Galena Biopharma Inc (NASDAQ:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, 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 NeuVaxTreatment) clinical trial. NeuVax™ is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting.
As anticipated, Galena over-enrolled the trial by 7.7% with a total of 758 patients now in the intent-to-treat (ITT) population. The protocol for the PRESENT trial, being conducted under an FDA approved Special Protocol Assessment (SPA), called for 700 patients; and, the Company expects this higher number of ITT patients will increase the confidence in both the timing and quality of the statistics and the final outcome of the trial. The primary endpoint is currently expected to be reached in 2018, after the last patient dosed reaches her 36th month of treatment, or a total of 141 events (recurrence or death) occur, whichever comes later.
“Completion of enrollment in our Phase 3 PRESENT trial is a landmark event for Galena and for breast cancer patients worldwide,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. “As we look forward to reaching our interim analysis by the end of this year or in Q1, 2016, it is important to note the significant medical need that Galena aims to address with NeuVax. Despite advances in the diagnosis and treatment of breast cancer, approximately 25% of node positive patients have a recurrence within three years after achieving no evidence of disease. NeuVax is designed to prevent these often fatal recurrences, and we anticipate that data from the PRESENT study, as well as our ongoing combination studies of NeuVax in breast cancer, will demonstrate this capability.”
“The women in the PRESENT trial are part of the approximately fifty percent of breast cancer patients who have tumors that are HER2 1+ or 2+, and currently have no available treatment options to maintain their disease-free status after their standard of care therapy. Based on our early work with NeuVax, we believe this agent can have a meaningful impact for these women. I am grateful to the hundreds of women who participated in this study and for all of the sites and investigators who devoted their time to help us accomplish this milestone,” added Elizabeth A. Mittendorf, M.D., Ph.D., Associate Professor, Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center and the Principal Investigator of the PRESENT trial.
PRESENT is a randomized, double blind, placebo controlled, international, Phase 3 trial and is the most advanced study in Galena’s pipeline. The trial is being run in 13 countries at more than 140 sites. The PRESENT trial targets the approximately 50%-60% of women with breast cancer who have low to intermediate (immunohistochemistry [IHC] 1+/2+ or fluorescence in situ hybridization [FISH] < 2.0) HER2 expression and achieved no evidence of disease following current standard of care treatment (surgery, chemotherapy, and radiation therapy). Patients enrolled must be lymph node positive, haplotype (HLA) A2 or A3 positive, and have Stage IIa-IIIa breast cancer. Once patients completed their current standard of care treatment, they are administered an injection once a month for six months (Primary Vaccine Series), then receive five booster injections once every six months for a total of eleven injections over a three year period. Currently there are no other treatment options for these patients to maintain their disease-free status. (Original Source)
Shares of Galena closed yesterday at $1.38 . GALE has a 1-year high of $3.58 and a 1-year low of $1.30. The stock’s 50-day moving average is $1.58 and it’s 200-day moving average is $1.72.
On the ratings front, Galena has been the subject of a number of recent research reports. In a report issued on March 30, Maxim Group analyst Jason Kolbert maintained a Buy rating on GALE, with a price target of $7, which represents a potential upside of 407.2% from where the stock is currently trading. Separately, on March 26, MLV & Co.’s Vernon Bernardino reiterated a Buy rating on the stock and has a price target of $5.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Vernon Bernardino have a total average return of 11.7% and -9.8% respectively. Kolbert has a success rate of 48.8% and is ranked #233 out of 3574 analysts, while Bernardino has a success rate of 35.3% and is ranked #3494.
In total, one research analyst has rated the stock with a Sell rating, 5 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $1.38 which is 274.6% above where the stock closed yesterday.
Galena Biopharma Inc, is abiopharmaceutical company focused on developing and commercializing targeted oncology therapeutics that address medical needs across the full spectrum of cancer care.