Celsion Corporation (NASDAQ:CLSN) investors have a smile on their faces Thursday morning, after the tiny drug maker won FDA clearance for OVATION II Study, the Company’s planned Phase I/II clinical trial of GEN-1, its DNA-based immunotherapy for the localized treatment of ovarian cancer.
Celsion shares reacted to the news, skyrocketing nearly 19% in pre-market trading Thursday.
Celsion’s Chief Medical Officer Dr. Nicholas Borys commented, “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 onetime dose escalation may prove to be even more impressive,” stated Dr. Nicholas Borys, Celsion’s senior vice president and chief medical officer […] 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.”
Celsion CEO Michael H. Tardugno added, “GEN-1 holds the potential for tremendous promise as a cancer treatment in the rapidly emerging area of immunotherapy. This new trial will evaluate GEN-1’s value as an adjuvant to current standard of care in newly diagnosed Stage III/IV ovarian cancer patients with a relatively healthy immune system. We look forward to initiating the study in the first half of 2018 […] Designed in consultation with leading medical experts, this Phase I/II trial is expected to define an optimal dose, demonstrate GEN-1’s clinical benefit when compared with current standard of care, and provide insights on powering for a registration program as the candidate progresses through development.”
The Company expects to initiate enrollment of the Phase I portion of the OVATION II Study in the first half of 2018. The Company expects to have 25% of the study enrolled by the end of 2018. Due to the open label design, clinical data will be disclosed throughout the execution of the trial as it is released by the study’s investigators.
On the ratings front, Celsion has been the subject of a number of recent research reports. In a report issued on November 20, Oppenheimer analyst Hartaj Singh initiated coverage with a Buy rating on CLSN and a price target of $9.00, which implies an upside of 231% from current levels. On October 4, Maxim Group’s Jason McCarthy upgraded the stock to Buy and has a price target of $7.00.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Hartaj Singh and Jason McCarthy have a yearly average return of 25.8% and 0.2% respectively. Singh has a success rate of 61% and is ranked #252 out of 4750 analysts, while McCarthy has a success rate of 38% and is ranked #3083.
Celsion is an oncology drug development company. It focuses on developing a portfolio of innovative cancer treatments, including directed chemotherapies, DNA-mediated immunotherapy and RNA- based therapies. The company’s products include ThermoDox and GEN-1.