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Over-Enrollment in Galena's (GALE) Phase III PRESENT Should Strengthen Validity of Results - Roth Capital

April 14, 2015 11:05 AM EDT
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Price: $0.21 --0%

Rating Summary:
    6 Buy, 4 Hold, 0 Sell

Rating Trend: = Flat

Today's Overall Ratings:
    Up: 13 | Down: 10 | New: 10
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Roth Capital affirms Galena Biophama (Nasdaq: GALE) at Buy with a price target of $8 after the company announced the completion of enrollment in the NeuVax (nelipepimut-S) Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical trial.

Analyst Joseph Pantginis commented, We believe the over-enrollment should help strengthen the validity of prior findings once data are unveiled. As we've mentioned in previous notes, we are optimistic regarding NeuVax's potential efficacy in HER2 1+/2+ breast cancer. We believe that NeuVax can bring about a robust immune response given the high incidence of HER2-specific T cells recruited by the vaccine, amounting to 2 percent of the T-cell compartment. This high level of recruitment is encouraging given that the aim in this study is to prevent (or delay) recurrence of the disease by eliminating micro-metastases that are the source of disease recurrence.

As this study now goes into "quiet mode" until the interim analysis, we focus on other 2015 catalysts for Galena: 1) launch of Zuplenz in 2Q15, 2) PRESENT interim safety/futility analysis in 4Q15/1Q16, 3) topline data from PhIIa of '301 in ovarian and endometrial carcinomas in mid 2015 and final data in 4Q15/1Q16, 4) topline data from PhII of '401 in thrombocythemia, secondary to myeloproliferative neoplasms in mid-2015 and final data in 4Q15/1Q16, 5) complete enrollment in PhII study of NeuVax+Herceptin in HER2 1+/2+ breast cancer in 4Q15/1Q16, 6) initiation of the Indian gastric cancer study of NeuVax by partner Dr. Reddy's laboratories (RDY-NC) in 2016.

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



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