Galena Biopharma Inc (NASDAQ:GALE) finishes Over-Enrollment of NeuVax Phase 3 PRESENT Clinical Trial Print E-mail
By William Kent   
Tuesday, 14 April 2015 15:12

Pharmaceutical firm, Galena Biopharma Inc. (NASDAQ:GALE), has confirmed finishing of enrollment in NeuVax  Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical trial.

 

NeuVax is a HER2-directed cancer immunotherapy that is currently being evaluated for prevention of recurrence of breast cancer after standard care treatment.

Galena had over-enrollment for trial by 7.7% with total of 758 patients in intent-to-treat population.

The firm which develops and commercialises targeted oncology therapeutics is looking to address a large number of medical needs across complete spectrum of cancer care.

The firm is expecting the number of ITT Patients to rise after the final outcome of the trial. The first endpoint may be there by 2018 post the last patient dose in the 36th month.

Mark W. Schwartz, Ph.D., President and Chief Executive Officer, stated that the completion of enrolment in Phase 3 PRESENT trial is a momentous event for the firm as well as for breast cancer patients worldwide.

He added that 25% of node positive patients have recurrence of breast cancer within three years and NeuVax is made for preventing the fatal recurrences.

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, opined that the women in the current trial have no treatment options for maintaining disease-free status post the standard of care therapy. 

She added that the drug can have an amazing impact on women. PRESENT is a randomized, double blind, placebo controlled, international, Phase 3 trial and is advanced study in Galena's pipeline. The trial is being done in over 13 countries.

The PRESENT trial aims at about 50%-60% of women with breast cancer having low to intermediate HER2 expression.  Patients are administered an injection once a month for six months after standard care whereas they get five booster injections once every six months for total of eleven injections over three years.

Shares of the company were up over 5% to $1.45.




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