+Celsion Corporation (NASDAQ: CLSN) is having an overwhelmingly strong start to the trading session in the pre-market hours this morning, and for good reason. The company announced FDA news that proved to be a source of excitement among investors. Today, we’ll talk about the news, what we’re seeing from the stock, and what we’ll be watching for with regard to CLSN ahead.
CLSN Announces FDA News
As mentioned above, Celsion Corporation is having an overwhelmingly strong start to the trading session in the pre-market hours this morning after releasing news it received from the FDA. According to an early-morning press release, the United States Food and Drug Administration has accepted the company’s submission with regard to a key clinical study. As a result, the FDA has provided clearance for CLSN to move forward with the OVATION II Study, a planned Phase I/II clinical trial of GEN-1, DNA-based immunotherapy for the localized treatment of ovarian cancer.
In the press release, CLSN said that the next Phase I/II clinical study is designed with a single dose escalation phase to 100 mg/m2 to identify a safe and tolerable dose while maximizing immune response. This will be followed up by a continuation at the selected dose in Phase II as part of an open label, 1:1 randomized design with up to 90 patients that are dealing with stage III/IV ovarian cancer in the United States.
The ultimate goal of the clinical trial, or primary endpoint if you will, is a 33% improvement in progression-free survival when comparing GEN-1 with neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone. In a statement, Dr. Nicholas Borys, Senior Vice President and Chief Medical Officer at CLSN, had the following to offer with regard to the news:
“In previous clinical studies performed to date, GEN-1 has demonstrated excellent safety and impressive clinical activity supported with dose dependent, pro-immune improvement in the tumor micro environment. A one time dose escalation may prove to be even more impressive… As we continue to follow patients, the latest PFS analysis from the OVATION Study is showing a median of at least 15.4 months in the as-treated group which compares favorably to a historical control of 12 months. OUr highest dose cohort has not demonstrated any progressions at our current 14 month follow up. This same cohort also had a 100% R0 surgical resection rate. One of our patients in the OVATION Study even had a complete pathological response.”
What We’re Seeing From The Stock
As investors, one of the first things that we learn is that the news moves the market. When it comes to biotechnology companies, there are few bits of news that can lead to movement like FDA news. So, with the overwhelmingly positive news, it only makes sense that we’re seeing strong gains in the value of the stock. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:14), CLSN is trading at $3.16 per share after a gain of $0.44 per share (16.18%) thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on CLSN. In particular, we’re interested in following the coming clinical trial as well as the ongoing PFS results from the OVATION trial. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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