optimal dose cohort of 1000 mcg E39. The vR patients displayed lower mean delayed type hypersensitivity (DTH) reactions as well as lower local reactions at every measured time point ... In the Phase 1 study, HLA-A2 positive patients were enrolled into the vaccine group and received intradermal inoculations of E39 + 250 mcg GM-CSF once a month for six months (the PVS) following assignment into a dose cohort: 100mcg, 500mcg, or 1000mcg of E39. In vivo IR was assessed by both local reaction (LR) after each inoculation and DTH reaction measured pre-vaccination and post-PVS (DTH2).

Roth analyst Joseph Pantginis said, We believe the results of the FBP study will help to elucidate the relevant patient population for further studies. Of the 30 enrolled patients, 50% (7) of the 14 control patients have recurred, whereas 25% (4) of the 16 vaccinated patients have recurred after completing PVS, and 12.5% (2) vaccinated patients have occurred prior to completing PVS. Differences between vR and vNR included vR demonstrating lower mean DTH1, DHT2, and LH index, all of which measure response to the vaccine. The study suggests that recurrence is related to trends in disease features and a diminished response to the vaccine. This is notable because it suggests that it may be beneficial to take the vaccine into less aggressive disease. Recall that the ongoing Phase IIa trial is aimed at addressing increasing the peptide dose to alleviate diminished vaccine response and to also evaluate the effect of a booster series.We are also encouraged to see that no patients in the Phase I have relapsed at the 1000 mg dose which is the optimal dose for the Phase II.

Bottom line: We continue to believe the company's fundamental thesis remains strong ,driven by a growing revenue stream from Abstral, a late stage development pipeline and promising earlier stage candidates.

For an analyst ratings summary and ratings history on Galena Biopharma click here. For more ratings news on Galena Biopharma click here.

Galena Biopharma closed at $2.30 yesterday.

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