In last few trading sessions, the stock of Galena Biopharma Inc (NASDAQ:GALE) has failed to impress shareholders. The stock has declined to $0.273 all the way from over $0.290.
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Recently the company presented interim safety report from its NeuVax™ (nelipepimut-S) Phase IIb combination trial with trastuzumab at the ESMO 2016 Congress in Denmark. The clinical study is a randomized, investigator-sponsored, multicenter, 300 patient Phase IIb trial. It for now is registering HER2 1+ and 2+ node positive, and also high-risk node negative subjects to study NeuVax medication in combination with trastuzumab.
The management view
Bijan Nejadnik, M.D., the Chief Medical Officer of Galena, said that this pre-specified, interim safety report is crucial to this trial. It will confirm that the medication of NeuVax in combination with trastuzumab gives positive results. It should be well-tolerated in patients, and should not increase the cardio-toxicity impacts known to be linked with trastuzumab.
There is a growing consensus in the industry that combination therapies may result in the greatest clinical benefit. This Phase 2b study remains ongoing with registration anticipated to complete by the year’s end. As a result, the company expect to release first interim immunologic and efficacy and data after 12 months of continuation, currently anticipated at the end of 2017. Nejadnik added that they were grateful to Dr. George Peoples and team who continue this revolutionary work.
The trial
Disease-free, HLA-A2+, A24+, A3+, or A26+, HER2 LE ‘breast cancer’ subjects at increased risk for reappearance were registered after standard care regimen and randomized to vaccine group obtaining NeuVax and trastuzumab or control group administered with GM-CSF and trastuzumab only. Trastuzumab regimen was 8mg/kg loading, after that 6mg/kg for every 3 weeks. Enrollments were given six total inoculations of GM-CSF or NeuVax, one every three weeks beginning with the third trastuzumab infusion, and then four booster inoculations given every 6 months. Safety and demographic report was assessed and collected with appropriate statistical tests.
In 2Q2016, net income was $5.4 million against net loss of $15.7 million for the comparable quarter of 2015. Net loss for 1H2016 was $11.1 million compared to $26.2 million in the comparable period of 2015.
