July 12, 2017
By Mark Terry, BioSpace.com Breaking News Staff
In March, San Ramon, Calif.-based Galena Biopharma announced it had hired Canaccord Genuity to help it develop a plan to sell the company or its assets. Today, the company released an update on its financial situation and the status of its most advanced clinical development program.
The company said that it had “significantly reduced the staffing levels and certain operational expenses to preserve cash.”
In late January, the company’s chief executive officer, Mark Schwartz, stepped down over a civil and criminal investigation into the company’s marketing of Abstral (fentanyl). The company was under investigation by the U.S. Department of Justice, looking into several employees, as well as two high-prescribing physicians, over a rebate arrangement between the company and the two doctors.
The company’s interim chief executive officer and chief financial officer, Stephen Ghiglieri, said in a statement, “Given the challenges that Galena has faced, we are diligently addressing all aspects of our business and proactively removing potential impediments to executing a transaction. Reducing our expenses and simplifying our capital structure is paramount for us as we work to successfully complete the strategic alternative process.”
In terms of its two core clinical programs, Galena reports that its NeuVax (Nelipepimut-S) is in an almost fully enrolled Phase IIb clinical trial for node positive and triple negative HER2 IHC 1+/2+ patients in combination with trastuzumab (Herceptin). There are currently 293 patients enrolled out of a planned 300. It expects full enrollment over the next few weeks. An interim analysis is expected six months after that by the Data Safety Monitoring Board.
Galena also has a Phase II trial for high-risk node positive or negative HER2 IHC 3+ patients, and a Phase II trial is screening patients for NeuVax in patients with ductal carcinoma in situ (DCIS). A Phase II trial of the drug in patients with gastric cancer is also being planned.
Although an update wasn’t provided, Galena also has GALE-401 in a Phase III-ready program for essential thrombocythemia.
The NewVax Phase III trial was problematic. The drug didn’t perform as well as placebo, causing independent data monitors to recommend halting the trial, which was officially closed on August 10, 2016. George Peoples, the San Antonio-based scientist who developed NeuVax, told Xconomy in March, “Although the Phase III PRESENT trial of the HER2 vaccine was terminated early, after unblinding the data, it appears that the trial failed due to a design flaw in the study and not due to lack of activity of the vaccine.”
Ghiglieri also discussed a potential sale, saying in a statement, “Thus far, we have had initial interest in potential transactions from a number of companies. Though this process is still evolving, we are committed to updating the market as key events unfold. My goal is to find the best available option, or options, for the Company and our assets to bring value to our shareholders. We appreciate the patience and continued support from our shareholders during this period.”
Galena are currently trading for $0.56.
